OseltamivirOseltamivir Lupin
Treatment of infections due to influenza A and B viruses in adults and children aged one year and older, commencing treatment within 48 hours of symptom onset.
Decision on record
- Meeting Nov 2008 Not recommended Anti-viral agent to treat influenza
Access path
- TGA registered · Oseltamivir Lupin
TGA label narrower than the PBS population
- Nov 2008Not recommended
uncertain cost-effectiveness, uncertainty about clinical benefit in all groups, concern about use outside the intended…
Cost-effectiveness
The submission stated the weighted ICER per QALY was 'less than $15,000', but the PBAC considered the estimate highly uncertain due to model assumptions and did not accept the submission on cost-effectiveness grounds.
The PBAC considered that there were significant uncertainties in the economic model and that these had been well captured in the ESC advice. PBAC · 2008
Decision context
PopulationAdults and children aged one year and older presenting with influenza-like illness, with treatment commencing within 48 hours of symptom onset.
Why it was knocked back
- uncertain cost-effectiveness, uncertainty about clinical benefit in all groups, concern about use outside the intended restriction, potential for toxicity (particularly gastrointestinal adverse events), uncertain impact on resistance patterns in influenza viruses, high potential for off-label use in patients with influenza-like illness who do not have confirmed influenza
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2008 | Not recommended | placebo | $15k | RCT · Time to alleviation of symptoms |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC excludes the TGA-registered prevention indication, covering only treatment of confirmed or suspected influenza-like illness.