National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013 (No. 12) (No. PB 69 of 2013)

Link to law: https://www.comlaw.gov.au/Details/F2013L01768

PB 69 of 2013
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2013
(No. 12)
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 3rd October 2013
 
 
 
 
 
 
 
 
 
 
 
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 2013 (No. 12).
            (2)        This Instrument may also be cited as PB 69 of 2013.
2          Commencement
This Instrument commences on 1 November 2013.
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]           Schedule 1, entry for Amino acid formula with vitamins and minerals without phenylalanine
omit from the column headed “Circumstances” (all instances):                                C1286                   substitute:             C4295
[2]           Schedule 1, after entry for Amino acid formula with vitamins and minerals without phenylalanine in the form Oral liquid 174 mL, 30
(PKU Cooler 20)
insert in the columns in the order indicated:
 
Oral semi-solid 109 g, 36 (PKU Lophlex Sensation 20)
Oral
PKU Lophlex Sensation 20
SB
MP NP
C4295
 
3
5
1
 
 
[3]           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)
(a)      omit:
 
 
 
Amoxycillin/ Clavulanic Acid 500/125 generichealth
GQ
PDP
C1836 C1837
 
10
0
10
 
 
(b)      omit:
 
 
 
Amoxycillin/ Clavulanic Acid 500/125 generichealth
GQ
MP NP MW
C1836 C1837
 
10
1
10
 
 
[4]           Schedule 1, entry for Azithromycin in the form Tablet 500 mg (as dihydrate) [Maximum Quantity 2; Number of Repeats 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Azithromycin-GA
UA
MP NP
C1405 C1838 C1839
P1838 P1839
2
0
2
 
 
[5]           Schedule 1, entry for Azithromycin in the form Tablet 500 mg (as dihydrate) [Maximum Quantity 2; Number of Repeats 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Azithromycin-GA
UA
MP NP
C1405 C1838 C1839
P1405
2
2
2
 
 
[6]           Schedule 1, entry for Candesartan in the form Tablet containing candesartan cilexetil 4 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pharmacor Candesartan 4
CR
MP NP
 
 
30
5
30
 
 
[7]           Schedule 1, entry for Candesartan in the form Tablet containing candesartan cilexetil 8 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pharmacor Candesartan 8
CR
MP NP
 
 
30
5
30
 
 
[8]           Schedule 1, entry for Candesartan in the form Tablet containing candesartan cilexetil 16 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pharmacor Candesartan 16
CR
MP NP
 
 
30
5
30
 
 
[9]           Schedule 1, entry for Candesartan in the form Tablet containing candesartan cilexetil 32 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Pharmacor Candesartan 32
CR
MP NP
 
 
30
5
30
 
 
[10]         Schedule 1, entry for Docetaxel in the form Injection set containing 1 single use vial concentrate for I.V. infusion 80 mg (anhydrous)
in 2 mL with solvent
omit:
 
 
 
Taxotere
SW
MP
C3888 C3892 C3916 C3956 C4078 C4140 C4160 C4239
 
See Note 3
See
Note 3
1
D(100)
[11]         Schedule 1, entry for Dornase Alfa
omit all codes from the column headed “Circumstances” and substitute:
4288  C4290  C4291  C4296  C4297  C4298  C4300  C4301
[12]         Schedule 1, entry for Doxycycline in the form Tablet 50 mg (as monohydrate)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Doxycycline Sandoz
HX
MP NP
C1346 C1851 C1852
 
25
5
25
 
 
[13]         Schedule 1, entry for Famciclovir in the form Tablet 250 mg [Maximum Quantity 21; Number of Repeats 0]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Famciclovir SCP 250
CR
MP NP
C3622 C3623
P3622
21
0
21
 
 
 
[14]         Schedule 1, entry for Famciclovir in the form Tablet 250 mg [Maximum Quantity 56; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Famciclovir SCP 250
CR
MP NP
C3622 C3623
P3623
56
5
56
 
 
[15]         Schedule 1, entry for High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate in the form
Oral powder 300 g (KetoCal)
(a)      omit from the column headed “Form”:                                (KetoCal)             substitute:             (KetoCal 4:1)
(b)      omit from the column headed “Brand”:               KetoCal                substitute:             KetoCal 4:1
(c)      omit from the column headed “Circumstances”:               C1578  C1579  C1580      substitute:             C4289
[16]         Schedule 1, entry for Imiquimod in the form Cream 50 mg per g, 250 mg single use sachets, 12
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Aldiq
QA
MP
C4229
 
