National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2011 (No. 11) (No. PB 74 of 2011)

Link to law: https://www.comlaw.gov.au/Details/F2011L02132

PB 74 of 2011
National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2011
(No.11)1
National Health Act 1953
I, FELICITY McNEILL, Acting First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this Instrument under sections 84AF, 85, 85A, 88 and 101 of the National Health Act 1953.
Dated 18 October 2011
 
 
 
 
 
 
 
 
 
 
 
FELICITY McNEILL
Acting First Assistant Secretary
Pharmaceutical Benefits Division
Department of Health and Ageing
 
1          Name of Instrument
            (1)        This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2011 (No. 11).
            (2)        This Instrument may also be cited as PB 74 of 2011.
2          Commencement
            This Instrument commences on 1 November 2011.
3          Amendment of the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010)
            Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (PB 108 of 2010).
Schedule 1     Amendments
 
[1]           Schedule 1, entry for Adefovir
omit from the column headed “Circumstances”:
C2931  C3313
substitute:
C3863  C3864
[2]           Schedule 1, entry for Benzathine benzylpenicillin
omit from the column headed “Responsible Person”:                 AS        substitute:          PF
[3]           Schedule 1, entry for Bupropion
omit from the column headed “Responsible Person” (twice occurring):                                AF        substitute:          GM
[4]           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-GA
GN
MP NP
C1211
 
28
5
 
[5]           Schedule 1, entry for Clopidogrel in the form Tablet 75 mg (as hydrogen sulfate) [brands Clopidogrel Winthrop; Iscover; Plavix]
omit from the column headed “Circumstances”:
C3245
substitute:
C3879
[6]           Schedule 1, entry for Clopidogrel with aspirin
omit from the column headed “Circumstances” (all instances):
C3246
substitute:
C3880
 
[7]           Schedule 1, entry for Colchicine
omit from the column headed “Number of Repeats” (twice occurring):                  2          substitute:          5
[8]           Schedule 1, entry for Donepezil in each of the forms: Tablet containing donepezil hydrochloride 5 mg;
and Tablet containing donepezil hydrochloride 10 mg
omit from the column headed “Circumstances”:
C2933  C2934
C2936  C2938
substitute:
C2934  C2938
C3875  C3876
[9]           Schedule 1, entry for Dothiepin in the form Capsule containing dothiepin hydrochloride 25 mg
omit:
 
 
 
Prothiaden
AB
MP NP
 
 
50
2
 
[10]         Schedule 1, after entry for Eletriptan in the form Tablet 80 mg (as hydrobromide)
insert:
Eltrombopag
Tablet 25 mg (as olamine)
Oral
Revolade
GK
MP
See Note 1
See Note 3
See Note 3
See Note 3
See Note 3
D

 
Tablet 50 mg (as olamine)
Oral
Revolade
GK
MP
See Note 1
See Note 3
See Note 3
See Note 3
See Note 3
D

[11]         Schedule 1, entry for Entecavir in the form Tablet containing entecavir monohydrate 0.5 mg
omit from the column headed “Circumstances”:
C2937  C3352
substitute:
C3871  C3872
 
[12]         Schedule 1, entry for Entecavir in the form Tablet containing entecavir monohydrate 1 mg
omit from the column headed “Circumstances”:
C2935  C3353
substitute:
C3873  C3874
[13]         Schedule 1, entry for Esomeprazole
omit:
 
Tablet (enteric coated) 40 mg (as magnesium trihydrate)
Oral
Nexium
AP
MP NP
C1628 C3429
P1628
30
1
 

 
 
 
 
 
MP NP
C1628 C3429
P3429
30
5
 

substitute:
 
Tablet (enteric coated) 40 mg (as magnesium trihydrate)
Oral
Nexium
AP
MP NP
C1337 C1628 C3429
P1628
30
1
 

 
 
 
 
 
MP NP
C1337 C1628 C3429
P1337 P3429
30
5
 

[14]         Schedule 1, entry for Fluorouracil in the form Injection 1000 mg in 20 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
DBL Fluorouracil Injection BP
HH
MP
See Note 1
 
 
5
0
 
[15]         Schedule 1, entry for Fluorouracil in the form Injection 2500 mg in 50 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
DBL Fluorouracil Injection BP
HH
MP
See Note 1
 
 
2
0
 
[16]         Schedule 1, entry for Galantamine in each of the forms: Capsule (prolonged release) 8 mg (as hydrobromide); Capsule (prolonged release) 16 mg (as hydrobromide); and Capsule (prolonged release) 24 mg (as hydrobromide)
omit from the column headed “Circumstances” (all instances):
C2933  C2934
C2936  C2938
substitute:
C2934  C2938
C3875  C3876
[17]         Schedule 1, entry for Interferon Alfa-2a in each of the forms: Injection 3,000,000 I.U. in 0.5 mL single dose pre-filled syringe; Injection 4,500,000 I.U. in 0.5 mL single dose pre-filled syringe; Injection 6,000,000 I.U. in 0.5 mL single dose pre-filled syringe;
and Injection 9,000,000 I.U. in 0.5 mL single dose pre-filled syringe
omit from the column headed “Circumstances”:
C1463  C2939
C3382  C3383
substitute:
C1463  C3382
C3869  C3870
[18]         Schedule 1, entry for Interferon Alfa-2b in each of the forms: Solution for injection 10,000,000 I.U. in 1 mL single dose vial; Solution for injection 18,000,000 I.U. in 3 mL single dose vial; Solution for injection 18,000,000 I.U. in 1.2 mL multi-dose injection pen; Solution for injection 25,000,000 I.U. in 2.5 mL single dose vial; Solution for injection 60,000,000 I.U. in 1.2 mL multi-dose injection pen; and Solution for injection 30,000,000 I.U. in 1.2 mL multi-dose injection pen
omit from the column headed “Circumstances”:
C1009  C1463
C2939  C3382
C3383  C3384
substitute:
C1009  C1463
C3382  C3384
C3869  C3870
[19]         Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Irinotecan Actavis 500
TA
MP
See Note 1
C3184
 
