VareniclinePHARMACOR VARENICLINE
Nicotine dependence; continuation of a short-term course of treatment (12 weeks or up to 24 weeks) as an aid to achieving abstinence from smoking.
Decisions on record
- Meeting May 2022 Recommended Smoking cessation no PSD
- Meeting Nov 2017 Recommended Nicotine dependence
- Meeting Nov 2016 Recommended Nicotine dependence
- Meeting Mar 2014 Recommended Champix® Pfizer Australia Pty Ltd Smoking cessation Re-submission to change the NOTE to the restriction to permit a further course of varenicline tartrate in patients who did not cease smoking after a 12 week course of treatment, provided 6 months have elapsed between varenicline treatments.
- Meeting Nov 2012 Not recommended Smoking cessation
- Meeting Mar 2011 Recommended Smoking Cessation no PSD
- Meeting Nov 2009 Recommended Anti-nicotine dependence
- Meeting Mar 2009 Not recommended Smoking cessation agent no PSD
Access path
- TGA registered · PHARMACOR VARENICLINE
TGA label narrower than the PBS population
- Nov 2012Not recommended
clinical evidence presented was for varenicline-naïve patients and not representative of the population proposed for…
- Nov 2012Not recommended
evidence presented was for smoking cessation in varenicline naïve patients and not representative of the proposed…
- ↻ resubmittedMar 2014Recommended
Comparator changed: bupropion, nicotine replacement therapy (transdermal patches)…
- Nov 2016Recommended · restricted
Comparator changed: placebo, bupropion, and nicotine replacement therapy (NRT) → placebo…
- Nov 2017Recommended
Listing: Authority Required → Restricted
- PBS listing · Restricted
From the public summary
4.1 The PBAC recommended the removal of the requirement for the initiation of treatment to be PBS subsidised for the continuing treatment (item 9129L) listing. The PBAC considered it unlikely that this amendment would result in any issues or potential leakage for varenicline.PSD · Nov 2017
4.2 The PBAC proposed no changes to item 5469W which completes the course of varenicline. Outcome: RecommendedPSD · Nov 2017
6.13 The re-submission presented a cost-utility analysis and a cost effectiveness analysis.PSD · Mar 2014
The economic model presented in the re-submission was the same as that presented in the November 2012 submission in terms of structure. Compared with the November 2012 submission, the re-submission’s model had updated efficacy inputs (from Trial A3051139), updated inputs for raw population and mortality rates (Year 2007, AIHW 2010) and population attributable risk proportions (PAR%s) extrapolated to 2013. The model had a reference year of 2014. 5PSD · Mar 2014
4.16 The submission claimed the presented evidence addressed the safety concerns raised by the PBAC in its consideration of the submission to the Post Market Review of Authority Required PBS listings, and claimed the risk-benefit profile of varenicline was favourable.PSD · Nov 2016
4.17 The PBAC reaffirmed its previous consideration that varenicline was superior in regards to comparative effectiveness compared to bupropion, NRT and placebo.PSD · Nov 2016
Cost-effectiveness
This was a minor submission; no economic evaluation or ICER calculated.
The minor submission estimated there to be no significant financial implications to the PBS. PSD · 2016
Decision context
PopulationPatients with nicotine dependence requiring continuation of a short-term course of treatment (12 weeks or up to 24 weeks), including those who received an initiation pack as an inpatient in a public hospital.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2017 | Recommended | — | — | — |
| Nov 2016 | Recommended · restricted | placebo, bupropion, nicotine replacement therapy | — | RCT · Neuropsychiatric adverse events |
| Mar 2014 | Recommended | placebo, bupropion, and nicotine replacement therapy (NRT) | $15k | RCT · Continuous abstinence rate (CAR) from weeks 9 to 52 |
| Nov 2012 | Not recommended | bupropion, PBS subsidised nicotine replacement therapy (NRT) (transdermal patches) and placebo (no treatment) | — | RCT |
| Nov 2012 | Not recommended | bupropion, nicotine replacement therapy (transdermal patches), placebo (no treatment) | — | RCT |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| EAGLES (Study A3051123) | Ph 4 | 8,144 | Occurrence of Neuropsychiatric (NPS) Adverse Events (AE) - the Primary Study Endpoint | completed |
Consumer voice
No consumer comments were received for this resubmission.
The PBAC noted that no consumer comments were received for this resubmission. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to short-term treatment (12-24 weeks) as aid to achieving abstinence; TGA label covers nicotine dependence broadly without duration or outcome restrictions.