PB 26 of 2015
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2015
(No. 3)
National Health Act 1953
I, FELICITY McNEILL, First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.
Dated 23 March 2015
 
 
 
 
 
 
 
 
 
 
 
FELICITY McNEILL
First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health
 
1          Name of Instrument
            (1)        This Instrument is the National Health (Listing of Pharmaceutical                            Benefits) Amendment Instrument 2015 (No. 3).
            (2)        This Instrument may also be cited as PB 26 of 2015.
2          Commencement
This Instrument commences on 1 April 2015.
3          Amendment of National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)
            Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).
 
Schedule 1     Amendments
[1]           Section 4
insert after the definition of “electronic communication”:
electronic prescription has the meaning given by the Regulations;
[2]           Section 4
insert after the definition of “palliative care patient”:
paper-based prescription has the meaning given by the Regulations;
[3]           Section 4
insert after the definition of “Regulations”:
residential care service has the meaning given by the Regulations;
[4]           After subsection 11(2)
            insert:
             (3)  In all circumstances mentioned in Part 1 of Schedule 4 for a circumstances code mentioned in Schedule 1 for the pharmaceutical benefit, except those which include a Streamlined Authority Code, a medication chart prescription for a person receiving treatment in a residential care service may not be authorised under the authority required procedures in sections 11 to 15.
[5]           Subsection 12(1)
            substitute:
             (1)  A prescription is submitted in accordance with this subsection if:
                     (a)  the authorised prescriber submits to the Chief Executive Medicare:
                              (i)  the prescription itself; or
                             (ii)  for a medication chart prescription that is not an electronic prescription — the medication chart by which the prescription was written, or a copy of so much of that chart as would indicate that subregulation 19AA(2) of the Regulations has been complied with; or
                     (b)  the authorised prescriber submits details of the prescription by telephone to the Chief Executive Medicare; or
                     (c)  the authorised prescriber submits the prescription in accordance with the instructions in an emergency telephone message provided to the authorised prescriber by the Chief Executive Medicare; or
                     (d)  the authorised prescriber submits details of the prescription to the Chief Executive Medicare, by means of electronic communication of a kind approved in writing by the Chief Executive Medicare.
 
[6]           Subsection 13(1)
            substitute:
             (1)  A paper-based prescription (other than a prescription submitted in accordance with paragraph 12(1)(b), (c) or (d)) may be authorised by the Chief Executive Medicare signing his or her authorisation on the prescription, and:
                     (a)  if the Chief Executive Medicare requires the authorised prescriber to alter the prescription — returning it to the authorised prescriber for alteration before the authorised prescriber gives it to the person in respect of whom it was prepared; or
                     (b)  by returning it to the authorised prescriber; or
                     (c)  if requested by the authorised prescriber — sending it to the person in respect of whom it was prepared.
[7]           After subsection 13(1)
            insert:
          (1A)  A medication chart prescription (other than an electronic prescription, or a prescription submitted in accordance with paragraphs 12(1)(b), (c) or (d)) may be authorised by the Chief Executive Medicare signing his or her authorisation on the medication chart prescription, or a copy of the medication chart prescription, and:
                     (a)  if the Chief Executive Medicare requires the authorised prescriber to alter the prescription— indicating this on the medication chart prescription or copy; and
                     (b)  returning the medication chart or copy to the authorised prescriber for alteration.
          (1B) An electronic prescription (other than a prescription submitted in accordance with paragraphs 12(1)(b), (c) or (d)) may be authorised by the Chief Executive Medicare writing his or her authorisation on the electronic prescription, and:
                     (a)  if the Chief Executive Medicare requires the authorised prescriber to alter the prescription— by returning it, including by means of an electronic communication, to the authorised prescriber for alteration; or
                     (b)  by returning it, including by means of electronic communication to the authorised prescriber; or
                     (c)  if requested by the authorised prescriber — sending it to the person in respect of whom it was prepared.
[8]           Paragraph 13(4)(a)
            omit:       given by the CEO to the prescription
                substitute:             that has been allotted to the authorised prescription
[9]           Subparagraph 13(4)(b)(ii)
insert after “copy of the prescription”:           showing the number marked in accordance with subparagraph (i)
[10]         Subsection 14(2)
            omit:       authorised prescriber has:
                substitute:             authorised prescriber has written the Streamlined Authority Code on the prescription.
[11]         Omit paragraphs 14(2)(a) and 14(2)(b)
[12]         Schedule 1, entry for Adalimumab in all forms 
omit from the column headed “Authorised Prescriber” (wherever occurring):     See Note 1
[13]         Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 2]
(a)      omit from the column headed “Circumstances”:               C3486   
(b)      omit from the column headed “Circumstances”:               C3749  C3750
(c)      insert in numerical order”:     C4826  C4840  C4845  C4851  C4864
[14]         Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 3]
(a)      omit from the column headed “Circumstances”:               C3486   
(b)      omit from the column headed “Circumstances”:               C3749  C3750
(c)      insert in numerical order”:     C4826  C4840  C4845  C4851  C4864
(d)      omit from the column headed “Purposes”:         P3486  P3749    
(e)      insert in numerical order”:     P4826  P4840  P4851
[15]         Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 4]
(a)      omit from the column headed “Circumstances”:               C3486   
(b)      omit from the column headed “Circumstances”:               C3749  C3750
(c)      insert in numerical order”:     C4826  C4840  C4845  C4851  C4864
[16]         Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled syringe [Maximum Quantity: 2; Number of Repeats: 5]
(a)      omit from the column headed “Circumstances”:               C3486   
(b)      omit from the column headed “Circumstances”:               C3749  C3750
(c)      insert in numerical order”:     C4826  C4840  C4845  C4851  C4864
(d)      omit from the column headed “Purposes”:         P3750   
(e)      insert in numerical order”:     P4845  P4864
[17]         Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 2]
(a)      omit from the column headed “Circumstances”:               C3486   
(b)      omit from the column headed “Circumstances”:               C3749  C3750    
(c)      insert in numerical order”:     C4826  C4840  C4845  C4851  C4864
[18]         Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 3]
(a)      omit from the column headed “Circumstances”:               C3486   
(b)      omit from the column headed “Circumstances”:               C3749  C3750    
(c)      insert in numerical order”:     C4826  C4840  C4845  C4851  C4864
(d)      omit from the column headed “Purposes”:         P3486  P3749    
(e)      insert in numerical order”:     P4826  P4840  P4851
[19]         Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 4]
(a)      omit from the column headed “Circumstances”:               C3486   
(b)      omit from the column headed “Circumstances”:               C3749  C3750    
(c)      insert in numerical order”:     C4826  C4840  C4845  C4851  C4864
[20]         Schedule 1, entry for Adalimumab in the form Injection 40 mg in 0.8 mL pre-filled pen [Maximum Quantity: 2; Number of Repeats: 5]
(a)      omit from the column headed “Circumstances”:               C3486   
(b)      omit from the column headed “Circumstances”:               C3749  C3750    
(c)      insert in numerical order”:     C4826  C4840  C4845  C4851  C4864
(d)      omit from the column headed “Purposes”:         P3750   
(e)      insert in numerical order”:     P4845  P4864
[21]         Schedule 1, after entry for Albendazole in the form Tablet 400 mg
insert:
Alemtuzumab
Solution concentrate for I.V. infusion 12 mg in 1.2 mL
Injection
Lemtrada
GZ
MP
C4829 C4834 C4838 C4850
P4829 P4850
3
0
1
 
D(100)

 
 
 
 
 
MP
C4829 C4834 C4838 C4850
P4834 P4838
5
0
1
 
D(100)

[22]         Schedule 1, entry for Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 70 micrograms colecalciferol
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Alendronate D3 70 mg/70 microgram
UA
MP NP
C4070 C4087 C4110
 
4
5
4
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Alendronate Plus D3 70 mg/70 mcg
TX
MP NP
C4070 C4087 C4110
 
4
5
4
 
 
[23]         Schedule 1, entry for Alendronic acid with colecalciferol in the form Tablet 70 mg (as alendronate sodium) with 140 micrograms colecalciferol
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Alendronate D3 70 mg/140 microgram
UA
MP NP
C4122 C4123 C4133
 
4
5
4
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Alendronate Plus D3 70 mg/140 mcg
TX
MP NP
C4122 C4123 C4133
 
4
5
4
 
 
[24]         Schedule 1, entry for Alendronic acid with colecalciferol and calcium
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Alendronate Plus D3 and Calcium Sandoz
SZ
MP NP
C4122 C4123 C4133
 
1
5
1
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Alendronate Plus D3 Calcium Actavis
UA
MP NP
C4122 C4123 C4133
 
1
5
1
 
 
(c)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
ReddyMax Plus D-Cal
RZ
MP NP
C4122 C4123 C4133
 
1
5
1
 
 
[25]         Schedule 1, entry for Allopurinol in the form Tablet 100 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Allopurinol
TX
MP NP
 
 
200
2
200
 
 
[26]         Schedule 1, entry for Allopurinol in the form Tablet 300 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Allopurinol
TX
MP NP
 
 
60
2
60
 
 
[27]         Schedule 1, entry for Amiodarone in the form Tablet containing amiodarone hydrochloride 200 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Amiodarone Actavis
GN
MP NP
C1350
 
30
5
30
 
 
[28]         Schedule 1, entry for Amitriptyline in the form Tablet containing amitriptyline hydrochloride 10 mg
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Amitriptyline 10
TX
MP NP
 
 
50
2
50
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Chem mart Amitriptyline
CH
MP NP
 
 
50
2
50
 
 
(c)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Terry White Chemists Amitriptyline
TW
MP NP
 
 
50
2
50
 
 
 
[29]         Schedule 1, entry for Amitriptyline in the form Tablet containing amitriptyline hydrochloride 25 mg
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Amitriptyline 25
TX
MP NP
 
 
50
2
50
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Chem mart Amitriptyline
CH
MP NP
 
 
50
2
50
 
 
(c)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Terry White Chemists Amitriptyline
TW
MP NP
 
 
50
2
50
 
 
[30]         Schedule 1, entry for Amitriptyline in the form Tablet containing amitriptyline hydrochloride 50 mg
(a)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Amitriptyline 50
TX
MP NP
 
 
50
2
50
 
 
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Chem mart Amitriptyline
CH
MP NP
 
 
50
2
50
 
 
(c)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Terry White Chemists Amitriptyline
TW
MP NP
 
 
50
2
50
 
 
[31]         Schedule 1, entry for Amlodipine in each of the forms: Tablet 5 mg (as besylate); and Tablet 10 mg (as besylate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Amlodipine AN
EA
MP NP
 