1
3
 
[20]         Schedule 1, entry for Lamivudine in each of the forms: Tablet 100 mg; and Oral solution 5 mg per mL, 240 mL
omit from the column headed “Circumstances”:
C2932  C3386
substitute:
C3871  C3872
[21]         Schedule 1, entry for Levetiracetam in each of the forms: Tablet 250 mg; Tablet 500 mg; and Tablet 1 g
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Levitaccord
RA
MP NP
C2664
 
60
5
 
[22]         Schedule 1, entry for Memantine in each of the forms: Tablet containing memantine hydrochloride 10 mg; and Tablet containing memantine hydrochloride 20 mg
omit from the column headed “Circumstances” (all instances):
C2608  C2609
C2610  C2611
substitute:
C2609  C2611
C3877  C3878
[23]         Schedule 1, entry for Methotrexate in the form Tablet 10 mg [Max Quantity 15; Number of Repeats 1]
omit from the column headed “Number of Repeats”:                  1          substitute:          3
[24]         Schedule 1, entry for Methotrexate in the form Injection 50 mg in 2 mL vial
omit from the column headed “Number of Repeats” (twice occurring):                  0          substitute:          5
[25]         Schedule 1, after entry for Milk powder—lactose free formula in the form Oral powder 900 g (S-26 LF)
insert in the columns in the order indicated:
 
Oral powder 900 g (Karicare Aptamil De-Lact)
Oral
Karicare Aptamil De-Lact
NU
MP NP
C2760 C2762
P2762
5
0
 

 
 
 
 
 
MP NP
C2760 C2762
P2760
5
5
 

[26]         Schedule 1, entry for Milk powder—lactose free formula in the form Oral powder 900 g (Karicare De-Lact)
omit from the column headed “Responsible Person”:                 NU          substitute:             SB
[27]         Schedule 1, entry for Nicotine in each of the forms: Transdermal patch 52.5 mg; and Transdermal patch 114 mg
insert in numerical order in the column headed “Circumstances”:
C3042
[28]         Schedule 1, entry for Peginterferon Alfa-2a in each of the forms: Injection 135 micrograms in 0.5 mL single use pre-filled syringe;
and Injection 180 micrograms in 0.5 mL single use pre-filled syringe
omit from the column headed “Circumstances”:
C2234  C2940
C3411  C3412
substitute:
C2234  C3412
C3867  C3868
[29]         Schedule 1, entry for Prochlorperazine in the form Tablet containing prochlorperazine maleate 5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Prochlorperazine GH
GQ
PDP MP NP
 
 
25
0
 
 
[30]         Schedule 1, after entry for Protein hydrolysate formula with medium chain triglycerides in the form Oral powder 400 g (Alfaré)
insert in the columns in the order indicated:
 
Oral powder 450 g (Karicare Aptamil Pepti-Junior Gold)
Oral
Karicare Aptamil Pepti-Junior Gold
NU
MP NP
C1034 C1059 C1080 C1092 C1310 C1364 C1670 C2567 C2806 C2811 C2812 C2813 C2814 C2815
 
8
5
 
[31]         Schedule 1, entry for Protein hydrolysate formula with medium chain triglycerides in the form Oral powder 450 g (Pepti-Junior Gold)
omit from the column headed “Responsible Person”:                 NU          substitute:             SB
[32]         Schedule 1, entry for Rivastigmine in each of the forms: Capsule 1.5 mg (as hydrogen tartate); Capsule 3 mg (as hydrogen tartate); Capsule 4.5 mg (as hydrogen tartate); Capsule 6 mg (as hydrogen tartate); Oral solution 2 mg (as hydrogen tartate) per mL, 120 mL; Transdermal patch 9 mg; and Transdermal patch 18 mg
omit from the column headed “Circumstances”:
C2933  C2934
C2936  C2938
substitute:
C2934  C2938
C3875  C3876
[33]         Schedule 1, entry for Roxithromycin in the form Tablet 150 mg [Max Quantity 10; Number of Repeats 0]
(a)        omit from the column headed “Responsible Person”:                 SZ          substitute:             HX
(b)        insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Roxithromycin Sandoz
SZ
PDP
 
 
10
0
 
[34]         Schedule 1, entry for Roxithromycin in the form Tablet 150 mg [Max Quantity 10; Number of Repeats 1]
(a)        omit from the column headed “Responsible Person”:                 SZ          substitute:             HX
(b)        insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
 
 
 
Roxithromycin Sandoz
SZ
MP NP
 
 
10
1
 
[35]         Schedule 1, entry for Telbivudine
omit from the column headed “Circumstances”:
C3052  C3416
substitute:
C3865  C3866
[36]         Schedule 1, entry for Tenofovir
omit from the column headed “Circumstances”:
C2931  C3203
C3313  C3417
insert in numerical order in the column headed “Circumstances”:
C3863  C3864
C3865  C3866
[37]         Schedule 1, entry for Tiotropium
omit from the column headed “Circumstances”:          C1646               substitute:          C3883
[38]         Schedule 1, entry for Zoledronic acid in the form Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL
omit from the column headed “Circumstances”:
C1035  C1233
C1500  C1797
C3341  C3342
C3343  C3422
substitute:
C1035  C1233
C1500  C3341
C3342  C3343
C3881  C3882
[39]         Schedule 4, Part 1, entry for Adefovir
substitute:
 
Adefovir
C3863
 
Where the patient is receiving treatment at/from a private hospital
Chronic hepatitis B in a patient who has failed antihepadnaviral therapy and who satisfies all of the following criteria:
(a) Repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration in conjunction with documented chronic hepatitis B infection; or
(b) Repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months, whilst on previous antihepadnaviral therapy except in patients with evidence of poor compliance
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures

