Hospital Circular 04/2005: Hospital Circulars - Department of Health, Victoria, Australia

Hospital Circular 04/2005

Date Issued: 17 March 2005

Distribution: Public Hospitals

Subject: Highly Specialised Drugs Program

Purpose: To advise hospitals of changes to the Highly Specialised Drugs Program, effective 1 April 2005.

We have had recent advice from the Commonwealth Government of changes to the Highly Specialised Drugs Program, effective 1 April 2005.

1. ADDED DRUGS

Emtricitabine

Treatment of HIV infection in patients with:

CD4 cell counts of less than 500 per cubic millimetre; or
viral load of greater than 10,000 copies per mL.

6137B

Capsule 200 mg

$282.00

Emtriva

Iloprost trometamol

NOTE:
Any queries concerning the arrangements to prescribe iloprost trometamol may be directed to the Health Insurance Commission on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).

Written applications for authority to prescribe iloprost trometamol should be forwarded to:

Health Insurance Commission
Prior Written Approval of Specialised Drugs
Reply Paid 9826
GPO Box 9826
HOBART TAS 7001

NOTE:
Iloprost trometamol is not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with scleroderma, where the total lung capacity is less than 70% of that predicted.
Iloprost trometamol is not PBS-subsidised when used in combination with PBS-subsidised bosentan monohydrate.

The following provides some explanatory notes regarding the availability of PBS-subsidised treatment with:

bosentan monohydrate, of primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma, in patients with disease of WHO Functional Class III or IV severity; AND
iloprost trometamol, of primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease, in adult patients with disease of WHO Functional Class III or IV severity.

From 1 April 2005, adult patients with primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma will be able to access, through the PBS, either bosentan monohydrate or iloprost trometamol. Once these patients are approved initial treatment with 1 of these 2 drugs, they may swap between bosentan monohydrate and iloprost trometamol at any time without having to re-qualify for treatment with the alternate agent. This means that patients may commence treatment with the alternate agent irrespective of the severity of their disease at the time the application to swap therapy is submitted. It also means that no new baseline measurements will be necessary (unless the prescriber wishes to submit new baselines).

Patients may only swap to bosentan monohydrate or iloprost trometamol if they have not failed prior PBS-subsidised treatment with that drug.

Patients with pulmonary arterial hypertension secondary to connective tissue disease other than scleroderma or with drug-induced pulmonary arterial hypertension are only eligible for treatment with iloprost trometamol. They may not swap to bosentan monohydrate.

Patients aged less than 18 years with primary pulmonary hypertension are only eligible to receive treatment with bosentan monohydrate. They may qualify for treatment with iloprost trometamol when they are aged 18 years or older.

1. Definition of primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease, including scleroderma.

Primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease, including scleroderma, are defined as follows:

mean pulmonary artery pressure (mPAP) greater than 25 mmHg at rest and pulmonary capillary wedge pressure (PCWP) less than 18 mmHg; or
mPAP greater than 30 mmHg with exercise and PCWP less than 18 mmHg; or
where a right heart catheter cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
Definition of WHO Functional Class III or IV disease severity.
1. WHO Functional Class III disease severity is defined as follows:
Patients with pulmonary hypertension resulting in marked limitation of physical activity who are comfortable at rest and on ordinary physical activity experience dyspnoea or fatigue, chest pain or near syncope.
1. WHO Functional Class IV disease severity is defined as follows:

Patients with the inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure. Dyspnoea and/or fatigue may even be present at rest. Discomfort is increased by any physical activity.

3. Designated hospitals.

Refer to the HIC website for a list of designated hospitals.

4. Test requirements to establish baseline for initiation of treatment and response to treatment for continuation of treatment.

Initiation of treatment.
1. New patients.
  The first written application for PBS-subsidised treatment with the first of either bosentan monohydrate or iloprost trometamol should be accompanied by the results of a right heart catheter (RHC) composite assessment, plus an ECHO composite assessment, plus a 6 minute walk test (6MWT) to establish the patient's baseline measurements.
  
  Where it is not possible to perform all 3 tests above on clinical grounds, the following list outlines the preferred test combination, in descending order, for the purposes of initiation of PBS-subsidised treatment:
  1. RHC plus ECHO composite assessments;
  2. RHC composite assessment plus 6MWT;
  3. RHC composite assessment only.
  In circumstances where a RHC cannot be performed on clinical grounds, applications may be submitted to the HIC for consideration based on the results of the following test combinations, which are listed in descending order of preference:
  1. ECHO composite assessment plus 6MWT;
  2. ECHO composite assessment only.
  Where fewer than 3 tests are able to be performed on clinical grounds, a reason outlining why the particular test/s could not be conducted must be provided with the authority application.
  
  Where patients were initiated on PBS-subsidised treatment either with bosentan monohydrate on or after 1 March 2004, or with iloprost trometamol on or after 1 April 2005, the test results provided with the initial application must be no more than 2 months old at the time of application. These results will form the baseline against which response assessments will be made.
  
  Where patients received treatment with either bosentan monohydrate or iloprost trometamol prior to being commenced on PBS-subsidised treatment with the first of either bosentan monohydrate or iloprost trometamol, the test requirements above still apply. The results that will form the baseline against which response assessments will be made will be those measured at the time patients commenced non-PBS-subsidised treatment with either bosentan monohydrate or iloprost trometamol, whichever of the 2 drugs the patient received first.
2. Patients who received non-PBS-subsidised treatment with iloprost trometamol prior to 1 April 2005.
  For patients with primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease who were commenced on iloprost trometamol treatment prior to 1 April 2005 and who have received less than 6 months of treatment with iloprost trometamol at the time of application, the first application for PBS-subsidised treatment must include, where available, all 3 test results at the time that the patient commenced treatment with iloprost trometamol or bosentan monohydrate, whichever was initiated first.
  