 
30
5
30
 
 
[32]         Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Tablet containing 500 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)
omit from the column headed “Brand” (twice occurring):       Amoxiclav AN 500/125              substitute:             Amoxyclav AN 500/125
[33]         Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Tablet containing 875 mg amoxycillin (as trihydrate) with 125 mg clavulanic acid (as potassium clavulanate)
omit from the column headed “Brand” (twice occurring):       Amoxiclav AN 875/125              substitute:             Amoxyclav AN 875/125
 
[34]         Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Powder for oral suspension containing 125 mg amoxycillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL [Maximum Quantity: 1; Number of Repeats 0] 
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Amoxycillin and Clavulanic Acid 125/31.25
TX
PDP
C1836 C1837
 
1
0
1
 
 
[35]         Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Powder for oral suspension containing 125 mg amoxycillin (as trihydrate) with 31.25 mg clavulanic acid (as potassium clavulanate) per 5 mL, 75 mL [Maximum Quantity: 1; Number of Repeats 1] 
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Amoxycillin and Clavulanic Acid 125/31.25
TX
MP NP
C1836 C1837
 
1
1
1
 
 
[36]         Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Powder for oral suspension containing 400 mg amoxycillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL [Maximum Quantity: 1; Number of Repeats 0] 
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Amoxycillin and Clavulanic Acid 400/57
TX
PDP
C1836 C1837
 
1
0
1
 
 
[37]         Schedule 1, entry for Amoxycillin with Clavulanic Acid in the form Powder for oral suspension containing 400 mg amoxycillin (as trihydrate) with 57 mg clavulanic acid (as potassium clavulanate) per 5 mL, 60 mL [Maximum Quantity: 1; Number of Repeats 1] 
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
APO-Amoxycillin and Clavulanic Acid 400/57
TX
MP NP
C1836 C1837
 
1
1
1
 
 
[38]         Schedule 1, entry for Apomorphine
insert as first item in the columns in the order indicated:
 
Injection containing apomorphine hydrochloride 10 mg in 1 mL
Injection
Apomine
HH
MP
C4833 C4860
 
360
5
5
 
D(100)
[39]         Schedule 1, entry for Apomorphine in the form Injection containing apomorphine hydrochloride 20 mg in 2 mL
(a)      omit from the column headed “Authorised Prescriber”:  See Note 1
(b)      omit from the column headed “Circumstances”:               C1256  C3314    substitute              C4833 C4860
[40]         Schedule 1, entry for Apomorphine in the form Injection containing apomorphine hydrochloride 50 mg in 5 mL
(a)      omit from the column headed “Authorised Prescriber”:  See Note 1
(b)      omit from the column headed “Circumstances”:               C1256  C3314    substitute              C4833 C4860
 
[41]         Schedule 1, entry for Apomorphine in the form Solution for subcutaneous infusion containing apomorphine hydrochloride 50 mg
in 10 mL pre-filled syringe
(a)      omit from the column headed “Authorised Prescriber”:  See Note 1
(b)      omit from the column headed “Circumstances”:               C1256  C3314    substitute              C4833 C4860
[42]         Schedule 1, entry for Atorvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity: 30; Number of Repeats 5] 
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Blooms the Chemist Atorvastatin
IB
MP
C1540 C3047
P1540
30
5
30
 
 

 
 
 
 
 
NP
C1540
 
30
5
30
 
 

[43]         Schedule 1, entry for Atorvastatin in the form Tablet 10 mg (as calcium) [Maximum Quantity: 30; Number of Repeats 11]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Blooms the Chemist Atorvastatin
IB
MP
C1540 C3047
P3047
30
11
30
 
 
[44]         Schedule 1, entry for Baclofen in the form Tablet 25 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Terry White Chemists Baclofen
TW
MP NP
 
 
100
5
100
 
 
[45]         Schedule 1, entry for Captopril in each of the forms: Tablet 12.5 mg; Tablet 25 mg; and Tablet 50 mg
omit:
 
 
 
APO-Captopril
TX
MP NP
 
 
90
5
90
 
 
[46]         Schedule 1, entry for Certolizumab pegol
insert in numerical order in the column headed “Circumstances”:         C4830  C4831  C4839  C4842  C4843  C4853  C4863
[47]         Schedule 1, entry for Citalopram in the form Tablet 20 mg (as hydrobromide)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Citalopram Actavis
VN
MP NP
C1211
 
28
5
28
 
 
[48]         Schedule 1, entry for Cyclophosphamide in the form Tablet 50 mg
omit from the column headed “Responsible Person”:             PF        substitute:             ZX
[49]         Schedule 1, entry for Dapagliflozin
omit from the column headed “Circumstances”:        C4736   substitute:             C4825  C4844
[50]         Schedule 1, entry for Desvenlafaxine in the form Tablet (extended release) 50 mg (as succinate)
omit from the column headed “Circumstances”:        C1211   substitute:             C4855
[51]         Schedule 1, after entry for Desvenlafaxine in the form Tablet (extended release) 50 mg (as succinate)
insert in the columns in the order indicated:
 
Tablet (modified release) 50 mg
Oral
Desfax
AF
MP NP
C4855
 
28
5
28
 
 

 
 
 
Desvenlafaxine Actavis
GN
MP NP
C4855
 
28
5
28
 
 

 
Tablet (modified release) 50 mg (as benzoate)
Oral
Desvenlafaxine GH XR
GQ
MP NP
C4855
 
28
5
28
 
 

[52]         Schedule 1, entry for Desvenlafaxine in the form Tablet (extended release) 100 mg (as succinate)
omit from the column headed “Circumstances”:        C1211   substitute:             C4855
[53]         Schedule 1, after entry for Desvenlafaxine in the form Tablet (extended release) 100 mg (as succinate)
insert in the columns in the order indicated:
 
Tablet (modified release) 100 mg
Oral
Desfax
AF
MP NP
C4855
 
28
5
28
 
 

 
 
 
Desvenlafaxine Actavis
GN
MP NP
C4855
 
28
5
28
 
 

 
Tablet (modified release) 100 mg (as benzoate)
Oral
Desvenlafaxine GH XR
GQ
MP NP
C4855
 
28
5
28
 
 

[54]         Schedule 1, entry for Diazepam in the form Tablet 5 mg
(a)      omit:
 
 
 
Diazepam‑GA
GN
MP NP PDP
 
 
50
0
50
 
 

 
 
 
 
 
MP NP
 
P3656
50
CN3656
0
50
 
 

(b)      omit:
 
 
 
Diazepam‑GA
GN
MP NP
 
P3655
50
CN3655
3
CN3655
50
 
 
[55]         Schedule 1, after entry for Diphtheria and tetanus vaccine, adsorbed, diluted for adult use in the form Injection 0.5 mL in pre-filled syringe
insert in the columns in the order indicated:
 
Injection 0.5 mL
Injection
MassBiologics tetanus and diphtheria toxoids adsorbed
CS
MP NP
 
 
10
0
10
 
PB(MP)
PB(NP)
[56]         Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 1 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Dotax
RZ
MP
 
 
See Note 3
See
Note 3
1
 
D(100)
[57]         Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 20 mg in 2 mL
omit:
 
 
 
Docetaxel Sandoz
SZ
MP
 
 
See Note 3
See
Note 3
1
 
D(100)
[58]         Schedule 1, entry for Docetaxel in the form Solution concentrate for I.V. infusion 80 mg in 4 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Dotax
RZ
MP
 
 
See Note 3
See
Note 3
1
 
D(100)
[59]         Schedule 1, after entry for Dolutegravir
insert:
Dolutegravir with abacavir and lamivudine
Tablet containing dolutegravir 50 mg with abacavir 600 mg and lamivudine 300 mg
Oral
Triumeq
VI
MP
C4472 C4480 C4495 C4523
 
60
5
30
 
D(100)
[60]         Schedule 1, entry for Dorzolamide
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Trusamide
QA
MP AO
 
 
1
5
1
 
 
[61]         Schedule 1, entry for Doxorubicin in each of the forms: Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 10 mg in 5 mL single dose vial; and Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 50 mg in 25 mL single dose vial
omit:
 
 
 
Doxorubicin Ebewe
SZ
MP
 
 
See Note 3
See
Note 3
1
 
D(100)
[62]         Schedule 1, entry for Doxorubicin in the form Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 200 mg in 100 mL single dose vial
omit:
 
 
 
Doxorubicin Ebewe
SZ
MP
 
 
See Note 3
See
Note 3
1
 
D(100)
[63]         Schedule 1, entry for Empagliflozin in each of the forms: Tablet 10 mg; and Tablet 25 mg
omit from the column headed “Circumstances”:        C4770   substitute:             C4848
 
[64]         Schedule 1, entry for Epirubicin in each of the forms: Solution for injection containing epirubicin hydrochloride 10 mg in 5 mL; Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL; Solution for injection containing epirubicin hydrochloride 100 mg in
50 mL; and Solution for injection containing epirubicin hydrochloride 200 mg in 100 mL
omit:
 
 
 
Epirubicin Ebewe
SZ
MP
 
 
See Note 3
See
Note 3
1
 
D(100)
[65]         Schedule 1, entry for Esomeprazole in the form Tablet (enteric coated) 20 mg (as magnesium trihydrate)
(a)      omit:
 
 
 
Esomeprazole Actavis
GN
MP NP
C1337 C1629 C2273 C3429
P2273
30
1
30
 
 
(b)      omit:
 
 
 
Esomeprazole Actavis
GN
MP NP
C1337 C1629 C2273 C3429
P1337 P1629 P3429
30
5
30
 
 
[66]         Schedule 1, entry for Esomeprazole in the form Tablet (enteric coated) 40 mg (as magnesium trihydrate)
(a)      omit:
 
 
 
Esomeprazole Actavis
GN
MP NP
C1337 C1628 C3429
P1628
30
1
30
 
 
(b)      omit:
 
 
 
