MilnacipranJoncia
Management of fibromyalgia in adult patients after failure of standard treatment options, initiated by a specialist qualified to diagnose fibromyalgia according to the 1990 American College of Rheumatology diagnosis criteria.
Decision on record
- Meeting Nov 2012 Not recommended Fibromyalgia
Access path
- TGA registered · Joncia
TGA label narrower than the PBS population
- Nov 2012Not recommended
small response rates (NNT 9-15), uncertain comparative effectiveness versus duloxetine and pregabalin, small mean…
- ↻ resubmittedNov 2012Recommended · restricted
- PBS listing · Restricted
Cost-effectiveness
The submission presented an incremental cost-effectiveness ratio (ICER) of between $15,000 and $45,000 per quality adjusted life years gained (QALY), which was based on converting SF-36 results to SF-6D from the clinical trials at three months and extrapolating to one year. PSD · 2012
Decision context
PopulationAdults with fibromyalgia who have failed standard treatment options, meeting 1990 American College of Rheumatology diagnosis criteria, initiated by a specialist.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2012 | Not recommended | duloxetine | $15k–45k | RCT · QoL, pain relief |
| Nov 2012 | Recommended · restricted | duloxetine | $15k–45k | RCT |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to adults with fibromyalgia after failure of standard treatment options; TGA label permits management of fibromyalgia without prior treatment requirement.