National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2013 (No. 2) (No. PB 16 of 2013)

Link to law: https://www.comlaw.gov.au/Details/F2013L00562

 
PB 16 of 2013
National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2013 (No. 2)
 
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       25 March 2013
 
 
 
 
 
 
 
 
 
 
 
 
 
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 2013 (No.2).
 
(2)                This Instrument may also be cited as PB 16 of 2013.
 
2              Commencement
This Instrument commences on 1 April 2013.
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
Section 3
[1]           Schedule 1, after entry for Baclofen
Insert:
Boceprevir
Capsule 200 mg
Oral
Victrelis
MK
EMP
C4182 C4196 C4202 C4205
 
336
10
D
[2]           Schedule 1, entry for Lamivudine in the form Tablet 100 mg with manner of administration Oral and brand Zeffix
In the column headed ‘Responsible Person’, Omit:
GK
Substitute:
AS
[3]           Schedule 1, entry for Lamivudine in the form Oral solution 5 mg per mL, 240 mL with manner of administration Oral and brand Zeffix
In the column headed ‘Responsible Person’, Omit:
GK
Substitute:
AS
[4]           Schedule 1, entry for Pamidronic Acid in the form Concentrated injection containing disodium pamidronate 30 mg in 10 mL with manner of administration Injection and brand Pamisol
Substitute:

 
Concentrated injection containing disodium pamidronate 30 mg in 10 mL
Injection
Pamidronate Strides
YA
EMP
C1500 C3341
 
2
2
C

 
 
 
Pamisol
HH
EMP
C1500 C3341
 
2
2
C

[5]           Schedule 1, entry for Pamidronic Acid in the form Concentrated injection containing disodium pamidronate 90 mg in 10 mL with manner of administration Injection and brand Pamisol
Substitute:

 
Concentrated injection containing disodium pamidronate 90 mg in 10 mL
Injection
Pamidronate Strides
YA
EMP
C1035 C1233 C1500 C3341 C3342 C3343
 
1
11
PB

 
 
 
Pamisol
HH
EMP
C1035 C1233 C1500 C3341 C3342 C3343
 
1
11
PB

[6]           Schedule 1, entry for Ribavirin and Peginterferon Alfa-2a
Omit from the column headed “Circumstances” (all instances):
 
C3053 C3055 C3413 C3414
 
Substitute (all instances):
 
C4184 C4185 C4187 C4188 C4193 C4197 C4206 C4207
 
[7]            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
Omit from the column headed “Circumstances”:
 
C3053 C3414 C3948 C3949
 
Substitute:
 
C4184 C4185 C4187 C4188 C4189 C4192 C4193 C4197 C4198 C4199 C4200 C4203 C4206 C4207 C4208 C4209
 
[8]           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
Omit from the column headed “Circumstances”:
 
C3053 C3414 C3948 C3949
 
Substitute:
 
C4184 C4185 C4187 C4188 C4189 C4192 C4193 C4197 C4198 C4199 C4200 C4203 C4206 C4207 C4208 C4209
 
[9]           Schedule 1, entry for Ribavirin and Peginterferon Alfa-2b in the form Pack containing 140 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 80 micrograms with diluent
Omit from the column headed “Circumstances”:
 
C3053 C3055 C3413 C3414
 
Substitute:
 
C4184 C4185 C4187 C4188 C4193 C4197 C4206 C4207
 
[10]         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
Omit from the column headed “Circumstances”:
 
C3053 C3414 C3948 C3949
 
Substitute:
 
C4184 C4185 C4187 C4188 C4189 C4192 C4193 C4197 C4198 C4199 C4200 C4203 C4206 C4207 C4208 C4209
 
[11]         Schedule 1, entry for Ribavirin and Peginterferon Alfa-2b in the form Pack containing 140 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 120 micrograms with diluent
Omit from the column headed “Circumstances”:
 
C3053 C3055 C3413 C3414
 
Substitute:
 
C4184 C4185 C4187 C4188 C4193 C4197 C4206 C4207
 
[12]         Schedule 1, entry for Ribavirin and Peginterferon Alfa-2b in the form Pack containing 140 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 150 micrograms with diluent
Omit from the column headed “Circumstances”:
 
C3053 C3055 C3413 C3414
 
Substitute:
 
C4184 C4185 C4187 C4188 C4193 C4197 C4206 C4207
 
[13]         Schedule 1, entry for Ribavirin and Peginterferon Alfa-2b in the form Pack containing 168 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 150 micrograms with diluent
Omit from the column headed “Circumstances”:
 
C3053 C3055 C3413 C3414
 
Substitute:
 
C4184 C4185 C4187 C4188 C4193 C4197 C4206 C4207
 
[14]         Schedule 1, entry for Ribavirin and Peginterferon Alfa-2b in the form Pack containing 196 capsules ribavirin 200 mg and 4 single use injection pens containing peginterferon alfa-2b powder for injection 150 micrograms with diluent
Omit from the column headed “Circumstances”:
 
