Primary pulmonary and pulmonary arterial hypertension

Authority to prescribe ambrisentan (Volibris®), bosentan monohydrate (Tracleer®), epoprostenol sodium (Flolan®), iloprost trometamol (Ventavis®), sildenafil citrate (Revatio®) and tadalafil (Adcirca®)  for eligible patients, through the Pharmaceutical Benefits Scheme (PBS) is provided under Section 100 of the National Health Act 1953.

Interchangeability between ambrisentan, bosentan monohydrate, epoprostenol sodium, iloprost trometamol, sildenafil citrate and tadalafil (known as the PAH agents) to treat primary pulmonary hypertension (PPH) or pulmonary arterial hypertension (PAH), in eligible patients is defined in the Schedule of Pharmaceutical Benefits (the Schedule).

Section 100 arrangements

These items are only available to a patient who is attending either:

• an approved private hospital
• a public participating hospital

or

• a public hospital

and is either a:

• day admitted patient
• non admitted patient

or

• a 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 and pulmonary arterial hypertension

• Physician’s guide [PDF, 261Kb]

PAH designated centres

• PAH designated centres [PDF, 81Kb]

Names of designated centres are available in the attachment above or by calling 1800 700 270* option 1, Monday to Friday 8.00am to 5.00pm EST.

Restriction details

View a full transcript of the restriction details.

‡ WHO Class III patients must fail to respond to an alternate PBS subsidised PAH agent before being eligible to receive treatment with this agent

Ambrisentan is available under the PBS as an Authority required item for the treatment of the following conditions:

• World Health Organization (WHO) functional Class III or IV PPH
• WHO functional Class III or IV PAH secondary to connective tissue disease

Bosentan monohydrate is available under the PBS as an Authority required item for the treatment of the following conditions:

• WHO functional Class III or IV PPH
• WHO functional Class III or IV PAH secondary to connective tissue disease
• 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 IV PPH
• WHO functional Class IV PAH secondary to connective tissue disease
• WHO functional Class III PPH where the patient has previously failed treatment with a PBS subsidised PAH agent.
• WHO functional Class III PAH  secondary to connective tissue disease where the patient has previously failed treatment with a PBS subsidised PAH agent.

Iloprost trometamol is available under the PBS as an Authority required item for the treatment of:

• WHO functional Class IV PPH
• WHO functional Class IV PAH secondary to connective tissue disease
• WHO functional Class III PPH where the patient has previously failed treatment with a PBS subsidised PAH agent
• WHO functional Class III PAH secondary to connective tissue disease where the patient has previously failed treatment with a PBS subsidised PAH agent
• 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
• WHO functional Class III PAH secondary to connective tissue disease.

Tadalafil is available under the PBS as an Authority required item for the treatment of:

• WHO functional Class III PPH
• WHO functional Class III PAH secondary to connective tissue disease.

Note: ambrisentan, bosentan monohydrate, epoprostenol sodium, iloprost trometamol, sildenafil citrate and tadalafil are not PBS subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70 per cent of that predicted.

For more information call 1800 700 270* option 1 Monday to Friday 8.00 am and 5.00 pm EST.

Item details

Dose

Ambrisentan

Ambrisentan should be taken orally at a dose of 5 mg once daily.  Additional benefit may be obtained by increasing the dose to 10 mg.  It is available in a pack size of 30 tablets.

Note: ambrisentan is a category X medicine 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 medicine.

Children

There is no data available on the use of ambrisentan in patients under 18 years of age, and therefore its use in this age group is not recommended.

Bosentan monohydrate

Bosentan monohydrate is available in 62.5 mg and 125 mg tablets. No applications for increased maximum quantities will be authorised.

Note: bosentan monohydrate is a category X medicine 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 medicine.

The quantity approved will be based on the dosage recommendations in the Therapeutic Goods Administration (TGA) approved product information.

Dose adjustment for patients with low body weight

The recommended initial and maintenance dose is 62.5 mg, twice daily, in patients who are over 12 years of age and below 40 kg in weight.

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 is available as:

• Powder for I.V. infusion 500 micrograms (base) infusion administration set
• Powder for I.V. infusion 1.5 mg (base) infusion administration set

The quantity approved will be based on the dosage recommendations in the TGA approved product information.

Iloprost trometamol

Iloprost trometamol is available as a nebuliser solution, 27.2 microgram (equivalent to 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.

Sildenafil citrate

Sildenafil citrate 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.

Tadalafil

Tadalafil 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.

Patient eligibility

Patients must meet the relevant criteria as indicated in the restrictions and be eligible to receive pharmaceutical benefits.

Who is eligible for the PBS?

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 want to temporarily stop treatment with a PAH agent must submit a Continuation, change or demonstration of response to PBS subsidised treatment for PPH or PAH [PDF, 135Kb] form for their current treatment within one month of stopping treatment.

Fax your completed form to 1300 154 190* so 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 eligibility according to PBS criteria. Results of a right heart catheterisation (RHC) composite assessment, plus an echocardiography (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 provided for patients with WHO functional Class III with mean right arterial pressure (mRAP) less than or equal to 8 mm Hg.

Bosentan monohydrate

Initial application for PBS subsidised treatment for PPH or PAH [PDF, 142Kb] 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 or to lodge an application for discontinuing treatment (Bosentan only), call the specialised drugs enquiry line on 1800 700 270* option 1 Monday to Friday 8.00am to 5.00pm EST.

Ambrisentan, epoprostenol sodium, iloprost trometamol, sildenafil citrate and tadalafil

Initial application for PBS subsidised treatment for PPH or PAH [PDF, 142Kb] 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 PBS criteria. Results of a RHC composite assessment, an ECHO composite assessment, and a 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 want to change to an alternate agent for which they are eligible, must include a complete set of new baseline results.

Applications for continuing approvals 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
• ambrisentan, epoprostenol sodium, iloprost trometamol sildenafil citrate and tadalafil must include an authority prescription for up to six months of therapy.

Send all written applications to:

Department of Human Services
Prior written approval of specialised drugs
Reply Paid 9826
Hobart TAS 7001

(No stamp required if posted in Australia)

For more information call 1800 700 270* option 1 Monday to Friday 8.00am to 5.00pm EST. 

Application forms—PAH agents

• Initial application for PBS subsidised treatment for PPH or PAH [PDF, 142Kb] (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, 135Kb] (Form 4146)
  Lodge this form for a patient continuing, changing to an alternate PAH agent or demonstrating a response to treatment before stopping treatment.

* Call charges apply from mobile or pay phones only.

Some documents on this page may require the free Adobe PDF reader.

Last updated: 30 April, 2013

Explore Medicare