Varenicline TartratePHARMACOR VARENICLINE
Aid to smoking cessation for adults over 18 years of age who have successfully completed an initial 12-week course and require a further 12-week course to maintain abstinence.
Decisions on record
- Meeting Mar 2008 Recommended Smoking cessation no PSD
- Meeting Nov 2007 Recommended Smoking cessation no PSD
- Meeting Jul 2007 Recommended Aid smoking cessation
Access path
- TGA registered · PHARMACOR VARENICLINE
TGA label narrower than the PBS population
- Jul 2007Recommended · restricted
Listing: Authority required → Authority Required
- Jul 2007Recommended · restricted
Listing: Authority required → Authority Required
- Nov 2009Recommended
Comparator changed: bupropion → placebo
- Nov 2009Recommended · restricted
Comparator changed: bupropion → placebo
- PBS listing · Authority Required
Cost-effectiveness
ICER stated as 'less than $15,000' per additional QALY; presented as a range ceiling rather than a precise figure.
The PBAC considered the incremental cost of varenicline versus placebo per additional QALY which was less than $15,000 to be uncertain due to translation issues, but nevertheless acceptable. PBAC · 2009
Decision context
PopulationPatients who have ceased smoking after an initial 12-week course of varenicline treatment and are enrolled in a comprehensive support and counselling program.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2009 | Recommended | placebo | $15k | RCT · Continuous Abstinence Rate (CA) from Week 13 through Week 52 |
| Nov 2009 | Recommended · restricted | placebo | $15k | RCT |
| Jul 2007 | Recommended · restricted | bupropion | $15k | RCT · OS | PFS | DFS | ORR | QoL | Surrogate | Cost-minimisation | Other | null |
| Jul 2007 | Recommended · restricted | bupropion | $15k | RCT |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to responders completing initial 12-week course, enrolled in support program, seeking maintenance therapy.