C3053 C3055 C3413 C3414
 
Substitute:
 
C4184 C4185 C4187 C4188 C4193 C4197 C4206 C4207
 
[15]         Schedule 1, after entry for Tadalafil
Insert:
Telaprevir
Tablet 375 mg
Oral
Incivo
JC
EMP
C4186 C4191 C4194 C4201
 
252
0
D
[16]         Schedule 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) with manner of administration Oral and brand Valtrex
In the column headed ‘Responsible Person’, Omit:
GK
Substitute:
AS
[17]         Schedule 1, entry for Valaciclovir in the form Tablet 500 mg (as hydrochloride) with manner of administration Oral and brand Valvala
Omit.
[18]         Schedule 2, after entry for XA
Insert:
YA
Agila Australasia Pty Ltd
12 154 055 339
[19]         Schedule 3, after entry for Baclofen
Insert:
Boceprevir
C4182
 
Where the patient is receiving treatment at/from a public hospital
Chronic genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
Patient must have compensated liver disease;
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C;
The treatment must be in combination with peginterferon alfa and ribavirin;
The treatment must be limited to a maximum duration of 32 weeks in patients without hepatic cirrhosis who were partial responders or relapsers to the prior course of interferon based therapy for hepatitis C; OR
The treatment must be limited to a maximum duration of 44 weeks in patients without hepatic cirrhosis who were null responders to the prior course of interferon based therapy for hepatitis C; OR
The treatment must be limited to a maximum duration of 44 weeks for all patients with hepatic cirrhosis;
The treatment must cease after the first 8 weeks of boceprevir treatment if plasma HCV RNA is detectable by an HCV RNA qualitative assay at treatment week 12;
The treatment must cease after the first 20 weeks of boceprevir treatment if plasma HCV RNA is detectable by an HCV RNA qualitative assay at treatment week 24;
Patient must be 18 years or older;
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Chronic genotype 1 hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Patients who have received prior treatment with an NS3/4A protease inhibitor are not eligible to receive PBS-subsidised boceprevir, except where the patient has developed an intolerance to the other NS3/4A protease inhibitor of a severity necessitating permanent treatment withdrawal. Details of the intolerance must be documented in the patient's medical records
For patients without hepatic cirrhosis who were partial responders or relapsers to the prior course of interferon based therapy, a maximum of 7 repeats may be prescribed
For patients without hepatic cirrhosis who were null responders to the prior course of interferon based therapy, a maximum of 10 repeats may be prescribed
For patients with hepatic cirrhosis, a maximum of 10 repeats may be prescribed
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4182

 
C4196
 
Where the patient is receiving treatment at/from a private hospital
Chronic genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
Patient must have compensated liver disease;
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C;
The treatment must be in combination with peginterferon alfa and ribavirin;
The treatment must be limited to a maximum duration of 24 weeks in patients without hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 44 weeks in patients with hepatic cirrhosis;
The treatment must cease after the first 20 weeks of boceprevir treatment if plasma HCV RNA is detectable by an HCV RNA qualitative assay at treatment week 24;
Patient must be 18 years or older;
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Evidence of chronic genotype 1 hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Patients who have received prior treatment with an NS3/4A protease inhibitor are not eligible to receive PBS-subsidised boceprevir, except where the patient has developed an intolerance to the other NS3/4A protease inhibitor of a severity necessitating permanent treatment withdrawal. Details of the intolerance must be documented in the patient's medical records
For patients without hepatic cirrhosis, a maximum of 5 repeats may be prescribed
For patients with hepatic cirrhosis, a maximum of 10 repeats may be prescribed
Compliance with Written or Telephone Authority Required procedures


 
C4202
 
Where the patient is receiving treatment at/from a public hospital
Chronic genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
Patient must have compensated liver disease;
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C;
The treatment must be in combination with peginterferon alfa and ribavirin;
The treatment must be limited to a maximum duration of 24 weeks in patients without hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 44 weeks in patients with hepatic cirrhosis;
The treatment must cease after the first 20 weeks of boceprevir treatment if plasma HCV RNA is detectable by an HCV RNA qualitative assay at treatment week 24;
Patient must be 18 years or older;
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Evidence of chronic genotype 1 hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Patients who have received prior treatment with an NS3/4A protease inhibitor are not eligible to receive PBS-subsidised boceprevir, except where the patient has developed an intolerance to the other NS3/4A protease inhibitor of a severity necessitating permanent treatment withdrawal. Details of the intolerance must be documented in the patient's medical records
For patients without hepatic cirrhosis, a maximum of 5 repeats may be prescribed
For patients with hepatic cirrhosis, a maximum of 10 repeats may be prescribed
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4202