 
C3864
 
Where the patient is receiving treatment at/from a public hospital
Chronic hepatitis B
Chronic hepatitis B in a patient who has failed antihepadnaviral therapy and who satisfies all of the following criteria:
(a) Repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration in conjunction with documented chronic hepatitis B infection; or
(b) Repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months, whilst on previous antihepadnaviral therapy except in patients with evidence of poor compliance
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3864


[40]         Schedule 4, Part 1, entry for Clopidogrel
omit:
 
 
C3245
 
Treatment of acute coronary syndromes (myocardial infarction or unstable angina) in combination with aspirin
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3245

substitute:
 
 
C3879
 
Treatment of acute coronary syndrome (myocardial infarction or unstable angina) in combination with aspirin
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3879

[41]         Schedule 4, Part 1, entry for Clopidogrel with aspirin
omit:
 
 
C3246
 
Treatment of acute coronary syndromes (myocardial infarction or unstable angina)
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3246

substitute:
 
 
C3880
 
Treatment of acute coronary syndrome (myocardial infarction or unstable angina)
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3880

[42]         Schedule 4, Part 1, entry for Donepezil
(a)        omit:
 
 
C2933
 
Initial treatment, for up to 2 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more, where the diagnosis is confirmed by a specialist or consultant physician, where the result of the baseline MMSE or SMMSE is included in the authority application, and where, if the patient's baseline MMSE or SMMSE is 25 to 30 points and it is so desired, the result of a baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale, is also included in the authority application

Compliance with Authority Required procedures


 
 
 
Continuation of initial treatment, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more, where the patient has previously been issued with an authority prescription for initial treatment with this drug for a period of up to 2 months, where the application includes the baseline scores submitted with the first application for initial treatment, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 6 months' duration in total
Initial treatment, for up to 6 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more, where the diagnosis is confirmed by a specialist or consultant physician, where the result of the baseline MMSE or SMMSE is included in the authority application, and where, if the patient's baseline MMSE or SMMSE is 25 to 30 points and it is so desired, the result of a baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale, is also included in the authority application
Compliance with Written Authority Required procedures


(b)        omit:
 
 
C2936
 
Initial treatment, for up to 2 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease as they are from 1 or more of the qualifying groups specified below, where the patient is assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale and the diagnosis is confirmed by a specialist or consultant physician, and where the authority application includes the result of the baseline MMSE or SMMSE and specifies to which of the following qualifying groups patient belongs:
Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;
Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;
Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an MMSE or SMMSE test;
Intellectual (developmental or acquired) disability;
Significant sensory impairment despite best correction, which precludes completion of an MMSE or SMMSE test;
Prominent dysphasia, out of proportion to other cognitive and functional impairment

Compliance with Written Authority Required procedures


 
 
 
Continuation of initial treatment, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease, where the patient has previously been issued with an authority prescription for initial treatment with this drug for a period of up to 2 months, where the application includes the information submitted with the first application for initial treatment, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 6 months' duration in total

Compliance with Written Authority Required procedures

 
 
 
Initial treatment, for up to 6 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease as they are from 1 or more of the qualifying groups specified below, where the patient is assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale and the diagnosis is confirmed by a specialist or consultant physician, and where the authority application includes the result of the baseline MMSE or SMMSE and specifies to which of the following qualifying groups the patient belongs:
Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;
Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;
Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an MMSE or SMMSE test;
Intellectual (developmental or acquired) disability;
Significant sensory impairment despite best correction, which precludes completion of an MMSE or SMMSE test;
Prominent dysphasia, out of proportion to other cognitive and functional impairment
Compliance with Written Authority Required procedures


(c)        insert after existing text in the columns in the order indicated:
 
 
C3875
 
Initial treatment, for up to 2 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more, where the diagnosis is confirmed by or in consultation with a specialist or consultant physician, where the result of the baseline MMSE or SMMSE is included in the authority application, and where, if the patient's baseline MMSE or SMMSE is 25 to 30 points and it is so desired, the result of a baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale, is also included in the authority application

Compliance with Authority Required procedures

 

 
 
 
Continuation of initial treatment, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more, where the patient has previously been issued with an authority prescription for initial treatment with this drug for a period of up to 2 months, where the application includes the baseline scores submitted with the first application for initial treatment, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 6 months' duration in total

Compliance with Written Authority Required procedures


 
 
 
Initial treatment, for up to 6 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more, where the diagnosis is confirmed by or in consultation with a specialist or consultant physician, where the result of the baseline MMSE or SMMSE is included in the authority application, and where, if the patient's baseline MMSE or SMMSE is 25 to 30 points and it is so desired, the result of a baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale, is also included in the authority application
Compliance with Written Authority Required procedures


 
C3876
 
Initial treatment, for up to 2 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease as they are from 1 or more of the qualifying groups specified below, where the patient is assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale and the diagnosis is confirmed by or in consultation with a specialist or consultant physician, and where the authority application includes the result of the baseline MMSE or SMMSE and specifies to which of the following qualifying groups patient belongs:
Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;
Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;
Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an MMSE or SMMSE test;
Intellectual (developmental or acquired) disability;
Significant sensory impairment despite best correction, which precludes completion of an MMSE or SMMSE test;
Prominent dysphasia, out of proportion to other cognitive and functional impairment

Compliance with Authority Required procedures


 
 
 
Continuation of initial treatment, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease, where the patient has previously been issued with an authority prescription for initial treatment with this drug for a period of up to 2 months, where the application includes the information submitted with the first application for initial treatment, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 6 months' duration in total

Compliance with Written Authority Required procedures


 
 
 
Initial treatment, for up to 6 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease as they are from 1 or more of the qualifying groups specified below, where the patient is assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale and the diagnosis is confirmed by or in consultation with a specialist or consultant physician, and where the authority application includes the result of the baseline MMSE or SMMSE and specifies to which of the following qualifying groups the patient belongs:
Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;
Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;
Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an MMSE or SMMSE test;
Intellectual (developmental or acquired) disability;
Significant sensory impairment despite best correction, which precludes completion of an MMSE or SMMSE test;
Prominent dysphasia, out of proportion to other cognitive and functional impairment
Compliance with Written Authority Required procedures


