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PB 5 of 2012 Arrangements as made
This instrument amends the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 (No. PB 116 of 2010) to make changes to the special arrangement relating to the highly specialised drugs program for hospitals.
Administered by: Health
Registered 23 Feb 2012
Tabling HistoryDate
Tabled HR27-Feb-2012
Tabled Senate27-Feb-2012
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

 

PB 5 of 2012

National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2012 (No. 1)

 

National Health Act 1953

___________________________________________________________________________

 

 

I, FELICITY McNEILL, First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health and Ageing, delegate of the Minister for Health, make this Amendment Instrument under subsections 100(1) and 100(2) of the National Health Act 1953.

Dated       16 February 2012

 

 

 

 

 

 

 

 

 

 

 

FELICITY McNEILL

First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health and Ageing

 

___________________________________________________________________________

 

 

 

 


1              Name of Instrument

 

(1)                This Instrument is the National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2012 (No.1).

 

(2)                This Instrument may also be cited as PB 5 of 2012.

 

2             Commencement

This Instrument commences on 1 March 2012.

3              Amendments to PB 116 of 2010

Schedule 1 amends the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 (PB 116 of 2010).

 

 


Schedule 1                   Amendments

[1]    Paragraph 24(2)(m)

omit:

PBSsubsidised

substitute:

PBS-subsidised

[2]    Subparagraph 45(2)(b)(ii)

omit:

paragraph (a)

substitute:

subparagraph (i)

[3]    Schedule 1, entry for Abacavir with Lamivudine and Zidovudine in the form Tablet containing abacavir 300 mg (as sulphate) with lamivudine 150 mg and zidovudine 300 mg

omit from the column headed “Circumstances”:

C3590  C3591  C3592  C3593

substitute:

C3979  C3980  C3981  C3982

[4]    Schedule 1, entry for Adefovir in the form Tablet containing adefovir dipivoxil 10 mg

omit from the column headed “Circumstances”:

C3863  C3864

substitute:

C3971  C3972  C3973  C3974

[5]    Schedule 1, after entry for Darunavir in the form Tablet 400 mg (as ethanolate)

insert in the columns in the order indicated:

 

Tablet 600 mg (as ethanolate)

Oral

Prezista

JC

EMP

C3594 C3595

 

120

5

D

 

[6]    Schedule 1, entry for Entecavir in the form Tablet containing entecavir monohydrate 0.5 mg

omit from the column headed “Circumstances”:

C3871  C3872

substitute:

C3959  C3960  C3961  C3962

[7]    Schedule 1, entry for Entecavir in the form Tablet containing entecavir monohydrate 1 mg

omit from the column headed “Circumstances”:

C3873  C3874

substitute:

C3963  C3964  C3965  C3966

 

[8]    Schedule 1, after entry for Filgrastim after the form Injection 300 micrograms in 0.5 mL single use pre-filled syringe (Nivestim):

insert in the columns in the order indicated:

 

Injection 300 micrograms in 0.5 mL single use pre-filled syringe (TevaGrastim)

Injection

TevaGrastim

AS

EMP

C2912 C2913 C2914 C2915 C2916 C2917 C2918 C2919 C2920 C2921 C2922 C2923 C2924 C2925 C2926 C2927 C2928 C2929 C2930 C3087 C3187 C3357 C3358 C3359 C3360 C3361 C3362 C3363 C3364 C3365 C3366 C3367 C3368 C3369 C3370 C3371 C3372 C3373 C3374 C3375 C3376 C3377 C3833 C3834

 

20

11

D

 

[9]    Schedule 1, after entry for Filgrastim after the form Injection 480 micrograms in 0.5 mL single use pre-filled syringe (Nivestim):

insert in the columns in the order indicated:

 

Injection 480 micrograms in 0.8 mL single use pre-filled syringe (TevaGrastim)

Injection

TevaGrastim

AS

EMP

C2912 C2913 C2914 C2915 C2916 C2917 C2918 C2919 C2920 C2921 C2922 C2923 C2924 C2925 C2926 C2927 C2928 C2929 C2930 C3087 C3187 C3357 C3358 C3359 C3360 C3361 C3362 C3363 C3364 C3365 C3366 C3367 C3368 C3369 C3370 C3371 C3372 C3373 C3374 C3375 C3376 C3377 C3833 C3834

 

20

11

D

[10]  Schedule 1, entry for Foscarnet in the form I.V. infusion containing foscarnet sodium 24 mg per mL, 250 mL

omit from the column headed “Responsible Person”:

AP

substitute:

IX

[11]  Schedule 1, entry for Interferon Alfa-2a

omit from the column headed “Circumstances” (all instances):

C3869  C3870

substitute:

C3959  C3960  C3961  C3962

[12]  Schedule 1, entry for Interferon Alfa-2b

omit from the column headed “Circumstances” (all instances):

C3869  C3870

substitute:

C3959  C3960  C3961  C3962

[13]  Schedule 1, entry for Lamivudine in the form Tablet 100 mg

omit from the column headed “Circumstances”:

C3871  C3872

substitute:

C3959  C3960  C3961  C3962

[14]  Schedule 1, entry for Lamivudine in the form Oral solution 5 mg per mL, 240 mL

omit from the column headed “Circumstances”:

C3871  C3872

substitute:

C3959  C3960  C3961  C3962

[15]  Schedule 1, entry for Peginterferon Alfa-2a

omit from the column headed “Circumstances” (all instances):

C3867  C3868

substitute:

C3975  C3976  C3977  C3978

[16]  Schedule 1, entry for Telbivudine

omit from the column headed “Circumstances”:

C3865  C3866

substitute:

C3967  C3968  C3969  C3970

[17]  Schedule 1, entry for Tenofovir

omit from the column headed “Circumstances”:

C3863  C3864  C3865  C3866

substitute:

C3967  C3968  C3969  C3970  C3971  C3972  C3973  C3974

[18]  Schedule 1, entry for Tenofovir with emtricitabine and efavirenz

omit from the column headed “Circumstances”:

C3586  C3587  C3588  C3589

substitute:

C3983  C3984  C3985  C3986

[19]  Schedule 2, entry for AP

omit:

AP

AstraZeneca Pty Ltd

54 009 682 311

 

[20]  Schedule 2, after entry for AN

insert:

AS

Aspen Pharmacare Australia Pty Ltd

 51 096 236 985

 

[21]  Schedule 2, after entry for IS

insert:

IX

Clinect Pty Ltd

76 150 558 473

 

[22]  Schedule 3, entry for Abacavir with Lamivudine and Zidovudine

substitute:

Abacavir with Lamivudine and Zidovudine

C3979

 

Where the patient is receiving treatment at/from a private hospital

Initial treatment of human immunodeficiency virus (HIV) infection in a patient over 12 years of age, weighing 40 kg or more, with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease

Compliance with Authority Required procedures

 

C3980

 

Where the patient is receiving treatment at/from a private hospital

Continuing treatment of human immunodeficiency virus (HIV) infection where the patient over 12 years of age, weighing 40 kg or more, has previously received PBS-subsidised therapy for HIV infection

Compliance with Authority Required procedures

 

C3981

 

Where the patient is receiving treatment at/from a public hospital

Initial treatment of human immunodeficiency virus (HIV) infection in a patient over 12 years of age, weighing 40 kg or more, with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease

Compliance with Authority Required procedures - Streamlined Authority Code 3981

 

C3982

 

Where the patient is receiving treatment at/from a public hospital

Continuing treatment of human immunodeficiency virus (HIV) infection where the patient over 12 years of age, weighing 40 kg or more, has previously received PBS-subsidised therapy for HIV infection

Compliance with Authority Required procedures - Streamlined Authority Code 3982

[23]  Schedule 3, entry for Adefovir

substitute:

Adefovir

C3971

 

Where the patient is receiving treatment at/from a private hospital

Chronic hepatitis B in a patient without cirrhosis 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;

Compliance with Authority Required procedures

 

C3972

 

Where the patient is receiving treatment at/from a private hospital

Chronic hepatitis B in a patient with cirrhosis who has failed antihepadnaviral therapy and who has detectable HBV DNA.

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 Authority Required procedures

 

C3973

 

Where the patient is receiving treatment at/from a public hospital

Chronic hepatitis B in a patient without cirrhosis 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

Compliance with Authority Required procedures - Streamlined Authority Code 3973

 

C3974

 

Where the patient is receiving treatment at/from a public hospital

Chronic hepatitis B in a patient with cirrhosis who has failed antihepadnaviral therapy and who has detectable HBV DNA.

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 Authority Required procedures - Streamlined Authority Code 3974

 

[24]  Schedule 3, entry for Entecavir

substitute:

Entecavir

C3959

 

Where the patient is receiving treatment at/from a private hospital

Chronic hepatitis B in a patient with cirrhosis who has detectable HBV DNA.