 
C4205
 
Where the patient is receiving treatment at/from a private hospital
Chronic genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
Patient must have compensated liver disease;
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C;
The treatment must be in combination with peginterferon alfa and ribavirin;
The treatment must be limited to a maximum duration of 32 weeks in patients without hepatic cirrhosis who were partial responders or relapsers to the prior course of interferon based therapy for hepatitis C; OR
The treatment must be limited to a maximum duration of 44 weeks in patients without hepatic cirrhosis who were null responders to the prior course of interferon based therapy for hepatitis C; OR
The treatment must be limited to a maximum duration of 44 weeks for all patients with hepatic cirrhosis;
The treatment must cease after the first 8 weeks of boceprevir treatment if plasma HCV RNA is detectable by an HCV RNA qualitative assay at treatment week 12;
The treatment must cease after the first 20 weeks of boceprevir treatment if plasma HCV RNA is detectable by an HCV RNA qualitative assay at treatment week 24;
Patient must be 18 years or older;
*Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Chronic genotype 1 hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Patients who have received prior treatment with an NS3/4A protease inhibitor are not eligible to receive PBS-subsidised boceprevir, except where the patient has developed an intolerance to the other NS3/4A protease inhibitor of a severity necessitating permanent treatment withdrawal. Details of the intolerance must be documented in the patient's medical records
For patients without hepatic cirrhosis who were partial responders or relapsers to the prior course of interferon based therapy, a maximum of 7 repeats may be prescribed.
For patients without hepatic cirrhosis who were null responders to the prior course of interferon based therapy, a maximum of 10 repeats may be prescribed
For patients with hepatic cirrhosis, a maximum of 10 repeats may be prescribed
Compliance with Written or Telephone Authority Required procedures


[20]         Schedule 3, entry for Ribavirin and Peginterferon Alfa-2a
Omit:
Ribavirin and Peginterferon Alfa‑2a
C3053
 
Where the patient is receiving treatment at/from a private hospital
Patients who have failed one prior attempt at 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 more than one prior treatment with interferon alfa or peginterferon alfa 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. 
The treatment course is limited to 48 weeks. Patients may only continue treatment after the first 12 weeks of treatment if plasma HCV RNA is not detectable by an HCV RNA qualitative assay at week 12.
Compliance with Written or Telephone Authority Required procedures

 
C3055
 
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 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 Written or Telephone Authority Required procedures

 
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 Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 3413

 
C3414
 
Where the patient is receiving treatment at/from a public hospital
Patients who have failed one prior attempt at 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 more than one prior treatment with interferon alfa or peginterferon alfa 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. 
The treatment course is limited to 48 weeks. Patients may only continue treatment after the first 12 weeks of treatment if plasma HCV RNA is not detectable by an HCV RNA qualitative assay at week 12
Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 3414

 
Substitute
Ribavirin and Peginterferon Alfa-2a
C4184
 
Where the patient is receiving treatment at/from a public hospital
Chronic genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
Patient must have compensated liver disease;
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated);
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin without an NS3 protease inhibitor, or, in triple combination therapy with boceprevir; OR
Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin in triple combination therapy with telaprevir;
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir who were prior treatment relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 4 and 12; OR
The treatment must be limited to a maximum duration of 36 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir who were prior treatment partial responders or relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 8 and 12; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin without an NS3 protease inhibitor; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir who: (i) were prior treatment null responders; or (ii) were prior treatment partial responders or relapsers and in whom plasma HCV RNA is detectable by an HCV RNA qualitative assay at week 8, and undetectable by an HCV RNA qualitative assay at week 12; or (iii) have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir who: (i) were prior treatment partial or null responders; or (ii) were prior treatment relapsers and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than or equal to 1000 IU/mL; or (iii) have hepatic cirrhosis;
The treatment must cease in patients using peginterferon and ribavirin without an NS3 protease inhibitor if HCV RNA is detectable by an HCV RNA qualitative assay at week 12;
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12;
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24;
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL;
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12;
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24;
Patient must be aged 18 years or older;
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4184

 
C4185
 
Where the patient is receiving treatment at/from a private hospital
Chronic genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
Patient must have compensated liver disease;
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C;
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 4 and 12; OR
The treatment must be limited to a maximum duration of 28 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 8 and 24; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin without an NS3 protease inhibitor; OR
The treatment must be limited to a maximum duration of 48 weeks in patients: (i) using peginterferon and ribavirin in triple combination therapy with boceprevir and in whom plasma HCV RNA is detectable by an HCV RNA qualitative assay at week 8, and undetectable by an HCV RNA qualitative assay at week 24; or (ii) using peginterferon and ribavirin in triple combination therapy with boceprevir who have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients: (i) using peginterferon and ribavirin in triple combination therapy with telaprevir and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than or equal to 1000 IU/mL; or (ii) using peginterferon and ribavirin in triple combination therapy with telaprevir who have hepatic cirrhosis;
The treatment must cease in patients using peginterferon and ribavirin without an NS3 protease inhibitor unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop;
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24;
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL;
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12;
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24;
Patient must be aged 18 years or older;
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
For patients using peginterferon and ribavirin without an NS3 protease inhibitor who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary
Compliance with Written or Telephone Authority Required procedures


