Epoprostenol SodiumFlolan for Injection
Treatment of pulmonary arterial hypertension (PAH) secondary to scleroderma spectrum of diseases: second-line therapy for WHO functional class III patients who have failed prior PBS-subsidised PAH agent treatment, and first-line therapy for WHO functional class IV patients.
Decisions on record
- Meeting Nov 2011 Recommended Pulmonary arterial hypertension
- Meeting Nov 2011 Recommended Pulmonary arterial hypertension secondary to the scleroderma spectrum of diseases
- Meeting Mar 2009 Recommended Pulmonary hypertension no PSD
- Meeting Jul 2008 Recommended Pulmonary arterial hypertension no PSD
Access path
- TGA registered · Flolan for Injection
TGA label narrower than the PBS population
- Mar 2006Recommended · restricted
Evidence: RCT → Meta-analysis
- Mar 2006Recommended · restricted
Evidence: RCT → Meta-analysis
- Nov 2011Recommended · restricted
Comparator changed: bosentan monohydrate → iloprost and bosentan
- Nov 2011Recommended · restricted
Comparator changed: bosentan monohydrate → iloprost and bosentan
- PBS listing · Authority Required
Cost-effectiveness
Cost minimisation analysis conducted; no ICER calculated by design.
The submission presented a cost minimisation analysis. PSD · 2011
Decision context
PopulationAdult and paediatric patients with WHO functional class III or IV pulmonary arterial hypertension secondary to scleroderma spectrum of diseases; for class III, those who have failed prior PBS-subsidised treatment with alternate PAH agent.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2011 | Recommended · restricted | iloprost and bosentan | — | RCT, Single-arm · 6-MWD, haemodynamic parameters |
| Nov 2011 | Recommended · restricted | iloprost and bosentan | — | Meta-analysis · 6MWD |
| Mar 2006 | Recommended · restricted | bosentan monohydrate | — | RCT · OS | PFS | DFS | ORR | QoL | Surrogate | Cost-minimisation | Other | null |
| Mar 2006 | Recommended · restricted | bosentan monohydrate | — | Meta-analysis · 6MWD |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to CTD-associated PAH and specifies line-of-therapy (second-line class III, first-line class IV); TGA label includes PPH and broader PAH indications.