  For patients with primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease who were commenced on iloprost trometamol treatment prior to 1 April 2005 and who have received 6 or more months of treatment at the time of application, the first application for PBS-subsidised treatment must include, where available, all 3 test results at the time that the patient commenced treatment with iloprost trometamol or bosentan monohydrate, whichever was initiated first. The results at the time of application for initial treatment must also be provided and must be no older than 3 months.
Continuation of treatment.
The following list outlines the preferred test combination, in descending order, for the purposes of continuation of PBS-subsidised treatment:
1. RHC plus ECHO composite assessments plus 6MWT;
2. RHC plus ECHO composite assessments;
3. RHC composite assessment plus 6MWT;
4. ECHO composite assessment plus 6MWT;
5. RHC composite assessment only;
6. ECHO composite assessment only.

The results of the same tests as conducted at baseline should be provided with each written continuing treatment application (i.e. every 6 months), except for patients who were able to undergo all 3 tests at baseline, and whose subsequent ECHO and 6MWT results demonstrate disease stability or improvement, in which case RHC can be omitted. In all other patients, where the same test(s) conducted at baseline cannot be performed for assessment of response on clinical grounds, a reason why the test(s) could not be conducted must be provided with the application.

The test(s) results provided with the application for continuing treatment must be no more than 2 months old at the time of application.

5. Definition of response to iloprost trometamol, bosentan monohydrate or prior vasodilator treatment.

For adult patients with 2 or more baseline tests, response to treatment is defined as 2 or more tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

For adult patients with a RHC composite assessment alone at baseline, response to treatment is defined as a RHC result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

For adult patients with an ECHO composite assessment alone at baseline, response to treatment is defined as an ECHO result demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

NOTE:

6. Authority approval requirements. [The following 2 sections are only relevant to the PBS listing of iloprost trometamol. The requirements specific to bosentan monohydrate are given in parts 6 and 7 of the NOTE included in the bosentan monohydrate Schedule entry.]

Initiation of PBS-subsidised treatment with iloprost trometamol, where the patient has not received prior PBS-subsidised treatment with bosentan monohydrate.
All applications for initial treatment must be made in writing.

Patients who commence PBS-subsidised iloprost trometamol treatment after 1 April 2005 and patients who received 6 or more months of iloprost trometamol treatment prior to 1 April 2005 are eligible to receive up to 6 months of treatment per authority application.

Patients who commenced treatment with iloprost trometamol prior to 1 April 2005 and who have received less than 6 months of treatment at the time of application are eligible to receive sufficient supply to allow the patient to complete a total of 6 months of combined PBS-subsidised and non-PBS-subsidised treatment.

All patients with primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease who commenced treatment with iloprost trometamol prior to 1 April 2005 will be eligible to commence PBS-subsidised treatment with iloprost trometamol. Thereafter, to be eligible for further PBS-subsidised supply, these patients must demonstrate a response to iloprost trometamol treatment, as defined above under definition of response.
Continuation of treatment.
Written applications for continuing treatment must be submitted to the HIC for authorisation every 6 months. Approvals will be limited to provide sufficient supply for up to a maximum of 6 months of treatment.

Applications for continuing treatment will only be approved for patients who have demonstrated a response to an initial course of treatment with iloprost trometamol.

The assessment of the patient's response to the first and subsequent 6 month courses of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated. Applications for continuing treatment with iloprost trometamol should be made prior to the completion of the 6 month treatment course to ensure continuity for those patients who respond to treatment, as assessed by the treating physician.
Swapping between bosentan monohydrate and iloprost trometamol.
For eligible patients, applications to swap between these 2 drugs must be made under the relevant initial treatment restriction. Patients should be assessed for response to the treatment they are ceasing at the time the application to swap therapy is being made. Patients who fail to demonstrate a response or for whom no assessment results are submitted with the application to swap therapy may not re-commence PBS-subsidised treatment with the drug they are ceasing.
Cessation of treatment.
Patients who fail to demonstrate a response to PBS-subsidised iloprost trometamol treatment at the times where an assessment is required must cease PBS-subsidised iloprost trometamol therapy.

7. Re-treatment with iloprost trometamol.

Patients who do not respond to treatment are not eligible to receive further PBS-subsidised treatment with iloprost trometamol under any circumstances.

8. Further information.

A diagrammatical representation of the above information and the restriction can be obtained from the HIC website.

Application for initial PBS-subsidised treatment with iloprost trometamol of adult patients who have not received prior PBS-subsidised treatment with bosentan monohydrate and who have been assessed by a physician from a designated hospital to have:

WHO Functional Class III primary pulmonary hypertension and a mean right atrial pressure of 8 mmHg or less, as measured by RHC, unless a RHC is contraindicated on clinical grounds; OR
WHO Functional Class III pulmonary arterial hypertension secondary to connective tissue disease and a mean right atrial pressure of 8 mmHg or less, as measured by RHC, unless a RHC is contraindicated on clinical grounds; OR
WHO Functional Class III drug-induced pulmonary arterial hypertension and a mean right atrial pressure of 8 mmHg or less, as measured by RHC, unless a RHC is contraindicated on clinical grounds.

Patients must have failed to respond [see Note for definition of response] to 6 or more weeks of appropriate vasodilator treatment unless intolerance or a contraindication to such treatment exists.

In circumstances where a RHC cannot be performed on clinical grounds, applications may be submitted to the HIC for consideration based on the test results of the ECHO composite assessment plus 6MWT or the ECHO composite assessment only.

Applications for authorisation must be in writing and must include:

a completed authority prescription form [see Note for authority approval requirements]; and
a completed Bosentan Monohydrate (Tracleer) and Iloprost Trometamol (Ventavis) PBS Authority Application - Supporting Information form may be downloaded from the HIC website which includes results from the 3 tests below, where available:
1. RHC composite assessment; and
2. ECHO composite assessment; and
3. 6MWT; and
a copy of a signed patient acknowledgment form indicating that the patient understands and acknowledges that PBS-subsidised treatment with iloprost trometamol for primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease, OR with bosentan monohydrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma, will cease if the treating physician determines that the patient has not achieved a response to treatment [see Note for definition of response].

