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PB 86 of 2011 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 30 Nov 2011
Tabling HistoryDate
Tabled HR07-Feb-2012
Tabled Senate07-Feb-2012
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

 

PB 86 of 2011

National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2011 (No. 11)

 

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 Amendment Instrument under subsections 100(1) and 100(2) of the National Health Act 1953.

Dated  22 November 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 (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2011 (No.11).

 

(2)                This Instrument may also be cited as PB 86 of 2011.

 

2             Commencement

                             This Instrument commences on 1 December 2011.

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]    Schedule 1, after entry for Darunavir in the form Tablet 300 mg (as ethanoate)

insert:

 

Tablet 400 mg (as ethanolate)

Oral

Prezista

JC

EMP

C3940 C3941

 

120

5

D

 

[2]    Schedule 1, entry for Doxorubicin - Pegylated Liposomal, in the column headed ‘Section 100 only’

omit:

          C

          Substitute:

          D

[3]    Schedule 1, entry for Ribavirin and Peginterferon Alfa-2b in the form Pack containing 112 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 50 micrograms with diluent, in the column headed ‘Circumstances’

omit:

C3053 C3055  C3413 C3414

substitute:

C3053 C3414 C3948  C3949

[4]    Schedule 1, entry for Ribavirin and Peginterferon Alfa-2b in the form Pack containing 84 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 80 micrograms with diluent, in the column headed ‘Circumstances’

omit:

C3053 C3055  C3413 C3414

substitute:

C3053 C3414 C3948  C3949

[5]    Schedule 1, entry for Ribavirin and Peginterferon Alfa-2b in the form Pack containing 112 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 100 micrograms with diluent, in the column headed ‘Circumstances’

omit:

C3053 C3055  C3413 C3414

substitute:

C3053 C3414 C3948  C3949

[6]    Schedule 1, entry for Rituximab, in the column headed ‘Section 100 only’

omit:

          C

          Substitute:

          D

[7]    Schedule 3, entry for Darunavir

insert after the last circumstance code in numerical order:

 

C3940

 

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

Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents, and co-administered with 100 mg ritonavir in an antiretroviral experienced patient who, after at least one antiretroviral regimen, has experienced virological failure or clinical failure or genotypic resistance, and who has not demonstrated darunavir resistance associated mutations detected on resistance testing.
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity

Compliance with Authority Required procedures

 

C3941

 

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

Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents, and co-administered with 100 mg ritonavir in an antiretroviral experienced patient who, after at least one antiretroviral regimen, has experienced virological failure or clinical failure or genotypic resistance, and who has not demonstrated darunavir resistance associated mutations detected on resistance testing.
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity

Compliance with Authority Required procedures - Streamlined Authority Code 3941


 

 

[8]    Schedule 3, after entry for Ribavirin and Peginterferon Alfa-2b with circumstances code C3055

insert:

 

C3413

 

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

Patients naive to interferon based therapies (non-pegylated or pegylated)

Treatment, managed by an accredited treatment centre, of chronic hepatitis C in patients 18 years or older who have compensated liver disease and who have received no prior interferon alfa or peginterferon alfa treatment for hepatitis C and who satisfy all of the following criteria:
(1) Documented chronic hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive);
(2) Female patients of child-bearing age are not pregnant, not breast-feeding, and both patient and their partner are using effective forms of contraception (one for each partner). Male patients and their partners are using effective forms of contraception (one for each partner). Female partners of male patients are not pregnant.
For patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or bridging fibrosis, the treatment course is limited to 24 weeks. For hepatitis C patients with genotype 1, 4, 5 or 6 and those genotype 2 or 3 patients with hepatic cirrhosis or bridging fibrosis, the treatment course is limited to 48 weeks.
Patients with genotype 1, 4, 5 or 6 who are eligible for 48 weeks of treatment may only continue treatment after the first 12 weeks if the result of an HCV RNA quantitative assay (performed at the same laboratory using the same test) shows that the plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop. (An HCV RNA assay at week 12 is unnecessary for genotype 2 and 3 patients because of the high likelihood of early viral response by week 12).
Patients with genotype 1, 4, 5 or 6 who are viral positive at week 12 but have attained at least a 2 log drop in viral load may only continue treatment after the first 24 weeks of treatment if plasma HCV RNA is not detectable by an HCV RNA qualitative assay at week 24. Similarly, genotype 2 or 3 patients with hepatic cirrhosis or bridging fibrosis may only continue treatment after the first 24 weeks if plasma HCV RNA is not detectable by an HCV RNA qualitative assay at week 24. An HCV RNA qualitative assay at week 24 is unnecessary for those patients with genotype 1, 4, 5 or 6 who became viral negative at week 12