 
C4187
 
Where the patient is receiving treatment at/from a public hospital
Chronic non-genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
The treatment must be the sole PBS-subsidised treatment for hepatitis C;
Patient must have compensated liver disease;
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C;
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C;
The treatment must be limited to a maximum duration of 24 weeks for patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or bridging fibrosis; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 4, 5 or 6 hepatitis C; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 2 or 3 hepatitis C with hepatic cirrhosis or bridging fibrosis;
The treatment must cease in patients with genotype 4, 5, or 6 hepatitis C unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) shows that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop;
The treatment must cease in patients eligible for 48 weeks of treatment if HCV RNA is detectable by an HCV RNA qualitative assay at week 24;
Patient must be aged 18 years or older;
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
For patients with genotype 4, 5, or 6 who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary
For patients with genotype 2 or 3 without cirrhosis, an HCV RNA assay at week 12 is unnecessary because of the high likelihood of early viral response by week 12
For patients who are eligible for 24 weeks of treatment, a maximum of 2 repeats may be prescribed
For patients who are eligible for 48 weeks of treatment, a maximum of 5 repeats may be prescribed
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4187

 
C4188
 
Where the patient is receiving treatment at/from a private hospital
Chronic genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
Patient must have compensated liver disease;
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated);
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin without an NS3 protease inhibitor
or, in triple combination therapy with boceprevir; OR
Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin in triple combination therapy with telaprevir;
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir who were prior treatment relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 4 and 12; OR
The treatment must be limited to a maximum duration of 36 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir who were prior treatment partial responders or relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 8 and 12; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin without an NS3 protease inhibitor; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir who: (i) were prior treatment null responders; or (ii) were prior treatment partial responders or relapsers and in whom plasma HCV RNA is detectable by an HCV RNA qualitative assay at week 8, and undetectable by an HCV RNA qualitative assay at week 12; or (iii) have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir who: (i) were prior treatment partial or null responders; or (ii) were prior treatment relapsers and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than or equal to 1000 IU/mL; or (iii) have hepatic cirrhosis;
The treatment must cease in patients using peginterferon and ribavirin without an NS3 protease inhibitor if HCV RNA is detectable by an HCV RNA qualitative assay at week 12;
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12;
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24;
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL;
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12;
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24;
Patient must be aged 18 years or older;
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures


 
C4193
 
Where the patient is receiving treatment at/from a private hospital
Chronic non-genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
The treatment must be the sole PBS-subsidised treatment for hepatitis C;
Patient must have compensated liver disease;
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C;
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated);
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C;
The treatment must be limited to a maximum duration of 48 weeks;
The treatment must cease if HCV RNA is detectable by an HCV RNA qualitative assay at week 12;
Patient must be aged 18 years or older;
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures


 
C4197
 
Where the patient is receiving treatment at/from a public hospital
Chronic genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
Patient must have compensated liver disease;
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C;
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 4 and 12; OR
The treatment must be limited to a maximum duration of 28 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 8 and 24; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin without an NS3 protease inhibitor; OR
The treatment must be limited to a maximum duration of 48 weeks in patients: (i) using peginterferon and ribavirin in triple combination therapy with boceprevir and in whom plasma HCV RNA is detectable by an HCV RNA qualitative assay at week 8, and undetectable by an HCV RNA qualitative assay at week 24; or (ii) using peginterferon and ribavirin in triple combination therapy with boceprevir who have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients: (i) using peginterferon and ribavirin in triple combination therapy with telaprevir and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than or equal to 1000 IU/mL; or (ii) using peginterferon and ribavirin in triple combination therapy with telaprevir who have hepatic cirrhosis;
The treatment must cease in patients using peginterferon and ribavirin without an NS3 protease inhibitor unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop;
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24;
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL;
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12;
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24;
Patient must be aged 18 years or older;
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
For patients using peginterferon and ribavirin without an NS3 protease inhibitor who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4197

 
C4206
 
Where the patient is receiving treatment at/from a public hospital
Chronic non-genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
The treatment must be the sole PBS-subsidised treatment for hepatitis C;
Patient must have compensated liver disease;
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C;
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated);
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C;
The treatment must be limited to a maximum duration of 48 weeks;
The treatment must cease if HCV RNA is detectable by an HCV RNA qualitative assay at week 12;
Patient must be aged 18 years or older;
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4206

 
C4207
 
Where the patient is receiving treatment at/from a private hospital
Chronic non-genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
The treatment must be the sole PBS-subsidised treatment for hepatitis C;
Patient must have compensated liver disease;
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C;
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C;
The treatment must be limited to a maximum duration of 24 weeks for patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or bridging fibrosis; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 4, 5 or 6 hepatitis C; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 2 or 3 hepatitis C with hepatic cirrhosis or bridging fibrosis;
The treatment must cease in patients with genotype 4, 5, or 6 hepatitis C unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) shows that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop;
The treatment must cease in patients eligible for 48 weeks of treatment if HCV RNA is detectable by an HCV RNA qualitative assay at week 24;
Patient must be aged 18 years or older;
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
For patients with genotype 4, 5, or 6 who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary
For patients with genotype 2 or 3 without cirrhosis, an HCV RNA assay at week 12 is unnecessary because of the high likelihood of early viral response by week 12
For patients who are eligible for 24 weeks of treatment, a maximum of 2 repeats may be prescribed
For patients who are eligible for 48 weeks of treatment, a maximum of 5 repeats may be prescribed
Compliance with Written or Telephone Authority Required procedures