1
1
1
 
 
[17]         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
5
5
 
 

 
 
Ferrum H
AS
MP NP
 
 
5
0
5
 
 

 
 
 
 
MP NP
 
P4302
5
5
5
 
 

[18]         Schedule 1, entry for Iron Sucrose
(a)      omit from the column headed “Form”:                                ampoule
(b)      omit from the column headed “Circumstances”:               C2070   substitute:          C4292
(c)      omit from the column headed “Number of Repeats”:        0          substitute:          5
[19]         Schedule 1, entry for Mannitol
omit all codes from the column headed “Circumstances” and substitute:              
C4293  C4294  C4299  C4303
[20]         Schedule 1, entry for Metoprolol in each of the forms: Tablet containing metoprolol tartrate 50 mg; and Tablet containing
metoprolol tartrate 100 mg
omit from the column headed “Brand”:          Metohexal           substitute:             Metoprolol Sandoz
[21]         Schedule 1, entry for Milk powder—lactose free formula in the form Oral powder 900 g (S-26 LF)
omit from the column headed “Responsible Person”:                  PF          substitute:             AS
 
[22]         Schedule 1, entry for Montelukast in the form Tablet, chewable, 4 mg (as sodium)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
T Lukast
AF
MP NP
C2617
 
28
5
28
 
 
[23]         Schedule 1, entry for Montelukast in the form Tablet, chewable, 5 mg (as sodium)
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
T Lukast
AF
MP NP
C2618 C3217
 
28
5
28
 
 
[24]         Schedule 1, entry for Olanzapine in each of the forms: Powder for injection 210 mg (as pamoate monohydrate) with diluent; Powder for injection 300 mg (as pamoate monohydrate) with diluent; and Powder for injection 405 mg (as pamoate monohydrate) with diluent
omit from the column headed “Circumstances”:           C1589    substitute:             C4304
[25]         Schedule 1, entry for Omeprazole in the form Tablet 20 mg
(a)      omit:
 
 
 
Omeprazole Winthrop
WA
MP NP
C4074 C4075 C4089 C4152
P4074
30
1
30
 
 
(b)      omit:
 
 
 
Omeprazole Winthrop
WA
MP NP
C4074 C4075 C4089 C4152
P4075 P4089 P4152
30
5
30
 
 
[26]         Schedule 1, entry for Perindopril in the form Tablet containing perindopril erbumine 2 mg
omit:
 
 
 
Perindopril generichealth
GQ
MP NP
 
30
5
30
 
[27]         Schedule 1, entry for Quinapril in the form Tablet 5 mg (as hydrochloride)
omit:
 
 
 
Quinapril generichealth
GQ
MP NP
 
30
5
30
 
[28]         Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated) [Maximum Quantity 30; Number of Repeats 2]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Rabeprazole Actavis 20
UA
MP NP
C1177 C1337 C1533
P1177
30
2
30
 
 
 
[29]         Schedule 1, entry for Rabeprazole in the form Tablet containing rabeprazole sodium 20 mg (enteric coated) [Maximum Quantity 30; Number of Repeats 5]
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Rabeprazole Actavis 20
UA
MP NP
C1177 C1337 C1533
P1337 P1533
30
5
30
 
 
[30]         Schedule 1, entry for Ramipril in the form Capsule 1.25 mg
omit:
 
 
 
Ramipril generichealth
GQ
MP NP
 
30
5
30
 
[31]         Schedule 1, omit entry for Tiaprofenic Acid
[32]         Schedule 1, entry for Trandolapril in each of the forms: Capsule 500 micrograms; Capsule 1 mg; Capsule 2 mg; and Capsule 4 mg
omit:
 
 
 
Trandolapril generichealth
GQ
MP NP
 
28
5
28
 
[33]         Schedule 4, Part 1, entry for Amino acid formula with vitamins and minerals without phenylalanine
omit from the column headed “Circumstances Code”:                                C1286    substitute:             C4295
[34]         Schedule 4, Part 1, entry for Dornase Alfa
substitute:

Dornase Alfa
C4288 
 
 
Where the patient is receiving treatment at/from a public hospital
Cystic fibrosis
Patient must have a forced vital capacity (FVC) greater than 40% predicted for age, gender and weight;
Patient must have evidence of chronic suppurative lung disease (cough and sputum most days of the week, or greater than 3 respiratory tract infections of more than 2 weeks' duration in any 12 months, or objective evidence of obstructive airways disease);
Patient must be 5 years of age or older
Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis. The prescribing of dornase alfa therapy under the HSD program is limited to such physicians. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be by a specialist physician or paediatrician in consultation with such a unit
The measurement of lung function is to be conducted by independent (other than the treating doctor) experienced personnel at an established lung function testing laboratory, unless this is not possible because of geographical isolation
Prior to dornase alfa therapy, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease
Initial therapy is limited to 3 months treatment with dornase alfa at a dose of 2.5 mg daily
FEV1 measurement (single test under conditions as above) and a global assessment of the patient involving the patient, the patient's family (in the case of paediatric patients), the treating physician(s) and an additional independent member of the cystic fibrosis treatment team must be undertaken and documented following 3 months of initial therapy
To be eligible for continued PBS-subsidised treatment with dornase alfa following 3 months of initial treatment:
(1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND
(2) the patient or the patient's family (in the case of paediatric patients) must report improvement in the patient's airway clearance; AND
(3) the treating physician(s) must report a benefit in the clinical status of the patient
Further reassessments involving the patient, the patient's family (in the case of paediatric patients), the treating physician(s) and an additional independent member of the cystic fibrosis treatment team must be undertaken and documented at six-monthly intervals to establish that all agree that dornase alfa treatment is continuing to produce worthwhile benefits. Dornase alfa therapy should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use
Other aspects of treatment, such as physiotherapy, must be continued
Where there is documented evidence that a patient already receiving dornase alfa therapy would have met the criteria for subsidy, then the patient is eligible to continue treatment under the HSD program. Where such evidence is not available, patients will need to satisfy the initiation and continuation criteria as for new patients. (Four weeks is considered a suitable wash-out period.)
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4288

 
C4290 
 
 
Where the patient is receiving treatment at/from a private hospital
Cystic fibrosis
Patient must have a forced vital capacity (FVC) greater than 40% predicted for age, gender and weight;
Patient must have evidence of chronic suppurative lung disease (cough and sputum most days of the week, or greater than 3 respiratory tract infections of more than 2 weeks' duration in any 12 months, or objective evidence of obstructive airways disease)
Patient must be 5 years of age or older
Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis. The prescribing of dornase alfa therapy under the HSD program is limited to such physicians. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be by a specialist physician or paediatrician in consultation with such a unit
The measurement of lung function is to be conducted by independent (other than the treating doctor) experienced personnel at an established lung function testing laboratory, unless this is not possible because of geographical isolation
Prior to dornase alfa therapy, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease
Initial therapy is limited to 3 months treatment with dornase alfa at a dose of 2.5 mg daily
FEV1 measurement (single test under conditions as above) and a global assessment of the patient involving the patient, the patient's family (in the case of paediatric patients), the treating physician(s) and an additional independent member of the cystic fibrosis treatment team must be undertaken and documented following 3 months of initial therapy
To be eligible for continued PBS-subsidised treatment with dornase alfa following 3 months of initial treatment:
(1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND
(2) the patient or the patient's family (in the case of paediatric patients) must report improvement in the patient's airway clearance; AND
(3) the treating physician(s) must report a benefit in the clinical status of the patient
Further reassessments involving the patient, the patient's family (in the case of paediatric patients), the treating physician(s) and an additional independent member of the cystic fibrosis treatment team must be undertaken and documented at six-monthly intervals to establish that all agree that dornase alfa treatment is continuing to produce worthwhile benefits. Dornase alfa therapy should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use
Other aspects of treatment, such as physiotherapy, must be continued
Where there is documented evidence that a patient already receiving dornase alfa therapy would have met the criteria for subsidy, then the patient is eligible to continue treatment under the HSD program. Where such evidence is not available, patients will need to satisfy the initiation and continuation criteria as for new patients. (Four weeks is considered a suitable wash-out period.)
Compliance with Written or Telephone Authority Required procedures

