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PB 76 of 2011 Arrangements as made
This instrument amends the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 (No. PB 116 of 2010) with the circumstances associated with 6 listed drugs for the treatment of Hepatitis B, the listed drug ‘Peginterferon Alfa 2a’ for the treatment of Hepatitis C and the listed drug ‘Zoledronic Acid’ for the treatment of prostate cancer, adds a new restriction for the listed drug ‘Romiplostin’ and adds a new listed drug ‘Eltrombopag’ to the Highly Specialised Drugs Program.
Administered by: Health
Registered 26 Oct 2011
Tabling HistoryDate
Tabled HR31-Oct-2011
Tabled Senate31-Oct-2011
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

 

PB 76 of 2011

National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2011 (No. 10)

 

National Health Act 1953

___________________________________________________________________________

 

 

I, FELICITY MCNEILL, Acting First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this Amendment Instrument under subsections 100(1) and 100(2) of the National Health Act 1953.

Dated    18 October 2011

 

 

 

 

 

 

 

 

 

 

 

FELICITY MCNEILL

Acting First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health and Ageing

 

___________________________________________________________________________

 

 

 

 


1              Name of Instrument

 

(1)                This Instrument is the National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2011 (No.10).

 

(2)                This Instrument may also be cited as PB 76 of 2011.

 

2             Commencement

                             This Instrument commences on 1 November 2011.

3              Amendments to PB 116 of 2010

                Schedule 1 amends the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 (PB 116 of 2010)

.

 

 


Schedule 1                   Amendments

[1]    Schedule 1, entry for Adefovir in the form Tablet containing adefovir dipivoxil 10 mg

omit from the column headed ‘Circumstances’:

C2931  C3313

substitute:

C3863  C3864

[2]    Schedule 1, after entry for Efavirenz

insert:

Eltrombopag

Tablet 25 mg (as olamine)

Oral

Revolade

GK

EMP

C3855 C3856 C3857 C3858

 

28

5

D

 

Tablet 50 mg (as olamine)

Oral

Revolade

GK

EMP

C3855 C3856 C3857 C3858

 

28

5

D

[3]    Schedule 1, entry for Entecavir in the form Tablet containing entecavir monohydrate 0.5 mg

omit from the column headed ‘Circumstances’:

C2937  C3352

substitute:

C3871  C3872

[4]    Schedule 1, entry for Entecavir in the form Tablet containing entecavir monohydrate 1 mg

omit from the column headed ‘Circumstances’:

C2935  C3353

substitute:

C3873  C3874

[5]    Schedule 1, entry for Interferon Alfa-2a

omit from the column headed ‘Circumstances’ (all instances):

C2939  C3383

insert following the last circumstances code in numerical order:

C3869  C3870

 

[6]    Schedule 1, entry for Interferon Alfa-2b

omit from the column headed ‘Circumstances’ (all instances):

C2939  C3383

insert after last circumstances code in numerical order:

C3869  C3870

[7]    Schedule 1, entry for Lamivudine in the form Tablet 100 mg

omit from the column headed ‘Circumstances’:

C2932  C3386

substitute:

C3871  C3872

[8]    Schedule 1, entry for Lamivudine in the form Oral solution 5 mg per mL, 240 mL

omit from the column headed ‘Circumstances’:

C2932  C3386

substitute:

C3871  C3872

[9]    Schedule 1, entry for Peginterferon Alfa-2a

omit from the column headed ‘Circumstances’ (all instances):

C2334  C2940  C3411  C3412

substitute:

C2334  C3412  C3867  C3868

[10]  Schedule 1, entry for Romiplostin

omit from the column headed ‘Circumstances’ (all instances):

C3699  C3700  C3701  C3702

substitute:

C3851  C3852  C3853  C3854

 

 

 

[11]  Schedule 1, entry for Telbivudine

omit from the column headed ‘Circumstances’:

C3052  C3416

substitute:

C3865  C3866

[12]  Schedule 1, entry for Tenofovir

omit from the column headed ‘Circumstances’:

C2931  C3203  C3313  C3417

insert following the last circumstances code in numerical order:

C3863  C3864  C3865  C3866

[13]  Schedule 1, entry for Zoledronic Acid

omit from the column headed ‘Circumstances’:

C1797  C3422

insert following the last circumstances code in numerical order:

C3881  C3882

[14]  Schedule 3, entry for Adefovir

substitute:

Adefovir

C3863

 

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

Chronic hepatitis B in a patient who has failed antihepadnaviral therapy and who satisfies all of the following criteria:
(a) Repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration in conjunction with documented chronic hepatitis B infection; or
(b) Repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months, whilst on previous antihepadnaviral therapy except in patients with evidence of poor compliance.
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy.