Details of prior vasodilator treatment, including the dose and duration of treatment, must be provided at the time of application. Where the patient is commenced on iloprost trometamol treatment due to an adverse event or a contraindication to vasodilator treatment, details on the nature of the adverse event or contraindication according to the TGA-approved Product Information must also be provided with the application.

Where fewer than 3 tests (see requirement 2 above) are able to be performed on clinical grounds, a reason outlining why the particular test/s could not be conducted must be provided with the authority application [see Note for test requirements].

The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment. A maximum of 5 repeats may be requested. Where fewer than 5 repeats are requested at the time of application, authority approvals for sufficient repeats to complete a maximum of 6 months of treatment may be requested by telephone.

WHO Functional Class III primary pulmonary hypertension and a mean right atrial pressure greater than 8 mmHg, as measured by RHC, unless a RHC is contraindicated on clinical grounds; OR
WHO Functional Class III pulmonary arterial hypertension secondary to connective tissue disease and a mean right atrial pressure greater than 8 mmHg, as measured by RHC, unless a RHC is contraindicated on clinical grounds; OR
WHO Functional Class III drug-induced pulmonary arterial hypertension and a mean right atrial pressure greater than 8 mmHg, as measured by RHC, unless a RHC is contraindicated on clinical grounds; OR
WHO Functional Class IV primary pulmonary hypertension; OR
WHO Functional Class IV pulmonary arterial hypertension secondary to connective tissue disease; OR
WHO Functional Class IV drug-induced pulmonary arterial hypertension.

Applications for authorisation must be in writing and must include:

a completed authority prescription form [see Note for authority approval requirements]; and
a completed Bosentan Monohydrate (Tracleer) and Iloprost Trometamol (Ventavis) PBS Authority Application - Supporting Information form may be downloaded from the HIC website which includes results from the 3 tests below, where available:
1. RHC composite assessment; and
2. ECHO composite assessment; and
3. 6MWT; and
a copy of a signed patient acknowledgment form indicating that the patient understands and acknowledges that PBS-subsidised treatment with iloprost trometamol for primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease, OR with bosentan monohydrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma, will cease if the treating physician determines that the patient has not achieved a response to treatment [see Note for definition of response].

Application for initial PBS-subsidised treatment with iloprost trometamol of adult patients who were receiving treatment with iloprost trometamol prior to 1 April 2005, who have not received prior PBS-subsidised treatment with bosentan monohydrate and who have been assessed by a physician from a designated hospital to have:

WHO Functional Class III or IV primary pulmonary hypertension; OR
WHO Functional Class III or IV drug-induced pulmonary arterial hypertension; OR
WHO Functional Class III or IV pulmonary arterial hypertension secondary to connective tissue disease.

Applications for authorisation must be in writing and must include:

a completed authority prescription form [see Note for authority approval requirements]; and
1. for patients who have received less than 6 months of iloprost trometamol treatment at the time of application — a completed Bosentan Monohydrate (Tracleer) and Iloprost Trometamol (Ventavis) PBS Authority Application - Supporting Information form [may be downloaded from the HIC website (www.hic.gov.au)] which includes results of the following 3 tests, where available, at the time treatment with iloprost trometamol was commenced:
  1. RHC composite assessment; and
  2. ECHO composite assessment; and
  3. 6MWT; or
2. for patients who have received 6 or more months of iloprost trometamol treatment at the time of application — a completed Bosentan Monohydrate (Tracleer) and Iloprost Trometamol (Ventavis) PBS Authority Application - Supporting Information form may be downloaded from the HIC website which includes results of the following 3 tests, both at the time treatment with iloprost trometamol was commenced and at the time of application, where available:
  1. RHC composite assessment; and
  2. ECHO composite assessment; and
  3. 6MWT; and
the date of commencement of iloprost trometamol treatment; and
a copy of a signed patient acknowledgment form indicating that the patient understands and acknowledges that PBS-subsidised treatment with iloprost trometamol for primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease, OR with bosentan monohydrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma, will cease if the treating physician determines that the patient has not achieved a response to treatment [see Note for definition of response].

The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment. The number of repeats authorised will be dependent on the duration of prior iloprost trometamol therapy. Where patients have received less than 6 months of non-PBS-subsidised treatment with iloprost trometamol, sufficient repeats to allow the patient to complete a total of 6 months of combined PBS-subsidised and non-PBS-subsidised therapy may be requested. Where patients have received 6 months or more of non-PBS-subsidised treatment with iloprost trometamol, a maximum of 5 repeats may be requested. Where fewer than the maximum allowable number of repeats are requested at the time of application, authority approvals for the remainder of the allowable repeats may be requested by telephone.

Application for initial treatment with iloprost trometamol of adult patients with either of the following:

primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease who wish to re-commence PBS-subsidised iloprost trometamol after a break in therapy and who have demonstrated a response to their most recent course of PBS-subsidised treatment with iloprost trometamol; OR
primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma and whose most recent course of PBS-subsidised treatment was with bosentan monohydrate.

Applications for authorisation must be in writing and must include:

a completed authority prescription form [see Note for authority approval requirements]; and
a completed Bosentan Monohydrate (Tracleer) and Iloprost Trometamol (Ventavis) PBS Authority Application - Supporting Information form may be downloaded from the HIC website which includes the results on which approval for the first application for PBS-subsidised iloprost trometamol or bosentan monohydrate, whichever was initiated first, was granted; and
the date of the first application for PBS-subsidised treatment with iloprost trometamol or bosentan monohydrate, whichever was initiated first; and
the results of the patient's response to treatment with their last course of PBS-subsidised iloprost trometamol and bosentan monohydrate.

Continuing PBS-subsidised treatment with iloprost trometamol of patients with primary pulmonary hypertension, pulmonary arterial hypertension secondary to connective tissue disease or drug-induced pulmonary arterial hypertension, who have received approval for initial PBS-subsidised treatment with iloprost trometamol, and who have been assessed by a physician from a designated hospital to have achieved a response to their most recent course of iloprost trometamol treatment [see Note for definition of response].

