PBAC's latest decision on Ropinirole: Not recommended (2006). Considered for treatment of severe primary restless legs syndrome in patients who score greater than or equal to 21 on the International Restless Legs Severity Scale (IRLS) and who manifest the four diagnostic criteria below: International Restless Legs Syndrome Study Group (IRLSSG) Diagnostic criteria - a desire to move the limbs usually associated with paraesthesias or dysaesthesias, motor restlessness, symptoms worse or exclusively present by activity, symptoms worse in the evening or night.
PBAC outcome
Not recommended
Authority Required
ICER (AUD/QALY)
$45k/QALY
Range: $15k/QALY–$45k/QALY
Submissions
1
first 2006
Submissions
1
2006 → 2006
Eligible population
patients suffering with severe primary restless legs syndrome who score greater than or equal to 21 on the International Restless Legs Severity Scale (IRLS) and who manifest the four diagnostic criteria below: International Restless Legs Syndrome Study Group (IRLSSG) Diagnostic criteria - a desire to move the limbs usually associated with paraesthesias or dysaesthesias, motor restlessness, symptoms worse or exclusively present by activity, symptoms worse in the evening or night
Therapy area
Neurology
Evidence base
RCT
Primary endpoint
Other
Key trials
Study 190, Study 191, Study 194, Study 249
Comparator
placebo
Economic model
CUA
Why PBAC said no
Reasons cited in the latest PSD: uncertainty about the extent of clinical benefit, high placebo response rate, concerns about treatment effect size, higher toxicity with ropinirole than placebo, concerns with economic model including bias in utility questionnaire, ICER highly sensitive to utility changes