EpoprostenolFlolan for Injection
Long-term treatment via continuous intravenous infusion of pulmonary arterial hypertension (idiopathic, familial, or associated with scleroderma spectrum of diseases) in WHO functional Class III or Class IV patients.
Decisions on record
- Meeting Nov 2016 Recommended Pulmonary arterial hypertension
- Meeting Jul 2014 Recommended 500 microgram injection, vial 1.5 mg injection, vial Veletri® Actelion Pharmaceuticals Australia Pty Ltd New listing (Minor submission) Pulmonary arterial hypertension Section 100 Highly Specialised Drugs Program listing of a new presentation of epoprostenol for the treatment of patients with pulmon
- Meeting Jul 2004 Not recommended A form of prostacyclin or prostaglandin PGI used 2 for the treatment of primary pulmonary hypertension. no PSD
Access path
- TGA registered · Flolan for Injection
TGA label narrower than the PBS population
- Jul 2014Recommended
vs Flolan (epoprostenol, existing brand)
- Nov 2016Recommended
- PBS listing · Authority Required
From the public summary
5.1 The PBAC recommended the listing of epoprostenol sodium (Flolan) without the administration set, as a new brand of the currently listed drug epoprostenol with the same form as the Veletri® brand. The PBAC also noted the change to the diluent formulation of the Flolan brand and that this may offer some advantages in terms of reconstitution and storage during infusion.PSD · Nov 2016
5.2 In making this recommendation, the PBAC noted that although the administration set was being removed from the pack supplied through the PBS, the sponsor had provide an assurance it would continue to provide the administration sets through an alternative method of supply at no additional cost to the patient. 2PSD · Nov 2016
4.2 As a minor submission, there was no economic comparison presented.PSD · Nov 2016
Cost-effectiveness
As a minor submission (formulation and supply method change only), no economic comparison was presented.
The PBAC considered that there would be no additional financial impact to the government as the changes to supply the Flolan brand of epoprostenol sodium with the new diluent formulation and to remove the administration pack were proposed at the same price as for the currently listed forms of epoprostenol sodium. PBAC · 2016
Decision context
PopulationWHO Functional Class III or Class IV patients with idiopathic pulmonary arterial hypertension, anorexigen-induced PAH, hereditable PAH, or PAH secondary to connective tissue disease, who have not received prior PBS-subsidised treatment with a PAH agent and have been assessed by a physician at a designated hospital.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2016 | Recommended | — | — | Cost-minimisation |
| Jul 2014 | Recommended | Flolan (epoprostenol, existing brand) | — | Cost-minimisation · Cost-minimisation |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to treatment-naïve patients and requires hospital physician assessment; TGA label has no prior-therapy or assessment prerequisites.