Chronic thromboembolic pulmonary hypertension

The PBS subsidises riociguat for patients with chronic thromboembolic pulmonary hypertension.

Treatment with riociguat can be subsidised through the Pharmaceutical Benefits Scheme (PBS) under section 100 of the National Health Act 1953 for patients with chronic thromboembolic pulmonary hypertension (CTEPH).

CTEPH that is inoperable by pulmonary endarterectomy is defined as:

  • right heart catheterisation (RHC) demonstrating pulmonary vascular resistance (PVR) of greater than 300 dyn*sec*cm-5 measured at least 90 days after the start of full anticoagulation, and
  • a mean pulmonary artery pressure (PAPmean) of greater than 25 mmHg at least 90 days after the start of full anticoagulation

CTEPH that’s recurrent or persistent subsequent to pulmonary endarterectomy is defined as:

  • RHC demonstrating a PVR of greater than 300 dyn*sec*cm-5 measured at least 180 days following& pulmonary endarterectomy

Section 100 arrangements

This item is available to a patient 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

You must include the hospital provider on the application form.

This item is not available as a PBS benefit for hospital in-patients.

Patient eligibility

Patients must meet the relevant criteria in the restrictions and be eligible for the PBS.

The Schedule of Pharmaceutical Benefits on the PBS website outlines restrictions for prescribing riociguat.

This is a category X drug and must not be given to pregnant women. Pregnancy must be avoided during treatment and for at least 1 month after ending therapy.

Demonstration of a response

The assessment of the patient's response to the initial 20 week course of treatment should be made following the first 16 weeks of treatment, in order to allow sufficient time for a response to be demonstrated.

Patients who fail to respond to PBS subsidised treatment with this agent must stop PBS subsidised therapy with this agent.

To establish baseline measurements, your application must include (where available):

  • a RHC composite assessment
  • an ECHO composite assessment, and
  • a 6 Minute Walk Test (6MWT)

Applications

All patients applying for riociguat treatment must be treated in a centre with expertise in the management of CTEPH.

Initial treatment

Make all initial applications for authority approval to prescribe riociguat for the treatment of CTEPH in writing and:

All applications must include a completed:

If a RHC cannot be performed due to right ventricular dysfunction, an echocardiogram demonstrating the dysfunction must be provided with the application.

Grandfathered patients - initial treatment

For patients starting initial PBS subsidised treatment with riociguat, and who started non PBS subsidised treatment before 1 January 2017, lodge the Chronic thromboembolic pulmonary hypertension grandfather Initial PBS authority application form.

Applications for initial PBS subsidised treatment for grandfathered patients will be provided for a maximum of 1 month of treatment.

A Grandfathered patient can only qualify for PBS subsidised treatment under this restriction once. For continuing treatment, they must qualify under the continuing treatment criteria.

Continuing treatment

Make all applications for continuing authority approval to prescribe riociguat for the treatment of CTEPH in writing and:

All applications must include a completed:

Applications for continuing treatment should be made 2 weeks before the 6 month treatment course ends to ensure continuity for patients who respond to treatment, as assessed by the treating physician.

Further information

For more information call the PBS Complex Drugs Programs enquiry line.

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Page last updated: 3 January 2017

This information was printed Saturday 22 July 2017 from humanservices.gov.au/health-professionals/enablers/chronic-thromboembolic-pulmonary-hypertension It may not include all of the relevant information on this topic. Please consider any relevant site notices at humanservices.gov.au/siteinformation when using this material.