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 Authority Required procedures

 

C3960

 

Where the patient is receiving treatment at/from a private hospital

Chronic hepatitis B in a patient without cirrhosis 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;

Compliance with Authority Required procedures

 

C3961

 

Where the patient is receiving treatment at/from a public hospital

Chronic hepatitis B in a patient without cirrhosis 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

Compliance with Authority Required procedures - Streamlined Authority Code 3961

 

C3962

 

Where the patient is receiving treatment at/from a public hospital

Chronic hepatitis B in a patient with cirrhosis who has detectable HBV DNA.

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 Authority Required procedures - Streamlined Authority Code 3962

 

C3963

 

Where the patient is receiving treatment at/from a private hospital

Chronic hepatitis B in a patient without cirrhosis who has failed lamivudine 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;

Compliance with Authority Required procedures

 

C3964

 

Where the patient is receiving treatment at/from a public hospital

Chronic hepatitis B
Chronic hepatitis B in a patient without cirrhosis who has failed lamivudine 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

Compliance with Authority Required procedures - Streamlined Authority Code 3964


 

C3965

 

Where the patient is receiving treatment at/from a private hospital

Chronic hepatitis B in a patient with cirrhosis who has failed lamivudine and who has detectable HBV DNA.

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 Authority Required procedures

 

C3966

 

Where the patient is receiving treatment at/from a public hospital

Chronic hepatitis B in a patient with cirrhosis who has failed lamivudine and who has detectable HBV DNA.
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 Authority Required procedures - Streamlined Authority Code 3966

 

[25]  Schedule 3, entry for Interferon Alfa-2a

omit:

 

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 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 Authority Required procedures - Streamlined Authority Code 3870

 

and insert in numerical order following the last circumstance:

 

 

C3959

 

Where the patient is receiving treatment at/from a private hospital

Chronic hepatitis B in a patient with cirrhosis who has detectable HBV DNA.

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 Authority Required procedures

 

C3960

 

Where the patient is receiving treatment at/from a private hospital

Chronic hepatitis B in a patient without cirrhosis 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;

Compliance with Authority Required procedures

 

C3961

 

Where the patient is receiving treatment at/from a public hospital

Chronic hepatitis B in a patient without cirrhosis 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

Compliance with Authority Required procedures - Streamlined Authority Code 3961

 

C3962

 

Where the patient is receiving treatment at/from a public hospital

Chronic hepatitis B in a patient with cirrhosis who has detectable HBV DNA.

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 Authority Required procedures - Streamlined Authority Code 3962

 

[26]  Schedule 3, entry for Interferon Alfa-2b

omit:

 

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 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 Authority Required procedures - Streamlined Authority Code 3870

and insert in numerical order following the last circumstance:

 

C3959

 

Where the patient is receiving treatment at/from a private hospital

Chronic hepatitis B in a patient with cirrhosis who has detectable HBV DNA.

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 Authority Required procedures

 

C3960

 

Where the patient is receiving treatment at/from a private hospital

Chronic hepatitis B in a patient without cirrhosis 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;

Compliance with Authority Required procedures

 

C3961

 

Where the patient is receiving treatment at/from a public hospital

Chronic hepatitis B in a patient without cirrhosis 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

Compliance with Authority Required procedures - Streamlined Authority Code 3961

 

C3962

 

Where the patient is receiving treatment at/from a public hospital

Chronic hepatitis B in a patient with cirrhosis who has detectable HBV DNA.

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 Authority Required procedures - Streamlined Authority Code 3962

 

[27]  Schedule 3, entry for Lamivudine

omit:

 

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 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 Authority Required procedures - Streamlined Authority Code 3872

and insert in numerical order following the last circumstance:

 

C3959

 

Where the patient is receiving treatment at/from a private hospital

Chronic hepatitis B in a patient with cirrhosis who has detectable HBV DNA.

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 Authority Required procedures

 

C3960

 

Where the patient is receiving treatment at/from a private hospital

Chronic hepatitis B in a patient without cirrhosis 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;

Compliance with Authority Required procedures

 

C3961

 

Where the patient is receiving treatment at/from a public hospital

Chronic hepatitis B in a patient without cirrhosis 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

Compliance with Authority Required procedures - Streamlined Authority Code 3961

 

C3962

 

Where the patient is receiving treatment at/from a public hospital

Chronic hepatitis B in a patient with cirrhosis who has detectable HBV DNA.

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 Authority Required procedures - Streamlined Authority Code 3962

 

[28]  Schedule 3, entry for Peginterferon Alfa-2a

omit:

 

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 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 Authority Required procedures - Streamlined Authority Code 3868

and insert in numerical order following the last circumstance:

 

C3975

 

Where the patient is receiving treatment at/from a private hospital

Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B without cirrhosis 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) Has received no prior peginterferon alfa therapy for the treatment of hepatitis B;

Compliance with Authority Required procedures

 

C3976

 

Where the patient is receiving treatment at/from a private hospital

Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B with cirrhosis who has detectable HBV DNA.