Esomeprazole Actavis
GN
MP NP
C1337 C1628 C3429
P1337 P3429
30
5
30
 
 
[67]         Schedule 1, entry for Etanercept in all forms 
omit from the column headed “Authorised Prescriber” (wherever occurring):     See Note 1
[68]         Schedule 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Maximum Quantity: 1;
Number of Repeats: 3]
(a)      omit from the column headed “Circumstances”:               C3489  C3776  C3777     
(b)      insert in numerical order:       C4826  C4840  C4845  C4851  C4864
(c)      omit from the column headed “Purposes”:         P3489  P3776    
(d)      insert in numerical order:       P4826  P4840  P4851
[69]         Schedule 1, entry for Etanercept in the form Injection 50 mg in 1 mL single use auto-injector, 4 [Maximum Quantity: 1;
Number of Repeats: 5]
(a)      omit from the column headed “Circumstances”:               C3489  C3776  C3777     
(b)      insert in numerical order:       C4826  C4840  C4845  C4851  C4864
(c)      omit from the column headed “Purposes”:         P3777   
(d)      insert in numerical order:       P4845  P4864
[70]         Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Maximum Quantity: 1;
Number of Repeats: 3]
(a)      omit from the column headed “Circumstances”:               C3489  C3776  C3777     
(b)      insert in numerical order:       C4826  C4840  C4845  C4851  C4864
(c)      omit from the column headed “Purposes”:         P3489  P3776    
(d)      insert in numerical order:       P4826  P4840  P4851
[71]         Schedule 1, entry for Etanercept in the form Injections 50 mg in 1 mL single use pre-filled syringes, 4 [Maximum Quantity: 1;
Number of Repeats: 5]
(a)      omit from the column headed “Circumstances”:               C3489  C3776  C3777     
(b)      insert in numerical order:       C4826  C4840  C4845  C4851  C4864
(c)      omit from the column headed “Purposes”:         P3777   
(d)      insert in numerical order:       P4845  P4864
[72]         Schedule 1, entry for Etanercept in the form Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent
1 mL [Maximum Quantity: 2; Number of Repeats: 3]
(a)      omit from the column headed “Circumstances”:               C3489  C3776  C3777     
(b)      insert in numerical order:       C4826  C4840  C4845  C4851  C4864
(c)      omit from the column headed “Purposes”:         P3489  P3776    
(d)      insert in numerical order:       P4826  P4840  P4851
[73]         Schedule 1, entry for Etanercept in the form Injection set containing 4 vials powder for injection 25 mg and 4 pre‑filled syringes solvent
1 mL [Maximum Quantity: 2; Number of Repeats: 5]
(a)      omit from the column headed “Circumstances”:               C3489  C3776  C3777     
(b)      insert in numerical order:       C4826  C4840  C4845  C4851  C4864
(c)      omit from the column headed “Purposes”:         P3777   
(d)      insert in numerical order:       P4845  P4864
[74]         Schedule 1, entry for Everolimus in the form Tablet 5 mg [Maximum Quantity: 30; Number of Repeats: 2]
(a)      insert in numerical order in the column headed “Circumstances”:           C4837 C4861
(b)      insert in numerical order in the column headed “Purposes”:         P4861
[75]         Schedule 1, entry for Everolimus in the form Tablet 5 mg [Maximum Quantity: 30; Number of Repeats: 5]
(a)      insert in numerical order in the column headed “Circumstances”:           C4837 C4861
(b)      insert in numerical order in the column headed “Purposes”:         P4837
[76]         Schedule 1, entry for Everolimus in the form Tablet 10 mg [Maximum Quantity: 30; Number of Repeats: 2]
(a)      insert in numerical order in the column headed “Circumstances”:           C4837 C4861
(b)      insert in numerical order in the column headed “Purposes”:         P4861
[77]         Schedule 1, entry for Everolimus in the form Tablet 10 mg [Maximum Quantity: 30; Number of Repeats 5]
(a)      omit from the column headed “Circumstances”:            C4557
(b)      insert in numerical order:       C4812  C4837  C4861
(c)      omit from the column headed “Purposes”:       P4557
(d)      insert in numerical order:       P4812  P4837
[78]         Schedule 1, entry for Exenatide in each of the forms: Injection solution 5 micrograms per dose in pre-filled pen, 60 doses; and
Injection solution 10 micrograms per dose in pre-filled pen, 60 doses
omit from the column headed “Circumstances”:        C4392  C4405    substitute:             C4856  C4857
[79]         Schedule 1, entry for Fluorouracil in the form Injection 500 mg in 10 mL
omit:
 
 
 
Fluorouracil Ebewe
SZ
MP
See Note 3
See Note 3
See Note 3
See
Note 3
5
 
D(100)
[80]         Schedule 1, entry for Folinic acid in the form Injection containing calcium folinate equivalent to 50 mg folinic acid in 5 mL
omit:
 
 
 
Calcium Folinate Ebewe
SZ
MP
See Note 1
 
 
10
2
5
 
 
[81]         Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled syringe [Maximum Quantity: 1;
Number of Repeats: 3]
(a)      omit from the column headed “Circumstances”:               C3495  C3497  C3784  C3785      
(b)      insert in numerical order:       C4826  C4840  C4845  C4851  C4864
(c)      omit from the column headed “Purposes”:         P3495  P3784    
(d)      insert in numerical order:       P4826  P4840  P4851
[82]         Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled syringe [Maximum Quantity: 1;
Number of Repeats: 5]
(a)      omit from the column headed “Circumstances”:               C3495  C3497  C3784  C3785      
(b)      insert in numerical order:       C4826  C4840  C4845  C4851  C4864
(c)      omit from the column headed “Purposes”:         P3497  P3785    
(d)      insert in numerical order:       P4845  P4864
[83]         Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled pen [Maximum Quantity: 1;
Number of Repeats: 3]
(a)      omit from the column headed “Circumstances”:               C3495  C3497  C3784  C3785      
(b)      insert in numerical order:       C4826  C4840  C4845  C4851  C4864
(c)      omit from the column headed “Purposes”:         P3495  P3784    
(d)      insert in numerical order:       P4826  P4840  P4851
[84]         Schedule 1, entry for Golimumab in the form Injection 50 mg in 0.5 mL single use pre-filled pen [Maximum Quantity: 1;
Number of Repeats: 5]
(a)      omit from the column headed “Circumstances”:               C3495  C3497  C3784  C3785      
(b)      insert in numerical order:       C4826  C4840  C4845  C4851  C4864
(c)      omit from the column headed “Purposes”:         P3497  P3785    
(d)      insert in numerical order:       P4845  P4864
[85]         Schedule 1, after entry for Imiquimod in the form Cream 50 mg per g, 250 mg single use sachets, 12 [Brand: APO-Imiquimod]
insert in the columns in the order indicated:
IncobotulinumtoxinA
Lyophilised powder for injection 100 units
Injection
Xeomin
EZ
MP
See Note 3
See Note 3
See Note 3
See
Note 3
1
 
D(100)
[86]         Schedule 1, entry for Iron Polymaltose Complex
substitute:
Iron Polymaltose Complex
Injection 100 mg (iron) in 2 mL
Injection
Ferrosig
SI
MP NP
 
 
5
0
5
 
 

 
 
 
 
 
MP NP
 
P4302
5
CN4302
5
CN4302
5
 
 

 
 
 
Ferrum H
AS
MP NP
 
 
5
0
5
 
 

 
 
 
 
 
MP NP
 
P4302
5
CN4302
5
CN4302
5
 
 

[87]         Schedule 1, entry for Iron Sucrose
substitute:
Iron sucrose
Concentrate for solution for infusion 2.7 g (equivalent to 100 mg iron (III)) in 5 mL
Injection
Venofer
AS
MP NP
 
 
5
0
5
 
 

 
 
 
 
 
MP NP
 
P4302
5
CN4302
5
CN4302
5
 
 

[88]         Schedule 1, entry for Lanthanum in the form Tablet, chewable, 500 mg (as carbonate hydrate) [Maximum Quantity: 90;
Number of Repeats: 5]
omit from the column headed “Circumstances”:          C3546  C3547    substitute:             C4827
[89]         Schedule 1, entry for Lanthanum in the form Tablet, chewable, 500 mg (as carbonate hydrate) [Maximum Quantity: 180;
Number of Repeats: 5]
(a)      omit from the column headed “Authorised Prescriber”:              See Note 1
(b)      omit from the column headed “Circumstances”:            C3103  C3104  C3390  C3391     substitute:          C4832  C4847
[90]         Schedule 1, entry for Lanthanum in the form Tablet, chewable, 750 mg (as carbonate hydrate) [Maximum Quantity: 90;
Number of Repeats: 5]
omit from the column headed “Circumstances”:          C3546  C3547    substitute:             C4827
[91]         Schedule 1, entry for Lanthanum in the form Tablet, chewable, 750 mg (as carbonate hydrate) [Maximum Quantity: 180;
Number of Repeats: 5]
(a)      omit from the column headed “Authorised Prescriber”:              See Note 1
(b)      omit from the column headed “Circumstances”:            C3103  C3104  C3390  C3391     substitute:          C4832  C4847
[92]         Schedule 1, entry for Lanthanum in the form Tablet, chewable, 1000 mg (as carbonate hydrate) [Maximum Quantity: 90;
Number of Repeats: 5]
omit from the column headed “Circumstances”:          C3546  C3547    substitute:             C4827
[93]         Schedule 1, entry for Lanthanum in the form Tablet, chewable, 1000 mg (as carbonate hydrate) [Maximum Quantity: 180;
Number of Repeats: 5]
(a)      omit from the column headed “Authorised Prescriber”:              See Note 1
(b)      omit from the column headed “Circumstances”:            C3103  C3104  C3390  C3391     substitute:          C4832  C4847
[94]         Schedule 1, entry for Macrogol 3350 in the form Sachets containing powder for oral solution 17 g, 30
omit from the column headed “Brand”:       MediHealth       substitute:             Herron
[95]         Schedule 1, after entry for Mesalazine in the form Sachet containing prolonged release granules, 2 g per sachet
insert in the columns in the order indicated:
 
Sachet containing prolonged release granules, 4 g per sachet
Oral
Pentasa
FP
MP NP
C4824
 
30
5
30
 
 
[96]         Schedule 1, entry for Methotrexate in the form Solution concentrate for I.V. infusion 1000 mg in 10 mL vial
omit:
 
 
 
Methotrexate Ebewe
SZ
MP
 
See Note 3
See Note 3
See
Note 3
1
 
PB(100)
[97]         Schedule 1, omit entry for Mifepristone
[98]         Schedule 1, omit entry for Misoprostol
[99]         Schedule 1, entry for Morphine in the form Tablet containing morphine sulfate 60 mg (controlled release)
omit from the column headed “Brand”:       APOTEX-MORPHINE MR          substitute:             MORPHINE MR APOTEX
[100]       Schedule 1, entry for Nicorandil in each of the forms: Tablets 10 mg, 60; and Tablets 20 mg, 60
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Ikotab
QA
MP NP
 
 
1
5
1
 
 
[101]       Schedule 1, after entry for Oestriol in the form Vaginal cream 1 mg per g, 15 g
insert:
Ofatumumab
Solution concentrate for I.V. infusion 100 mg in 5 mL
Injection
Arzerra
GK
MP
C4828

 
See Note 3
See Note 3
3
 
D(100)

 
Solution concentrate for I.V. infusion 1000 mg in 50 mL
Injection
Arzerra
GK
MP
C4828 C4858
 
See Note 3
See Note 3
1
 
D(100)

[102]       Schedule 1, entry for Oxaliplatin in the form Powder for I.V. infusion 50 mg
omit:
 
 
 
Oxaliplatin Ebewe
SZ
MP
 
 
See Note 3
See
Note 3
1
 
D(100)
[103]       Schedule 1, entry for Oxaliplatin in the form Powder for I.V. infusion 100 mg
omit:
 
 
 
