PBAC's latest decision on Pramipexole: Not recommended (2006). Considered for use in moderate to very severe, idiopathic Restless Legs Syndrome (RLS) in patients who meet certain criteria.
PBAC outcome
Not recommended
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2006
Submissions
1
2006 → 2006
Eligible population
patients with moderate to very severe, idiopathic Restless Legs Syndrome (RLS) who meet certain criteria
Therapy area
Neurology
Evidence base
RCT | Single-arm
Primary endpoint
QoL
Key trials
Trial 515, Trial 520, Trial 543, Stiasny-Kolster 2004, TREAT RLS 1 study, Allen et al (2004), Walters et al (2004), Bogan et al (2006)
Comparator
cabergoline
Economic model
Cost-minimisation
ICER note
Cost-minimisation approach attempted but not completed; no ICER calculated due to uncertain comparator cost-effectiveness
Why PBAC said no
Reasons cited in the latest PSD: uncertain clinical benefit, non-inferiority against cabergoline not substantiated, outcome measures not comparable across trials, comparator cost-effectiveness not established for PBS purposes