 
[21]         Schedule 3, entry for Ribavirin and Peginterferon Alfa-2b
Omit
Ribavirin and Peginterferon Alfa‑2b
C3053
 
Where the patient is receiving treatment at/from a private hospital
Patients who have failed one prior attempt at 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 more than one prior treatment with interferon alfa or peginterferon alfa 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. 
The treatment course is limited to 48 weeks. Patients may only continue treatment after the first 12 weeks of treatment if plasma HCV RNA is not detectable by an HCV RNA qualitative assay at week 12.
Compliance with Written or Telephone Authority Required procedures

 
C3055
 
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 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 Written or Telephone Authority Required procedures

 
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 Written or Telephone Authority Required procedures – Streamlined Authority Code 3413

 
C3414
 
Where the patient is receiving treatment at/from a public hospital
Patients who have failed one prior attempt at 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 more than one prior treatment with interferon alfa or peginterferon alfa 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. 
The treatment course is limited to 48 weeks. Patients may only continue treatment after the first 12 weeks of treatment if plasma HCV RNA is not detectable by an HCV RNA qualitative assay at week 12
Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 3414

 
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 Written or Telephone 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 Written or Telephone Authority Required procedures – Streamlined Authority Code 3949

 
Substitute:
Ribavirin and Peginterferon Alfa-2b
C4184
 
Where the patient is receiving treatment at/from a public hospital
Chronic genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
Patient must have compensated liver disease;
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated);
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin without an NS3 protease inhibitor, or, in triple combination therapy with boceprevir; OR
Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin in triple combination therapy with telaprevir;
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir who were prior treatment relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 4 and 12; OR
The treatment must be limited to a maximum duration of 36 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir who were prior treatment partial responders or relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 8 and 12; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin without an NS3 protease inhibitor; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir who: (i) were prior treatment null responders; or (ii) were prior treatment partial responders or relapsers and in whom plasma HCV RNA is detectable by an HCV RNA qualitative assay at week 8, and undetectable by an HCV RNA qualitative assay at week 12; or (iii) have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir who: (i) were prior treatment partial or null responders; or (ii) were prior treatment relapsers and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than or equal to 1000 IU/mL; or (iii) have hepatic cirrhosis;
The treatment must cease in patients using peginterferon and ribavirin without an NS3 protease inhibitor if HCV RNA is detectable by an HCV RNA qualitative assay at week 12;
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12;
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24;
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL;
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12;
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24;
Patient must be aged 18 years or older
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4184

 
C4185
 
Where the patient is receiving treatment at/from a private hospital
Chronic genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
Patient must have compensated liver disease;
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C;
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 4 and 12; OR
The treatment must be limited to a maximum duration of 28 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 8 and 24; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin without an NS3 protease inhibitor; OR
The treatment must be limited to a maximum duration of 48 weeks in patients: (i) using peginterferon and ribavirin in triple combination therapy with boceprevir and in whom plasma HCV RNA is detectable by an HCV RNA qualitative assay at week 8, and undetectable by an HCV RNA qualitative assay at week 24; or (ii) using peginterferon and ribavirin in triple combination therapy with boceprevir who have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients: (i) using peginterferon and ribavirin in triple combination therapy with telaprevir and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than or equal to 1000 IU/mL; or (ii) using peginterferon and ribavirin in triple combination therapy with telaprevir who have hepatic cirrhosis;
The treatment must cease in patients using peginterferon and ribavirin without an NS3 protease inhibitor unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop;
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24;
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL;
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12;
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24;
Patient must be aged 18 years or older;
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
For patients using peginterferon and ribavirin without an NS3 protease inhibitor who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary
Compliance with Written or Telephone Authority Required procedures


 
C4187
 
Where the patient is receiving treatment at/from a public hospital
Chronic non-genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
The treatment must be the sole PBS-subsidised treatment for hepatitis C;
Patient must have compensated liver disease;
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C;
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C;
The treatment must be limited to a maximum duration of 24 weeks for patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or bridging fibrosis; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 4, 5 or 6 hepatitis C; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 2 or 3 hepatitis C with hepatic cirrhosis or bridging fibrosis;
The treatment must cease in patients with genotype 4, 5, or 6 hepatitis C unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) shows that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop;
The treatment must cease in patients eligible for 48 weeks of treatment if HCV RNA is detectable by an HCV RNA qualitative assay at week 24;
Patient must be aged 18 years or older;
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
For patients with genotype 4, 5, or 6 who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary
For patients with genotype 2 or 3 without cirrhosis, an HCV RNA assay at week 12 is unnecessary because of the high likelihood of early viral response by week 12
For patients who are eligible for 24 weeks of treatment, a maximum of 2 repeats may be prescribed
For patients who are eligible for 48 weeks of treatment, a maximum of 5 repeats may be prescribed
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4187

