National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2011 (No. 10) (No. PB 76 of 2011) (Cth)

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

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

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

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

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

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

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

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

omit from the column headed ‘Circumstances’:

C2932 C3386

substitute:

C3871 C3872

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

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

Compliance with Written or Telephone Authority Required procedures

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

omit:

C3383

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

Compliance with Authority Required procedures

C3870

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

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.

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Citations

National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2011 (No. 10) (No. PB 76 of 2011) (Cth)

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