National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2012 (No. 1) (No. PB 5 of 2012)

Link to law: https://www.comlaw.gov.au/Details/F2012L00380

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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.