 

 
C4291 
 
 
Where the patient is receiving treatment at/from a private hospital
Cystic fibrosis
Continuing treatment
Patient must have initiated treatment with dornase alfa at an age of less than 5 years;
Patient must have undergone a comprehensive assessment, involving the patient's family, the treating physician and an additional independent member of the cystic fibrosis treatment team which documents agreement that dornase alfa treatment is continuing to produce worthwhile benefit;
Patient must be 5 years of age or older
Further reassessments must be undertaken and documented at six-monthly intervals. Treatment with dornase alfa should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use
Compliance with Written or Telephone Authority Required procedures

 
C4296 
 
 
Where the patient is receiving treatment at/from a public hospital
Cystic fibrosis
Continuing treatment
Patient must have initiated treatment with dornase alfa at an age of less than 5 years;
Patient must have undergone a comprehensive assessment, involving the patient's family, the treating physician and an additional independent member of the cystic fibrosis treatment team which documents agreement that dornase alfa treatment is continuing to produce worthwhile benefit;
Patient must be 5 years of age or older
Further reassessments must be undertaken and documented at six-monthly intervals. Treatment with dornase alfa should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4296

 
C4297 
 
 
Where the patient is receiving treatment at/from a private hospital
Cystic fibrosis
Patient must have initiated treatment with dornase alfa prior to 1 November 2009;
Patient must have undergone a comprehensive assessment, involving the patient's family, the treating physician and an additional independent member of the cystic fibrosis treatment team which documents agreement that dornase alfa treatment is continuing to produce worthwhile benefit;
Patient must be less than 5 years of age
Further reassessments must be undertaken and documented at six-monthly intervals. Treatment with dornase alfa should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use
Compliance with Written or Telephone Authority Required procedures

 
C4298 
 
 
Where the patient is receiving treatment at/from a public hospital
Cystic fibrosis
Patient must have initiated treatment with dornase alfa prior to 1 November 2009;
Patient must have undergone a comprehensive assessment, involving the patient's family, the treating physician and an additional independent member of the cystic fibrosis treatment team which documents agreement that dornase alfa treatment is continuing to produce worthwhile benefit;
Patient must be less than 5 years of age
Further reassessments must be undertaken and documented at six-monthly intervals. Treatment with dornase alfa should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4298

 
C4300 
 
 
Where the patient is receiving treatment at/from a public hospital
Cystic fibrosis
Patient must have a severe clinical course with frequent respiratory exacerbations or chronic respiratory symptoms (including chronic or recurrent cough, wheeze or tachypnoea) requiring hospital admissions more frequently than 3 times per year; OR
Patient must have significant bronchiectasis on chest high resolution computed tomography scan; OR
Patient must have severe cystic fibrosis bronchiolitis with persistent wheeze non-responsive to conventional medicines; OR
Patient must have severe physiological deficit measure by forced oscillation technique or multiple breath nitrogen washout and failure to respond to conventional therapy;
Patient must be less than 5 years of age
Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis. The prescribing of dornase alfa therapy under the HSD program is limited to such physicians. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be by a specialist physician or paediatrician in consultation with such a unit
Following an initial 6 months therapy, a comprehensive assessment must be undertaken and documented involving the patient, the patient's family, the treating physician and an additional independent member of the cystic fibrosis treatment team to establish agreement that dornase alfa treatment is continuing to produce worthwhile benefit. Treatment with dornase alfa should cease if there is not agreement of benefit, as there is always the possibility of harm from unnecessary use. Further reassessments must be undertaken and documented at six-monthly intervals
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4300

