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National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2011 (No. 11) (No. PB 86 of 2011)

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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


 
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.