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PB 122 of 2010 Arrangements as made
This Arrangement amends the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 (No. PB 116 of 2010) to amend the prescribing circumstances for the Complex Authority Required drug.
Administered by: Health
Registered 17 Dec 2010
Tabling HistoryDate
Tabled HR08-Feb-2011
Tabled Senate08-Feb-2011
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

 

PB 122 of 2010

National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2010 (No. 1)

 

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      15 December 2010

 

 

 

 

 

 

 

 

 

 

 

FELICITY MCNEILL

Acting First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health and Ageing

 

___________________________________________________________________________

 

 

 

 


1              Name of Amendment Instrument

 

(1)                This Amendment Instrument is the National Health (Highly                    

             specialised drugs program for hospitals) Special Arrangement

            Amendment Instrument 2010 (No.1).

 

(2)                This instrument may also be cited as PB 122 of 2010.

 

2             Commencement

                             This Amendment Instrument commences on 1 January 2011.

3              Amendments to PB 116 of 2010

                             Schedule 1 amends PB 116 of 2010.

 

 


Schedule 1                   Amendments

 

[1]                 section 4, definition of manufacturer’s pack

omit:

subsection 6 (2) of the Commonwealth price (Pharmaceutical benefits supplied by approved pharmacists) Determination 2010

and insert:

the determination made under paragraph 98B(1)(a) of the Act

 

[2]                 subsection 39(1)

              omit (all instances):

           Commonwealth price (Pharmaceutical benefits supplied by approved pharmacists) Determination 2010

                and insert:

            the determination made under paragraph 98B(1)(a) of the Act

 

[3]                 paragraph 45(2)(a)

omit:

              Determination made pursuant to subsection 84BA(2) of the National Health Act 1953

and insert:

the determination made under subsection 84BA(2) of the Act

 

[4]                 Schedule 1, entry for Abacavir

omit from the column headed ‘Circumstances’ (twice occuring):

                C1820  C1821  C3309  C3310

and insert:

                C3586  C3587  C3588  C3589

 

[5]                 Schedule 1, entry for Abacavir with Lamivudine

omit from the column headed ‘Circumstances’:

                C1822  C1823  C3311  C3312

and insert:

                C3590  C3591  C3592  C3593

[6]                 Schedule 1, entry for Abacavir with Lamivudine and Zidovudine

omit from the column headed ‘Circumstances’:

                C1822  C1823  C3311  C3312

and insert:

                C3590  C3591  C3592  C3593

 

[7]                 Schedule 1, entry for Atanzavir

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

                C1832  C1833  C3315  C3316 

and insert:

                C3586  C3587  C3588  C3589

 

[8]                 Schedule 1, entry for Darunavir

omit from the column headed ‘Circumstances’ (twice occuring):

                C3279  C3335 

and insert:

                C3594  C3595

 

[9]                 Schedule 1, entry for Didanosine

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

                C1820  C1821  C3309  C3310 

and insert:

                C3586  C3587  C3588  C3589

 

[10]             Schedule 1, entry for Efavirenz

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

                C1820  C1821  C3309  C3310 

and insert:

                C3586  C3587  C3588  C3589

 

[11]             Schedule 1, entry for Emtricitabine

omit from the column headed ‘Circumstances’:

                C1820  C1821  C3309  C3310

and insert:

                C3856  C3587  C3588  C3589

 

[12]             Schedule 1, entry for Enfuvirtide

omit from the column headed ‘Circumstances’:

                C2007  C2008  C3350  C3351 

and insert:

                C3596  C3597

 

[13]             Schedule 1, entry for Etravirine

omit from the column headed ‘Circumstances’:

                C2956  C3354 

and insert:

                C3596  C3597

 

[14]             Schedule 1, entry for Fosamprenavir in the form Tablet 700 mg (as calcium)

omit from the column headed ‘Responsible Person’ GK and insert VI

 

[15]             Schedule 1, entry for Fosemprenavir

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

                C1832  C1833  C3315  C3316 

and insert:

                C3586  C3587  C3588  C3589

 

[16]             Schedule 1, entry for Indinavir

omit from the column headed ‘Circumstances’:

                C1820  C1821  C3309  C3310 

and insert:

                C3586  C3587  C3588  C3589

 

[17]             Schedule 1, entry for Infliximab

omit from the column headed ‘Circumstances’:

                C3006

and insert in the column headed ‘Circumstances’ in numerical order following the last circumstance:

                C3585 

 

[18]        Schedule 1, entry for Lamivudine in each of the forms: Tablet 150mg; Tablet 300mg; and Oral solution 10mg per mL, 240mL

omit from the column headed ‘Circumstances’:

                C1820  C1821  C3309  C3310 

and insert:

                C3586  C3587  C3588  C3589

 

[19]             Schedule 1, entry for Lamivudine with Zidovudine

omit from the column headed ‘Circumstances’:

                C1820  C1821  C3309  C3310 

and insert:

                C3586  C3587  C3588  C3589

 

[20]             Schedule 1, entry for Lopinavir with Ritonavir

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

                C1832  C1833  C3315  C3316 

and insert:

                C3586  C3587  C3588  C3589

 

[21]             Schedule 1, entry for Maraviroc

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

                C3286  C3406 

and insert:

                C3598  C3599

 

[22]             Schedule 1, entry for Nevirapine

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

                C1820  C1821  C3309  C3310 

and insert:

                C3586  C3587  C3588  C3589

 

[23]             Schedule 1, entry for Raltegravir

omit from the column headed ‘Circumstances’:

                C3505  C3506  C3507  C3508 

and insert:

                C3586  C3587  C3588  C3589

 

[24]             Schedule 1, entry for Ritonavir

omit from the column headed ‘Circumstances’ (twice occuring):

                C1820  C1821  C3309  C3310 

and insert:

                C3586  C3587  C3588  C3589

 

[25]             Schedule 1, entry for Saquanavir

omit from the column headed ‘Circumstances’:

                C1820  C1821  C3309  C3310 

and insert:

                C3586  C3587  C3588  C3589

 

[26]             Schedule 1, entry for Stavudine

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

                C1820  C1821  C3309  C3310 

and insert:

                C3586  C3587  C3588  C3589

 

[27]             Schedule 1, entry for Tenofovir

omit from the column headed ‘Circumstances’:

                C1820  C1821  C2931  C3203  C3309  C3310  C3313  C3417 

and insert:

                C2931  C3203  C3313  C3417  C3586  C3587  C3588  C3589 

 

[28]             Schedule 1, entry for Tenofovir with Emtricitabine

omit from the column headed ‘Circumstances’:

                C1820  C1821  C3309  C3310 

and insert:

                C3586  C3587  C3588  C3589

 

[29]             Schedule 1, entry for Tenofovir with emtricitabine and efavirenz

omit from the column headed ‘Circumstances’:

C1820  C1821  C3309  C3310 

and insert:

                C3586  C3587  C3588  C3589

 

[30]             Schedule 1, entry for Tipranavir in the form Capsule 250mg

omit from the column headed ‘Circumstances’:

                C2700  C3418 

and insert:

                C3600  C3601 

 

[31]             Schedule 1, entry for Tipranavir in the form Oral liquid 100 mg per mL, 95 mL

omit from the column headed ‘Circumstances’:

                C3500  C3501 

and insert:

                C3602  C3603

 

[32]             Schedule 1, entry for Zidovudine

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

C1820  C1821  C3309  C3310 

and insert:

                C3586  C3587  C3588  C3589

 

[32]       Schedule 2, after:

PF

Pfizer Australia Pty Ltd

50 008 422 348

               omit in the columns in the order indicated:

PF

ViiV Healthcare Pty Ltd

46 138 687 448

 

[33]             Schedule 3, entry for Abacavir
substitute:

Abacavir

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 Written or Telephone 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 Written or Telephone 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 Written or Telephone 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 Written or Telephone Authority Required procedures -

Streamlined Authority Code 3589

[34]             Schedule 3, entry for Abacavir with Lamivudine 
substitute:

Abacavir with Lamivudine

C3590

 

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 over 12 years of age, weighing 40 kg or more, with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease

Compliance with Written or Telephone Authority Required procedures

 

C3591

 