Oxaliplatin Ebewe
SZ
MP
 
 
See Note 3
See
Note 3
1
 
D(100)
[104]       Schedule 1, after entry for Oxycodone with naloxone in the form Tablet (controlled release) containing oxycodone hydrochloride 40 mg with naloxone hydrochloride 20 mg
insert:
Oxytocin
Injection 10 I.U. in 1 mL
Injection
Oxytocin Sandoz
SZ
See Note 4
See Note 4
See Note 4
See Note 4
See Note 4
5
 
D(MP)
[105]       Schedule 1, entry for Paclitaxel in the form Solution concentrate for I.V. infusion 100 mg in 16.7 mL
omit:
 
 
 
Paclitaxel Ebewe
SZ
MP
 
 
See Note 3
See
Note 3
1
 
D(100)
[106]       Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 2 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Blooms the Chemist Perindopril
IB
MP NP
 
 
30
5
30
 
 
[107]       Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 4 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Blooms the Chemist Perindopril
IB
MP NP
 
 
30
5
30
 
 
[108]       Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 8 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Blooms the Chemist Perindopril
IB
MP NP
 
 
30
5
30
 
 
 
[109]       Schedule 1, entry for Polyvinyl Alcohol
omit:
 
Eye drops 30 mg per mL, 15 mL
Application to the eye
Liquifilm Forte
AG
MP
C1362 C3036
P1362
1
5
1
 
 

 
 
 
 
 
NP AO
C1362
 
1
5
1
 
 

 
 
 
PVA Forte
PE
MP
C1362 C3036
P1362
1
5
1
 
 

 
 
 
 
 
NP AO
C1362
 
1
5
1
 
 

 
 
 
Liquifilm Forte
AG
MP
C1362 C3036
P3036
1
11
1
 
 

 
 
 
PVA Forte
PE
MP
C1362 C3036
P3036
1
11
1
 
 

[110]       Schedule 1, entry for Raloxifene
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Raloxifene AN
EA
MP NP
C4071
 
28
5
28
 
 
[111]       Schedule 1, entry for Ramipril in the form Tablet 10 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Ramipril Winthrop
WA
MP NP
 
 
30
5
30
 
 
[112]       Schedule 1, entry for Ranitidine in the form Tablet 300 mg (as hydrochloride)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Ranitidine GH
GQ
MP NP
 
 
30
5
30
 
 
[113]       Schedule 1, entry for Salcatonin
omit:
 
Injection 50 I.U. in 1 mL ampoule
Injection
Miacalcic 50
NV
MP NP
C1412 C3256
 
30
5
5
 
 
[114]       Schedule 1, entry for Sevelamer in the form Tablet containing sevelamer hydrochloride 800 mg [Maximum Quantity: 180;
Number of Repeats: 5]
omit from the column headed “Circumstances”:          C3548  C3549    substitute:             C4827
[115]       Schedule 1, entry for Sevelamer in the form Tablet containing sevelamer hydrochloride 800 mg [Maximum Quantity: 360;
Number of Repeats: 5]
(a)      omit from the column headed “Authorised Prescriber”:  See Note 1
(b)      omit from the column headed “Brand”:                        Renagel 
(c)      omit from the column headed “Responsible Person”:      GZ
(d)      omit from the column headed “Circumstances”:            C3103  C3104  C3390  C3391     substitute:          C4832  C4847
[116]       Schedule 1, entry for Sildenafil
(a)      omit from the column headed “Authorised Prescriber” (wherever occurring):        See Note 1
(b)      insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Sildenafil AN PHT 20
EA
MP

See Note 3
See Note 3
See Note 3
See
Note 3
90
 
D(100)
[117]       Schedule 1, entry for Sorafenib
substitute:
Sorafenib
Tablet 200 mg (as tosylate)
Oral
Nexavar
BN
MP
C4230 C4234 C4820 C4841
P4230 P4234 P4841
120
2
60
 
 

 
 
 
 
 
 
C4230 C4234 C4820 C4841
P4820
120
5
60
 
 

 
[118]       Schedule 1, after entry for Sucralfate
insert:
Sucroferric oxyhydroxide
Tablet, chewable, 2.5 g (equivalent to 500 mg iron)
Oral
Velphoro
FN
MP NP
C4827
 
90
5
90
 
 

 
 
 
 
 
MP
C4832 C4847
 
180
5
90
 
C(100)

[119]       Schedule 1, entry for Sumatriptan in the form Tablet 50 mg (as succinate) [Maximum Quantity: 4; Number of Repeats 5; Pack Quantity: 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Iptam
AL
MP NP
C4558
 
4
5
2
 
 
[120]       Schedule 1, entry for Sumatriptan in the form Tablet 50 mg (as succinate) [Maximum Quantity: 4; Number of Repeats 5; Pack Quantity: 4]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Iptam
AL
MP NP
C4558
 
4
5
4
 
 
[121]       Schedule 1, entry for Sunitinib in the form Capsule 12.5 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 1]
omit from the column headed “Circumstances”:          C4341  C4354     substitute:             C4837  C4862
[122]       Schedule 1, entry for Sunitinib in the form Capsule 12.5 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 2]
(a)      omit from the column headed “Circumstances”:               C4341  C4354     substitute:             C4837  C4862
(b)      omit from the column headed “Purposes”:         P4354   substitute:             P4862 
[123]       Schedule 1, entry for Sunitinib in the form Capsule 12.5 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 3]
omit from the column headed “Circumstances”:          C4341  C4354     substitute:             C4837  C4862
[124]       Schedule 1, entry for Sunitinib in the form Capsule 12.5 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 5]
(a)      omit from the column headed “Circumstances”:               C4341  C4354     substitute:             C4837  C4862
(b)      omit from the column headed “Purposes”:         P4341   substitute:             P4837 
 
[125]       Schedule 1, entry for Sunitinib in the form Capsule 25 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 1]
omit from the column headed “Circumstances”:          C4341  C4354     substitute:             C4837  C4862
[126]       Schedule 1, entry for Sunitinib in the form Capsule 25 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 2]
(a)      omit from the column headed “Circumstances”:               C4341  C4354     substitute:             C4837  C4862
(b)      omit from the column headed “Purposes”:         P4354   substitute:             P4862 
[127]       Schedule 1, entry for Sunitinib in the form Capsule 25 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 3]
omit from the column headed “Circumstances”:          C4341  C4354     substitute:             C4837  C4862
[128]       Schedule 1, entry for Sunitinib in the form Capsule 25 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 5]
(a)      omit from the column headed “Circumstances”:               C4341  C4354     substitute:             C4837  C4862
(b)      omit from the column headed “Purposes”:         P4341   substitute:             P4837 
[129]       Schedule 1, entry for Sunitinib in the form Capsule 50 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 1]
omit from the column headed “Circumstances”:          C4341  C4354     substitute:             C4837  C4862
[130]       Schedule 1, entry for Sunitinib in the form Capsule 50 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 2]
(a)      omit from the column headed “Circumstances”:               C4341  C4354     substitute:             C4837  C4862
(b)      omit from the column headed “Purposes”:         P4354   substitute:             P4862 
[131]       Schedule 1, entry for Sunitinib in the form Capsule 50 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 3]
omit from the column headed “Circumstances”:          C4341  C4354     substitute:             C4837  C4862
[132]       Schedule 1, entry for Sunitinib in the form Capsule 50 mg (as malate) [Maximum Quantity: 28; Number of Repeats: 5]
(a)      omit from the column headed “Circumstances”:               C4341  C4354     substitute:             C4837  C4862
(b)      omit from the column headed “Purposes”:         P4341   substitute:             P4837 
[133]       Schedule 1, entry for Tacrolimus in all forms
omit from the column headed “Authorised Prescriber” (wherever occurring):     See Note 1
[134]       Schedule 1, entry for Tacrolimus in each of the forms: Capsule 0.5 mg; Capsule 1 mg; and Capsule 5 mg
omit from the column headed “Responsible Person” for the brand “Prograf” (all instances):       JC        substitute:             LL
[135]       Schedule 1, entry for Tacrolimus in the form Capsule 0.5 mg (once daily prolonged release)
(a)      omit from the column headed “Responsible Person” for the brand “Prograf XL” (first instance):      JC        substitute:    LL
(b)      omit from the column headed “Brand” (second instance):              Prograf XL
(c)      omit from the column headed “Responsible Person” (second instance):      JC
[136]       Schedule 1, entry for Tacrolimus in the form Capsule 1 mg (once daily prolonged release)
(a)      omit from the column headed “Responsible Person” for the brand “Prograf XL” (first instance):      JC        substitute:    LL
(b)      omit from the column headed “Brand” (second instance):              Prograf XL
(c)      omit from the column headed “Responsible Person” (second instance):      JC
[137]       Schedule 1, entry for Tacrolimus in the form Capsule 5 mg (once daily prolonged release)
(a)      omit from the column headed “Responsible Person” for the brand “Prograf XL” (first instance):      JC        substitute:    LL
(b)      omit from the column headed “Brand” (second instance):              Prograf XL
(c)      omit from the column headed “Responsible Person” (second instance):      JC
[138]       Schedule 1, entry for Testosterone in each of the forms: Capsule containing testosterone undecanoate 40 mg; Injection containing testosterone enanthate 250 mg in 1 mL; I.M. injection containing testosterone undecanoate 1,000 mg in 4 mL; Transdermal gel 50 mg
in 5 g sachet, 30; Transdermal patches 12.2 mg, 60; Transdermal patches 24.3 mg, 30; and Transdermal solution (pump pack) 30 mg per 1.5 mL dose, 60 doses
omit from the column headed “Circumstances”:          C4815  C4816  C4817  C4818  C4819        substitute:             C4866  C4867  C4868  C4869  C4870
[139]       Schedule 1, entry for Ursodeoxycholic Acid
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Ursosan
BZ
MP NP
C1700
 
200
2
100
 
 
[140]       Schedule 1, entry for Varenicline in the form Tablet 1 mg (as tartrate) [Maximum Quantity: 56; Number of Repeats: 2]
(a)      omit from the column headed “Circumstances”:               C4647   
(b)      insert in numerical order:       C4835
(c)      omit from the column headed “Purposes”:         P4647   
(d)      substitute:   P4835
[141]       Schedule 1, entry for Varenicline in the form Tablet 1 mg (as tartrate) [Maximum Quantity: 112; Number of Repeats: 0]
(a)      omit from the column headed “Circumstances”:               C4647   
(b)      insert in numerical order:       C4835
[142]       Schedule 3, after details relevant to Responsible Person code EU
insert:
EZ
Merz Australia Pty Ltd
 62 151 073 559
[143]       Schedule 3, after details relevant to Responsible Person code FM
insert:
FN
Fresenius Medical Care Australia Pty Ltd
 80 067 557 877
[144]       Schedule 3, after details relevant to Responsible Person code ZP
insert:
ZX
Zenex Pharmaceuticals Pty Ltd
 51 603 281 509
[145]       Schedule 4, Part 1, entry for Adalimumab
(a)      omit:

 
C3486
P3486
 
Psoriatic arthritis — initial treatment 1
Initial treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:
(1) have severe active psoriatic arthritis; and
(2) have received no prior PBS‑subsidised treatment with a biological agent for this condition, or, where the patient has previously received PBS‑subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS‑subsidised therapy with a biological agent for this condition was approved; and
(3) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months and to either sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months or leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; and
where biological agent means adalimumab, etanercept, golimumab or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS‑subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
failure to achieve an adequate response to the treatment regimens specified at (3) above is demonstrated by the following:
(a) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C‑reactive protein (CRP) level greater than 15 mg per L; and
(b) either:
(i) an active joint count of at least 20 active (swollen and tender) joints; or
(ii) at least 4 active joints from the following list of major joints:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied;
if treatment with any of the drugs mentioned at (3) above is contraindicated according to the relevant Therapeutic Goods Administration‑approved Product Information, the authority application includes details of the contraindication;
if intolerance to treatment with the regimens specified at (3) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;
the authority application is made in writing and includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application ‑ Supporting Information Form and a signed patient acknowledgment;
a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment
Compliance with Written Authority Required procedures

 
 
 
 
Continuation of a course of initial treatment with adalimumab in a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures

(b)      omit:

 
C3749
P3749
 
Psoriatic arthritis — initial treatment 2
Initial treatment, or recommencement of treatment, with adalimumab within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:
(1) have a documented history of severe active psoriatic arthritis; and
(2) have received prior PBS‑subsidised treatment with a biological agent for this condition in this Treatment Cycle and are eligible to receive further therapy with a biological agent; and
(3) have not failed treatment with adalimumab during the current Treatment Cycle; and
where biological agent means adalimumab, etanercept, golimumab or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS‑subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
patients are eligible to receive further therapy with a biological agent within this Treatment Cycle provided they have not already failed, or ceased to respond to, PBS‑subsidised treatment with 3 biological agents within this Treatment Cycle;
the authority application is made in writing and includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application ‑ Supporting Information Form;
where a patient has received PBS‑subsidised treatment with adalimumab within this Treatment Cycle and wishes to recommence therapy with this drug within this same cycle, the authority application is accompanied by evidence of a response to the patient’s most recent course of PBS‑subsidised adalimumab treatment;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS‑subsidised adalimumab treatment is a 16‑week initial treatment course, is made following a minimum of 12 weeks of therapy;
a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment
Compliance with Written Authority Required procedures

 
 
 
 
Continuation of a course of initial treatment, or of a course which recommences treatment, with adalimumab within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures

 
C3750
P3750
 
Psoriatic arthritis — continuing treatment
Continuing treatment with adalimumab within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults:
(1) who have a documented history of severe active psoriatic arthritis; and
(2) whose most recent course of PBS‑subsidised treatment with a biological agent for this condition in the current Treatment Cycle was with adalimumab; and
(3) who, at the time of application, demonstrate an adequate response to treatment with adalimumab; and
where biological agent means adalimumab, etanercept, golimumab or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS‑subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to treatment with adalimumab is defined as:
(a) an erythrocyte sedimentation rate no greater than 25 mm per hour or a C‑reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
(b) either of the following:
(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(ii) a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the same indices of disease severity used to establish baseline at the commencement of an initial course of treatment are used to determine response to that course, and subsequent courses, of treatment;
the authority application is made in writing and includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application ‑ Supporting Information Form, and a measurement of response to the most recent prior course of therapy with adalimumab;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the cessation of the treatment course;
if the most recent course of adalimumab therapy is a 16‑week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
if the response assessment to a course of treatment is not submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed that course of treatment;
a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment
Compliance with Written Authority Required procedures

 
 
 
 
Continuation of a course of continuing treatment with adalimumab within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures

(c)      insert in numerical order after existing text:

 
C4826
P4826
 
Severe psoriatic arthritis
Initial treatment – Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more)
Patient must have severe active psoriatic arthritis; AND
Patient must have received no prior PBS-subsidised treatment with a biological agent for this condition; OR
Patient must have received no PBS-subsidised treatment with a biological agent for at least 5 years if they have previously received PBS-subsidised treatment with a biological agent for this condition; AND
Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND
Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; OR
Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND
Patient must not receive more than 16 weeks of treatment under this restriction
Patient must be an adult
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis
For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab or infliximab.
Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application
Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application
The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and either
(a) an active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth)
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form; and
(3) a signed patient acknowledgement
Compliance with Written Authority Required procedures


 
C4840
P4840
 
Severe psoriatic arthritis
Initial treatment – Initial 2 (change or recommencement of treatment)
Patient must have a documented history of severe active psoriatic arthritis; AND
Patient must have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle; AND
Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug during the current Treatment Cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction
Patient must be an adult
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis
For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab or infliximab
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form
Applications for a patient who has previously received PBS-subsidised treatment with this drug within this Treatment Cycle and who wishes to recommence therapy with this drug within this same Cycle, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug
Where the most recent course of PBS-subsidised treatment was approved under either of the initial treatment restrictions (i.e. for patients with no prior PBS-subsidised biological therapy or, under this restriction, for patients who have received previous PBS-subsidised biological therapy), the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must have been submitted no later than 4 weeks from the date that course was ceased
Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment submitted no later than 4 weeks from the date that course was ceased
Where a response assessment was not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth)
Compliance with Written Authority Required procedures


 
C4845
P4845
 
Severe psoriatic arthritis
Continuing treatment - balance of supply
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis
Compliance with Written or Telephone Authority Required procedures


 
C4851
P4851
 
Severe psoriatic arthritis
Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) or Initial 2 (change or recommencement of treatment) - balance of supply
Patient must have received insufficient therapy with this drug under the Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement of treatment) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis
Compliance with Written or Telephone Authority Required procedures


 
C4864
P4864
 
Severe psoriatic arthritis
Continuing treatment
Patient must have a documented history of severe active psoriatic arthritis; AND
Patient must have received this drug as their most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle; AND
Patient must demonstrate, at the time of application, an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction
Patient must be an adult
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis
For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab or infliximab
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth)
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be provided for all subsequent continuing treatment applications
All applications for continuing treatment with this drug must include a measurement of response to the most recent course of PBS-subsidised therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with the initial treatment course
Where a response assessment is not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form
Compliance with Written Authority Required procedures


[146]       Schedule 4, Part 1, after entry for Albendazole
insert:

Alemtuzumab
C4829
P4829
 
Multiple sclerosis
Continuing
Patient must have previously been issued with an authority prescription for this drug; AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
Patient must not receive more than one PBS-subsidised treatment per year; AND
The treatment must be as monotherapy; AND
Patient must have demonstrated compliance with, and an ability to tolerate this therapy
Must be treated by a neurologist
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4829


 
C4834
P4834
 
Multiple sclerosis
Initial treatment
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR;
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
The treatment must be as monotherapy; AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to the multiple sclerosis, in the preceding 2 years; AND
Patient must be ambulatory (without assistance or support)
Must be treated by a neurologist
Where applicable, the date of the magnetic resonance imaging scan must be provided with the authority application
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4834


 
C4838
P4838
 
Multiple sclerosis
Initial treatment
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
The treatment must be as monotherapy; AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to the multiple sclerosis, in the preceding 2 years; AND
Patient must be ambulatory (without assistance or support)
Must be treated by a neurologist
Where applicable, the date of the magnetic resonance imaging scan must be provided with the authority application
Compliance with Written or Telephone Authority Required procedures


 
C4850
P4850
 
Multiple sclerosis
Continuing treatment
Patient must have previously been issued with an authority prescription for this drug; AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
Patient must not receive more than one PBS-subsidised treatment per year; AND
The treatment must be as monotherapy; AND
Patient must have demonstrated compliance with, and an ability to tolerate this therapy
Must be treated by a neurologist
Compliance with Written and Telephone Authority Required procedures


[147]       Schedule 4, Part 1, entry for Apomorphine
substitute:

Apomorphine
C4833
 
 
Parkinson disease
Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4833

 
C4860
 
 
Parkinson disease
Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy
Compliance with Written or Telephone Authority Required procedures

[148]       Schedule 4, Part 1, entry for Certolizumab pegol
insert in numerical order after existing text:

 
C4830
 
 
Severe psoriatic arthritis
Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) or Initial 2 (change or recommencement of treatment) - balance of supply
Patient must have received insufficient therapy with this drug under the Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete 18 to 20 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement of treatment) restriction to complete 18 to 20 weeks treatment; AND
The treatment must provide no more than the balance of up to 18 to 20 weeks treatment available under the above restrictions
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis
Compliance with Written or Telephone Authority Required procedures


 
C4831
 
 
Severe psoriatic arthritis
Initial treatment - Initial 3 (initial PBS-subsidised supply for continuing treatment in a patient commenced on non-PBS-subsidised therapy) - balance of supply
Patient must have received insufficient therapy with this drug under the Initial 3 (initial PBS-subsidised supply for continuing treatment in a patient commenced on non-PBS-subsidised therapy) restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis
Compliance with Written or Telephone Authority Required procedures


 
C4839
 
 
Severe psoriatic arthritis
Initial treatment – Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more)
Patient must have severe active psoriatic arthritis; AND
Patient must have received no prior PBS-subsidised treatment with a biological agent for this condition; OR
Patient must have received no PBS-subsidised treatment with a biological agent for at least 5 years if they have previously received PBS-subsidised treatment with a biological agent for this condition; AND
Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND
Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; OR
Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND
Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction
Patient must be an adult
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis
For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab or infliximab
Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application
Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application
The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and either
(a) an active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth)
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form; and
(3) a signed patient acknowledgement
Compliance with Written Authority Required procedures


 
C4842
 
 
Severe psoriatic arthritis
Initial treatment – Initial 2 (change or recommencement of treatment)
Patient must have a documented history of severe active psoriatic arthritis; AND
Patient must have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle; AND
Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug during the current Treatment Cycle; AND
Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction
Patient must be an adult
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis
For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab or infliximab
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form
Applications for a patient who has previously received PBS-subsidised treatment with this drug within this Treatment Cycle and who wishes to recommence therapy with this drug within this same Cycle, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug
Where the most recent course of PBS-subsidised treatment was approved under either of the initial treatment restrictions (i.e. for patients with no prior PBS-subsidised biological therapy or, under this restriction, for patients who have received previous PBS-subsidised biological therapy), the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must have been submitted no later than 4 weeks from the date that course was ceased
Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment submitted no later than 4 weeks from the date that course was ceased
Where a response assessment was not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth)
Compliance with Written Authority Required procedures