Compliance with Authority Required procedures

 

C3864

 

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

Chronic hepatitis B
Chronic hepatitis B in a patient who has failed antihepadnaviral therapy and who satisfies all of the following criteria:
(a) Repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration in conjunction with documented chronic hepatitis B infection; or
(b) Repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months, whilst on previous antihepadnaviral therapy except in patients with evidence of poor compliance.
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy

Compliance with Authority Required procedures - Streamlined Authority Code 3864


 

[15]  Schedule 3, after entry for Efavirenz

insert:

Eltrombopag

C3855

 

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

Initial (new patients)
Initial treatment, as the sole PBS-subsidised thrombopoietin receptor agonist (TRA), of severe thrombocytopenia in an adult patient with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP) who is:
(1) Splenectomised and:
(a) has had an inadequate response to, or is intolerant to, corticosteroid therapy post splenectomy; and
(b) has had an inadequate response to, or is intolerant to, immunoglobulin therapy post splenectomy; or
(2) Not splenectomised and:
(a) has had an inadequate response, or is intolerant to, corticosteroid therapy at a dose equivalent to 0.5-2 mg/kg/day of prednisone for at least 4-6 weeks; and
(b) has had an inadequate response, or is intolerant to, immunoglobulin therapy; and
(c) in whom splenectomy is contraindicated for medical reasons.

The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of initial application:
(a) a platelet count of less than or equal to 20,000 million per L; or
(b) a platelet count of 20,000 million to 30,000 million per L, where the patient is experiencing significant bleeding or has a history of significant bleeding in this platelet range.

The authority application must be made in writing and must include:
(1) a completed authority prescription form,
(2) a signed patient acknowledgement,
(3) a completed Idiopathic Thrombocytopenic Purpura Initial PBS Authority Application - Supporting Information Form,
(4) a copy of a full blood count pathology report supporting the diagnosis of ITP, and
(5) where the application is sought on the basis of a medical contraindication to surgery, a signed and dated letter from the clinician making this assessment which includes the date upon which the patient was assessed for surgery and the clinical grounds upon which surgery is contraindicated.

The full blood count must be no more than 1 month old at the time of application.

A maximum of 24 weeks of treatment with eltrombopag will be authorised under this criterion

Compliance with Authority Required procedures

 

C3856

 

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

Initial (previous treatment with eltrombopag not PBS-subsidised)
Initial treatment, as the sole PBS-subsidised thrombopoietin receptor agonist (TRA), of severe thrombocytopenia in an adult patient with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP) who was receiving treatment with eltrombopag prior to 1 November 2011 and in whom the criteria for initial treatment can be demonstrated to have been met at the time eltrombopag was commenced.

The authority application must be made in writing and must include:
(1) a completed authority prescription form,
(2) a signed patient acknowledgement,
(3) a completed Idiopathic Thrombocytopenic Purpura Initial PBS Authority Application - Supporting Information Form, and
(4) where the application is sought on the basis of a medical contraindication to surgery, a signed and dated letter from the clinician making this assessment which includes the date upon which the patient was assessed for surgery and the clinical grounds upon which surgery is contraindicated.

A maximum of 24 weeks of treatment with eltrombopag will be authorised under this criterion

Compliance with Authority Required procedures

 

C3857

 

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

Continuing therapy or re-initiation after a break in therapy
First period of PBS-subsidised continuing treatment or re-initiation of interrupted PBS-subsidised treatment, as the sole PBS-subsidised thrombopoietin receptor agonist (TRA), of severe thrombocytopenia in an adult patient with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who has displayed a sustained platelet response to treatment with eltrombopag during the initial period of PBS-subsidised treatment.