Applications for authorisation must be in writing and must include:

a completed authority prescription form; and
a completed Bosentan Monohydrate (Tracleer) and Iloprost Trometamol (Ventavis) PBS Authority Application - Supporting Information form can be downloaded from the HIC website which includes results from the 3 tests below, where available:
1. RHC composite assessment; and
2. ECHO composite assessment; and
3. 6MWT.

6456T Solution for inhalation 20 micrograms

(base) in 2 mL 30 $1,076.00 Ventavis SC

NOTE:

This price is based on special supply arrangements—see Pharmaceutical Benefits Pricing Authority relativity sheet for full details.

2. AMENDED RESTRICTIONS

Bosentan monohydrate

CAUTION:

Bosentan monohydrate is a category X drug and must not be given to pregnant women. Pregnancy must be avoided during treatment and for at least 3 months following cessation of treatment with this drug.

NOTE:

Any queries concerning the arrangements to prescribe bosentan monohydrate may be directed to the Health Insurance Commission on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday).

Written applications for authority to prescribe bosentan monohydrate should be forwarded to:

Health Insurance Commission
Prior Written Approval of Specialised Drugs
Reply Paid 9826
GPO Box 9826
HOBART TAS 7001

NOTE:
Bosentan monohydrate is not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with scleroderma, where the total lung capacity is less than 70% of that predicted.

Bosentan monohydrate is not PBS-subsidised when used in combination with PBS-subsidised iloprost trometamol.

The following provides some explanatory notes regarding the availability of PBS-subsidised treatment with :

bosentan monohydrate , of primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma, in patients with disease of WHO Functional Class III or IV severity; AND
iloprost trometamol, of primary pulmonary hypertension and , drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to scleroderma connective tissue disease, in adult patients with disease of WHO Functional Class III or IV severity.

Primary From 1 April 2005, adult patients with primary pulmonary hypertension and or pulmonary arterial hypertension secondary to scleroderma are defined as follows: will be able to access, through the PBS, either bosentan monohydrate or iloprost trometamol. Once these patients are approved initial treatment with 1 of these 2 drugs, they may swap between bosentan monohydrate and iloprost trometamol at any time without having to re-qualify for treatment with the alternate agent. This means that patients may commence treatment with the alternate agent irrespective of the severity of their disease at the time the application to swap therapy is submitted. It also means that no new baseline measurements will be necessary (unless the prescriber wishes to submit new baselines).

Patients may only swap to bosentan monohydrate or iloprost trometamol if they have not failed prior PBS-subsidised treatment with that drug.

1. Definition of primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease, including scleroderma.

Primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease, including scleroderma, are defined as follows:

mean pulmonary artery pressure (mPAP) greater than 25 mmHg at rest and pulmonary capillary wedge pressure (PCWP) less than 18 mmHg; or
mPAP greater than 30 mmHg with exercise and PCWP less than 18 mmHg; or
where a right heart catheter cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.

2. Definition of WHO Functional Class III or IV disease severity.

WHO Functional Class III disease severity is defined as follows:

Patients with pulmonary hypertension resulting in marked limitation of physical activity who are comfortable at rest and on ordinary physical activity experience dyspnoea or fatigue, chest pain or near syncope.
WHO Functional Class IV disease severity is defined as follows:

Patients with the inability to carry out any physical activity without symptoms. These patients manifest signs of right heart failure. Dyspnoea and/or fatigue may even be present at rest. Discomfort is increased by any physical activity.

3. Designated hospitals.

Refer to the HIC website for a list of designated hospitals.

4. Test requirements to establish baseline for initiation of treatment and response to treatment for continuation of treatment.

Initiation of treatment.

Written applications The first written application for PBS-subsidised treatment with the first of either bosentan monohydrate or iloprost trometamol should be accompanied by the results of a right heart catheter (RHC) composite assessment, plus an ECHO composite assessment, plus a 6 minute walk test (6MWT) to establish the patient's baseline measurements.

Where it is not possible to perform all 3 tests above on clinical grounds, the following list outlines the preferred test combination, in descending order, for the purposes of initiation of PBS-subsidised treatment:
1. RHC plus ECHO composite assessments;
2. RHC composite assessment plus 6MWT;
3. RHC composite assessment only.
In circumstances where a RHC cannot be performed on clinical grounds, applications may be submitted to the HIC for consideration based on the results of the following test combinations, which are listed in descending order of preference:
1. ECHO composite assessment plus 6MWT;
2. ECHO composite assessment only.
Where fewer than 3 tests are able to be performed on clinical grounds, a reason outlining why the particular test/s could not be conducted must be provided with the authority application.

For Where patients who commence bosentan monohydrate therapy were initiated on PBS-subsidised treatment either with bosentan monohydrate on or after 1 March 2004, or with iloprost trometamol on or after 1 April 2005, the test results provided with the initial application for initial treatment must be no more than 2 months old at the time of application. These results will form the baseline against which response assessments will be made.

For patients with primary pulmonary hypertension and pulmonary arterial hypertension secondary to scleroderma who were commenced on bosentan monohydrate treatment prior to 1 March 2004 and who have received less than 6 months of treatment with bosentan monohydrate at the time of application, the first application for PBS-subsidised treatment must include, where available, all 3 test results at the time that the patient commenced treatment with bosentan monohydrate (baseline).

For patients with primary pulmonary hypertension and pulmonary arterial hypertension secondary to scleroderma who were commenced on bosentan monohydrate treatment prior to 1 March 2004 and who have received 6 or more months of treatment at the time of application, the first application for PBS-subsidised treatment must include, where available, all 3 test results at the time that the patient commenced treatment with bosentan monohydrate (baseline), plus the test results at the time of application. The latter test results must be no more than 3 months old.

