PBAC's latest decision on Milnacipran: Not recommended (2012). Considered for Management of an adult patient with fibromyalgia, after failure of standard treatment options.
PBAC outcome
Not recommended
2012
ICER (AUD/QALY)
$45k/QALY
Range: $15k/QALY–$45k/QALY
Submissions
1
first 2012
Submissions
1
2012 → 2012
Eligible population
adult patients with fibromyalgia after failure of standard treatment options
Therapy area
Pain
Line of therapy
Later-line
Evidence base
RCT
Primary endpoint
QoL, pain relief
Key trials
GE302, MD02, MD03, FMS031, FMS021
Comparator
duloxetine
Economic model
Cost-minimisation
Budget impact
$10M
Why PBAC said no
Reasons cited in the latest PSD: small response rates (NNT 9-15), uncertain comparative effectiveness versus duloxetine and pregabalin, small mean differences in secondary outcomes, significant adverse events leading to discontinuation, extrapolation of 3-month SF-36 data to estimate QALYs at 1 year