 
C4188
 
Where the patient is receiving treatment at/from a private hospital
Chronic genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
Patient must have compensated liver disease;
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated);
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin without an NS3 protease inhibitor, or, in triple combination therapy with boceprevir; OR
Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C if using peginterferon and ribavirin in triple combination therapy with telaprevir;
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir who were prior treatment relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 4 and 12; OR
The treatment must be limited to a maximum duration of 36 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir who were prior treatment partial responders or relapsers and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 8 and 12; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin without an NS3 protease inhibitor; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir who: (i) were prior treatment null responders; or (ii) were prior treatment partial responders or relapsers and in whom plasma HCV RNA is detectable by an HCV RNA qualitative assay at week 8, and undetectable by an HCV RNA qualitative assay at week 12; or (iii) have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir who: (i) were prior treatment partial or null responders; or (ii) were prior treatment relapsers and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than or equal to 1000 IU/mL; or (iii) have hepatic cirrhosis;
The treatment must cease in patients using peginterferon and ribavirin without an NS3 protease inhibitor if HCV RNA is detectable by an HCV RNA qualitative assay at week 12;
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12;
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24;
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL;
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12;
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24;
Patient must be aged 18 years or older;
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures


 
C4189
 
Where the patient is receiving treatment at/from a public hospital
Chronic genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
The treatment must be the sole PBS-subsidised treatment for hepatitis C;
Patient must have compensated liver disease;
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated);
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C;
The treatment must be limited to a maximum duration of 48 weeks;
The treatment must cease if HCV RNA is detectable by an HCV RNA qualitative assay at week 12;
Patient must weigh at least 27 kg;
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4189

 
C4192
 
Where the patient is receiving treatment at/from a public hospital
Chronic non-genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
The treatment must be the sole PBS-subsidised treatment for hepatitis C;
Patient must have compensated liver disease;
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C;
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C;
The treatment must be limited to a maximum duration of 24 weeks for patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or bridging fibrosis; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 4, 5 or 6 hepatitis C; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 2 or 3 hepatitis C with hepatic cirrhosis or bridging fibrosis;
The treatment must cease in patients with genotype 4, 5, or 6 hepatitis C unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) shows that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop;
The treatment must cease in patients eligible for 48 weeks of treatment if HCV RNA is detectable by an HCV RNA qualitative assay at week 24;
Patient must weigh at least 27 kg;
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
For patients with genotype 4, 5, or 6 who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary
For patients with genotype 2 or 3 without cirrhosis, an HCV RNA assay at week 12 is unnecessary because of the high likelihood of early viral response by week 12
For patients who are eligible for 24 weeks of treatment, a maximum of 2 repeats may be prescribed
For patients who are eligible for 48 weeks of treatment, a maximum of 5 repeats may be prescribed
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4192

 
C4193
 
Where the patient is receiving treatment at/from a private hospital
Chronic non-genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre,
The treatment must be the sole PBS-subsidised treatment for hepatitis C;
Patient must have compensated liver disease;
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C;
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated);
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C;
The treatment must be limited to a maximum duration of 48 weeks;
The treatment must cease if HCV RNA is detectable by an HCV RNA qualitative assay at week 12;
Patient must be aged 18 years or older;
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures


 
C4197
 
Where the patient is receiving treatment at/from a public hospital
Chronic genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
Patient must have compensated liver disease;
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C;
The treatment must be limited to a maximum duration of 24 weeks in patients using peginterferon and ribavirin in triple combination therapy with telaprevir and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 4 and 12; OR
The treatment must be limited to a maximum duration of 28 weeks in patients using peginterferon and ribavirin in triple combination therapy with boceprevir and in whom plasma HCV RNA is undetectable by an HCV RNA qualitative assay at weeks 8 and 24; OR
The treatment must be limited to a maximum duration of 48 weeks in patients using peginterferon and ribavirin without an NS3 protease inhibitor; OR
The treatment must be limited to a maximum duration of 48 weeks in patients: (i) using peginterferon and ribavirin in triple combination therapy with boceprevir and in whom plasma HCV RNA is detectable by an HCV RNA qualitative assay at week 8, and undetectable by an HCV RNA qualitative assay at week 24; or (ii) using peginterferon and ribavirin in triple combination therapy with boceprevir who have hepatic cirrhosis; OR
The treatment must be limited to a maximum duration of 48 weeks in patients: (i) using peginterferon and ribavirin in triple combination therapy with telaprevir and for whom the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is detectable but less than or equal to 1000 IU/mL; or (ii) using peginterferon and ribavirin in triple combination therapy with telaprevir who have hepatic cirrhosis;
The treatment must cease in patients using peginterferon and ribavirin without an NS3 protease inhibitor unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop;
The treatment must cease in patients using peginterferon and ribavirin in combination with boceprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24;
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL;
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 12;
The treatment must cease in patients using peginterferon and ribavirin in combination with telaprevir if HCV RNA is detectable by an HCV RNA qualitative assay at week 24;
Patient must be aged 18 years or older;
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
For patients using peginterferon and ribavirin without an NS3 protease inhibitor who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4197