For the purposes of this restriction, a sustained platelet response is defined as use of rescue medication (corticosteroids or immunoglobulins) on no more than one occasion during the initial period of PBS-subsidised eltrombopag, and either of the following:
(a) a platelet count greater than or equal to 50,000 million per L on at least four occasions, each at least one week apart; or
(b) a platelet count greater than 30,000 million per L and which is double the baseline (pre-treatment) platelet count on at least four occasions, each at least one week apart.

Applications for the first period of continuing PBS-subsidised treatment or re-initiation of interrupted treatment must be made in writing and must include:
(1) a completed authority prescription form,
(2) a completed Idiopathic Thrombocytopenic Purpura Continuing PBS Authority Application - Supporting Information Form, and
(3) copies of the platelet count pathology reports (unless previously provided for patients re-initiating therapy).

The most recent platelet count must be no more than one month old at the time of application.

A maximum of 24 weeks of treatment with eltrombopag will be authorised under this criterion.

Where fewer than 5 repeats are initially requested with the authority prescription, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment may be made by telephone

Compliance with Authority Required procedures

 

C3858

 

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

Second and subsequent applications for continuing therapy
Continuing treatment, as the sole PBS-subsidised thrombopoietin receptor agonist (TRA), of severe thrombocytopenia in an adult patient with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who has previously received PBS-subsidised therapy with eltrombopag and who continues to display a response to treatment with eltrombopag.

For the purposes of this restriction, a continuing response to treatment with eltrombopag is defined as use of rescue medication (corticosteroids or immunoglobulins) on no more than one occasion during the most recent 24 week period of PBS-subsidised treatment with eltrombopag, and either of the following:
(a) a platelet count greater than or equal to 50,000 million per L; or
(b) a platelet count greater than 30,000 million per L and which is double the baseline platelet count.

Platelet counts must be no more than 1 month old at the time of application.

Authority applications for second and subsequent periods of continuing therapy may be made by telephone

Compliance with Authority Required procedures

 

[16]  Schedule 3, entry for Entecavir

substitute :

Entecavir

C3871

 

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

Chronic hepatitis B in a patient who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy.
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy.

Compliance with Authority Required procedures

 

C3872

 

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

Chronic hepatitis B in a patient who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAG positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAG negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy.
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L) should have their treatment discussed with a transplant unit prior to initiating therapy

Compliance with Authority Required procedures - Streamlined Authority Code 3872

 

C3873

 

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

Chronic hepatitis B in a patient who has failed lamivudine therapy and who satisfies all of the following criteria:
(a) Repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration in conjunction with documented chronic hepatitis B infection; or
(b) Repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months, whilst on previous antihepadnaviral therapy except in patients with evidence of poor compliance.
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy.

Compliance with Authority Required procedures

 

C3874

 

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

Chronic hepatitis B
Chronic hepatitis B in a patient who has failed lamivudine therapy and who satisfies all of the following criteria:
(a) Repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration in conjunction with documented chronic hepatitis B infection; or
(b) Repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months, whilst on previous antihepadnaviral therapy except in patients with evidence of poor compliance.
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy

Compliance with Authority Required procedures - Streamlined Authority Code 3874


 

[17]  Schedule 2, entry for Interferon Alfa-2a

omit:

 

C2939

 

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

Patients with chronic hepatitis B who satisfy all of the following criteria:
(1) Histological evidence of chronic hepatitis on liver biopsy (except in patients with coagulation disorders considered severe enough to prevent liver biopsy);
(2)(a) Abnormal serum ALT levels in conjunction with documented chronic hepatitis B infection; or
(b) Elevated HBV DNA levels in conjunction with documented chronic hepatitis B infection;
(3) Are not persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L);

(4) Female patients of child‑bearing age are not pregnant, not breast‑feeding, and are using an effective form of contraception.

Compliance with Written or Telephone Authority Required procedures

[18]  Schedule 3, entry for Interferon Alfa-2a

omit:

 

C3383

 

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

Patients with chronic hepatitis B who satisfy all of the following criteria:
(1) Histological evidence of chronic hepatitis on liver biopsy (except in patients with coagulation disorders considered severe enough to prevent liver biopsy);
(2)(a) Abnormal serum ALT levels in conjunction with documented chronic hepatitis B infection; or
(b) Elevated HBV DNA levels in conjunction with documented chronic hepatitis B infection;
(3) Are not persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L);
(4) Female patients of child‑bearing age are not pregnant, not breast‑feeding, and are using an effective form of contraception

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 3383

[19]  Schedule 3, entry for Interferon Alfa-2a

insert following the last circumstance in numerical order:

 

C3869

 

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

Chronic hepatitis B in a patient who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy;
(3) Is not a person with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L).