[43]         Schedule 4, Part 1, entry for Emtricitabine [Circumstances Codes 3588 and 3589]
omit from the column headed “Authority Requirements–Part of Circumstances”:               Wrtten                   substitute:                Written
[44]         Schedule 4, Part 1, entry for Entecavir
substitute:
 
Entecavir
C3871
 
Where the patient is receiving treatment at/from a private hospital
Chronic hepatitis B in a patient who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy.
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures

 
C3872
 
Where the patient is receiving treatment at/from a public hospital
Chronic hepatitis B in a patient who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAG positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAG negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy.
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3872


 
C3873
 
Where the patient is receiving treatment at/from a private hospital
Chronic hepatitis B in a patient who has failed lamivudine therapy and who satisfies all of the following criteria:
(a) Repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration in conjunction with documented chronic hepatitis B infection; or
(b) Repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months, whilst on previous antihepadnaviral therapy except in patients with evidence of poor compliance.
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures

 
 
C3874
 
Where the patient is receiving treatment at/from a public hospital
Chronic hepatitis B
Chronic hepatitis B in a patient who has failed lamivudine therapy and who satisfies all of the following criteria:
(a) Repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration in conjunction with documented chronic hepatitis B infection; or
(b) Repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months, whilst on previous antihepadnaviral therapy except in patients with evidence of poor compliance.
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3874

[45]         Schedule 4, Part 1, entry for Galantamine
(a)        omit:
 
C2933
 
Initial treatment, for up to 2 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more, where the diagnosis is confirmed by a specialist or consultant physician, where the result of the baseline MMSE or SMMSE is included in the authority application, and where, if the patient's baseline MMSE or SMMSE is 25 to 30 points and it is so desired, the result of a baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale, is also included in the authority application
Compliance with Authority Required procedures


 
 
 
Continuation of initial treatment, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more, where the patient has previously been issued with an authority prescription for initial treatment with this drug for a period of up to 2 months, where the application includes the baseline scores submitted with the first application for initial treatment, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 6 months' duration in total
Compliance with  Written Authority Required procedures


 
 
 
Initial treatment, for up to 6 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more, where the diagnosis is confirmed by a specialist or consultant physician, where the result of the baseline MMSE or SMMSE is included in the authority application, and where, if the patient's baseline MMSE or SMMSE is 25 to 30 points and it is so desired, the result of a baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale, is also included in the authority application
Compliance with  Written Authority Required procedures


(b)        omit:
 
 
C2936
 
Initial treatment, for up to 2 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease as they are from 1 or more of the qualifying groups specified below, where the patient is assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale and the diagnosis is confirmed by a specialist or consultant physician, and where the authority application includes the result of the baseline MMSE or SMMSE and specifies to which of the following qualifying groups patient belongs:
Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;
Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;
Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an MMSE or SMMSE test;
Intellectual (developmental or acquired) disability;
Significant sensory impairment despite best correction, which precludes completion of an MMSE or SMMSE test;
Prominent dysphasia, out of proportion to other cognitive and functional impairment

Compliance with Written Authority Required procedures


 
 
 
Continuation of initial treatment, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease, where the patient has previously been issued with an authority prescription for initial treatment with this drug for a period of up to 2 months, where the application includes the information submitted with the first application for initial treatment, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 6 months' duration in total

Compliance with Written Authority Required procedures


 
 
 
Initial treatment, for up to 6 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease as they are from 1 or more of the qualifying groups specified below, where the patient is assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale and the diagnosis is confirmed by a specialist or consultant physician, and where the authority application includes the result of the baseline MMSE or SMMSE and specifies to which of the following qualifying groups the patient belongs:
Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;
Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;
Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an MMSE or SMMSE test;
Intellectual (developmental or acquired) disability;
Significant sensory impairment despite best correction, which precludes completion of an MMSE or SMMSE test;
Prominent dysphasia, out of proportion to other cognitive and functional impairment
Compliance with Written Authority Required procedures


(c)        insert after existing text in the columns in the order indicated:
 
 
C3875
 
Initial treatment, for up to 2 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more, where the diagnosis is confirmed by or in consultation with a specialist or consultant physician, where the result of the baseline MMSE or SMMSE is included in the authority application, and where, if the patient's baseline MMSE or SMMSE is 25 to 30 points and it is so desired, the result of a baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale, is also included in the authority application

Compliance with Authority Required procedures


 
 
 
Continuation of initial treatment, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more, where the patient has previously been issued with an authority prescription for initial treatment with this drug for a period of up to 2 months, where the application includes the baseline scores submitted with the first application for initial treatment, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 6 months' duration in total

Compliance with Written Authority Required procedures


 
 
 
Initial treatment, for up to 6 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more, where the diagnosis is confirmed by or in consultation with a specialist or consultant physician, where the result of the baseline MMSE or SMMSE is included in the authority application, and where, if the patient's baseline MMSE or SMMSE is 25 to 30 points and it is so desired, the result of a baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale, is also included in the authority application
Compliance with Written Authority Required procedures


 
C3876
 
Initial treatment, for up to 2 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease as they are from 1 or more of the qualifying groups specified below, where the patient is assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale and the diagnosis is confirmed by or in consultation with a specialist or consultant physician, and where the authority application includes the result of the baseline MMSE or SMMSE and specifies to which of the following qualifying groups patient belongs:
Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;
Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;
Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an MMSE or SMMSE test;
Intellectual (developmental or acquired) disability;
Significant sensory impairment despite best correction, which precludes completion of an MMSE or SMMSE test;
Prominent dysphasia, out of proportion to other cognitive and functional impairment

Compliance with Authority Required procedures


 
 
 
Continuation of initial treatment, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease, where the patient has previously been issued with an authority prescription for initial treatment with this drug for a period of up to 2 months, where the application includes the information submitted with the first application for initial treatment, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 6 months' duration in total
Compliance with Written Authority Required procedures