Where patients received treatment with either bosentan monohydrate or iloprost trometamol prior to being commenced on PBS-subsidised treatment with the first of either bosentan monohydrate or iloprost trometamol, the test requirements above still apply. The results that will form the baseline against which response assessments will be made will be those measured at the time patients commenced non-PBS-subsidised treatment with either bosentan monohydrate or iloprost trometamol, whichever of the 2 drugs the patient received first.
Continuation of treatment.

The following list outlines the preferred test combination, in descending order, for the purposes of continuation of PBS-subsidised treatment:
1. RHC plus ECHO composite assessments plus 6MWT;
2. RHC plus ECHO composite assessments;
3. RHC composite assessment plus 6MWT;
4. ECHO composite assessment plus 6MWT;
5. RHC composite assessment only;
6. ECHO composite assessment only.

The test(s) results provided with the application for continuing treatment must be no more than 2 months old at the time of application.

5. Definition of response to iloprost trometamol, bosentan monohydrate or prior vasodilator treatment.

For patients aged less than 18 years, response to treatment is defined as at least 1 of the baseline tests demonstrating stability or improvement of disease, as assessed by a physician from a designated hospital.

NOTE:

6. Authority approval requirements. [The following 2 sections are only relevant to the PBS listing of bosentan monohydrate. The requirements specific to iloprost trometamol are given in parts 6 and 7 of the NOTE included in the iloprost trometamol Schedule entry.]

Initiation of PBS-subsidised treatment with bosentan monohydrate, where the patient has not received prior PBS-subsidised treatment with iloprost trometamol.
1. De-novo patients.
  For the All applications for initial treatment of patients who commence therapy on or after 1 March 2004, 1 written application which includes must be made in writing, must include 2 separate authority prescriptions and must be submitted to the HIC for authorisation. The total duration of initial PBS-subsidised treatment that will be approved with this first written application is up to 6 months.
  
  Approvals for the first authority prescription will be limited to 1 month of therapy with the 62.5 mg strength tablet, with the quantity approved based on the dosage recommendations in the Therapeutic Goods Administration (TGA)-approved Product Information. No repeats will be authorised for this prescription. The second authority prescription may be written for either the 62.5 mg tablet or the 125 mg tablet strengths. Where the 62.5 mg tablet strength is required, please contact the HIC on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday) for further advice. Approvals for the second authority prescription will be limited to 1 month of treatment, with the quantity approved based on the dosage recommendations in the TGA-approved Product Information, and a maximum of 4 repeats. The approved second authority prescription will be returned to the prescriber by the HIC 2 weeks after the date of the approval of the first authority prescription, to allow for the uninterrupted completion of the 6 month initial treatment course. The HIC will contact prescribers prior to dispatch of the second authority prescription to confirm the tablet strength required for the patient.
2. Patients who commenced bosentan monohydrate prior to 1 March 2004.
  For patients with primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma who commenced treatment with bosentan monohydrate prior to 1 March 2004 and who have received less than 6 months of treatment at the time of application, a written application, accompanied by 1 authority prescription, must be submitted to the HIC for authorisation. Approvals will provide sufficient supply to allow the patient to complete a total of 6 months of combined PBS-subsidised and non-PBS-subsidised treatment, with the quantity approved based on the dosage recommendations in the TGA-approved Product Information.
  
  For patients with primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma who commenced treatment with bosentan monohydrate prior to 1 March 2004 and who have received 6 or more months of treatment at the time of application, a written application, accompanied by 1 authority prescription, must be submitted to the HIC for authorisation. Approvals will be limited to provide sufficient supply of PBS-subsidised treatment to allow the patient to receive 6 months of treatment, with the quantity approved based on the dosage recommendations in the TGA-approved Product Information.
  
  All patients with primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma who commenced treatment with bosentan monohydrate prior to 1 March 2004 will be eligible to commence PBS-subsidised treatment with bosentan monohydrate. Thereafter, to be eligible for further PBS-subsidised supply, patients must demonstrate a response to bosentan monohydrate treatment, as defined above under definition of response.
Continuation of treatment.
Written applications for continuing treatment must be submitted to the HIC for authorisation every 6 months. Approvals will be limited to provide sufficient supply for up to a maximum of 6 months of treatment, based on the dosage recommendations in the TGA-approved Product Information.

Applications for continuing treatment will only be approved for patients who have demonstrated a response to bosentan monohydrate treatment. The assessment of the patient's response to the an initial course of treatment with bosentan monohydrate.

The assessment of the patient's response to the first and subsequent 6 month courses of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated. Applications for continuing treatment with bosentan monohydrate should be made prior to the completion of the 6 month treatment course to ensure continuity for those patients who respond to treatment, as assessed by the treating physician.
Swapping between bosentan monohydrate and iloprost trometamol.
For eligible patients, applications to swap between these 2 drugs must be made under the relevant initial treatment restriction. Patients should be assessed for response to the treatment they are ceasing at the time the application to swap therapy is being made. Patients who fail to demonstrate a response or for whom no assessment results are submitted with the application to swap therapy may not re-commence PBS-subsidised treatment with the drug they are ceasing.
Cessation of treatment.
Patients who fail to demonstrate a response to PBS-subsidised bosentan monohydrate treatment at the times where an assessment is required must cease PBS-subsidised bosentan monohydrate therapy.

For patients ceasing treatment, approval will only be granted to provide sufficient supply of the 62.5 mg tablet strength to allow gradual dose reduction over a period of no more than 1 month duration. Prescribers should telephone the HIC on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday) to receive authorisation for this final supply and to ensure no unintended break in treatment occurs.

7. Re-treatment with bosentan monohydrate.

Patients who do not respond to treatment are not eligible to receive further PBS-subsidised treatment with bosentan monohydrate under any circumstances.

8. Further information.

A diagrammatical representation of the above information and the restriction can be obtained from the HIC website at www.hic.gov.au.

Initial Application for initial PBS-subsidised treatment with bosentan monohydrate of adult patients who have not received prior PBS-subsidised treatment with iloprost trometamol and who have been assessed by a physician from a designated hospital to have:

WHO Functional Class III primary pulmonary hypertension and a mean right atrial pressure of 8 mmHg or less, as measured by RHC, unless a RHC is contraindicated on clinical grounds;
OR
WHO Functional Class III pulmonary arterial hypertension secondary to scleroderma and a mean right atrial pressure of 8 mmHg or less, as measured by RHC, unless a RHC is contraindicated on clinical grounds.