Compliance with Authority Required procedures

 

C3870

 

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

Chronic hepatitis B in a patient who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAG positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAG negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy;
(3) Is not a person with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L)

Compliance with Authority Required procedures - Streamlined Authority Code 3870

[20]  Schedule 3, entry for Interferon Alfa-2b

omit:

 

C2939

 

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

Patients with chronic hepatitis B who satisfy all of the following criteria:
(1) Histological evidence of chronic hepatitis on liver biopsy (except in patients with coagulation disorders considered severe enough to prevent liver biopsy);
(2)(a) Abnormal serum ALT levels in conjunction with documented chronic hepatitis B infection; or
(b) Elevated HBV DNA levels in conjunction with documented chronic hepatitis B infection;
(3) Are not persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L);

(4) Female patients of child‑bearing age are not pregnant, not breast‑feeding, and are using an effective form of contraception.

Compliance with Written or Telephone Authority Required procedures

 

[21]  Schedule 3, entry for Interferon Alfa-2b

omit:

 

C3383

 

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

Patients with chronic hepatitis B who satisfy all of the following criteria:
(1) Histological evidence of chronic hepatitis on liver biopsy (except in patients with coagulation disorders considered severe enough to prevent liver biopsy);
(2)(a) Abnormal serum ALT levels in conjunction with documented chronic hepatitis B infection; or
(b) Elevated HBV DNA levels in conjunction with documented chronic hepatitis B infection;
(3) Are not persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L);
(4) Female patients of child‑bearing age are not pregnant, not breast‑feeding, and are using an effective form of contraception

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 3383

[22]  Schedule 3, entry for Interferon Alfa-2b

insert following the last circumstance in numerical order:

 

C3869

 

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

Chronic hepatitis B in a patient who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy;
(3) Is not a person with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L).

Compliance with Authority Required procedures

 

C3870

 

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

Chronic hepatitis B in a patient who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAG positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAG negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy;
(3) Is not a person with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L)

Compliance with Authority Required procedures - Streamlined Authority Code 3870


[23]  Schedule 3, entry for Lamivudine

substitute:

Lamivudine

C3586

 

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

Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease

Compliance with Authority Required procedures

 

C3587

 

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

Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection

Compliance with Authority Required procedures

 

C3588

 

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

Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease

Compliance with Authority Required procedures - Streamlined Authority Code 3588

 

C3589

 

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

Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection

Compliance with Authority Required procedures - Streamlined Authority Code 3589

 

C3871

 

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

Chronic hepatitis B in a patient who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy.
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy.

Compliance with Authority Required procedures

 

C3872

 

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

Chronic hepatitis B in a patient who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAG positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAG negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy.
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L) should have their treatment discussed with a transplant unit prior to initiating therapy

Compliance with Authority Required procedures - Streamlined Authority Code 3872

[24]  Schedule 3, entry for Peginterferon Alfa-2a

omit:

 

C2940

 

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

Chronic hepatitis B
Monotherapy in patients with chronic hepatitis B and compensated liver disease who satisfy all of the following criteria:
(1) Histological evidence of chronic hepatitis on liver biopsy (except in patients with coagulation disorders considered severe enough to prevent liver biopsy);
(2)(a) Abnormal serum ALT levels in conjunction with documented chronic hepatitis B infection; or
(b) Elevated HBV DNA levels in conjunction with documented chronic hepatitis B infection;
(3) Have received no prior peginterferon alfa therapy for the treatment of hepatitis B;
(4) Female patients of child‑bearing age are not pregnant, not breast‑feeding, and are using an effective form of contraception;
(5) Are not persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L).
Treatment is limited to 1 course of treatment for a duration of up to 48 weeks

Compliance with Written or Telephone Authority Required procedures

 

C3411

 