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 over 12 years of age, weighing 40 kg or more, has previously received PBS-subsidised therapy for HIV infection

Compliance with Written or Telephone Authority Required procedures

 

C3592

 

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 over 12 years of age, weighing 40 kg or more, with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease

Compliance with Written or Telephone Authority Required procedures -

Streamlined Authority Code 3592

 

C3593

 

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 over 12 years of age, weighing 40 kg or more, has previously received PBS-subsidised therapy for HIV infection

Compliance with Written or Telephone Authority Required procedures -

Streamlined Authority Code 3593

[35]             Schedule 3, entry for Abacavir with Lamivudine and Zidovudine
substitute:

Abacavir with Lamivudine and Zidovudine

C3590

 

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 over 12 years of age, weighing 40 kg or more, with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease

Compliance with Written or Telephone Authority Required procedures

 

C3591

 

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 over 12 years of age, weighing 40 kg or more, has previously received PBS-subsidised therapy for HIV infection

Compliance with Written or Telephone Authority Required procedures

 

C3592

 

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 over 12 years of age, weighing 40 kg or more, with a CD4 count of less than 500 per cubic millimetre or symptomatic HIV disease

Compliance with Written or Telephone Authority Required procedures -

Streamlined Authority Code 3592

 

C3593

 

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 over 12 years of age, weighing 40 kg or more, has previously received PBS-subsidised therapy for HIV infection

Compliance with Written or Telephone Authority Required procedures -

Streamlined Authority Code 3593

[36]             Schedule 3, entry for Atazanavir
substitute:

Atazanavir

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 Written or Telephone 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 Written or Telephone 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 Written or Telephone 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 Written or Telephone Authority Required procedures - Streamlined Authority Code 3589

[37]             Schedule 3, entry for Darunavir 

substitute:

Darunavir

C3594

 

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

Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents, and co‑administered with 100 mg ritonavir twice daily in an antiretroviral experienced patient who, after at least one antiretroviral regimen, has experienced virological failure or clinical failure or genotypic resistance

Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity

Compliance with Written or Telephone Authority Required procedures

 

C3595

 

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

Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents, and co‑administered with 100 mg ritonavir twice daily in an antiretroviral experienced patient who, after at least one antiretroviral regiment, has experienced virological failure or clinical failure or genotypic resistance

Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity

Compliance with Written or Telephone Authority Required procedures -

Streamlined Authority Code 3595

[38]             Schedule 3, entry for Didanosine

  substitute:

Didanosine

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 Written or Telephone 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 Written or Telephone 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 Written or Telephone 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 Written or Telephone Authority Required procedures - Streamlined Authority Code 3589

[39]             Schedule 3, entry for Efavirenz

substitute:

Efavirenz

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 Written or Telephone 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 Written or Telephone 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 Written or Telephone 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 Written or Telephone Authority Required procedures - Streamlined Authority Code 3589

[40]             Schedule 3, entry for Emtricitabine

substitute:

Emtricitabine

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 Written or Telephone 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 Written or Telephone 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 Written or Telephone 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 Written or Telephone Authority Required procedures - Streamlined Authority Code 3589

[41]             Schedule 3, entry for Enfuvirtide 
substitute:

Enfurvirtide

C3596

 

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

Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents in an antiretroviral experienced patient who, after each of at least three different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes, has experienced virological failure or clinical failure or genotypic resistance.

Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity

Compliance with Written or Telephone Authority Required procedures

 

C3597

 

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

Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents in an antiretroviral experienced patient who, after each of at least three different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes, has experienced virological failure or clinical failure or genotypic resistance.

Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity

Compliance with Written or Telephone Authority Required procedures – Streamlined Authority Code 3597

[42]             Schedule 3, entry for Etravirine

substitute:

Etravirine

C3596

 

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

Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents in an antiretroviral experienced patient who, after each of at least three different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes, has experienced virological failure or clinical failure or genotypic resistance.

Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity

Compliance with Written or Telephone Authority Required procedures

 

C3597

 

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

Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents in an antiretroviral experienced patient who, after each of at least three different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes, has experienced virological failure or clinical failure or genotypic resistance.

Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity

Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3597

 

[43]             Schedule 3, entry for Fosamprenavir 

substitute:

Fosamprenavir

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 Written or Telephone 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 Written or Telephone 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 Written or Telephone 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 Written or Telephone Authority Required procedures - Streamlined Authority Code 3589

[44]             Schedule 3, entry for Indinavir 

substitute:

Indinavir

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 Written or Telephone 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 Written or Telephone 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 Written or Telephone 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 Written or Telephone Authority Required procedures - Streamlined Authority Code 3589

[45]             Schedule 3, entry for Infliximab    
omit:

 

C3006

 

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

Crohn disease — initial treatment
(paediatric patient)
Initial PBS-subsidised treatment by a gastroenterologist, paediatrician, consultant physician in internal medicine specialising in gastroenterology or consultant physician in general medicine specialising in gastroenterology, of a patient aged 6 to 17 years inclusive with moderate to severe refractory Crohn disease who satisfies the following criteria:
(a) has confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician as specified above; and
(b) whose parent or authorised guardian has signed a patient acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment will cease if the patient does not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and
(c) has failed to achieve an adequate response to 2 of the following 3 conventional prior therapies including:
(i) a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period;
(ii) an 8 week course of enteral nutrition;
(iii) immunosuppressive therapy including:
— azathioprine at a dose of at least 2 mg per kg daily for 3 or more months; or
— 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months; or
— methotrexate at a dose of at least 10 mg per square metre weekly for 3 or more months; and
where the following conditions apply:
if treatment with any of the drugs mentioned at (c) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication;
if intolerance to treatment with the regimens mentioned at (c) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;
failure to achieve an adequate response is indicated by severity of disease activity which results in a Paediatric Crohn Disease Activity Index (PCDAI) Score greater than or equal to 30, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment, and is demonstrated in the patient at the time of the authority application;
the most recent PCDAI assessment is no more than 1 month old at the time of application;
all tests and assessments are performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment;
the application for authorisation is made in writing and includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Paediatric Crohn Disease Activity Index (PCDAI) calculation sheet including the date of assessment of the patient's condition; and
(ii) details of previous systemic drug therapy (dosage, date of commencement and duration of therapy), or dates of enteral nutrition; and
(iii) the signed patient acknowledgement;
a course of initial treatment is limited to a maximum of 3 doses at 5 mg per kg body weight per dose, to be administered at weeks 0, 2 and 6 of the course;
if a supply insufficient for 3 doses is authorised when the written application is made, a subsequent authority application for a supply sufficient to allow the patient to complete the initial course of 3 doses may be submitted by telephone

Compliance with modified Authority Required procedures

and insert in the columns in the order indicated, and in numerical order for the column headed “Circumstances Code”:

 

C3585

 

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

Crohn disease — initial treatment
(paediatric patient)
Initial PBS-subsidised treatment by a gastroenterologist, paediatrician, consultant physician in internal medicine specialising in gastroenterology or consultant physician in general medicine specialising in gastroenterology, of a patient aged 6 to 17 years inclusive with moderate to severe refractory Crohn disease who satisfies the following criteria:
(a) has confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician as specified above; and
(b) whose parent or authorised guardian has signed a patient acknowledgement indicating they understand and acknowledge that PBS-subsidised treatment will cease if the patient does not meet the predetermined response criterion for ongoing PBS-subsidised treatment, as outlined in the restriction for continuing treatment; and
(c) has failed to achieve an adequate response to 2 of the following 3 conventional prior therapies including:
(i) a tapered course of steroids, starting at a dose of at least 1 mg per kg or 40 mg (whichever is the lesser) prednisolone (or equivalent), over a 6 week period;
(ii) an 8 week course of enteral nutrition;
(iii) immunosuppressive therapy including:
— azathioprine at a dose of at least 2 mg per kg daily for 3 or more months; or
— 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months; or
— methotrexate at a dose of at least 10 mg per square metre weekly for 3 or more months; and
where the following conditions apply:
if treatment with any of the drugs mentioned at (c) above is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, the authority application includes details of the contraindication;
if intolerance to treatment with the regimens mentioned at (c) above develops during the relevant period of use and is of a severity necessitating permanent treatment withdrawal, the authority application includes details of the degree of this toxicity;
failure to achieve an adequate response is indicated by severity of disease activity which results in a Paediatric Crohn Disease Activity Index (PCDAI) Score greater than or equal to 30, as assessed preferably whilst still on treatment but no longer than 1 month following cessation of the most recent prior treatment, and is demonstrated in the patient at the time of the authority application;
the most recent PCDAI assessment is no more than 1 month old at the time of application;
all tests and assessments are performed preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior treatment;
the application for authorisation is made in writing and includes a completed copy of the appropriate Crohn Disease PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Paediatric Crohn Disease Activity Index (PCDAI) calculation sheet including the date of assessment of the patient's condition; and
(ii) details of previous systemic drug therapy (dosage, date of commencement and duration of therapy), or dates of enteral nutrition; and
(iii) the signed patient acknowledgement;
a course of initial treatment is limited to a maximum of 3 doses at 5 mg per kg body weight per dose, to be administered at weeks 0, 2 and 6 of the course;
if a supply insufficient for 3 doses is authorised when the written application is made, a subsequent authority application for a supply sufficient to allow the patient to complete the initial course of 3 doses may be submitted by telephone