 
C4198
 
Where the patient is receiving treatment at/from a public hospital
Chronic genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
The treatment must be the sole PBS-subsidised treatment for hepatitis C;
Patient must have compensated liver disease;
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C;
The treatment must be limited to a maximum duration of 48 weeks;
The treatment must cease unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop;
Patient must weigh at least 27 kg;
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
For patients who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4198

 
C4199
 
Where the patient is receiving treatment at/from a public hospital
Chronic non-genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
The treatment must be the sole PBS-subsidised treatment for hepatitis C;
Patient must have compensated liver disease;
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C;
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated);
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C;
The treatment must be limited to a maximum duration of 48 weeks;
The treatment must cease if HCV RNA is detectable by an HCV RNA qualitative assay at week 12;
Patient must weigh at least 27 kg;
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4199

 
C4200
 
Where the patient is receiving treatment at/from a private hospital
Chronic genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
The treatment must be the sole PBS-subsidised treatment for hepatitis C;
Patient must have compensated liver disease;
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated);
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C;
The treatment must be limited to a maximum duration of 48 weeks;
The treatment must cease if HCV RNA is detectable by an HCV RNA qualitative assay at week 12;
Patient must weigh at least 27 kg;
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures


 
C4203
 
Where the patient is receiving treatment at/from a private hospital
Chronic genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
The treatment must be the sole PBS-subsidised treatment for hepatitis C;
Patient must have compensated liver disease;
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C;
The treatment must be limited to a maximum duration of 48 weeks;
The treatment must cease unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop;
Patient must weigh at least 27 kg;
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records.
For patients who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary
Compliance with Written or Telephone Authority Required procedures


 
C4206
 
Where the patient is receiving treatment at/from a public hospital
Chronic non-genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
The treatment must be the sole PBS-subsidised treatment for hepatitis C;
Patient must have compensated liver disease;
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C;
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated);
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C;
The treatment must be limited to a maximum duration of 48 weeks;
The treatment must cease if HCV RNA is detectable by an HCV RNA qualitative assay at week 12;
Patient must be aged 18 years or older;
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4206

 
C4207
 
Where the patient is receiving treatment at/from a private hospital
Chronic non-genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
The treatment must be the sole PBS-subsidised treatment for hepatitis C;
Patient must have compensated liver disease;
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C;
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C;
The treatment must be limited to a maximum duration of 24 weeks for patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or bridging fibrosis; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 4, 5 or 6 hepatitis C; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 2 or 3 hepatitis C with hepatic cirrhosis or bridging fibrosis;
The treatment must cease in patients with genotype 4, 5, or 6 hepatitis C unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) shows that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop;
The treatment must cease in patients eligible for 48 weeks of treatment if HCV RNA is detectable by an HCV RNA qualitative assay at week 24;
Patient must be aged 18 years or older;
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
For patients with genotype 4, 5, or 6 who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary.
For patients with genotype 2 or 3 without cirrhosis, an HCV RNA assay at week 12 is unnecessary because of the high likelihood of early viral response by week 12.
For patients who are eligible for 24 weeks of treatment, a maximum of 2 repeats may be prescribed
For patients who are eligible for 48 weeks of treatment, a maximum of 5 repeats may be prescribed
Compliance with Written or Telephone Authority Required procedures


 
C4208
 
Where the patient is receiving treatment at/from a private hospital
Chronic non-genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
The treatment must be the sole PBS-subsidised treatment for hepatitis C;
Patient must have compensated liver disease;
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C;
Patient must have failed prior treatment with interferon based therapies (non-pegylated or pegylated);
Patient must have received no more than one prior treatment with interferon alfa or peginterferon alfa for hepatitis C;
The treatment must be limited to a maximum duration of 48 weeks;
The treatment must cease if HCV RNA is detectable by an HCV RNA qualitative assay at week 12;
Patient must weigh at least 27 kg;
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures


 
C4209
 
Where the patient is receiving treatment at/from a private hospital
Chronic non-genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
The treatment must be the sole PBS-subsidised treatment for hepatitis C;
Patient must have compensated liver disease;
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C;
The condition must be genotype 2, 3, 4, 5 or 6 hepatitis C;
The treatment must be limited to a maximum duration of 24 weeks for patients with genotype 2 or 3 hepatitis C without hepatic cirrhosis or bridging fibrosis; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 4, 5 or 6 hepatitis C; OR
The treatment must be limited to a maximum duration of 48 weeks for patients with genotype 2 or 3 hepatitis C with hepatic cirrhosis or bridging fibrosis;
The treatment must cease in patients with genotype 4, 5, or 6 hepatitis C unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) shows that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop;
The treatment must cease in patients eligible for 48 weeks of treatment if HCV RNA is detectable by an HCV RNA qualitative assay at week 24;
Patient must weigh at least 27 kg;
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Evidence of chronic hepatitis C infection (repeated anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
For patients with genotype 4, 5, or 6 who are viral negative at week 12, an HCV RNA qualitative assay at week 24 is unnecessary
For patients with genotype 2 or 3 without cirrhosis, an HCV RNA assay at week 12 is unnecessary because of the high likelihood of early viral response by week 12
For patients who are eligible for 24 weeks of treatment, a maximum of 2 repeats may be prescribed
For patients who are eligible for 48 weeks of treatment, a maximum of 5 repeats may be prescribed
Compliance with Written or Telephone Authority Required procedures


 
[22]         Schedule 3, after entry for Tadalafil
Insert:
Telaprevir
C4186
 
Where the patient is receiving treatment at/from a public hospital
Chronic genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
Patient must have compensated liver disease;
Patient must not have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C;
The treatment must be in combination with peginterferon alfa and ribavirin;
The treatment must be limited to a maximum duration of 12 weeks;
The treatment must cease if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL;
Patient must be 18 years or older;
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Patients who have received prior treatment with an NS3/4A protease inhibitor are not eligible to receive PBS-subsidised telaprevir, except where the patient has developed an intolerance to the other NS3/4A protease inhibitor of a severity necessitating permanent treatment withdrawal. Details of the intolerance must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4186

 
C4191
 
Where the patient is receiving treatment at/from a public hospital
Chronic genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
Patient must have compensated liver disease;
Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C;
The treatment must be in combination with peginterferon alfa and ribavirin;
The treatment must be limited to a maximum duration of 12 weeks;
The treatment must cease if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL;
Patient must be 18 years or older;
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Patients who have received prior treatment with an NS3/4A protease inhibitor are not eligible to receive PBS-subsidised telaprevir, except where the patient has developed an intolerance to the other NS3/4A protease inhibitor of a severity necessitating permanent treatment withdrawal. Details of the intolerance must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 4191

 
C4194
 
Where the patient is receiving treatment at/from a private  hospital
Chronic genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
Patient must have compensated liver disease;
Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C;
The treatment must be in combination with peginterferon alfa and ribavirin;
The treatment must be limited to a maximum duration of 12 weeks;
The treatment must cease if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL;
Patient must be 18 years or older;
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Patients who have received prior treatment with an NS3/4A protease inhibitor are not eligible to receive PBS-subsidised telaprevir, except where the patient has developed an intolerance to the other NS3/4A protease inhibitor of a severity necessitating permanent treatment withdrawal. Details of the intolerance must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures


 
C4201
 
Where the patient is receiving treatment at/from a private hospital
Chronic genotype 1 hepatitis C infection
Must be treated in an accredited treatment centre;
Patient must have compensated liver disease;
Patient must not have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C;
The treatment must be in combination with peginterferon alfa and ribavirin;
The treatment must be limited to a maximum duration of 12 weeks;
The treatment must cease if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is greater than 1000 IU/mL;
Patient must be 18 years or older;
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child-bearing age
Evidence of chronic genotype 1 hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records
Patients who have received prior treatment with an NS3/4A protease inhibitor are not eligible to receive PBS-subsidised telaprevir, except where the patient has developed an intolerance to the other NS3/4A protease inhibitor of a severity necessitating permanent treatment withdrawal. Details of the intolerance must be documented in the patient's medical records
Compliance with Written or Telephone Authority Required procedures


[23]         Schedule 4, Patient contributions
Omit:
Listed Drug
Form (strength, type, size, etc.)
Manner of Administration
Brand
Pack Quantity
Approved Ex-manufacturer Price or Proportional Ex-manufacturer Price
$
Claimed price
$

Desferrioxamine
Powder for injection containing desferrioxamine mesylate 500 mg
Injection
Desferal 500 mg
10
93.14
100.86

 
Powder for injection containing desferrioxamine mesylate 2 g
Injection
Desferal 2 g
1
37.25
37.63

Substitute:
Listed Drug
Form (strength, type, size, etc.)
Manner of Administration
Brand
Pack Quantity
Approved Ex-manufacturer Price or Proportional Ex-manufacturer Price
$
Claimed price
$

Desferrioxamine
Powder for injection containing desferrioxamine mesylate 500 mg
Injection
Desferal 500 mg
10
81.02
87.74

 
Powder for injection containing desferrioxamine mesylate 2 g
Injection
Desferal 2 g
1
32.40
32.73

 
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.comlaw.gov.au.
Read Entire Law on www.comlaw.gov.au