National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 2) (PB 13 of 2016) (Cth)

Case

PB 13 of 2016

National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 2)

National Health Act 1953
___________________________________________________________________________

I, JULIANNE QUAINE, Assistant Secretary, Pharmaceutical Access Branch, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health, make this Amendment Instrument under subsections 100(1) and 100(2) of the National Health Act 1953.

Dated    26   February 2016

Julianne Quaine
Assistant Secretary

Pharmaceutical Access Branch

Pharmaceutical Benefits Division

Department of Health

___________________________________________________________________________

1       Name of Instrument

(1)This Instrument is the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2016 (No. 2).

(2)This Instrument may also be cited as PB 13 of 2016.

2              Commencement

This Instrument commences on 1 March 2016.

3              Amendment

Amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010).

  1. Paragraph (c), Section 4 (definition of eligible medical practitioner)

    substitute into the definition after subsection (bb):

    (c)  who is, for the prescription of medication for the treatment of hepatitis C:

    (i) an accredited prescriber of medication for the treatment of hepatitis C; or

    (ii) a medical practitioner for Daclatasvir, Ledipasvir with sofosbuvir, Ribavirin, and Sofosbuvir; or

  2. Section 4

    Insert after the definition of ‘entitlement number’:

    General Statement for drugs for the treatment of hepatitis C means the statement set out in Schedule 3 Part 1.

  3. Sections 18 and 18A

    Repeal these sections, substitute:

    18    Supply of HSD pharmaceutical benefits under this Special Arrangement

    (1)HSD pharmaceutical benefits can be supplied under this Special Arrangement to an eligible patient by an:

    (a)     approved pharmacist; or

    (b)     approved medical practitioner; or

    (c)     approved hospital authority.

    (2)Section 94 of the Act applies in a modified manner to pharmaceutical benefits supplied by an approved hospital authority under this Special Arrangement.

    (3) An approved hospital authority may supply pharmaceutical benefits that are subject to this Special Arrangement to patients receiving treatment in or at the hospital of which it is the governing body or proprietor, or outside of the hospital. 

    (4)Subsection (1) does not require a hospital authority or an approved pharmacist to supply the HSD pharmaceutical benefit directly to a patient.

    (5)The HSD pharmaceutical benefit may be supplied by the hospital authority or approved pharmacist through an agent.

  4. Schedule 1, after entry for Cyclosporin  

    insert:  

Daclatasvir Tablet 30 mg Oral Daklinza BQ MP C5969 C5972 P5969 28 2
MP C5969 C5972 P5972 28 5
Tablet 60 mg Oral Daklinza BQ MP C5969 C5972 P5969 28 2
MP C5969 C5972 P5972 28 5

  1. Schedule 1, entry for Doxorubicin - pegylated liposomal in the form ‘Suspension for I.V. infusion containing pegylated liposomal doxorubicin hydrochloride 20 mg in 10 mL’ and brand ‘Liposomal Doxorubicin SUN’:

    omit from the column headed ‘Responsible Person’: ZF                substitute: RA

  2. Schedule 1, after entry for Lanthanum

    insert:   

Ledipasvir with sofosbuvir Tablet containing 90 mg ledipasvir with 400 mg sofosbuvir Oral Harvoni GI MP C5944 C5969 C5972 P5944 28 1
MP C5944 C5969 C5972 P5969 28 2
MP C5944 C5969 C5972 P5972 28 5

  1. Schedule 1, entry for Octreotide in each of the forms: ‘Injection 50 micrograms (as acetate) in 1 mL’; ‘Injection 100 micrograms (as acetate) in 1 mL’; and ‘Injection 500 micrograms (as acetate) in 1 mL’ and brand ‘Octreotide (SUN)’:

    omit from the column headed ‘Responsible Person’: ZF      substitute: RA

  2. Schedule 1, after entry for Raltegravir

    insert:   

Ribavirin Tablet 400 mg Oral Ibavyr IX MP C5957 C5958 P5957 28 2
MP C5957 C5958 P5958 28 5
Tablet 600 mg Oral Ibavyr IX MP C5957 C5958 P5957 28 2
MP C5957 C5958 P5958 28 5

  1. Schedule 1, entry for Ribavirin and peginterferon alfa-2a

    substitute:

Ribavirin and peginterferon alfa-2a Pack containing 112 tablets ribavirin 200 mg and 4 pre-filled syringes peginterferon alfa-2a injection 180 micrograms Injection/oral Pegasys RBV RO MP C4184 C4185 C4187 C4188 C4193 C4197 C4206 C4207 2 5 D
Pack containing 140 tablets ribavirin 200 mg and 4 pre-filled syringes peginterferon alfa-2a injection 180 micrograms Injection/oral Pegasys RBV RO MP C4184 C4185 C4187 C4188 C4193 C4197 C4206 C4207 C5956 P5956 1 2 D
MP C4184 C4185 C4187 C4188 C4193 C4197 C4206 C4207 C5956 P4184 P4185 P4187 P4188 P4193 P4197 P4206 P4207 2 5 D
Pack containing 168 tablets ribavirin 200 mg and 4 pre-filled syringes peginterferon alfa-2a injection 135 micrograms Injection/oral Pegasys RBV RO MP C4184 C4185 C4187 C4188 C4193 C4197 C4206 C4207 2 5 D
Pack containing 168 tablets ribavirin 200 mg and 4 pre-filled syringes peginterferon alfa-2a injection 180 micrograms Injection/oral Pegasys RBV RO MP C4184 C4185 C4187 C4188 C4193 C4197 C4206 C4207 C5956 P5956 1 2 D
MP C4184 C4185 C4187 C4188 C4193 C4197 C4206 C4207 C5956 P4184 P4185 P4187 P4188 P4193 P4197 P4206 P4207 2 5 D

  1. Schedule 1, entry for Simeprevir in the form ‘Capsule 150 mg (as sodium)’

    Omit from the column headed ‘Circumstances’: C4758 C4759              

  2. Schedule 1, after entry for Sirolimus

    insert:

Sofosbuvir Tablet 400 mg Oral Sovaldi GI MP C5969 C5972 P5969 28 2
MP C5969 C5972 P5972 28 5

  1. Schedule 1, entry for Valaciclovir

    Omit from the column headed ‘Circumstances’: C1494 C3419               substitute: C5939 C5975  

  2. Schedule 3, after entry for Cyclosporin  

    insert:

Daclatasvir C5969 P5969 Chronic hepatitis C infection
Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND
Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
The treatment must be limited to a maximum duration of 12 weeks. 		Compliance with Written or Telephone Authority Required procedures
C5972 P5972 Chronic hepatitis C infection
Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND
Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
The treatment must be limited to a maximum duration of 24 weeks. 		Compliance with Written or Telephone Authority Required procedures

  1. Schedule 3, after entry for Lanthanum

    insert:

Ledipasvir with sofosbuvir C5944 P5944 Chronic hepatitis C infection
Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND
Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
The treatment must be limited to a maximum duration of 8 weeks. 		Compliance with Written or Telephone Authority Required procedures
C5969 P5969 Chronic hepatitis C infection
Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND
Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
The treatment must be limited to a maximum duration of 12 weeks. 		Compliance with Written or Telephone Authority Required procedures
C5972 P5972 Chronic hepatitis C infection
Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND
Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
The treatment must be limited to a maximum duration of 24 weeks. 		Compliance with Written or Telephone Authority Required procedures

  1. Schedule 3, after entry for Raltegravir

    insert:

Ribavirin C5957 P5957 Chronic hepatitis C infection
Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND
Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
The treatment must be limited to a maximum duration of 12 weeks.
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. 		Compliance with Written or Telephone Authority Required procedures
C5958 P5958 Chronic hepatitis C infection
Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND
Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
The treatment must be limited to a maximum duration of 24 weeks.
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. 		Compliance with Written or Telephone Authority Required procedures

  1. Schedule 3, entry for Ribavirin and peginterferon alfa-2a

    insert after C4207:

C5956 P5956 Chronic hepatitis C infection
Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND
Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
The treatment must be limited to a maximum duration of 12 weeks.
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. 		Compliance with Written or Telephone Authority Required procedures

  1. Schedule 3, entry for Simeprevir

    substitute:

Simeprevir C4669 P4669 Chronic genotype 1 hepatitis C infection
Patient must have compensated liver disease; AND
Patient must have received prior treatment with interferon alfa or peginterferon alfa for hepatitis C; AND
The treatment must be in combination with peginterferon alfa and ribavirin; AND
The treatment must be limited to a maximum duration of 12 weeks; AND
The treatment must cease if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is 25 IU/mL or greater.
Patient must be 18 years or older; AND
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.
Must be treated in an accredited treatment centre.
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 simeprevir, 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
C4684 P4684 Chronic genotype 1 hepatitis C infection
Patient must have compensated liver disease; AND
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
The treatment must be in combination with peginterferon alfa and ribavirin; AND
The treatment must be limited to a maximum duration of 12 weeks; AND
The treatment must cease if the results of an HCV RNA quantitative assay at week 4 show that the plasma HCV RNA is 25 IU/mL or greater.
Patient must be aged 18 years or older; AND
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.
Must be treated in an accredited treatment centre.
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 simeprevir, 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

  1. Schedule 3, after entry for Sirolimus

    insert:

Sofosbuvir C5969 P5969 Chronic hepatitis C infection
Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND
Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
The treatment must be limited to a maximum duration of 12 weeks. 		Compliance with Written or Telephone Authority Required procedures
C5972 P5972 Chronic hepatitis C infection
Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND
Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
The treatment must be limited to a maximum duration of 24 weeks. 		Compliance with Written or Telephone Authority Required procedures

  1. Schedule 3, entry for Valaciclovir

    substitute:     

Valaciclovir C5939 P5939

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

Cytomegalovirus infection and disease
Prophylaxis
Patient must have undergone a renal transplant; AND
Patient must be at risk of cytomegalovirus disease.

 Compliance with Written or Telephone Authority Required procedures
C5975 P5975

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

Cytomegalovirus infection and disease
Prophylaxis
Patient must have undergone a renal transplant; AND
Patient must be at risk of cytomegalovirus disease.

 Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 5975

  1. After Schedule 3

    insert:

Schedule 3 Part 1—General statement for drugs for the treatment of hepatitis C

1  Criteria for eligibility for drugs for the treatment of chronic hepatitis C

The criteria for patient eligibility for drugs for the treatment of chronic hepatitis C are that:

  1. the patient is 18 years or older; and

  2. the patient has been assessed in accordance with paragraph 2 of this Part; and

  3. the patient is:

    a.treated by a medical practitioner who is experienced in the treatment of patients with chronic hepatitis C infection and is:

    i.a gastroenterologist; or

    ii.a hepatologist; or

    iii.an infectious diseases physician; or

    b.treated in consultation with a medical practitioner who is experienced in the treatment of patients with chronic hepatitis C infection and who is:

    i.a gastroenterologist; or

    ii.a hepatologist; or

    iii.an infectious diseases physician

2  Assessment of patient

For the purpose of subparagraph 1(2) of this Part, the patient has been assessed if the treating medical practitioner has:

  1. documented the following information in the patient’s medical records:

    a.evidence of chronic hepatitis C infection; and

    b.evidence of the patient’s hepatitis C virus genotype; and

  2. chosen a regimen in accordance with paragraph 3 of this Part; and

  3. collected the following information for the purposes of the authority application:

    a.the patient’s hepatitis C virus genotype; and

    b.whether the patient is:

    i. cirrhotic; or

    ii. Non-cirrhotic

  4. In this paragraph, evidence of chronic hepatitis C infection is documentation of:

    a.repeat test results showing antibody to hepatitis C virus (anti-HCV) positive; and

    b.test result showing hepatitis C virus ribonucleic acid (RNA) positive

3  Treatment regimen

For the purpose of subparagraph 2(2) of this Part, the treating medical practitioner has chosen a regimen in accordance with this paragraph if the patient:

  1. is a kind of patient mentioned for an Item in column 2 of the following table; and

  2. is to receive one of the regimens mentioned in column 3 of the same Item of the following table

Item Kind of patient Regimen
1

Patient:

(a)     with Genotype 1; and

(b)     who is treatment naïve; and

(c)     who is non-cirrhotic

Either:

(a)     LEDIPASVIR with SOFOSBUVIR for 8 weeks; or

(b)     LEDIPASVIR with SOFOSBUVIR for 12 weeks; or

(c)     DACLATASVIR and SOFOSBUVIR for 12 weeks; or

(d)     SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
2

Patient:

(a)     with Genotype 1; and

(b)     who is treatment experienced; and

(c)     who is non-cirrhotic

Either:

(a)     LEDIPASVIR with SOFOSBUVIR for 12 weeks; or

(b)     DACLATASVIR and SOFOSBUVIR for 12 weeks; or

(c)     DACLATASVIR and SOFOSBUVIR for 24 weeks; or

(d)     SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
3

Patient:

(a)     with Genotype 2; and

(b)     who is treatment naïve; and

(c)     who is non-cirrhotic

SOFOSBUVIR and RIBAVIRIN for 12 weeks.
4

Patient:

(a)     with Genotype 2; and

(b)     who is treatment experienced; and

(c)     who is non-cirrhotic

SOFOSBUVIR and RIBAVIRIN for 12 weeks.
5

Patient:

(a)     with Genotype 3; and

(b)     who is treatment naïve; and

(c)     who is non-cirrhotic

Either:

(a)     DACLATASVIR and SOFOSBUVIR for 12 weeks; or

(b)     SOFOSBUVIR and RIBAVIRIN for 24 weeks; or

(c)     SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
6

Patient:

(a)     with Genotype 3; and

(b)     who is treatment experienced; and

(c)     who is non-cirrhotic

Either:

(a)     DACLATASVIR and SOFOSBUVIR for 12 weeks; or

(b)     SOFOSBUVIR and RIBAVIRIN for 24 weeks; or

(c)     SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
7

Patient:

(a)     with:

(i)    Genotype 4; or

(ii)     Genotype 5; or

(iii)    Genotype 6; and

(b)     who is treatment naïve; and

(c)     who is non-cirrhotic

SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
8

Patient:

(a)     with:

(i)    Genotype 4; or

(ii)     Genotype 5; or

(iii)    Genotype 6; and

(b)     who is treatment experienced; and

(c)     who is non-cirrhotic

SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
9

Patient:

(a)     with Genotype 1; and

(b)   who is treatment naïve; and

(c)    who is cirrhotic

Either:

(a)     LEDIPASVIR with SOFOSBUVIR for 12 weeks; or

(b)     DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 12 weeks; or

(c)     DACLATASVIR and SOFOSBUVIR for 24 weeks; or

(d)     SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
10

Patient:

(a)     with Genotype 1; and

(b)     who is treatment experienced; and

(c)     who is cirrhotic

Either:

(a)     LEDIPASVIR with SOFOSBUVIR for 24 weeks; or

(b)     DACLATASVIR and SOFOSBUVIR for 24 weeks; or

(c)     DACLATASVIR and SOFOSBUVIR and RIBAVIRIN for 12 weeks; or

(d)     SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
11

Patient:

(a)     with Genotype 2; and

(b)     who is treatment naïve; and

(c)     who is cirrhotic

SOFOSBUVIR and RIBAVIRIN for 12 weeks.
12

Patient:

(a)     with Genotype 2; and

(b)     who is treatment experienced; and

(c)     who is cirrhotic

SOFOSBUVIR and RIBAVIRIN for 12 weeks.
13

Patient:

(a)     with Genotype 3; and

(b)     who is treatment naïve; and

(c)     who is cirrhotic

Either:

(a)     SOFOSBUVIR and RIBAVIRIN for 24 weeks; or

(b)     DACLATASVIR and SOFOSBUVIR for 24 weeks; or

(c)     SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
14

Patient:

(a)     with Genotype 3; and

(b)     who is treatment experienced; and

(c)     who is cirrhotic

Either:

(a)     DACLATASVIR and SOFOSBUVIR for 24 weeks; or

(b)     SOFOSBUVIR and RIBAVIRIN for 24 weeks; or

(c)     SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
15

Patient:

(a)     with:

(i)    Genotype 4; or

(ii)     Genotype 5; or

(iii)    Genotype 6; and

(b)   who is treatment naïve; and

(c)    who is cirrhotic

SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
16

Patient:

(a)     with:

(i)    Genotype 4; or

(ii)     Genotype 5; or

(iii)    Genotype 6; and

(b)   who is treatment experienced; and

(c)    who is cirrhotic

SOFOSBUVIR and PEGINTERFERON ALFA-2A with RIBAVIRIN for 12 weeks.
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