Compliance with modified Authority Required procedures

[46]             Schedule 3, entry for Lamivudine

substitute:

Lamivudine

C2932

 

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) Female patients of child-bearing age are not pregnant, not breast-feeding, and are using an effective form of contraception.
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 Written or Telephone Authority Required procedures

 

C3386

 

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) Female patients of child-bearing age are not pregnant, not breast-feeding, and are using an effective form of contraception.
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 Written or Telephone Authority Required procedures - Streamlined Authority Code 3386


 

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 Written or Telephone 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 Written or Telephone 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 Written or Telephone 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 Written or Telephone Authority Required procedures - Streamlined Authority Code 3589

[47]             Schedule 3, entry for Lamivudine with Zidovudine

            substitute:

Lamivudine with Zidovudine

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 Written or Telephone 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 Written or Telephone 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 Written or Telephone 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 Written or Telephone Authority Required procedures - Streamlined Authority Code 3589

 

[48]             Schedule 3, entry for Lopinavir with Ritonavir

substitute:

Lopinavir with Ritonavir

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 Written or Telephone 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 Written or Telephone 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 Written or Telephone 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 Written or Telephone Authority Required procedures - Streamlined Authority Code 3589

[49]             Schedule 3, entry for Maraviroc

substitute:

Maraviroc

C3598

 

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

Treatment, in addition to optimised background therapy in combination with other antiretroviral agents, of an antiretroviral experienced patient infected with only CCR5-tropic human immunodeficiency virus type 1 (HIV-1), who, after each of at least three difference antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes, has experienced virological failure or clinical failure or genotypic resistance. A tropism assay to determine CCR5 only strain status is required prior to initiation. Individuals with CXCR4 tropism demonstrated at any time point are not eligible.

Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-linking toxicity.

Compliance with Written or Telephone Authority Required procedures

 

C3599

 

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

Treatment, in addition to optimised background therapy in combination with other antiretroviral agents, of an antiretroviral experienced patient infected with only CCR5-tropic human immunodeficiency virus type 1 (HIV-1), who, after each of at least three difference antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes, has experienced virological failure or clinical failure or genotypic resistance. A tropism assay to determine CCR5 only strain status is required prior to initiation. Individuals with CXCR4 tropism demonstrated at any time point are not eligible.

Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-linking toxicity.

Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3599

[50]             Schedule 3, entry for Nevirapine

            substitute:

Nevirapine

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 Written or Telephone 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 Written or Telephone 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 Written or Telephone 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 Written or Telephone Authority Required procedures - Streamlined Authority Code 3589

 

[51]             Schedule 3, entry for Raltegravir

                substitute:

Raltegravir

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 Written or Telephone 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 Written or Telephone 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 Written or Telephone 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 Written or Telephone Authority Required procedures - Streamlined Authority Code 3589

[52]             Schedule 3, entry for Ritonavir

   substitute:

Ritonavir

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 Written or Telephone 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 Written or Telephone 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 Written or Telephone 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 Written or Telephone Authority Required procedures - Streamlined Authority Code 3589

[53]             Schedule 3, entry for Saquinavir

substitute:

Saquinavir

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 Written or Telephone 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 Written or Telephone 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 Written or Telephone 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 Written or Telephone Authority Required procedures - Streamlined Authority Code 3589

[54]             Schedule 3, entry for Stavudine

substitute:

Stavudine

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 Written or Telephone 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 Written or Telephone 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 Written or Telephone 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 Written or Telephone Authority Required procedures - Streamlined Authority Code 3589

[55]             Schedule 3, entry for Tenofovir

substitute:

Tenofovir

C2931

 

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

Chronic hepatitis B
Chronic hepatitis B in a patient who has failed antihepadnaviral therapy and who satisfies all of the following criteria:
(1)(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;
(2) Female patients of child-bearing age are not pregnant, not breast-feeding, and are using an effective form of contraception.
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 Written or Telephone Authority Required procedures

 

C3203

 

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

Chronic hepatitis B
Treatment, as sole PBS-subsidised therapy, of chronic hepatitis B in a patient who is nucleoside analogue naive and satisfies 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) Female patients of child-bearing age are not pregnant, not breast-feeding, and are using an effective form of contraception.
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 Written or Telephone Authority Required procedures

 

C3313

 

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:
(1)(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;
(2) Female patients of child-bearing age are not pregnant, not breast-feeding, and are using an effective form of contraception.
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 Written or Telephone Authority Required procedures - Streamlined Authority Code 3313


 

C3417

 

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

Chronic hepatitis B
Treatment, as sole PBS-subsidised therapy, of chronic hepatitis B in a patient who is nucleoside analogue naive and satisfies 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) Female patients of child-bearing age are not pregnant, not breast-feeding, and are using an effective form of contraception.
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 Written or Telephone Authority Required procedures - Streamlined Authority Code 3417


 

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 Written or Telephone 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 Written or Telephone 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 Written or Telephone 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 Written or Telephone Authority Required procedures - Streamlined Authority Code 3589

[56]             Schedule 3, entry for Tenofovir with Emtricitabine

substitute:

Tenofovir with Emtricitabine

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 Written or Telephone 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 Written or Telephone 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 Written or Telephone 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 Written or Telephone Authority Required procedures - Streamlined Authority Code 3589

[57]             Schedule 3, entry for Tenofovir with emtricitabine and efavirenz

                substitute:

Tenofovir with Emtricitabine and Efavirenz

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 Written or Telephone 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 Written or Telephone 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 Written or Telephone 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 Written or Telephone Authority Required procedures - Streamlined Authority Code 3589

[58]             Schedule 3, entry for Tipranavir

    substitute:

Tipranavir

C3600

 

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

Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents, and co-administered with 200 mg ritonavir twice daily in an antiretroviral experienced patient who, after each of at least three different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes, has experienced virological failure or clinical failure or genotypic resistance.
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity

Compliance with Written or Telephone Authority Required procedures

 

C3601

 

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

Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents, and co-administered with 200 mg ritonavir twice daily in an antiretroviral experienced patient who, after each of at least three different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes, has experienced virological failure or clinical failure or genotypic resistance.
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity

Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3601

 

C3602

 

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

Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents, and co-administered with ritonavir in an antiretroviral experienced patient who, after each of at least three different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes, has experienced virological failure or clinical failure or genotypic resistance.
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity

Compliance with Written or Telephone Authority Required procedures

 

C3603

 

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

Treatment of human immunodeficiency virus (HIV) infection, in addition to optimised background therapy in combination with other antiretroviral agents, and co-administered with ritonavir in an antiretroviral experienced patient who, after each of at least three different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes, has experienced virological failure or clinical failure or genotypic resistance.
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity

Compliance with Written or Telephone Authority Required procedures - Streamlined Authority Code 3603

[59]             Schedule 3, entry for Zidovudine
substitute:

Zidovudine

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 Written or Telephone 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 Written or Telephone 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 Written or Telephone 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 Written or Telephone Authority Required procedures - Streamlined Authority Code 3589

 

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.