Patients must have failed to respond [see Note for definition of response] to 6 or more weeks of appropriate vasodilator treatment unless intolerance or a contraindication to such treatment exists.

Applications for authorisation must be in writing and must include:

two completed authority prescription forms [see Note for authority approval requirements]; and
a completed Bosentan Monohydrate (Tracleer) and Iloprost Trometamol (Ventavis) PBS Authority Application - Supporting Information form may be downloaded from the HIC website which includes results from the 3 tests below, where available:
1. RHC composite assessment; and
2. ECHO composite assessment; and
3. 6MWT; and
a copy of a signed patient acknowledgment form indicating that the patient understands and acknowledges that PBS-subsidised treatment with bosentan monohydrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma , OR with iloprost trometamol for primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease, will cease if the treating physician determines that the patient has not achieved a response to treatment [see Note for definition of response].

Details of prior vasodilator treatment, including the dose and duration of treatment, must be provided at the time of application. Where the patient is commenced on bosentan monohydrate treatment due to an adverse event or a contraindication to vasodilator treatment, details on the nature of the adverse event or contraindication according to the TGA-approved Product Information must also be provided with the application.

The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information. No repeats will be authorised for the first authority prescription issued under this criterion [see Note for full details of authority approval requirements]. A maximum of 4 repeats will be authorised for the second authority prescription issued under this criterion. Where fewer than 4 repeats are initially requested with the second authority prescription, authority approvals for sufficient repeats to complete a maximum of 6 months of treatment may be requested by telephone.

WHO Functional Class III primary pulmonary hypertension and a mean right atrial pressure greater than 8 mmHg, as measured by RHC, unless a RHC is contraindicated on clinical grounds;
OR
WHO Functional Class III pulmonary arterial hypertension secondary to scleroderma and a mean right atrial pressure greater than 8 mmHg, as measured by RHC, unless a RHC is contraindicated on clinical grounds;
OR
WHO Functional Class IV primary pulmonary hypertension;
OR
WHO Functional Class IV pulmonary arterial hypertension secondary to scleroderma.

Applications for authorisation must be in writing and must include:

two completed authority prescription forms [see Note for authority approval requirements]; and
a completed Bosentan Monohydrate (Tracleer) and Iloprost Trometamol (Ventavis) PBS Authority Application - Supporting Information form may be downloaded from the HIC website which includes results from the 3 tests below, where available:
1. RHC composite assessment; and
2. ECHO composite assessment; and
3. 6MWT; and
a copy of a signed patient acknowledgment form indicating that the patient understands and acknowledges that PBS-subsidised treatment with bosentan monohydrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma , OR with iloprost trometamol for primary pulmonary hypertension, drug-induced pulmonary arterial hypertension or pulmonary arterial hypertension secondary to connective tissue disease, will cease if the treating physician determines that the patient has not achieved a response to treatment [see Note for definition of response].

Initial Application for initial PBS-subsidised treatment of patients aged less than 18 years who have been assessed by a physician from a designated hospital and who have WHO Functional Class III primary pulmonary hypertension and either a mean right atrial pressure of 8 mmHg or less, as measured by RHC, or, where a RHC cannot be performed on clinical grounds, normal right ventricular function as assessed by ECHO.

Patients must have failed to respond [see Note for definition of response] to 6 or more weeks of appropriate prior vasodilator treatment unless intolerance or a contraindication to such treatment exists.

Applications for authorisation must be in writing and must include:

two completed authority prescription forms [see Note for authority approval requirements]; and
a completed Bosentan Monohydrate (Tracleer) and Iloprost Trometamol (Ventavis) PBS Authority Application - Supporting Information form [may be downloaded from the HIC website (www.hic.gov.au)] which includes results from the 3 tests below, where available:
1. RHC composite assessment; and
2. ECHO composite assessment; and
3. 6MWT; and
a copy of a patient acknowledgment form, signed by the parent or authorised guardian, indicating that they understand and acknowledge that PBS-subsidised treatment with bosentan monohydrate for primary pulmonary hypertension will cease if the treating physician determines that the patient has not achieved a response to treatment [see Note for definition of response].

Initial Application for initial PBS-subsidised treatment of patients aged less than 18 years who have been assessed by a physician from a designated hospital to have:

WHO Functional Class III primary pulmonary hypertension and either a mean right atrial pressure greater than 8 mmHg, as measured by RHC, or, where a RHC cannot be performed on clinical grounds, right ventricular dysfunction as assessed by ECHO;
OR
WHO Functional Class IV primary pulmonary hypertension.

Applications for authorisation must be in writing and must include:

two completed authority prescription forms [see Note for authority approval requirements]; and
a completed Bosentan Monohydrate (Tracleer) and Iloprost Trometamol (Ventavis) PBS Authority Application - Supporting Information form may be downloaded from the HIC website which includes results from the 3 tests below, where available:
1. RHC composite assessment; and
2. ECHO composite assessment; and
3. 6MWT; and
a copy of a patient acknowledgment form, signed by the parent or authorised guardian, indicating that they understand and acknowledge that PBS-subsidised treatment with bosentan monohydrate for primary pulmonary hypertension will cease if the treating physician determines that the patient has not achieved a response to treatment [see Note for definition of response].

Initial PBS-subsidised supply for continuing treatment of patients who have been assessed by a physician from a designated hospital to have WHO Functional Class III or IV primary pulmonary hypertension, or WHO Functional Class III or IV pulmonary arterial hypertension secondary to scleroderma, and who were receiving treatment with bosentan monohydrate prior to 1 March 2004.

Application for initial treatment with bosentan monohydrate of adult patients with either of the following:

primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma who wish to re-commence PBS-subsidised bosentan monohydrate after a break in therapy and who have demonstrated a response to their most recent course of PBS-subsidised treatment with bosentan monohydrate; OR
primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma and whose most recent course of PBS-subsidised treatment was with iloprost trometamol.