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

Chronic hepatitis B
Monotherapy in patients with chronic hepatitis B and compensated liver disease who satisfy all of the following criteria:
(1) Histological evidence of chronic hepatitis on liver biopsy (except in patients with coagulation disorders considered severe enough to prevent liver biopsy);
(2)(a) Abnormal serum ALT levels in conjunction with documented chronic hepatitis B infection; or
(b) Elevated HBV DNA levels in conjunction with documented chronic hepatitis B infection;
(3) Have received no prior peginterferon alfa therapy for the treatment of hepatitis B;
(4) Female patients of child‑bearing age are not pregnant, not breast‑feeding, and are using an effective form of contraception;
(5) Are not persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L).
Treatment is limited to 1 course of treatment for a duration of up to 48 weeks

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 3411

and insert following the last circumstance in numerical order:

 

C3867

 

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

Monotherapy in a patient with chronic hepatitis B and compensated liver disease who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy;
(3) Have received no prior peginterferon alfa therapy for the treatment of hepatitis B;
(4) Is not a person with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L).
Treatment is limited to 1 course of treatment for a duration of up to 48 weeks;

Compliance with Authority Required procedures

 

C3868

 

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

Monotherapy in a patient with chronic hepatitis B who and compensated liver disease who satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAG positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAG negative - in conjunction with documented chronic hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum ALT; or
(b) Liver biopsy;
(3) Have received no prior peginterferon alfa therapy for the treatment of hepatitis B;
(4) Is not a person with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L.
Treatment is limited to 1 course of treatment for a duration of up to 48 weeks

Compliance with Authority Required procedures - Streamlined Authority Code 3868


[25]  Schedule 2, entry for Romiplostin

substitute:

Romiplostin

C3851

 

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

Initial (new patients)
Initial treatment, as the sole PBS-subsidised thrombopoietin receptor agonist (TRA), of severe thrombocytopenia in an adult patient with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP) who is:
(1) Splenectomised and:
(a) has had an inadequate response to, or is intolerant to, corticosteroid therapy post splenectomy; and
(b) has had an inadequate response to, or is intolerant to, immunoglobulin therapy post splenectomy; or
(2) Not splenectomised and:
(a) has had an inadequate response, or is intolerant to, corticosteroid therapy at a dose equivalent to 0.5-2 mg/kg/day of prednisone for at least 4-6 weeks; and
(b) has had an inadequate response, or is intolerant to, immunoglobulin therapy; and
(c) in whom splenectomy is contraindicated for medical reasons.

The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of initial application:
(a) a platelet count of less than or equal to 20,000 million per L; or
(b) a platelet count of 20,000 million to 30,000 million per L, where the patient is experiencing significant bleeding or has a history of significant bleeding in this platelet range.

The authority application must be made in writing and must include:
(1) a completed authority prescription form,
(2) a signed patient acknowledgement,
(3) a completed Idiopathic Thrombocytopenic Purpura Initial PBS Authority Application - Supporting Information Form,
(4) a copy of a full blood count pathology report supporting the diagnosis of ITP, and
(5) where the application is sought on the basis of a medical contraindication to surgery, a signed and dated letter from the clinician making this assessment which includes the date upon which the patient was assessed for surgery and the clinical grounds upon which surgery is contraindicated.

The full blood count must be no more than 1 month old at the time of application.

At the time of the written authority application, medical practitioners should request the appropriate quantity of vials of appropriate strength to provide sufficient drug for a single treatment at a dose of 1 microgram/kg. Up to 1 repeat may be requested with the initial written application.

Subsequently during the initial period of dose titration, authority applications for a single dose and up to 1 repeat may be made by telephone. The dose (microgram/kg/week) must be provided at the time of application.

Once a patient's dose has been stable for a period of 4 weeks, authority approvals for sufficient vials of appropriate strength based on the weight of the patient and dose (microgram/kg/week) for up to 4 weeks of treatment and up to 4 repeats may be granted, as long as the total period of treatment authorised under this restriction does not exceed 24 weeks.