 
 
 
Initial treatment, for up to 6 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease as they are from 1 or more of the qualifying groups specified below, where the patient is assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale and the diagnosis is confirmed by or in consultation with a specialist or consultant physician, and where the authority application includes the result of the baseline MMSE or SMMSE and specifies to which of the following qualifying groups the patient belongs:
Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;
Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;
Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an MMSE or SMMSE test;
Intellectual (developmental or acquired) disability;
Significant sensory impairment despite best correction, which precludes completion of an MMSE or SMMSE test;
Prominent dysphasia, out of proportion to other cognitive and functional impairment
Compliance with Written Authority Required procedures


 
[46]         Schedule 4, Part 1, entry for Interferon Alfa-2a
(a)        omit:
 
 
C2939
 
Where the patient is receiving treatment at/from a private hospital
Patients with chronic hepatitis B who satisfy all of the following criteria:
(1) Histological evidence of chronic hepatitis on liver biopsy (except in patients with coagulation disorders considered severe enough to prevent liver biopsy);
(2)(a) Abnormal serum ALT levels in conjunction with documented chronic hepatitis B infection; or
(b) Elevated HBV DNA levels in conjunction with documented chronic hepatitis B infection;
(3) Are not persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L);
(4) Female patients of child-bearing age are not pregnant, not breast-feeding, and are using an effective form of contraception
Compliance with Written or Telephone Authority Required procedures
(b)        omit:
 
 
C3383
 
Where the patient is receiving treatment at/from a public hospital
Patients with chronic hepatitis B who satisfy all of the following criteria:
(1) Histological evidence of chronic hepatitis on liver biopsy (except in patients with coagulation disorders considered severe enough to prevent liver biopsy);
(2)(a) Abnormal serum ALT levels in conjunction with documented chronic hepatitis B infection; or
(b) Elevated HBV DNA levels in conjunction with documented chronic hepatitis B infection;
(3) Are not persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L);
(4) Female patients of child-bearing age are not pregnant, not breast-feeding, and are using an effective form of contraception
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3383

(c)        insert after existing text in the columns in the order indicated:
 
 
C3869
 
Where the patient is receiving treatment at/from a private hospital
Chronic hepatitis B in a patient who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy;
(3) Is not a person with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L).
Compliance with Written or Telephone Authority Required procedures

 
C3870
 
Where the patient is receiving treatment at/from a public hospital
Chronic hepatitis B in a patient who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAG positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAG negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy;
(3) Is not a person with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L)
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3870


[47]         Schedule 4, Part 1, entry for Interferon Alfa-2b
(a)        omit from the column headed “Purposes”:    P1009
(b)        omit from the column headed “Purposes”:    P1463
(c)        omit:
 
 
C2939
P2939
Where the patient is receiving treatment at/from a private hospital
Patients with chronic hepatitis B who satisfy all of the following criteria:
(1) Histological evidence of chronic hepatitis on liver biopsy (except in patients with coagulation disorders considered severe enough to prevent liver biopsy);
(2)(a) Abnormal serum ALT levels in conjunction with documented chronic hepatitis B infection; or
(b) Elevated HBV DNA levels in conjunction with documented chronic hepatitis B infection;
(3) Are not persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L);
(4) Female patients of child-bearing age are not pregnant, not breast-feeding, and are using an effective form of contraception
Compliance with Written or Telephone Authority Required procedures
(d)        omit from the column headed “Purposes”:    P3382
(e)        omit:
 
 
C3383
P3383
Where the patient is receiving treatment at/from a public hospital
Patients with chronic hepatitis B who satisfy all of the following criteria:
(1) Histological evidence of chronic hepatitis on liver biopsy (except in patients with coagulation disorders considered severe enough to prevent liver biopsy);
(2)(a) Abnormal serum ALT levels in conjunction with documented chronic hepatitis B infection; or
(b) Elevated HBV DNA levels in conjunction with documented chronic hepatitis B infection;
(3) Are not persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L);
(4) Female patients of child-bearing age are not pregnant, not breast-feeding, and are using an effective form of contraception
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3383

(f)         omit from the column headed “Purposes”:    P3384
(g)        insert after existing text in the columns in the order indicated:
 
 
C3869
 
Where the patient is receiving treatment at/from a private hospital
Chronic hepatitis B in a patient who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy;
(3) Is not a person with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L).
Compliance with Written or Telephone Authority Required procedures

 
C3870
 
Where the patient is receiving treatment at/from a public hospital
Chronic hepatitis B in a patient who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAG positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAG negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy;
(3) Is not a person with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L)
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3870


[48]         Schedule 4, Part 1, entry for Lamivudine
(a)        omit:
 
 
C2932
 
Where the patient is receiving treatment at/from a private hospital
Patients with chronic hepatitis B who satisfy all of the following criteria:
(1) Histological evidence of chronic hepatitis on liver biopsy (except in patients with coagulation disorders considered severe enough to prevent liver biopsy);
(2)(a) Abnormal serum ALT levels in conjunction with documented chronic hepatitis B infection; or
(b) Elevated HBV DNA levels in conjunction with documented chronic hepatitis B infection;
(3) Female patients of child-bearing age are not pregnant, not breast-feeding, and are using an effective form of contraception.
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures

 
C3386
 
Where the patient is receiving treatment at/from a public hospital
Patients with chronic hepatitis B who satisfy all of the following criteria:
(1) Histological evidence of chronic hepatitis on liver biopsy (except in patients with coagulation disorders considered severe enough to prevent liver biopsy);
(2)(a) Abnormal serum ALT levels in conjunction with documented chronic hepatitis B infection; or
(b) Elevated HBV DNA levels in conjunction with documented chronic hepatitis B infection;
(3) Female patients of child-bearing age are not pregnant, not breast-feeding, and are using an effective form of contraception.
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3386