Compliance with Authority Required procedures - Streamlined Authority Code 3413


 

[9]    Schedule 3, entry for Ribavirin and Peginterferon Alfa-2b

insert after the last circumstance code:

 

C3948

 

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

Patients naive to interferon based therapies (non-pegylated or pegylated)

Treatment, managed by an accredited treatment centre, of chronic hepatitis C in patients weighing at least 27 kg who have compensated liver disease and who have received no prior interferon alfa or peginterferon alfa treatment for hepatitis C and who satisfy all of the following criteria:
(1) Documented chronic hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive);
(2) Female patients of child-bearing age are not pregnant, not breast-feeding, and both patient and their partner are using effective forms of contraception (one for each partner). Male patients and their partners are using effective forms of contraception (one for each partner). Female partners of male patients are not pregnant.
For patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or bridging fibrosis, the treatment course is limited to 24 weeks. For hepatitis C patients with genotype 1, 4, 5 or 6 and those genotype 2 or 3 patients with hepatic cirrhosis or bridging fibrosis, the treatment course is limited to 48 weeks.
Patients with genotype 1, 4, 5 or 6 who are eligible for 48 weeks of treatment may only continue treatment after the first 12 weeks if the result of an HCV RNA quantitative assay (performed at the same laboratory using the same test) shows that the plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop. (An HCV RNA assay at week 12 is unnecessary for genotype 2 and 3 patients because of the high likelihood of early viral response by week 12).
Patients with genotype 1, 4, 5 or 6 who are viral positive at week 12 but have attained at least a 2 log drop in viral load may only continue treatment after the first 24 weeks of treatment if plasma HCV RNA is not detectable by an HCV RNA qualitative assay at week 24. Similarly, genotype 2 or 3 patients with hepatic cirrhosis or bridging fibrosis may only continue treatment after the first 24 weeks if plasma HCV RNA is not detectable by an HCV RNA qualitative assay at week 24. An HCV RNA qualitative assay at week 24 is unnecessary for those patients with genotype 1, 4, 5 or 6 who became viral negative at week 12.

Compliance with Authority Required procedures

 

C3949

 

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

Patients naive to interferon based therapies (non-pegylated or pegylated)

Treatment, managed by an accredited treatment centre, of chronic hepatitis C in patients weighing at least 27 kg who have compensated liver disease and who have received no prior interferon alfa or peginterferon alfa treatment for hepatitis C and who satisfy all of the following criteria:
(1) Documented chronic hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive);
(2) Female patients of child-bearing age are not pregnant, not breast-feeding, and both patient and their partner are using effective forms of contraception (one for each partner). Male patients and their partners are using effective forms of contraception (one for each partner). Female partners of male patients are not pregnant.
For patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or bridging fibrosis, the treatment course is limited to 24 weeks. For hepatitis C patients with genotype 1, 4, 5 or 6 and those genotype 2 or 3 patients with hepatic cirrhosis or bridging fibrosis, the treatment course is limited to 48 weeks.
Patients with genotype 1, 4, 5 or 6 who are eligible for 48 weeks of treatment may only continue treatment after the first 12 weeks if the result of an HCV RNA quantitative assay (performed at the same laboratory using the same test) shows that the plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop. (An HCV RNA assay at week 12 is unnecessary for genotype 2 and 3 patients because of the high likelihood of early viral response by week 12).
Patients with genotype 1, 4, 5 or 6 who are viral positive at week 12 but have attained at least a 2 log drop in viral load may only continue treatment after the first 24 weeks of treatment if plasma HCV RNA is not detectable by an HCV RNA qualitative assay at week 24. Similarly, genotype 2 or 3 patients with hepatic cirrhosis or bridging fibrosis may only continue treatment after the first 24 weeks if plasma HCV RNA is not detectable by an HCV RNA qualitative assay at week 24. An HCV RNA qualitative assay at week 24 is unnecessary for those patients with genotype 1, 4, 5 or 6 who became viral negative at week 12

Compliance with Authority Required procedures - Streamlined Authority Code 3949


 

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