Applications for authorisation must be in writing and must include:

a two completed authority prescription form forms [see Note on for authority approval requirements];
and
1. for patients who have received less than 6 months of bosentan monohydrate treatment at the time of application - a completed Bosentan Monohydrate (Tracleer) and Iloprost Trometamol (Ventavis) PBS Authority Application - Supporting Information form may be downloaded from the HIC website which includes the results of on which approval for the following 3 tests, where available, at the time treatment with bosentan monohydrate first application for PBS-subsidised bosentan monohydrate or iloprost trometamol, whichever was commenced:
  1. RHC composite assessment; and
  2. ECHO composite assessment initiated first, was granted; and
  3. 6MWT;
  or
2. for patients who have received 6 or more months of bosentan monohydrate treatment at the time of application - a completed Bosentan Monohydrate (Tracleer) PBS Authority Application - Supporting Information form may be downloaded from the HIC website which includes results of the following 3 tests, both at the time treatment with bosentan monohydrate was commenced and at the time of application, where available:
  1. RHC composite assessment; and
  2. ECHO composite assessment; and
  3. 6MWT;
and
the date of commencement of bosentan monohydrate treatment; and
1. for adult patients - a copy of a signed patient acknowledgment form indicating that the patient understands and acknowledges that PBS-subsidised treatment (3) the date of the first application for PBS-subsidised treatment with bosentan monohydrate or iloprost trometamol, whichever was initiated first; and
  the results of the patient's response to treatment with their last course of PBS-subsidised bosentan monohydrate and iloprost trometamol.
  
  The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information. No repeats will be authorised for the first authority prescription issued under this criterion [see Note for full details of authority approval requirements]. A maximum of 4 repeats will be authorised for the second authority prescription issued under this criterion. Where fewer than 4 repeats are initially requested with bosentan monohydrate for primary pulmonary hypertension or pulmonary arterial hypertension secondary to scleroderma will cease if the treating physician determines that the patient has not achieved a response to treatment [see Note for definition of response]; or
2. for patients aged less than 18 years - a copy of a patient acknowledgment form, signed by the parent or authorised guardian, indicating that they understand and acknowledge that PBS-subsidised treatment with bosentan monohydrate for primary pulmonary hypertension will cease if the treating physician determines that the patient has not achieved a response to treatment [see Note for definition of response].

Where fewer than 3 tests (see requirement 2a or 2b above) are able to be performed on clinical grounds, a reason outlining why the particular test/s could not be conducted must be provided with the second authority application [see Note for test requirements].

The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information. The number of repeats authorised will be dependent on the duration of prior bosentan monohydrate therapy. Where patients have received less than 6 months of non-PBS-subsidised treatment with bosentan monohydrate, sufficient repeats to allow the patient to complete a total of 6 months of combined PBS-subsidised and non-PBS-subsidised therapy will be authorised. Where patients have received 6 months or more of non-PBS-subsidised treatment with bosentan monohydrate, up to 5 repeats will be authorised.

Where fewer than the number of repeats to allow the patient to complete a total of 6 months of non-PBS-subsidised and/or PBS-subsidised bosentan monohydrate therapy are initially requested under this criterion prescription, authority approvals for sufficient repeats to complete a total maximum of 6 months of non-PBS-subsidised and PBS-subsidised treatment may be requested by telephone.

Continuing PBS-subsidised treatment with bosentan monohydrate of patients with WHO Functional Class III or IV primary pulmonary hypertension or WHO Functional Class III or IV pulmonary arterial hypertension secondary to scleroderma, who have received approval for initial PBS-subsidised treatment with bosentan monohydrate and have completed the initial treatment course, and who have been assessed by a physician from a designated hospital to have achieved a response to their most recent course of bosentan monohydrate treatment [see Note for definition of response].

Applications for authorisation must be in writing and must include:

a completed authority prescription form; and
1. a completed Bosentan Monohydrate (Tracleer) and Iloprost Trometamol (Ventavis) PBS Authority Application - Supporting Information form [may be downloaded from the HIC website which includes results from the 3 tests below, where available:

RHC composite assessment; and
ECHO composite assessment; and
6MWT.

Where fewer than 5 repeats are initially requested under this criterion, authority approvals for sufficient repeats to complete a maximum of 6 months of treatment may be requested by telephone.

Final PBS-subsidised supply for patients with WHO Functional Class III or IV primary pulmonary hypertension or WHO Functional Class III or IV pulmonary arterial hypertension secondary to scleroderma who have not responded to bosentan monohydrate therapy [see Note for definition of response], to allow for gradual cessation of treatment.

Applications for authorisation under this criterion should be made on the telephone [see Note on authority approval requirements].

Approval will only be granted for the 62.5 mg tablet strength. The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment.

Under no circumstances will telephone approvals be granted for treatment that would extend the final treatment period beyond 1 month.

6429J	Tablet 62.5 mg (base)	60	$4,035.00	Tracleer	AT
6430K	Tablet 125 mg (base)	60	$4,035.00	Tracleer	AT

NOTE:

These prices are based on special supply arrangements - —see Pharmaceutical Benefits Pricing Authority relativity sheet for full details.

Etanercept

Initial treatment by a paediatric rheumatologist, or under the supervision of a paediatric rheumatology treatment centre, of patients under 18 years who have severe active polyarticular course juvenile chronic arthritis;

AND

whose parent or authorised guardian has signed a patient agreement form indicating that they understand and acknowledge that PBS-subsidised treatment will cease if the predetermined response criteria do not support continuation of PBS-subsidised treatment;
AND
who have demonstrated either:
1. severe intolerance of, or toxicity due to, methotrexate (see below for definition of severe intolerance and toxicity); or
2. failure to achieve an adequate response to 1 or more of the following treatment regimens:
  - oral or parenteral methotrexate at a dose of at least 20 mg per square metre weekly, alone or in combination with oral or intra-articular corticosteroids, for a minimum of 3 months; or
  - oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other DMARD, alone or in combination with corticosteroids, for a minimum of 3 months. (Note: use of alternative DMARDs in children is dependent on approval by the Therapeutic Goods Administration as age restrictions may apply.)