Authority approval will not be given for doses of higher than 10 micrograms/kg/week

Compliance with modified Authority Required procedures

 

C3852

 

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

Initial (previous treatment with romiplostin not PBS-subsidised)
Initial PBS-subsidised treatment, as the sole PBS-subsidised thrombopoietin receptor agonist (TRA), of severe thrombocytopenia in an adult patient with severe chronic immune (idiopathic) thrombocytopenic purpura (ITP) who was receiving treatment with romiplostin prior to 1 April 2011 and in whom the criteria for initial treatment can be demonstrated to have been met at the time romiplostin was commenced.

The authority application must be made in writing and must include:
(1) a completed authority prescription form,
(2) a signed patient acknowledgement,
(3) a completed Idiopathic Thrombocytopenic Purpura Initial PBS Authority Application - Supporting Information Form, and
(4) where the application is sought on the basis of a medical contraindication to surgery, a signed and dated letter from the clinician making this assessment which includes the date upon which the patient was assessed for surgery and the clinical grounds upon which surgery is contraindicated.

For patients whose dose of romiplostin had been stable for at least 4 weeks at the time of the initial application for PBS-subsidy, the medical practitioner should request sufficient number of vials based on the weight of the patient and dose (microgram/kg/week) to provide up to 4 weeks of treatment. Up to a maximum of 5 repeats may be authorised.

Where the patient is in the titration phase of treatment with romiplostin, medical practitioners should request the appropriate quantity of vials of appropriate strength to provide sufficient drug for a single treatment at a dose of 1 microgram/kg. Up to 1 repeat may be requested with the initial written application.

Subsequently during the initial period of dose titration, authority applications for a single dose and up to 1 repeat may be made by telephone. The dose (microgram/kg/week) must be provided at the time of application.

Once a patient's dose has been stable for a period of 4 weeks, authority approvals for sufficient vials of appropriate strength based on the weight of the patient and dose (microgram/kg/week) for up to 4 weeks of treatment and up to 4 repeats may be granted, as long as the total period of treatment authorised under this restriction does not exceed 24 weeks.

Authority approval will not be given for doses of higher than 10 micrograms/kg/week

Compliance with modified Authority Required procedures

 

C3853

 

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

Continuing therapy or re-initiation after a break in therapy
First period of PBS-subsidised continuing treatment or re-initiation of interrupted PBS-subsidised treatment, as the sole PBS-subsidised thrombopoietin receptor agonist (TRA), of severe thrombocytopenia in an adult patient with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who has displayed a sustained platelet response to treatment with romiplostin during the initial period of PBS-subsidised treatment.

For the purposes of this restriction, a sustained platelet response is defined as use of rescue medication (corticosteroids or immunoglobulins) on no more than one occasion during the initial period of PBS-subsidised romiplostin, and either of the following:
(a) a platelet count greater than or equal to 50,000 million per L on at least four occasions, each at least one week apart; or
(b) a platelet count greater than 30,000 million per L and which is double the baseline (pre-treatment) platelet count on at least four occasions, each at least one week apart.

Applications for the first period of continuing PBS-subsidised treatment or re-initiation of interrupted treatment must be made in writing and must include:
(1) a completed authority prescription form,
(2) a completed Idiopathic Thrombocytopenic Purpura Continuing PBS Authority Application - Supporting Information Form, and
(3) copies of the platelet count pathology reports (unless previously provided for patients re-initiating therapy).

The most recent platelet count must be no more than one month old at the time of application.

The medical practitioner should request sufficient number of vials of appropriate strength based on the weight of the patient and dose (microgram/kg/week) to provide 4 weeks of treatment. Up to a maximum of 5 repeats may be authorised.

Where fewer than 5 repeats are initially requested with the authority prescription, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment may be made by telephone.

Authority approval will not be given for doses of higher than 10 micrograms/kg/week

Compliance with modified Authority Required procedures

 

C3854

 

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

Second and subsequent applications for continuing therapy
Continuing treatment, as the sole PBS-subsidised thrombopoietin receptor agonist (TRA), of severe thrombocytopenia in an adult patient with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who has previously received PBS-subsidised therapy with romiplostin and who continues to display a response to treatment with romiplostin.

For the purposes of this restriction, a continuing response to treatment with romiplostin is defined as use of rescue medication (corticosteroids or immunoglobulins) on no more than one occasion during the most recent 24 week period of PBS-subsidised treatment with romiplostin, and either of the following:
(a) a platelet count greater than or equal to 50,000 million per L; or
(b) a platelet count greater than 30,000 million per L and which is double the baseline platelet count.