(b)        insert after existing text in the columns in the order indicated:
 
 
C3871
 
Where the patient is receiving treatment at/from a private hospital
Chronic hepatitis B in a patient who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy.
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures

 
C3872
 
Where the patient is receiving treatment at/from a public hospital
Chronic hepatitis B in a patient who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAG positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAG negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy.
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3872


[49]         Schedule 4, Part 1, entry for Memantine
(a)        omit:
 
 
C2608
 
Initial treatment, for up to 2 months, as the sole PBS-subsidised therapy, of moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 to 14, where the diagnosis is confirmed by a specialist or consultant physician, and where the result of the baseline MMSE or SMMSE is included in the authority application

Compliance with Authority Required procedures


 
 
 
Continuation of initial treatment, as the sole PBS-subsidised therapy, of moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 to 14, where the patient has previously been issued with an authority prescription for initial treatment with this drug for a period of up to 2 months, where the application includes the baseline score submitted with the first application for initial treatment, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 6 months' duration in total

Compliance with Written Authority Required procedures


 
 
 
Initial treatment, for up to 6 months, as the sole PBS-subsidised therapy, of moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 to 14, where the diagnosis is confirmed by a specialist or consultant physician, and where the result of the baseline MMSE or SMMSE is included in the authority application
Compliance with Written Authority Required procedures


(b)        omit:
 
 
C2610
 
Initial treatment, for up to 2 months, as the sole PBS-subsidised therapy, of moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 to 14 for reasons other than their Alzheimer's disease as they are from 1 or more of the qualifying groups specified below, where the patient is assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale and the diagnosis is confirmed by a specialist or consultant physician, and where the authority application includes the result of the baseline MMSE or SMMSE and specifies to which of the following qualifying groups patient belongs:
Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;
Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;
Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an MMSE or SMMSE test;
Intellectual (developmental or acquired) disability;
Significant sensory impairment despite best correction, which precludes completion of an MMSE or SMMSE test;
Prominent dysphasia, out of proportion to other cognitive and functional impairment

Compliance with Written Authority Required procedures


 
 
 
Continuation of initial treatment, as the sole PBS-subsidised therapy, of moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 to 14 for reasons other than their Alzheimer's disease, where the patient has previously been issued with an authority prescription for initial treatment with this drug for a period of up to 2 months, where the application includes the information submitted with the first application for initial treatment, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 6 months' duration in total

Compliance with Written Authority Required procedures


 
 
 
Initial treatment, for up to 6 months, as the sole PBS-subsidised therapy, of moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 to 14 for reasons other than their Alzheimer's disease as they are from 1 or more of the qualifying groups specified below, where the patient is assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale and the diagnosis is confirmed by a specialist or consultant physician, and where the authority application includes the result of the baseline MMSE or SMMSE and specifies to which of the following qualifying groups the patient belongs:
Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;
Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;
Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an MMSE or SMMSE test;
Intellectual (developmental or acquired) disability;
Significant sensory impairment despite best correction, which precludes completion of an MMSE or SMMSE test;
Prominent dysphasia, out of proportion to other cognitive and functional impairment
Compliance with Written Authority Required procedures


(c)        insert after existing text in the columns in the order indicated:
 
 
C3877
 
Initial treatment, for up to 2 months, as the sole PBS-subsidised therapy, of moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 to 14, where the diagnosis is confirmed by or in consultation with a specialist or consultant physician, and where the result of the baseline MMSE or SMMSE is included in the authority application

Compliance with Authority Required procedures


 
 
 
Continuation of initial treatment, as the sole PBS-subsidised therapy, of moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 to 14, where the patient has previously been issued with an authority prescription for initial treatment with this drug for a period of up to 2 months, where the application includes the baseline score submitted with the first application for initial treatment, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 6 months' duration in total

Compliance with Written Authority Required procedures


 
 
 
Initial treatment, for up to 6 months, as the sole PBS-subsidised therapy, of moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 to 14, where the diagnosis is confirmed by or in consultation with a specialist or consultant physician, and where the result of the baseline MMSE or SMMSE is included in the authority application
Compliance with Written Authority Required procedures


 
C3878
 
Initial treatment, for up to 2 months, as the sole PBS-subsidised therapy, of moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 to 14 for reasons other than their Alzheimer's disease as they are from 1 or more of the qualifying groups specified below, where the patient is assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale and the diagnosis is confirmed by or in consultation with a specialist or consultant physician, and where the authority application includes the result of the baseline MMSE or SMMSE and specifies to which of the following qualifying groups patient belongs:
Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;
Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;
Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an MMSE or SMMSE test;
Intellectual (developmental or acquired) disability;
Significant sensory impairment despite best correction, which precludes completion of an MMSE or SMMSE test;
Prominent dysphasia, out of proportion to other cognitive and functional impairment
Compliance with Authority Required procedures


 
 
 
Continuation of initial treatment, as the sole PBS-subsidised therapy, of moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 to 14 for reasons other than their Alzheimer's disease, where the patient has previously been issued with an authority prescription for initial treatment with this drug for a period of up to 2 months, where the application includes the information submitted with the first application for initial treatment, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 6 months' duration in total

Compliance with Written Authority Required procedures


 
 
 
Initial treatment, for up to 6 months, as the sole PBS-subsidised therapy, of moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 to 14 for reasons other than their Alzheimer's disease as they are from 1 or more of the qualifying groups specified below, where the patient is assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale and the diagnosis is confirmed by or in consultation with a specialist or consultant physician, and where the authority application includes the result of the baseline MMSE or SMMSE and specifies to which of the following qualifying groups the patient belongs:
Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;
Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;
Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an MMSE or SMMSE test;
Intellectual (developmental or acquired) disability;
Significant sensory impairment despite best correction, which precludes completion of an MMSE or SMMSE test;
Prominent dysphasia, out of proportion to other cognitive and functional impairment
Compliance with Written Authority Required procedures


