Sildenafil Citrate1
Treatment of adult patients with primary pulmonary hypertension or pulmonary hypertension associated with connective tissue disease (CTD), including scleroderma in patients categorised as WHO functional Class III.
Decisions on record
- Meeting Nov 2006 Recommended Pulmonary arterial hypertension
- Meeting Dec 2001 Recommended For erectile dysfunction. no PSD
Access path
- TGA registered · 1
TGA label narrower than the PBS population
- Nov 2006Recommended
Comparator changed: bosentan → bosentan monohydrate
- Nov 2006Recommended · restricted
Comparator changed: bosentan → bosentan monohydrate
- PBS listing · Restricted
Cost-effectiveness
Cost-minimisation analysis presented; incremental cost per metre gained in 6MWT was <$15,000 but no formal ICER ($/QALY or $/LY) was calculated or reported.
The incremental cost per metre gained in the 6 minute walk test was < $15,000. PSD · 2006
Decision context
PopulationAdult patients with primary pulmonary hypertension or pulmonary hypertension associated with connective tissue disease, WHO functional Class III.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2006 | Recommended | bosentan | — | RCT · QoL |
| Nov 2006 | Recommended · restricted | bosentan monohydrate | — | Meta-analysis · 6MWD |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to WHO Class III only and primary PH or CTD-associated PH; TGA label includes WHO Classes II and III.