Primary pulmonary and pulmonary arterial hypertension
Authority to prescribe bosentan monohydrate, epoprostenol sodium, iloprost trometamol, sildenafil citrate and sitaxentan sodium through the Pharmaceutical Benefits Scheme (PBS) under Section 100 of the National Health Act 1953.
Interchangeability between bosentan monohydrate, epoprostenol sodium, iloprost trometamol, sildenafil citrate and sitaxentan sodium (known as the PAH agents) to treat primary pulmonary hypertension or pulmonary arterial hypertension as defined in the Schedule of Pharmaceutical Benefits
(the Schedule).
Section 100 arrangements
These items are only available to a patient who is attending:
- an approved private hospital
- a public participating hospital
or
- a public hospital
and is a
- day admitted patient
- non-admitted patient
or
- patient on discharge.
These items are not available as PBS benefits for in-patients of the hospital. The hospital provider number must be included on the application form.
Physician’s guide—prescribing treatment for Primary Pulmonary Hypertension (PPH) and Pulmonary Arterial Hypertension (PAH) within the PBS Section 100 restriction criteria
PAH designated centres
Names of designated centres are available in the attachment above or by calling 1800 700 270* and selecting option 1.
Restriction details
View a full transcript of the Schedule restriction details.
Bosentan monohydrate is available under the PBS as an authority required item for the treatment of the following conditions:
- World Health Organisation (WHO) functional Class III or IV Primary Pulmonary Hypertension (PPH)
or - WHO functional Class lll or lV Pulmonary Arterial Hypertension (PAH) secondary to scleroderma.
or - WHO functional Class III or IV PAH associated with a congenital systemic-to-pulmonary shunt (including Eisenmenger’s physiology).
Epoprostenol sodium is available under the PBS as an authority required item for the treatment of:
- WHO functional class III or IV PPH.
Iloprost trometamol is available under the PBS as an authority required item for the treatment of:
- WHO functional Class III or IV PPH
- WHO functional Class lll or lV PAH secondary to connective tissue disease
or - WHO functional Class III or IV drug induced PAH.
Sildenafil citrate is available under the PBS as an authority required item for the treatment of:
- WHO functional Class III PPH
or - WHO functional Class lll PAH secondary to connective tissue disease.
Sitaxentan sodium is available under the PBS as an authority required item for the treatment of:
- WHO functional Class III PPH
or - WHO functional Class III PAH secondary to connective tissue disease.
Important: Bosentan monohydrate, epoprostenol sodium, iloprost trometamol, sildenafil citrate and sitaxentan sodium are 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 per cent of that predicted.
For more information please call 1800 700 270* and select option 1.
* Call charges apply from mobile and pay phones only.
Item details
Dose
Bosentan monohydrate
Bosentan monohydrate (Tracleer®) is available in 62.5 mg and 125 mg tablets. No applications for increased maximum quantities will be authorised.
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 three months following cessation of treatment with this drug.
The quantity approved will be based on the dosage recommendations in the Therapeutic Goods Administration (TGA) approved product information.
| Starting dose—first four weeks | Maintenance dose—week five onwards | |
|---|---|---|
| Adult > 40 kg Patients 18 years and under and > 40 kg |
62.5 mg twice daily | 125 mg twice daily |
| Adult < 40kg (over 12 years) | 62.5 mg twice daily | 62.5 mg twice daily |
| Patients 18 years and under with a body weight > 20 to 40 kg | 31.25 mg twice daily | 62.5 mg twice daily |
| Patients 18 years and under with a body weight 10 to 20 kg | 31.25 mg once daily | 31.25 mg twice daily |
Dose adjustment for patients with low body weight
In patients with a body weight below 40 kg but who are over 12 years of age the recommended initial and maintenance dose is 62.5 mg twice daily.
Dose adjustment in children
There is limited experience with the use of bosentan in children. On the basis of the available information, the recommended doses in children aged three years and over are listed in the table above.
Epoprostenol sodium
Epoprostenol sodium (Flolan®) is available in the following pack sizes:
- one vial containing equivalent to epoprostenol sodium 500 microgram, supplied with one 50 mL vial of buffer solution
- one vial containing equivalent to epoprostenol sodium 1.5 mg, supplied with two 50 mL vials of buffer solution.
The quantity approved will be based on the dosage recommendations in the TGA approved product information.
Iloprost trometamol
Iloprost trometamol (Ventavis®) is available as a nebuliser solution, 27.2 microgram (equiv. iloprost 20 microgram)/2 mL.
The quantity approved will be based on the dosage recommendations in the TGA approved product information.