[50]         Schedule 4, Part 1, entry for Peginterferon Alfa 2a
(a)        omit:
 
 
C2940
 
Where the patient is receiving treatment at/from a private hospital
Chronic hepatitis B
Monotherapy in patients with chronic hepatitis B and compensated liver disease who satisfy all of the following criteria:
(1) Histological evidence of chronic hepatitis on liver biopsy (except in patients with coagulation disorders considered severe enough to prevent liver biopsy);
(2)(a) Abnormal serum ALT levels in conjunction with documented chronic hepatitis B infection; or
(b) Elevated HBV DNA levels in conjunction with documented chronic hepatitis B infection;
(3) Have received no prior peginterferon alfa therapy for the treatment of hepatitis B;
(4) Female patients of child-bearing age are not pregnant, not breast-feeding, and are using an effective form of contraception;
(5) Are not persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L).
Treatment is limited to 1 course of treatment for a duration of up to 48 weeks
Compliance with Written or Telephone Authority Required procedures

 
C3411
 
Where the patient is receiving treatment at/from a public hospital
Chronic hepatitis B
Monotherapy in patients with chronic hepatitis B and compensated liver disease who satisfy all of the following criteria:
(1) Histological evidence of chronic hepatitis on liver biopsy (except in patients with coagulation disorders considered severe enough to prevent liver biopsy);
(2)(a) Abnormal serum ALT levels in conjunction with documented chronic hepatitis B infection; or
(b) Elevated HBV DNA levels in conjunction with documented chronic hepatitis B infection;
(3) Have received no prior peginterferon alfa therapy for the treatment of hepatitis B;
(4) Female patients of child-bearing age are not pregnant, not breast-feeding, and are using an effective form of contraception;
(5) Are not persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L).
Treatment is limited to 1 course of treatment for a duration of up to 48 weeks
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3411


(b)        insert after existing text in the columns in the order indicated:
 
 
C3867
 
Where the patient is receiving treatment at/from a private hospital
Monotherapy in a patient with chronic hepatitis B and compensated liver disease who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy;
(3) Have received no prior peginterferon alfa therapy for the treatment of hepatitis B;
(4) Is not a person with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L).
Treatment is limited to 1 course of treatment for a duration of up to 48 weeks
Compliance with Written or Telephone Authority Required procedures

 
C3868
 
Where the patient is receiving treatment at/from a public hospital
Monotherapy in a patient with chronic hepatitis B who and compensated liver disease who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAG positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAG negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy;
(3) Have received no prior peginterferon alfa therapy for the treatment of hepatitis B;
(4) Is not a person with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L.
Treatment is limited to 1 course of treatment for a duration of up to 48 weeks
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3868


[51]         Schedule 4, Part 1, entry for Rivastigmine
(a)        omit:
 
 
C2933
 
Initial treatment, for up to 2 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more, where the diagnosis is confirmed by a specialist or consultant physician, where the result of the baseline MMSE or SMMSE is included in the authority application, and where, if the patient's baseline MMSE or SMMSE is 25 to 30 points and it is so desired, the result of a baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale, is also included in the authority application

Compliance with Authority Required procedures


 
 
 
Continuation of initial treatment, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more, where the patient has previously been issued with an authority prescription for initial treatment with this drug for a period of up to 2 months, where the application includes the baseline scores submitted with the first application for initial treatment, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 6 months' duration in total

Compliance with Written Authority Required procedures


 
 
 
Initial treatment, for up to 6 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more, where the diagnosis is confirmed by a specialist or consultant physician, where the result of the baseline MMSE or SMMSE is included in the authority application, and where, if the patient's baseline MMSE or SMMSE is 25 to 30 points and it is so desired, the result of a baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale, is also included in the authority application
Compliance with Written Authority Required procedures


(b)        omit:
 
 
C2936
 
Initial treatment, for up to 2 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease as they are from 1 or more of the qualifying groups specified below, where the patient is assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale and the diagnosis is confirmed by a specialist or consultant physician, and where the authority application includes the result of the baseline MMSE or SMMSE and specifies to which of the following qualifying groups patient belongs:
Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;
Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;
Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an MMSE or SMMSE test;
Intellectual (developmental or acquired) disability;
Significant sensory impairment despite best correction, which precludes completion of an MMSE or SMMSE test;
Prominent dysphasia, out of proportion to other cognitive and functional impairment

Compliance with Written Authority Required procedures


 
 
 
Continuation of initial treatment, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease, where the patient has previously been issued with an authority prescription for initial treatment with this drug for a period of up to 2 months, where the application includes the information submitted with the first application for initial treatment, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 6 months' duration in total

Compliance with Written Authority Required procedures


 
 
 
Initial treatment, for up to 6 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease as they are from 1 or more of the qualifying groups specified below, where the patient is assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale and the diagnosis is confirmed by a specialist or consultant physician, and where the authority application includes the result of the baseline MMSE or SMMSE and specifies to which of the following qualifying groups the patient belongs:
Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;
Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;
Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an MMSE or SMMSE test;
Intellectual (developmental or acquired) disability;
Significant sensory impairment despite best correction, which precludes completion of an MMSE or SMMSE test;
Prominent dysphasia, out of proportion to other cognitive and functional impairment
Compliance with Written Authority Required procedures


(c)        insert after existing text in the columns in the order indicated:
 
C3875
 
Initial treatment, for up to 2 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more, where the diagnosis is confirmed by or in consultation with a specialist or consultant physician, where the result of the baseline MMSE or SMMSE is included in the authority application, and where, if the patient's baseline MMSE or SMMSE is 25 to 30 points and it is so desired, the result of a baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale, is also included in the authority application

Compliance with Authority Required procedures


 
 
 
Continuation of initial treatment, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more, where the patient has previously been issued with an authority prescription for initial treatment with this drug for a period of up to 2 months, where the application includes the baseline scores submitted with the first application for initial treatment, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 6 months' duration in total

Compliance with Written Authority Required procedures


 
 