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.

Treatment is limited to 1 course of treatment for a duration of up to 48 weeks;

Compliance with Authority Required procedures

 

C3977

 

Where the patient is receiving treatment at/from a public hospital

Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B without cirrhosis 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) Has received no prior peginterferon alfa therapy for the treatment of hepatitis B

Compliance with Authority Required procedures - Streamlined Authority Code 3977


 

C3978

 

Where the patient is receiving treatment at/from a public hospital

Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B with cirrhosis who has detectable HBV DNA.
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.
Treatment is limited to 1 course of treatment for a duration of up to 48 weeks

Compliance with Authority Required procedures - Streamlined Authority Code 3978

 

[29]  Schedule 3, entry for Telbivudine

substitute:

Telbivudine

C3967

 

Where the patient is receiving treatment at/from a private hospital

Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B without cirrhosis 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;

Compliance with Authority Required procedures

 

C3968

 

Where the patient is receiving treatment at/from a private hospital

Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B with cirrhosis who is nucleoside analogue naive and who has detectable HBV DNA.

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 Authority Required procedures

 

C3969

 

Where the patient is receiving treatment at/from a public hospital

Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B without cirrhosis 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

Compliance with Authority Required procedures - Streamlined Authority Code 3969

 

C3970

 

Where the patient is receiving treatment at/from a public hospital

Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B with cirrhosis who is nucleoside analogue naive and who has detectable HBV DNA.

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 Authority Required procedures - Streamlined Authority Code 3970

 

[30]  Schedule 3, entry for Tenfovir

omit:

 

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 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 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; 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 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; 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 Authority Required procedures - Streamlined Authority Code 3866


and insert in numerical order following the last circumstance:

 

C3967

 

Where the patient is receiving treatment at/from a private hospital

Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B without cirrhosis 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;

Compliance with Authority Required procedures

 

C3968

 

Where the patient is receiving treatment at/from a private hospital

Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B with cirrhosis who is nucleoside analogue naive and who has detectable HBV DNA.

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 Authority Required procedures

 

C3969

 

Where the patient is receiving treatment at/from a public hospital

Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B without cirrhosis 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

Compliance with Authority Required procedures - Streamlined Authority Code 3969

 

C3970

 

Where the patient is receiving treatment at/from a public hospital

Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B with cirrhosis who is nucleoside analogue naive and who has detectable HBV DNA.

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 Authority Required procedures - Streamlined Authority Code 3970

 

C3971

 

Where the patient is receiving treatment at/from a private hospital

Chronic hepatitis B in a patient without cirrhosis 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;

Compliance with Authority Required procedures

 

C3972

 

Where the patient is receiving treatment at/from a private hospital

Chronic hepatitis B in a patient with cirrhosis who has failed antihepadnaviral therapy and who has detectable HBV DNA.

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 Authority Required procedures

 

C3973

 

Where the patient is receiving treatment at/from a public hospital

Chronic hepatitis B in a patient without cirrhosis 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

Compliance with Authority Required procedures - Streamlined Authority Code 3973

 

C3974

 

Where the patient is receiving treatment at/from a public hospital

Chronic hepatitis B in a patient with cirrhosis who has failed antihepadnaviral therapy and who has detectable HBV DNA.

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 Authority Required procedures - Streamlined Authority Code 3974

 

[31]  Schedule 3, entry for Tenofovir with emtricitabine and efavirenz

substitute:

Tenofovir with emtricitabine and efavirenz

C3983

 

Where the patient is receiving treatment at/from a private hospital

Initial treatment of human immunodeficiency virus (HIV) infection in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease

Compliance with Authority Required procedures

 

C3984

 

Where the patient is receiving treatment at/from a private hospital

Continuing treatment of human immunodeficiency virus (HIV) infection where the patient has previously received PBS-subsidised therapy for HIV infection

Compliance with Authority Required procedures

 

C3985

 

Where the patient is receiving treatment at/from a public hospital

Initial treatment of human immunodeficiency virus (HIV) infection in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease

Compliance with Authority Required procedures - Streamlined Authority Code 3985

 

C3986

 

Where the patient is receiving treatment at/from a public hospital

Continuing treatment of human immunodeficiency virus (HIV) infection where the patient has previously received PBS-subsidised therapy for HIV infection

Compliance with Authority Required procedures - Streamlined Authority Code 3986

 

Note

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.