Post-market review of medicines for smoking cessation

Page last updated: 24 October 2019


There are currently three pharmacological interventions for smoking cessation available on the Pharmaceutical Benefits Scheme (PBS): nicotine replacement therapy (NRT), varenicline and bupropion.

In July 2017, the Pharmaceutical Benefits Advisory Committee (PBAC) deferred a major submission for the listing of nicotine replacement therapy in the form of gum and lozenges (2mg and 4mg strengths) on the PBS. The PBAC noted that the efficacy of nicotine lozenges and gum significantly improved when used in combination with nicotine patches, but that no evidence was provided in the submission about the cost-effectiveness of combination NRT.

In March 2018, PBAC recommended the listing of nicotine gum and lozenges as monotherapies on the PBS for treating nicotine dependence. The PBAC considered that a broader review of PBS-listed nicotine dependence treatments, in the context of the current clinical guidelines, would help inform whether the current subsidy arrangements should be altered to better support smoking cessation.

Information is available in the PBAC Public Summary Documents for July 2017 and March 2018.

The post-market review (PMR) of medicines for smoking cessation was approved by the Minister for Health on 18 September 2019. The PMR will re-assess the PBS restrictions in the context of the latest available evidence, best clinical practice and cost-effectiveness. The Review is being carried out under the Australian Government’s post-market monitoring program, which aims to ensure the continued safe, cost-effective and quality use of medicines listed on the PBS.

Medicines to be included in the Review are:

  • Nicotine Replacement Therapy (various forms)
  • Bupropion
  • Varenicline

E-cigarettes are out-of-scope of this post-market review.

Draft Terms of Reference

  1. Collate the current clinical guidelines for medicines for smoking cessation and compare these to the Therapeutic Goods Administration (TGA) and PBS restrictions for these medicines.
  2. Review the utilisation of PBS-listed medicines for smoking cessation including patient demographics, time on treatment, and the proportion using PBS subsidised combination treatment.
  3. Review the efficacy and safety of PBS-listed medicines and guideline-recommended medicines for smoking cessation, including those not currently PBS subsidised.
  4. Review the cost-effectiveness of PBS-listed and guideline-recommended medicines for smoking cessation.

Public consultation on draft terms of reference

Public consultation on the draft Terms of Reference will be open between 28 October 2019 and 25 November 2019. Please email your comments to the Review Secretariat. Public comments will be considered by the PBAC when making recommendations to the Minster on the final Terms of Reference for the Review.

To make a submission please go to the public consultation page for the post-market review of smoking cessation therapies.

Review process

This Review will follow the Post-market Review Framework available on the Review’s website. This process includes public consultation on the draft Terms of Reference, an opportunity to provide submissions containing information to inform the Review Terms of Reference, and an opportunity to comment on the draft Review Report.

Further information

Further information on post-market reviews is available on the Review’s website.

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