 
Initial treatment, for up to 6 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 10 or more, where the diagnosis is confirmed by or in consultation with a specialist or consultant physician, where the result of the baseline MMSE or SMMSE is included in the authority application, and where, if the patient's baseline MMSE or SMMSE is 25 to 30 points and it is so desired, the result of a baseline Alzheimer's Disease Assessment Scale, cognitive sub-scale, is also included in the authority application
Compliance with Written Authority Required procedures


 
C3876
 
Initial treatment, for up to 2 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease as they are from 1 or more of the qualifying groups specified below, where the patient is assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale and the diagnosis is confirmed by or in consultation with a specialist or consultant physician, and where the authority application includes the result of the baseline MMSE or SMMSE and specifies to which of the following qualifying groups patient belongs:
Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;
Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;
Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an MMSE or SMMSE test;
Intellectual (developmental or acquired) disability;
Significant sensory impairment despite best correction, which precludes completion of an MMSE or SMMSE test;
Prominent dysphasia, out of proportion to other cognitive and functional impairment

Compliance with Authority Required procedures


 
 
 
Continuation of initial treatment, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease, where the patient has previously been issued with an authority prescription for initial treatment with this drug for a period of up to 2 months, where the application includes the information submitted with the first application for initial treatment, and where approval of the application would enable the patient to complete a period of initial treatment of not more than 6 months' duration in total

Compliance with Written Authority Required procedures


 
 
 
Initial treatment, for up to 6 months, as the sole PBS-subsidised therapy, of mild to moderately severe Alzheimer's disease in patients with a baseline Mini-Mental State Examination (MMSE) or Standardised Mini-Mental State Examination (SMMSE) score of 9 or less who are unable to register a score of 10 or more for reasons other than their Alzheimer's disease as they are from 1 or more of the qualifying groups specified below, where the patient is assessed using the Clinicians Interview Based Impression of Severity (CIBIS) scale and the diagnosis is confirmed by or in consultation with a specialist or consultant physician, and where the authority application includes the result of the baseline MMSE or SMMSE and specifies to which of the following qualifying groups the patient belongs:
Unable to communicate adequately because of lack of competence in English, in people of non-English speaking background;
Limited education, as defined by less than 6 years of education, or who are illiterate or innumerate;
Aboriginal or Torres Strait Islanders who, by virtue of cultural factors, are unable to complete an MMSE or SMMSE test;
Intellectual (developmental or acquired) disability;
Significant sensory impairment despite best correction, which precludes completion of an MMSE or SMMSE test;
Prominent dysphasia, out of proportion to other cognitive and functional impairment
Compliance with Written Authority Required procedures


[52]         Schedule 4, Part 1, entry for Telbivudine
substitute:
 
Telbivudine
C3865
 
Where the patient is receiving treatment at/from a private hospital
Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B who is nucleoside analogue naive and satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative - in conjunction with documented hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy.
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures

 
C3866
 
Where the patient is receiving treatment at/from a public hospital
Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B who is nucleoside analogue naive and satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAG positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAG negative - in conjunction with documented hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy.
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3866


[53]         Schedule 4, Part 1, entry for Tenofovir
substitute:
 
Tenofovir
C3586
 
Where the patient is receiving treatment at/from a private hospital
Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease
Compliance with Written or Telephone Authority Required procedures

 
C3587
 
Where the patient is receiving treatment at/from a private hospital
Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection
Compliance with Written or Telephone Authority Required procedures

 
C3588
 
Where the patient is receiving treatment at/from a public hospital
Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3588

 
C3589
 
Where the patient is receiving treatment at/from a public hospital
Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3589

 
C3863
 
Where the patient is receiving treatment at/from a private hospital
Chronic hepatitis B in a patient who has failed antihepadnaviral therapy and who satisfies all of the following criteria:
(a) Repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration in conjunction with documented chronic hepatitis B infection; or
(b) Repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months, whilst on previous antihepadnaviral therapy except in patients with evidence of poor compliance.
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures

 
C3864
 
Where the patient is receiving treatment at/from a public hospital
Chronic hepatitis B
Chronic hepatitis B in a patient who has failed antihepadnaviral therapy and who satisfies all of the following criteria:
(a) Repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration in conjunction with documented chronic hepatitis B infection; or
(b) Repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months, whilst on previous antihepadnaviral therapy except in patients with evidence of poor compliance.
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3864


 
C3865
 
Where the patient is receiving treatment at/from a private hospital
Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B who is nucleoside analogue naive and satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative - in conjunction with documented hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy.
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures

 
C3866
 
Where the patient is receiving treatment at/from a public hospital
Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B who is nucleoside analogue naive and satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAG positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAG negative - in conjunction with documented hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy.
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3866


[54]         Schedule 4, Part 1, entry for Tiotropium
substitute:
 
Tiotropium
C3883
 
Chronic obstructive pulmonary disease
 
[55]         Schedule 4, Part 1, entry for Zoledronic acid
(a)        omit:
 
 
C1797
 
Where the patient is receiving treatment at/from a private hospital
Bone metastases from hormone-resistant prostate cancer, with demonstration of biochemical progression of disease despite maximal therapy with hormonal treatments;
Compliance with Written or Telephone Authority Required procedures
(b)        omit:
 
 
C3422
 
Where the patient is receiving treatment at/from a public hospital
Bone metastases from hormone-resistant prostate cancer, with demonstration of biochemical progression of disease despite maximal therapy with hormonal treatments
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3422
(c)        insert after existing text in the columns in the order indicated:
 
 
C3881
 
Where the patient is receiving treatment at/from a private hospital
Bone metastases from hormone-resistant prostate cancer
Compliance with Written or Telephone Authority Required procedures

 
C3882
 
Where the patient is receiving treatment at/from a public hospital
Bone metastases from hormone-resistant prostate cancer
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3882


 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1Note
All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. 
See http://www.frli.gov.au.
 
Read Entire Law on www.comlaw.gov.au