 
C4301
 
 
Where the patient is receiving treatment at/from a private hospital
Cystic fibrosis
Patient must have a severe clinical course with frequent respiratory exacerbations or chronic respiratory symptoms (including chronic or recurrent cough, wheeze or tachypnoea) requiring hospital admissions more frequently than 3 times per year; OR
Patient must have significant bronchiectasis on chest high resolution computed tomography scan; OR
Patient must have severe cystic fibrosis bronchiolitis with persistent wheeze non-responsive to conventional medicines; OR
Patient must have severe physiological deficit measure by forced oscillation technique or multiple breath nitrogen washout and failure to respond to conventional therapy
Patient must be less than 5 years of age
Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis. The prescribing of dornase alfa therapy under the HSD program is limited to such physicians. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be by a specialist physician or paediatrician in consultation with such a unit
Following an initial 6 months therapy, a comprehensive assessment must be undertaken and documented involving the patient, the patient's family, the treating physician and an additional independent member of the cystic fibrosis treatment team to establish agreement that dornase alfa treatment is continuing to produce worthwhile benefit. Treatment with dornase alfa should cease if there is not agreement of benefit, as there is always the possibility of harm from unnecessary use. Further reassessments must be undertaken and documented at six-monthly intervals
Compliance with Written or Telephone Authority Required procedures

[35]         Schedule 4, Part 1, entry for High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate
(a)      omit:

 
C1578
 
 
Patients with intractable seizures requiring treatment with a ketogenic diet
 

 
C1579
 
 
Glucose transport protein defects
 

 
C1580
 
 
Pyruvate dehydrogenase deficiency
 

(b)      insert in numerical order after existing text:
 
C4289
 
 
Ketogenic diet
Patient must have intractable seizures requiring treatment with a ketogenic diet; OR
Patient must have a glucose transport protein defect; OR
Patient must have pyruvate dehydrogenase deficiency
KetoCal 4:1 should only be used under strict supervision of a dietician, together with a metabolic physician and/or neurologist
 
 
[36]         Schedule 4, Part 1, after entry for Irinotecan
insert:
Iron Polymaltose Complex
 
P4302
 
Iron deficiency anaemia
Patient must be undergoing chronic haemodialysis

Compliance with Authority Required procedures - Streamlined Authority Code 4302
[37]         Schedule 4, Part 1, entry for Iron Sucrose
substitute:
Iron Sucrose
C4292
 
 
Iron deficiency anaemia
Patient must be undergoing chronic haemodialysis;
The treatment must be in combination with an erythropoiesis stimulating agent;
Patient must have had a documented hypersensitivity reaction to iron polymaltose;
Patient must be a person in whom continued intravenous iron therapy is appropriate
Compliance with Authority Required procedures - Streamlined Authority Code 4292
[38]         Schedule 4, Part 1, entry for Mannitol
substitute:

Mannitol
C4293 
 
 
Where the patient is receiving treatment at/from a public hospital
Cystic fibrosis
Patient must have initiated treatment with mannitol prior to 1 August 2012;
Patient must have undergone a comprehensive assessment involving the patient's family, the treating physician and an additional independent member of the cystic fibrosis team, which documents agreement that mannitol treatment is continuing to produce a worthwhile benefit;
Patient must be 6 years of age or older
Further reassessments are to be undertaken and documented every 6 months. Treatment with mannitol should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4293

 
C4294 
 
 
Where the patient is receiving treatment at/from a private hospital
Cystic fibrosis
Patient must have initiated treatment with mannitol prior to 1 August 2012;
Patient must have undergone a comprehensive assessment involving the patient's family, the treating physician and an additional independent member of the cystic fibrosis team, which documents agreement that mannitol treatment is continuing to produce a worthwhile benefit;
Patient must be 6 years of age or older
Further reassessments are to be undertaken and documented every 6 months. Treatment with mannitol should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use
Compliance with Written or Telephone Authority Required procedures