Severe intolerance is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant NSAIDs on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours.

(The remainder of the restriction is unchanged)

Interferon alfa-2a

Interferon alfa-2b

Peginterferon alfa-2a

Peginterferon alfa-2b

Ribavirin and interferon alfa-2b

Ribavirin and peginterferon alfa-2a

Ribavirin and peginterferon alfa-2b

NOTE:

Hospitals should adhere to the National Health and Medical Research Council's Taskforce report on hepatitis C regarding the facility requirements for the selection of treatment centres.

Treatment centres are required to have access to the following appropriate specialist facilities for the provision of clinical support services for hepatitis C:

a nurse educator/counsellor for patients; and
24 hour access by patients to medical advice; and
an established liver clinic; and
facilities for safe liver biopsy.

Ribavirin and peginterferon alfa-2a

Ribavirin and peginterferon alfa-2b

In addition to the treatment centres the following amendments to the restriction have been made:

Change from:

Treatment of chronic hepatitis C in patients 18 years or older who have compensated liver disease and who have received no prior interferon alfa or peginterferon alfa treatment and who satisfy all of the following criteria:

Histological evidence of Metavir (or equivalent index) stage 2, 3 or 4 fibrosis or stage 1 with grade A2 or A3 inflammation, i.e. moderate to severe inflammation evident on liver biopsy (except in patients with coagulation disorders considered severe enough to prevent liver biopsy);
Abnormal serum ALT levels in conjunction with documented chronic hepatitis C infection (repeatedly anti-HCV positive and/or HCV RNA positive);

Change to:

1. Histological evidence of Metavir (or equivalent index) stage 2, 3 or 4 fibrosis or stage 1 with grade A2 or A3 inflammation, i.e. moderate to severe inflammation evident on liver biopsy; or
2. in those patients with coagulation disorders considered severe enough to prevent liver biopsy, evidence of abnormal serum ALT levels;
Documented chronic hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive);

Tenofovir disoproxil fumarate

Treatment, in combination with other antiretroviral drugs, of HIV infection in patients who have:

failed treatment with their current antiretroviral regimen and for whom an effective regimen, including a regimen containing amprenavir, cannot otherwise be constructed; or
experienced treatment-limiting toxicity with their current antiretroviral regimen and for whom an effective regimen, including a regimen containing amprenavir, cannot otherwise be constructed.

Treatment of HIV infection in patients with:

CD4 cell counts of less than 500 per cubic millimetre; or
viral load of greater than 10,000 copies per mL.

6358P

Tablet 300 mg

$499.00

Viread

3. PRICE CHANGES

Baclofen

6284R	Intrathecal injection 10 mg in 5 mL	1	$148.37	Lioresal Intrathecal	NV
6285T	Intrathecal injection 10 mg in 20 mL	1	$148.37	Lioresal Intrathecal	NV

Clarithromycin

6151R

Tablet 250 mg

100

$ 78.50

Klacid

Tenofovir disoproxil fumarate

6358P

Tablet 300 mg

$ 499.00

Viread

4. DELETIONS

Ribavirin and peginterferon alfa-2b

6377P	Pack containing 84 capsules ribavirin 200 mg and 4 vials peginterferon alfa-2b powder for injection 50 micrograms with diluent ‡1	$1,014.02	Pegatron	SH
6378Q	Pack containing 112 capsules ribavirin 200 mg and 4 vials peginterferon alfa-2b powder for injection 50 micrograms with diluent ‡1	$1,171.51	Pegatron	SH
6379R	Pack containing 84 capsules ribavirin 200 mg and 4 vials peginterferon alfa-2b powder for injection 80 micrograms with diluent ‡1	$1,338.96	Pegatron	SH
6380T	Pack containing 140 capsules ribavirin 200 mg and 4 vials peginterferon alfa-2b powder for injection 80 micrograms with diluent ‡1	$1,496.44	Pegatron	SH
6381W	Pack containing 168 capsules ribavirin 200 mg and 4 vials peginterferon alfa-2b powder for injection 80 micrograms with diluent ‡1	$1,496.44	Pegatron	SH
6382X	Pack containing 84 capsules ribavirin 200 mg and 4 vials peginterferon alfa-2b powder for injection 100 micrograms with diluent ‡1	$1,555.58	Pegatron	SH
6383Y	Pack containing 112 capsules ribavirin 200 mg and 4 vials peginterferon alfa-2b powder for injection 100 micrograms with diluent ‡1	$1,713.07	Pegatron	SH
6384B	Pack containing 84 capsules ribavirin 200 mg and 4 vials peginterferon alfa-2b powder for injection 120 micrograms with diluent ‡1	$1,772.2	Pegatron	SH
6385C	Pack containing 140 capsules ribavirin 200 mg and 4 vials peginterferon alfa-2b powder for injection 120 micrograms with diluent ‡1	$1,929.69	Pegatron	SH
6386D	Pack containing 84 capsules ribavirin 200 mg and 4 vials peginterferon alfa-2b powder for injection 150 micrograms with diluent ‡1	$2,097.14	Pegatron	SH
6387E	Pack containing 140 capsules ribavirin 200 mg and 4 vials peginterferon alfa-2b powder for injection 150 micrograms with diluent ‡1	$2,254.63	Pegatron	SH
6388F	Pack containing 168 capsules ribavirin 200 mg and 4 vials peginterferon alfa-2b powder for injection 150 micrograms with diluent ‡1	$2,254.63	Pegatron	SH

Items discontinued at the request of the manufacturer.

Changes notified by hospital circular will be updated in the Guidelines on the Commonwealth/State Highly Specialised Drugs Program Guidelines website and the claim form amended.

Noreen Dowd
Director, Programs
Metropolitan Health & Aged Care Services