Platelet counts must be no more than 1 month old at the time of application.

Authority applications for second and subsequent periods of continuing therapy may be made by telephone.

The medical practitioner should request sufficient number of vials of appropriate strength based on the weight of the patient and dose (microgram/kg/week) to provide 4 weeks of treatment. Up to a maximum of 5 repeats may be authorised.

Authority approval will not be given for doses of higher than 10 micrograms/kg/week

Compliance with modified Authority Required procedures

 

[26]  Schedule 3, entry for Telbivudine

substitute:

Telbivudine

C3865

 

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

Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B who is nucleoside analogue naive and satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative - in conjunction with documented hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum; or
(b) Liver biopsy.
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy.

Compliance with Authority Required procedures

 

C3866

 

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

Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B who is nucleoside analogue naive and satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAG positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAG negative - in conjunction with documented hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum; or
(b) Liver biopsy.
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy

Compliance with Authority Required procedures - Streamlined Authority Code 3866


[27]  Schedule 3, entry for Tenofovir

substitute:

Tenofovir

C3586

 

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

Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease

Compliance with Authority Required procedures

 

C3587

 

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

Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection

Compliance with Authority Required procedures

 

C3588

 

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

Initial treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in a patient with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease

Compliance with Authority Required procedures - Streamlined Authority Code 3588

 

C3589

 

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

Continuing treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents where the patient has previously received PBS-subsidised therapy for HIV infection

Compliance with Authority Required procedures - Streamlined Authority Code 3589

 

C3863

 

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

Chronic hepatitis B in a patient who has failed antihepadnaviral therapy and who satisfies all of the following criteria:
(a) Repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration in conjunction with documented chronic hepatitis B infection; or
(b) Repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months, whilst on previous antihepadnaviral therapy except in patients with evidence of poor compliance.
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy.

Compliance with Authority Required procedures

 

C3864

 

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

Chronic hepatitis B
Chronic hepatitis B in a patient who has failed antihepadnaviral therapy and who satisfies all of the following criteria:
(a) Repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration in conjunction with documented chronic hepatitis B infection; or
(b) Repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months, whilst on previous antihepadnaviral therapy except in patients with evidence of poor compliance.
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy

Compliance with Authority Required procedures - Streamlined Authority Code 3864


 

C3865

 

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

Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B who is nucleoside analogue naive and satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative - in conjunction with documented hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum; or
(b) Liver biopsy.
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy;

Compliance with Authority Required procedures

 

C3866

 

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

Treatment, as sole PBS-subsidised therapy, in a patient with chronic hepatitis B who is nucleoside analogue naive and satisfies all of the following criteria:
(1) Elevated HBV DNA levels - greater than 20,000 IU/mL (100,000 copies/mL) if HBeAG positive, or greater than 2,000 IU/mL (10,000 copies/mL) if HBeAG negative - in conjunction with documented hepatitis B infection;
(2) Evidence of chronic liver injury as determined by:
(a) Confirmed elevated serum; or
(b) Liver biopsy.
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy

Compliance with Authority Required procedures - Streamlined Authority Code 3866


[28]  Schedule 3, entry for Zoledronic Acid

omit:

 

C1797

 

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

Bone metastases from hormone‑resistant prostate cancer, with demonstration of biochemical progression of disease despite maximal therapy with hormonal treatments;

Compliance with Written or Telephone Authority Required procedures

[29]  Schedule 3, entry for Zoledronic Acid

omit:

 

C3422

 

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

Bone metastases from hormone‑resistant prostate cancer, with demonstration of biochemical progression of disease despite maximal therapy with hormonal treatments

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 3422

[30]  Schedule 3, entry for Zoledronic Acid

insert following the last circumstance in numerical order

 

C3881

 

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

Bone metastases from hormone-resistant prostate cancer;

Compliance with Authority Required procedures

 

C3882

 

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

Bone metastases from hormone-resistant prostate cancer

Compliance with Authority Required procedures - Streamlined Authority Code 3882

 

 

Note

All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. 

See http://www.frli.gov.au.