 
C4843
 
 
Severe psoriatic arthritis
Continuing treatment
Patient must have a documented history of severe active psoriatic arthritis; AND
Patient must have received this drug as their most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle; AND
Patient must demonstrate, at the time of application, an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction
Patient must be an adult
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis
For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab or infliximab
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth)
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be provided for all subsequent continuing treatment applications
All applications for continuing treatment with this drug must include a measurement of response to the most recent course of PBS-subsidised therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with the initial treatment course
Where a response assessment is not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form
Compliance with Written Authority Required procedures


 
C4853
 
 
Severe psoriatic arthritis
Continuing treatment - balance of supply
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis
Compliance with Written or Telephone Authority Required procedures


 
C4863
 
 
Severe psoriatic arthritis
Initial treatment - Initial 3 (initial PBS-subsidised supply for continuing treatment in a patient commenced on non-PBS-subsidised therapy)
Patient must have a documented history of severe active psoriatic arthritis; AND
Patient must have been receiving treatment with certolizumab pegol for this condition prior to 1 April 2015; AND
Patient must be receiving treatment with certolizumab pegol at the time of application; AND
Patient must have demonstrated a response to treatment as specified in the criteria for continuing PBS-subsidised treatment with certolizumab pegol; AND
Patient must not receive more than 24 weeks of treatment under this restriction
Patient must be an adult
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form; and
(3) a signed patient acknowledgement
A patient may qualify for PBS-subsidised treatment under this restriction once only
Compliance with Written Authority Required procedures


[149]       Schedule 4, Part 1, entry for Dapagliflozin
substitute:

Dapagliflozin
C4825
 
 
Diabetes mellitus type 2
The treatment must be in combination with insulin; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with insulin and oral antidiabetic agents, or insulin alone where metformin is contraindicated
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records
Compliance with Authority Required procedures - Streamlined Authority Code 4825


 
C4844
 
 
Diabetes mellitus type 2
The treatment must be in combination with metformin; OR
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with either metformin or a sulfonylurea; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period despite treatment with either metformin or a sulfonylurea
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor is initiated
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this drug
Compliance with Authority Required procedures - Streamlined Authority Code 4844


[150]       Schedule 4, Part 1, entry for Desvenlafaxine
substitute:
Desvenlafaxine
C4855
 
 
Major depressive disorders
 
[151]       Schedule 4, Part 1, after entry for Dolutegravir
insert:

Dolutegravir with abacavir and lamivudine
C4472
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve;
Patient must be aged 12 years or older; AND
Patient must weigh 40 kg or more
Compliance with Written or Telephone Authority Required procedures


 
C4480
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection;
Patient must be aged 12 years or older; AND
Patient must weigh 40 kg or more
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4480

 
C4495
 
 
Where the patient is receiving treatment at/from a public hospital
HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve;
Patient must be aged 12 years or older; AND
Patient must weigh 40 kg or more
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4495


 
C4523
 
 
Where the patient is receiving treatment at/from a private hospital
HIV infection
Continuing treatment
Patient must have previously received PBS-subsidised therapy for HIV infection;
Patient must be aged 12 years or older; AND
Patient must weigh 40 kg or more
Compliance with Written or Telephone Authority Required procedures


[152]       Schedule 4, Part 1, entry for Empagliflozin
substitute:
Empagliflozin
C4848
 
 
Diabetes mellitus type 2
The treatment must be in combination with metformin; OR
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with either metformin or a sulfonylurea; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period despite treatment with either metformin or a sulfonylurea
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor is initiated
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this drug
Compliance with Authority Required procedures - Streamlined Authority Code 4848

[153]       Schedule 4, Part 1, entry for Etanercept
(a)      omit:

 
C3489
P3489
 
Psoriatic arthritis — initial treatment 1
Initial treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:
(1) have severe active psoriatic arthritis; and
(2) have received no prior PBS‑subsidised treatment with a biological agent for this condition, or, where the patient has previously received PBS‑subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS‑subsidised therapy with a biological agent for this condition was approved; and
(3) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months and to either sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months or leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; and
where biological agent means adalimumab, etanercept, golimumab or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS‑subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
failure to achieve an adequate response to the treatment regimens specified at (3) above is demonstrated by the following:
(a) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C‑reactive protein (CRP) level greater than 15 mg per L; and
(b) either:
(i) an active joint count of at least 20 active (swollen and tender) joints; or
(ii) at least 4 active joints from the following list of major joints:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied;
if treatment with any of the drugs mentioned at (3) above is contraindicated according to the relevant Therapeutic Goods Administration‑approved Product Information, the authority application includes details of the contraindication;
if intolerance to treatment with the regimens specified at (3) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;
the authority application is made in writing and includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application ‑ Supporting Information Form and a signed patient acknowledgment;
a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment
Compliance with Written Authority Required procedures

 
 
 
 
Continuation of a course of initial treatment with etanercept in a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures

 
C3776
P3776
 
Psoriatic arthritis — initial treatment 2
Initial treatment, or recommencement of treatment, with etanercept within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:
(1) have a documented history of severe active psoriatic arthritis; and
(2) have received prior PBS‑subsidised treatment with a biological agent for this condition in this Treatment Cycle and are eligible to receive further therapy with a biological agent; and
(3) have not failed treatment with etanercept during the current Treatment Cycle; and
where biological agent means adalimumab, etanercept, golimumab or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS‑subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
patients are eligible to receive further therapy with a biological agent within this Treatment Cycle provided they have not already failed, or ceased to respond to, PBS‑subsidised treatment with 3 biological agents within this Treatment Cycle;
the authority application is made in writing and includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application ‑ Supporting Information Form;
where a patient has received PBS‑subsidised treatment with etanercept within this Treatment Cycle and wishes to recommence therapy with this drug within this same cycle, the authority application is accompanied by evidence of a response to the patient’s most recent course of PBS‑subsidised etanercept treatment;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS‑subsidised etanercept treatment is a 16‑week initial treatment course, is made following a minimum of 12 weeks of therapy;
a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment
Compliance with Written Authority Required procedures

 
 
 
 
Continuation of a course of initial treatment, or of a course which recommences treatment, with etanercept within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures

 
C3777
P3777
 
Psoriatic arthritis — continuing treatment
Continuing treatment with etanercept within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults:
(1) who have a documented history of severe active psoriatic arthritis; and
(2) whose most recent course of PBS‑subsidised treatment with a biological agent for this condition in the current Treatment Cycle was with etanercept; and
(3) who, at the time of application, demonstrate an adequate response to treatment with etanercept; and
where biological agent means adalimumab, etanercept, golimumab or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS‑subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to treatment with etanercept is defined as:
(a) an erythrocyte sedimentation rate no greater than 25 mm per hour or a C‑reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
(b) either of the following:
(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(ii) a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the same indices of disease severity used to establish baseline at the commencement of an initial course of treatment are used to determine response to that course, and subsequent courses, of treatment;
the authority application is made in writing and includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application ‑ Supporting Information Form, and a measurement of response to the most recent prior course of therapy with etanercept;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the cessation of the treatment course;
if the most recent course of etanercept therapy is a 16‑week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
if the response assessment to a course of treatment is not submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed that course of treatment;
a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment
Compliance with Written Authority Required procedures

 
 
 
 
Continuation of a course of continuing treatment with etanercept within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures

(b)      insert in numerical order after existing text:

 
C4826
P4826
 
Severe psoriatic arthritis
Initial treatment – Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more)
Patient must have severe active psoriatic arthritis; AND
Patient must have received no prior PBS-subsidised treatment with a biological agent for this condition; OR
Patient must have received no PBS-subsidised treatment with a biological agent for at least 5 years if they have previously received PBS-subsidised treatment with a biological agent for this condition; AND
Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND
Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; OR
Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND
Patient must not receive more than 16 weeks of treatment under this restriction
Patient must be an adult
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis
For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab or infliximab
Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application
Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application
The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and either
(a) an active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth)
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form; and
(3) a signed patient acknowledgement
Compliance with Written Authority Required procedures


 
C4840
P4840
 
Severe psoriatic arthritis
Initial treatment – Initial 2 (change or recommencement of treatment)
Patient must have a documented history of severe active psoriatic arthritis; AND
Patient must have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle; AND
Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug during the current Treatment Cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction
Patient must be an adult
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis
For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab or infliximab
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form
Applications for a patient who has previously received PBS-subsidised treatment with this drug within this Treatment Cycle and who wishes to recommence therapy with this drug within this same Cycle, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug
Where the most recent course of PBS-subsidised treatment was approved under either of the initial treatment restrictions (i.e. for patients with no prior PBS-subsidised biological therapy or, under this restriction, for patients who have received previous PBS-subsidised biological therapy), the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must have been submitted no later than 4 weeks from the date that course was ceased
Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment submitted no later than 4 weeks from the date that course was ceased
Where a response assessment was not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth)
Compliance with Written Authority Required procedures


 
C4845
P4845
 
Severe psoriatic arthritis
Continuing treatment - balance of supply
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis
Compliance with Written or Telephone Authority Required procedures


 
C4851
P4851
 
Severe psoriatic arthritis
Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) or Initial 2 (change or recommencement of treatment) - balance of supply
Patient must have received insufficient therapy with this drug under the Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement of treatment) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis
Compliance with Written or Telephone Authority Required procedures


 
C4864
P4864
 
Severe psoriatic arthritis
Continuing treatment
Patient must have a documented history of severe active psoriatic arthritis; AND
Patient must have received this drug as their most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle; AND
Patient must demonstrate, at the time of application, an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction
Patient must be an adult
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis
For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab or infliximab
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth)
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be provided for all subsequent continuing treatment applications
All applications for continuing treatment with this drug must include a measurement of response to the most recent course of PBS-subsidised therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with the initial treatment course
Where a response assessment is not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form
Compliance with Written Authority Required procedures


[154]       Schedule 4, Part 1, entry for Everolimus
insert in numerical order after existing text:

 
C4837
P4837
 
Metastatic or unresectable, well-differentiated malignant pancreatic neuroendocrine tumour (pNET)
Continuing treatment
Patient must have previously been issued with an authority prescription for this drug; AND
Patient must not have disease progression; AND
The treatment must be as monotherapy
Patients who have progressive disease with this drug are no longer eligible for PBS-subsidised treatment with this drug
Compliance with Authority Required procedures


 
C4861
P4861
 
Metastatic or unresectable, well-differentiated malignant pancreatic neuroendocrine tumour (pNET)
Initial treatment
Patient must be symptomatic (despite somatostatin analogues); OR
Patient must have disease progression; AND
The treatment must be as monotherapy
Disease progression must be documented in the patient's medical records
Patients who have developed progressive disease on sunitinib are not eligible to receive PBS-subsidised everolimus
Patients who have developed intolerance to sunitinib of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised everolimus
Compliance with Authority Required procedures


