PBAC's latest decision on Varenicline tartrate: Recommended (2009). Considered for as an aid to smoking cessation for adults over the age of 18 years, with a second continuing treatment restriction added to allow a further 12 weeks of treatment for responders.
PBAC outcome
Recommended
Authority Required
ICER (AUD/QALY)
$15k/QALY
—–$15k/QALY · across 2 submissions
Submissions
2
first 2007
Submissions
2
2007 → 2009
Eligible population
patients who have successfully completed an initial 12 week course of varenicline and require a further 12 week course to aid in maintaining abstinence, and who are enrolled in a comprehensive support and counselling program
Therapy area
Other
Line of therapy
Later-line
Evidence base
RCT
Primary endpoint
Continuous Abstinence Rate (CA) from Week 13 through Week 52
Key trials
A3051035
Comparator
placebo
Economic model
CUA
ICER note
ICER stated as 'less than $15,000' per QALY; PBAC noted this figure was uncertain due to translation issues but nevertheless acceptable
ICER basis
Range aggregates 2 submissions (2007–2009) — not a single base case.