 
C4299 
 
 
Where the patient is receiving treatment at/from a public hospital
Cystic fibrosis
Patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved Product Information mannitol initiation dose assessment, prior to mannitol therapy. If the patient has a negative hyperresponsiveness test they may be eligible for PBS subsidised treatment with mannitol;
Patient must have a forced expiratory volume in 1 second (FEV1) greater than 30% predicted for age, gender and height;
Patient must be intolerant or inadequately responsive to dornase alfa;
Patient must have evidence of chronic suppurative lung disease (cough and sputum most days of the week, or greater than 3 respiratory tract infections of more than 2 weeks' duration in any 12 months, or objective evidence of obstructive airways disease);
Patient must be 6 years of age or older
Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis. The prescribing of mannitol therapy under the HSD program is limited to such physicians. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be by a specialist physician or paediatrician in consultation with such a unit
The measurement of lung function is to be conducted by independent (other than the treating doctor) experienced personnel at an established lung function testing laboratory, unless this is not possible because of geographical isolation
Prior to mannitol therapy, a baseline measurement of FEV1 must be undertaken during a stable period of the disease
Initial therapy is limited to 3 months treatment with mannitol at a dose of 400 mg twice daily
FEV1 measurement (single test under conditions as above) and a global assessment of the patient involving the patient, the patient's family (in the case of paediatric patients), the treating physician(s) and an additional independent member of the cystic fibrosis treatment team must be undertaken and documented following 3 months of initial therapy
To be eligible for continued PBS-subsidised treatment with mannitol following 3 months of initial treatment:
(1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND
(2) the patient or the patient's family (in the case of paediatric patients) must report improvement in the patient's airway clearance; AND
(3) the treating physician(s) must report a benefit in the clinical status of the patient
Further reassessments involving the patient, the patient's family (in the case of paediatric patients), the treating physician(s) and an additional independent member of the cystic fibrosis treatment team must be undertaken and documented at six-monthly intervals to establish that all agree that mannitol treatment is continuing to produce worthwhile benefits. Mannitol therapy should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use
Other aspects of treatment, such as physiotherapy, must be continued
Where there is documented evidence that a patient already receiving mannitol therapy would have met the criteria for subsidy then the patient is eligible to continue treatment under the HSD program. Where such evidence is not available, patients will need to satisfy the initiation and continuation criteria as for new patients. (Four weeks is considered a suitable wash-out period.)
Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 4299

 
C4303
 
 
Where the patient is receiving treatment at/from a private hospital
Cystic fibrosis
Patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved Product Information mannitol initiation dose assessment, prior to mannitol therapy. If the patient has a negative hyperresponsiveness test they may be eligible for PBS subsidised treatment with mannitol;
Patient must have a forced expiratory volume in 1 second (FEV1) greater than 30% predicted for age, gender and height;
Patient must be intolerant or inadequately responsive to dornase alfa;
Patient must have evidence of chronic suppurative lung disease (cough and sputum most days of the week, or greater than 3 respiratory tract infections of more than 2 weeks' duration in any 12 months, or objective evidence of obstructive airways disease);
Patient must be 6 years of age or older
Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis. The prescribing of mannitol therapy under the HSD program is limited to such physicians. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be by a specialist physician or paediatrician in consultation with such a unit
The measurement of lung function is to be conducted by independent (other than the treating doctor) experienced personnel at an established lung function testing laboratory, unless this is not possible because of geographical isolation
Prior to mannitol therapy, a baseline measurement of FEV1 must be undertaken during a stable period of the disease
Initial therapy is limited to 3 months treatment with mannitol at a dose of 400 mg twice daily
FEV1 measurement (single test under conditions as above) and a global assessment of the patient involving the patient, the patient's family (in the case of paediatric patients), the treating physician(s) and an additional independent member of the cystic fibrosis treatment team must be undertaken and documented following 3 months of initial therapy
To be eligible for continued PBS-subsidised treatment with mannitol following 3 months of initial treatment:
(1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND
(2) the patient or the patient's family (in the case of paediatric patients) must report improvement in the patient's airway clearance; AND
(3) the treating physician(s) must report a benefit in the clinical status of the patient
Further reassessments involving the patient, the patient's family (in the case of paediatric patients), the treating physician(s) and an additional independent member of the cystic fibrosis treatment team must be undertaken and documented at six-monthly intervals to establish that all agree that mannitol treatment is continuing to produce worthwhile benefits. Mannitol therapy should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use
Other aspects of treatment, such as physiotherapy, must be continued
Where there is documented evidence that a patient already receiving mannitol therapy would have met the criteria for subsidy then the patient is eligible to continue treatment under the HSD program. Where such evidence is not available, patients will need to satisfy the initiation and continuation criteria as for new patients. (Four weeks is considered a suitable wash-out period.)
Compliance with Written or Telephone Authority Required procedures

[39]         Schedule 4, Part 1, entry for Olanzapine
insert in numerical order after existing text:
 
C4304
 
 
Schizophrenia
Compliance with Authority Required procedures - Streamlined Authority Code 4304
[40]         Schedule 4, Part 1, omit entry for Tiaprofenic Acid
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