NicotineNicabate Minis (GC)
Nicotine dependence in cigarette smokers who wish to quit and enter into a behavioural support program. Available as gum (2 mg, 4 mg) and lozenge (2 mg, 4 mg) formulations.
Decisions on record
- Meeting Mar 2018 Recommended Nicotine dependence
- Meeting Jul 2017 Deferred Nicotine dependence
- Meeting Nov 2011 Recommended Smoking cessation no PSD
- Meeting Jul 2011 Deferred Smoking cessation no PSD
- Meeting Jul 2010 Recommended Smoking cessation aid no PSD
- Meeting Jul 2010 Recommended Smoking cessation aid no PSD
- Meeting Mar 2008 Recommended Smoking cessation aid no PSD
Access path
- TGA registered · Nicabate Minis (GC)
TGA label narrower than the PBS population
- Mar 2010Recommended · restricted
vs varenicline
- Jul 2017Deferred
Comparator changed: varenicline → nicotine patch
- Mar 2018Recommended · restricted
Comparator changed: nicotine patch → nicotine patches
- PBS listing · Restricted
From the public summary
4.1 The PBAC recommended the listing of nicotine gum and lozenge, as monotherapies on the PBS as a restricted benefit for treating nicotine dependence in cigarette smokers who wish to quit and enter into a behavioural support program.PSD · Mar 2018
4.2 The PBAC re affirmed that it was reasonable for nicotine patches to be considered the main comparator for nicotine gum and lozenges in the monotherapy setting.PSD · Mar 2018
6.34 The submission presented a cost-minimisation analysis of nicotine lozenges versus nicotine patches. This was in line with the clinical evidence of non-inferior efficacy and safety of nicotine lozenges compared with patches.PSD · Jul 2017
6.35 Table 10 summarises the estimated mean number of nicotine lozenges consumed over a 12-week treatment period, and the estimated equi-equivalent dose.PSD · Jul 2017
6.31 The submission described nicotine gum and nicotine lozenges as non-inferior in terms of comparative efficacy and safety compared with nicotine patches. This was adequately supported for statistical non-inferior efficacy and safety, as: A similar level of efficacy in achieving sustained abstinence was observed in the three trials comparing nicotine lozenges with nicotine patches and in the indirect comparison between nicotine gum and nicotine …PSD · Jul 2017
6.32 The pre-PBAC response re-iterated the submission’s claim of non-inferiority, citing the Cochrane overview of smoking cessation (Cahill et al. 2013), which concluded that there was little difference between the gum, patch, or lozenge forms of NRT.PSD · Jul 2017
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated. Gum and lozenges were priced to be cost-neutral against nicotine patches.
The PBAC considered that a substantial number of uncertainties with the approach taken by the submission to calculate the equi-effective doses were suitably addressed in the revised calculations. PBAC · 2018
Decision context
PopulationCigarette smokers with nicotine dependence (high or moderate) who wish to quit and are entering or undergoing a comprehensive behavioural support and counselling program
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2018 | Recommended · restricted | nicotine patches | — | Cost-minimisation · Cost-minimisation |
| Jul 2017 | Deferred | nicotine patch | — | RCT · Sustained abstinence |
| Mar 2010 | Recommended · restricted | varenicline | — | RCT · CAR |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to cigarette smokers actively entering behavioral support programs; TGA label covers all nicotine dependence without these conditions.