Each inhalation session should start with 2.5 micrograms iloprost (as delivered at the mouthpiece of the inhalation device). The dose can be increased to 5.0 micrograms iloprost according to the individual need and tolerability.
The dose per inhalation session should be administered six to nine times per day according to the individual need and tolerability.
Depending on the desired dose at the mouthpiece and on the nebuliser, the duration of an inhalation session is approximately five to 10 minutes.
Sildenafil citrate
Sildenafil citrate (Revatio®) is available in 20 mg tablets. No applications for increased maximum quantities will be authorised.
The quantity approved will be based on the dosage recommendations in the TGA approved product information.
Sitaxentan sodium
Sitaxentan sodium (Thelin®) is available in 100 mg tablets. No applications for increased maximum quantities will be authorised.
Caution: Sitaxentan sodium is a category X drug and must not be given to pregnant women. Pregnancy must be avoided during treatment.
The quantity approved will be based on the dosage recommendations in the TGA approved product information.
Patient eligibility
Patients must meet the relevant criteria as indicated in the restrictions and be eligible to receive pharmaceutical benefits.
Reciprocal Health Care Agreement
Where an eligible patient is a visitor from a country with which Australia has entered into a Reciprocal health care agreement, the supply will be limited to the original prescription only. Repeat prescriptions for these patients are not permitted.
Demonstration of a response
Prescribers with patients who wish to temporarily stop treatment with a PAH agent must submit a demonstration of response [PDF, 81Kb]
to current treatment within one month of stopping treatment.
Please fax your completed form to 03 6215 5640 so that it can be included in the patient’s treatment history.
Lodgement
Initial applications
All applications must be in writing and must include sufficient information to determine the patient’s eligibilty according to the PBS criteria. Results of a right heart catheter (RHC) composite assessment, plus an echocardiograph (ECHO) composite assessment, plus a six minute walk test (6MWT) must be provided unless contraindicated on medical grounds. Details of prior vasodilator therapy must be proivded for patients with WHO functional Class III with mean right arterial pressure (mRAP) ≤ 8 mm Hg.
Bosentan monohydrate
Initial applications [PDF, 85Kb] must include two written authority prescriptions, one for the first month of initiation therapy and another for the remaining five months of initial therapy.
For more information and to lodge an application for discontinuing treatment (for Bosentan only), please call the specialised drugs enquiry line on 1800 700 270* and select option 1.
Epoprostenol sodium, iloprost trometamol, sildenafil citrate and sitaxentan sodium
Applications for initial approvals [PDF, 85Kb] must be in writing and must include an authority prescription for up to six months of therapy.
Continuing or change applications
All applications must be in writing and must include sufficient information to determine the patient’s eligibility according to the PBS criteria. Results of a right heart catheter (RHC) composite assessment, plus an echocardiograph (ECHO) composite assessment, plus a six minute walk test (6MWT) must be provided unless contraindicated on medical grounds. A minimum of two test results must qualify for each continuation or change application where the patient has demonstrated stability or improvement of PPH or PAH relative to the baseline result. Applications for patients who have not demonstrated stability or improvement of PPH or PAH relative to the baseline result and who wish to change to an alternate agent for which they are eligible, must include a complete set of new baseline results.
Applications for continuing approvals [PDF, 81Kb] must be in writing and must include an authority prescription for up to six months of therapy.
Applications for change approvals for:
- Bosentan monohydrate must include two written authority prescriptions, one for the first month of initiation therapy and another for the remaining five months of initial therapy.
- Epoprostenol sodium, iloprost trometamol, sildenafil citrate and sitaxentan sodium must include an authority prescription for up to six months of therapy.
The postal address for all written applications is:
Medicare Australia
Prior written approval of specialised drugs
Reply paid 9826
GPO Box 9826
Hobart TAS 7001
(No stamp required if posted in Australia)
For more information please call 1800 700 270** and select option 1 (8 am to 5 pm EST Monday to Friday).
** Call charges apply from mobile and pay phones only.
Application forms—PAH agents
- Initial PBS subsidised treatment for PPH or PAH [PDF, 85Kb] (Form 4138)
Lodge this form for a patient starting initial PBS subsidised treatment with a PAH agent. The patient and prescriber acknowledgements must be completed. - Continuation, change or demonstration of response to PBS subsidised treatment for PPH or PAH [PDF, 81Kb] (Form 4146)
Lodge this form for a patient continuing, changing to an alternate PAH agent or demonstrating a response to treatment before stopping treatment.
Some documents on this page may require the free Adobe PDF reader.
Last updated: 7 August, 2008