[155]       Schedule 4, Part 1, entry for Exenatide
substitute:

Exenatide
C4856
 
 
Diabetes mellitus type 2
The treatment must be in combination with metformin; OR
The treatment must be in combination with a sulfonylurea; AND
Patient must have a contraindication to a combination of metformin and a sulfonylurea; OR
Patient must not have tolerated a combination of metformin and a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with either metformin or a sulfonylurea; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with either metformin or a sulfonylurea
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records
Compliance with Authority Required procedures - Streamlined Authority Code 4856


 
C4857
 
 
Diabetes mellitus type 2
The treatment must be in combination with metformin; AND
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% prior to the initiation of a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor despite treatment with maximally tolerated doses of metformin and a sulfonylurea; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period prior to initiation with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor despite treatment with maximally tolerated doses of metformin and a sulfonylurea
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor is initiated
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records
Compliance with Authority Required procedures - Streamlined Authority Code 4857


[156]       Schedule 4, Part 1, entry for Golimumab
(a)      omit:

 
C3495
P3495
 
Psoriatic arthritis — initial treatment 1
Initial treatment commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:
(1) have severe active psoriatic arthritis; and
(2) have received no prior PBS‑subsidised treatment with a biological agent for this condition, or, where the patient has previously received PBS‑subsidised treatment with a biological agent for this condition, have received no such treatment for a period of 5 years or more starting from the date the last application for PBS‑subsidised therapy with a biological agent for this condition was approved; and
(3) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months and to either sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months or leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; and
where biological agent means adalimumab, etanercept, golimumab or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS‑subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
failure to achieve an adequate response to the treatment regimens specified at (3) above is demonstrated by the following:
(a) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C‑reactive protein (CRP) level greater than 15 mg per L; and
(b) either:
(i) an active joint count of at least 20 active (swollen and tender) joints; or
(ii) at least 4 active joints from the following list of major joints:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
if the requirement to demonstrate an elevated ESR or CRP cannot be met, the authority application includes the reasons why this criterion cannot be satisfied;
if treatment with any of the drugs mentioned at (3) above is contraindicated according to the relevant Therapeutic Goods Administration‑approved Product Information, the authority application includes details of the contraindication;
if intolerance to treatment with the regimens specified at (3) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;
the authority application is made in writing and includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application ‑ Supporting Information Form and a signed patient acknowledgment;
a course of initial treatment commencing a Treatment Cycle is limited to a maximum of 16 weeks of treatment
Compliance with Written Authority Required procedures

 
 
 
 
Continuation of a course of initial treatment with golimumab in a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures

 
C3497
P3497
 
Psoriatic arthritis — initial treatment 3
Commencement of a Biological Treatment Cycle, with an initial PBS‑subsidised course of golimumab for continuing treatment, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:
(1) have a documented history of severe active psoriatic arthritis; and
(2) were receiving treatment with golimumab prior to 1 March 2010; and
(3) have demonstrated a response to golimumab treatment as specified in the criteria for continuing PBS‑subsidised treatment with golimumab; and
(4) are receiving treatment with golimumab at the time of application; and
where biological agent means adalimumab, etanercept, golimumab or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS‑subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
the authority application is made in writing and includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application ‑ Supporting Information Form and a signed patient acknowledgment;
the course of treatment is limited to a maximum of 24 weeks of treatment;
patients are eligible for PBS‑subsidised treatment under the above criteria once only
Compliance with Written Authority Required procedures

 
 
 
 
Continuation of a course of initial PBS‑subsidised treatment with golimumab commencing a Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures

 
C3784
P3784
 
Psoriatic arthritis — initial treatment 2
Initial treatment, or recommencement of treatment, with golimumab within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who:
(1) have a documented history of severe active psoriatic arthritis; and
(2) have received prior PBS‑subsidised treatment with a biological agent for this condition in this Treatment Cycle and are eligible to receive further therapy with a biological agent; and
(3) have not failed treatment with golimumab during the current Treatment Cycle; and
where biological agent means adalimumab, etanercept, golimumab or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS‑subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
patients are eligible to receive further therapy with a biological agent within this Treatment Cycle provided they have not already failed, or ceased to respond to, PBS‑subsidised treatment with 3 biological agents within this Treatment Cycle;
the authority application is made in writing and includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application ‑ Supporting Information Form;
where a patient has received PBS‑subsidised treatment with golimumab within this Treatment Cycle and wishes to recommence therapy with this drug within this same cycle, the authority application is accompanied by evidence of a response to the patient’s most recent course of PBS‑subsidised golimumab treatment;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS‑subsidised golimumab treatment is a 16‑week initial treatment course, is made following a minimum of 12 weeks of therapy;
a course of initial treatment within an ongoing Treatment Cycle is limited to a maximum of 16 weeks of treatment
Compliance with Written Authority Required procedures

 
 
 
 
Continuation of a course of initial treatment, or of a course which recommences treatment, with golimumab within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for initial treatment or recommencement of treatment with this drug for a period of less than 16 weeks, and where approval of the application would enable the patient to complete a course of 16 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures

 
C3785
P3785
 
Psoriatic arthritis — continuing treatment
Continuing treatment with golimumab within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults:
(1) who have a documented history of severe active psoriatic arthritis; and
(2) whose most recent course of PBS‑subsidised treatment with a biological agent for this condition in the current Treatment Cycle was with golimumab; and
(3) who, at the time of application, demonstrate an adequate response to treatment with golimumab; and
where biological agent means adalimumab, etanercept, golimumab or infliximab; and
where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS‑subsidised treatment with a biological agent for psoriatic arthritis in at least the previous 5 years) receives an initial course of PBS‑subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS‑subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and
where the following conditions apply:
an adequate response to treatment with golimumab is defined as:
(a) an erythrocyte sedimentation rate no greater than 25 mm per hour or a C‑reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
(b) either of the following:
(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(ii) a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth);
the same indices of disease severity used to establish baseline at the commencement of an initial course of treatment are used to determine response to that course, and subsequent courses, of treatment;
the authority application is made in writing and includes a completed copy of the appropriate Psoriatic Arthritis PBS Authority Application ‑ Supporting Information Form, and a measurement of response to the most recent prior course of therapy with golimumab;
the response assessment included in the application is provided to the Chief Executive Medicare no later than 4 weeks from the cessation of the treatment course;
if the most recent course of golimumab therapy is a 16‑week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
if the response assessment to a course of treatment is not submitted to the Chief Executive Medicare within the timeframes specified above, the patient will be deemed to have failed that course of treatment;
a course of continuing treatment within an ongoing Treatment Cycle is limited to a maximum of 24 weeks of treatment
Compliance with Written Authority Required procedures

 
 
 
 
Continuation of a course of continuing treatment with golimumab within an ongoing Biological Treatment Cycle, by a rheumatologist or by a clinical immunologist with expertise in the management of psoriatic arthritis, of adults who have a documented history of severe active psoriatic arthritis and who, qualifying under the criteria specified above, have previously been issued with an authority prescription for continuing treatment with this drug for a period of less than 24 weeks, and where approval of the application would enable the patient to complete a course of 24 weeks of treatment in total
Compliance with Written or Telephone Authority Required procedures

(b)      insert in numerical order after existing text:

 
C4826
P4826
 
Severe psoriatic arthritis
Initial treatment – Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more)
Patient must have severe active psoriatic arthritis; AND
Patient must have received no prior PBS-subsidised treatment with a biological agent for this condition; OR
Patient must have received no PBS-subsidised treatment with a biological agent for at least 5 years if they have previously received PBS-subsidised treatment with a biological agent for this condition; AND
Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND
Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; OR
Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND
Patient must not receive more than 16 weeks of treatment under this restriction
Patient must be an adult
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis
For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab or infliximab.
Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application
Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application
The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C-reactive protein (CRP) level greater than 15 mg per L; and either
(a) an active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth)
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form; and
(3) a signed patient acknowledgement
Compliance with Written Authority Required procedures


 
C4840
P4840
 
Severe psoriatic arthritis
Initial treatment – Initial 2 (change or recommencement of treatment)
Patient must have a documented history of severe active psoriatic arthritis; AND
Patient must have received prior PBS-subsidised treatment with a biological agent for this condition in this Treatment Cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological agents within this Treatment Cycle; AND
Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug during the current Treatment Cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction
Patient must be an adult
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis
For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab or infliximab
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form
Applications for a patient who has previously received PBS-subsidised treatment with this drug within this Treatment Cycle and who wishes to recommence therapy with this drug within this same Cycle, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug
Where the most recent course of PBS-subsidised treatment was approved under either of the initial treatment restrictions (i.e. for patients with no prior PBS-subsidised biological therapy or, under this restriction, for patients who have received previous PBS-subsidised biological therapy), the patient must have been assessed for response following a minimum of 12 weeks of therapy. This assessment must have been submitted no later than 4 weeks from the date that course was ceased
Where the most recent course of PBS-subsidised treatment with this drug was approved under the continuing treatment criteria, the patient must have been assessed for response, and the assessment submitted no later than 4 weeks from the date that course was ceased
Where a response assessment was not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth)
Compliance with Written Authority Required procedures


 
C4845
P4845
 
Severe psoriatic arthritis
Continuing treatment - balance of supply
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis
Compliance with Written or Telephone Authority Required procedures


 
C4851
P4851
 
Severe psoriatic arthritis
Initial treatment - Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) or Initial 2 (change or recommencement of treatment) - balance of supply
Patient must have received insufficient therapy with this drug under the Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement of treatment) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis
Compliance with Written or Telephone Authority Required procedures


 
C4864
P4864
 
Severe psoriatic arthritis
Continuing treatment
Patient must have a documented history of severe active psoriatic arthritis; AND
Patient must have received this drug as their most recent course of PBS-subsidised treatment with a biological agent for this condition in the current Treatment Cycle; AND
Patient must demonstrate, at the time of application, an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction
Patient must be an adult
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis
For the purposes of this restriction 'biological agent' means adalimumab, certolizumab pegol, etanercept, golimumab or infliximab
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C-reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth)
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be provided for all subsequent continuing treatment applications
All applications for continuing treatment with this drug must include a measurement of response to the most recent course of PBS-subsidised therapy. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with the initial treatment course
Where a response assessment is not submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed Psoriatic Arthritis PBS Authority Application - Supporting Information Form
Compliance with Written Authority Required procedures


[157]       Schedule 4, Part 1, entry for Iron Polymaltose Complex
insert in the column headed “Conditions Code”:        CN4302
[158]       Schedule 4, Part 1, entry for Iron Sucrose
substitute:
Iron sucrose
 
P4302
CN4302
Iron deficiency anaemia
Patient must be undergoing chronic haemodialysis

Compliance with Authority Required procedures - Streamlined Authority Code 4302
[159]       Schedule 4, Part 1, entry for Lanthanum
substitute:

Lanthanum
C4827
 
 
Hyperphosphataemia
Maintenance following initiation and stabilisation
The condition must not be adequately controlled by calcium; AND
Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; OR
The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND
The treatment must not be used in combination with any other phosphate binding agents
Patient must be undergoing dialysis for chronic kidney disease
Compliance with Authority Required procedures - Streamlined Authority Code 4827


 
C4832
 
 
Where the patient is receiving treatment at/from a public hospital
Hyperphosphataemia
Initiation and stabilisation
The condition must not be adequately controlled by calcium; AND
Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; OR
The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND
The treatment must not be used in combination with any other phosphate binding agents
Patient must be undergoing dialysis for chronic kidney disease
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4832


 
C4847
 
 
Where the patient is receiving treatment at/from a private hospital
Hyperphosphataemia
Initiation and stabilisation
The condition must not be adequately controlled by calcium; AND
Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; OR
The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND
The treatment must not be used in combination with any other phosphate binding agents
Patient must be undergoing dialysis for chronic kidney disease
Compliance with Written and Telephone Authority Required procedures


[160]       Schedule 4, Part 1, entry for Mesalazine
insert in numerical order in the columns in the order indicated:
 
C4824
 
 
Ulcerative colitis
Patient must have had a documented hypersensitivity reaction to a sulphonamide; OR
Patient must be intolerant to sulfasalazine
Compliance with Authority Required procedures - Streamlined Authority Code 4824
[161]       Schedule 4, Part 1, omit entry for Mifepristone
[162]       Schedule 4, Part 1, omit entry for Misoprostol
[163]       Schedule 4, Part 1, after entry for Octreotide
insert:

Ofatumumab
C4828
 
 
Chronic lymphocytic leukaemia (CLL)
Initial treatment
The condition must be CD20 positive chronic lymphocytic leukaemia (CLL); AND
The condition must be previously untreated; AND
The treatment must be in combination with chlorambucil; AND
Patient must be inappropriate for fludarabine based therapy
Compliance with Authority Required procedures - Streamlined Authority Code 4828


 
C4858
 
 
Chronic lymphocytic leukaemia (CLL)
Continuing treatment
The condition must be CD20 positive chronic lymphocytic leukaemia (CLL); AND
Patient must have previously been issued with an authority prescription for this drug; AND
Patient must not have progressive disease; AND
Patient must be inappropriate for fludarabine based therapy; AND
The treatment must be in combination with chlorambucil
Compliance with Authority Required procedures - Streamlined Authority Code 4858


[164]       Schedule 4, Part 1, entry for Sevelamer
substitute:

Sevelamer
C4827
 
 
Hyperphosphataemia
Maintenance following initiation and stabilisation
The condition must not be adequately controlled by calcium; AND
Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; OR
The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND
The treatment must not be used in combination with any other phosphate binding agents
Patient must be undergoing dialysis for chronic kidney disease
Compliance with Authority Required procedures - Streamlined Authority Code 4827


 
C4832
 
 
Where the patient is receiving treatment at/from a public hospital
Hyperphosphataemia
Initiation and stabilisation
The condition must not be adequately controlled by calcium; AND
Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; OR
The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND
The treatment must not be used in combination with any other phosphate binding agents
Patient must be undergoing dialysis for chronic kidney disease
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4832


 
C4847
 
 
Where the patient is receiving treatment at/from a private hospital
Hyperphosphataemia
Initiation and stabilisation
The condition must not be adequately controlled by calcium; AND
Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; OR
The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND
The treatment must not be used in combination with any other phosphate binding agents
Patient must be undergoing dialysis for chronic kidney disease
Compliance with Written or Telephone Authority Required procedures


[165]       Sorafenib
(a)      insert in numerical order in the column headed “Purposes Code” for Circumstances Code C4230:                    P4230
(b)      insert in numerical order in the column headed “Purposes Code” for Circumstances Code C4234:                    P4234
(c)      insert in numerical order after existing text:

 
C4820
P4820
 
Stage IV clear cell variant renal cell carcinoma (RCC)
Continuing treatment beyond 3 months
Patient must have previously been issued with an authority prescription for this drug for this condition; AND
Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND
The treatment must be the sole PBS-subsidised therapy for this condition
A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug
Compliance with Authority Required procedures


 
C4841
P4841
 
Stage IV clear cell variant renal cell carcinoma (RCC)
Initial treatment
Patient must have progressive disease according to the Response Evaluation Criteria In Solid Tumours (RECIST) following first-line treatment with a tyrosine kinase inhibitor; AND
Patient must have a WHO performance status of 2 or less; AND
The treatment must be the sole PBS-subsidised therapy for this condition
Patients who have developed intolerance to a tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised treatment with this drug
A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug
Compliance with Authority Required procedures


[166]       Schedule 4, Part 1, after entry for Strontium
insert:

Sucroferric oxyhydroxide
C4827
 
 
Hyperphosphataemia
Maintenance following initiation and stabilisation
The condition must not be adequately controlled by calcium; AND
Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; OR
The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND
The treatment must not be used in combination with any other phosphate binding agents
Patient must be undergoing dialysis for chronic kidney disease
Compliance with Authority Required procedures - Streamlined Authority Code 4827


 
C4832
 
 
Where the patient is receiving treatment at/from a public hospital
Hyperphosphataemia
Initiation and stabilisation
The condition must not be adequately controlled by calcium; AND
Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; OR
The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND
The treatment must not be used in combination with any other phosphate binding agents
Patient must be undergoing dialysis for chronic kidney disease
Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4832


 
C4847
 
 
Where the patient is receiving treatment at/from a private hospital
Hyperphosphataemia
Initiation and stabilisation
The condition must not be adequately controlled by calcium; AND
Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; OR
The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND
The treatment must not be used in combination with any other phosphate binding agents
Patient must be undergoing dialysis for chronic kidney disease
Compliance with Written and Telephone Authority Required procedures


[167]       Schedule 4, Part 1, entry for Sunitinib
omit:

 
C4341
P4341
 
Metastatic or unresectable, well‑differentiated malignant pancreatic neuroendocrine tumour (pNET)
Continuing treatment
Patient must have previously been issued with an authority prescription for sunitinib;
Patient must not have progressive disease;
The treatment must be as monotherapy
Compliance with Authority Required procedures

 
C4354
P4354
 
Metastatic or unresectable, well‑differentiated malignant pancreatic neuroendocrine tumour (pNET)
Initial treatment
Patient must be symptomatic (despite somatostatin analogues); OR
Patient must have disease progression;
The treatment must be as monotherapy
Disease progression must be documented in the patient’s medical records
Compliance with Authority Required procedures

substitute:

 
C4837
P4837
 
Metastatic or unresectable, well-differentiated malignant pancreatic neuroendocrine tumour (pNET)
Continuing treatment
Patient must have previously been issued with an authority prescription for this drug; AND
Patient must not have disease progression; AND
The treatment must be as monotherapy
Patients who have progressive disease with this drug are no longer eligible for PBS-subsidised treatment with this drug
Compliance with Authority Required procedures


 
C4862
P4862
 
Metastatic or unresectable, well-differentiated malignant pancreatic neuroendocrine tumour (pNET)
Initial treatment
Patient must be symptomatic (despite somatostatin analogues); OR
Patient must have disease progression; AND
The treatment must be as monotherapy
Disease progression must be documented in the patient's medical records
Patients who have developed progressive disease on everolimus are not eligible to receive PBS-subsidised sunitinib for this condition
Patients who have developed intolerance to everolimus of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised sunitinib
Compliance with Authority Required procedures


[168]       Schedule 4, Part 1, entry for Testosterone
substitute:

Testosterone
C4866
 
 
Androgen deficiency
Patient must not have an established pituitary or testicular disorder; AND
The condition must not be due to age, obesity, cardiovascular diseases, infertility or drugs
Patient must be male; AND
Patient must be aged 40 years or older
Must be treated by a specialist urologist, specialist endocrinologist or a registered member of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists
Androgen deficiency is defined as:
(i) testosterone level of less than 6 nmol per litre; OR
(ii) testosterone level between 6 and 15 nmol per litre with high luteinising hormone (LH) (greater than 1.5 times the upper limit of the eugonodal reference range for young men, or greater than 14 IU per litre, whichever is higher)
Androgen deficiency must be confirmed by at least two morning blood samples taken on different mornings
The dates and levels of the qualifying testosterone and LH measurements must be, or must have been provided in the authority application when treatment with this drug is or was initiated
The name of the specialist must be included in the authority application
Compliance with Authority Required procedures


 
C4867
 
 
Micropenis
Patient must be male; AND
Patient must be under 18 years of age
Must be treated by a specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a registered member of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists
The name of the specialist must be included in the authority application
Compliance with Authority Required procedures


 
C4868
 
 
Androgen deficiency
Patient must have an established pituitary or testicular disorder
Patient must be male
Must be treated by a specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a registered member of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists
The name of the specialist must be included in the authority application
Compliance with Authority Required procedures


 
C4869
 
 
Pubertal induction
Patient must be male; AND
Patient must be under 18 years of age
Must be treated by a specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a registered member of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists
The name of the specialist must be included in the authority application.
Compliance with Authority Required procedures


 
C4870
 
 
Constitutional delay of growth or puberty
Patient must be male; AND
Patient must be under 18 years of age
Must be treated by a specialist paediatric endocrinologist, specialist urologist, specialist endocrinologist or a registered member of the Australasian Chapter of Sexual Health Medicine; or in consultation with one of these specialists; or have an appointment to be assessed by one of these specialists
The name of the specialist must be included in the authority application
Compliance with Authority Required procedures


[169]       Schedule 4, Part 1, entry for Varenicline
(a)      omit:
 
C4647
P4647
 
Nicotine dependence
Completion of a short-term (24 weeks) course of treatment
The treatment must be as an aid to achieving abstinence from smoking; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have previously been issued with an authority prescription for this drug during this current course of treatment; AND
Patient must have ceased smoking following an initial 12-weeks of PBS-subsidised treatment with this drug in the current course of treatment
Patient must be undergoing concurrent counselling for smoking cessation through a comprehensive support and counselling program
Compliance with Authority Required procedures

(b)      insert in numerical order after existing text:
 
C4835
P4835
 
Nicotine dependence
Completion of a short-term (24 weeks) course of treatment
The treatment must be as an aid to achieving abstinence from smoking; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have previously been issued with an authority prescription for this drug during this current course of treatment; AND
Patient must have ceased smoking in the process of completing an initial 12-weeks or ceased smoking following an initial 12-weeks of PBS-subsidised treatment with this drug in the current course of treatment
Patient must be undergoing concurrent counselling for smoking cessation through a comprehensive support and counselling program
Compliance with Authority Required procedures