Post-market review of medicines for smoking cessation

Page last updated: 09 November 2020


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

Public Consultation on the draft Terms of Reference (Closed)

Public consultation on the draft Review Terms of Reference closed on 25 November 2019. To view submissions please go to the Public Consultation page.

Final Terms of Reference

The PBAC considered the draft Review Terms of Reference and comments from stakeholders at the December 2019 PBAC intra-cycle meeting. Following the December 2019 PBAC intra-cycle meeting the Minister for Health approved the final Terms of Reference for the Review:

  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 but not limited to patient demographics, time on treatment, and the proportion using PBS subsidised combination treatment.
  3. Review the efficacy and safety of nicotine replacement therapy, varenicline and bupropion for smoking cessation including combination therapies not currently PBS subsidised.
  4. Subject to the findings of Terms of Reference 1, 2 and 3, review the cost-effectiveness of medicines for smoking cessation.

Note: E‑cigarette devices and nicotine liquids are out of scope of this PMR.

No e-cigarette products have been TGA approved for marketing as a therapeutic good for smoking cessation in Australia. In order for a medicine to be considered for listing on the PBS to treat a given condition, that medicine has to be registered in Australia by the Therapeutic Goods Administration (TGA) for the treatment of that condition.

There is concern and uncertainty about the safety of these products in statements from the Chief Medical Officer and State and Territory Health Officers, NHMRC and the Cancer Council, which precludes their consideration at this time1.

1Chief Medical Officer and State and Territory Chief Health Officers, 13 September 2019, E-cigarettes linked to severe lung illness.

Cancer Council (referencing the National Heart Foundation), E-cigarettes page updated 13 November 2019

National Health and Medical Research Council, 3 April 2017, Electronic Cigarettes.

Consultation on the Review (Closed)

Public consultation addressing the Review and final Terms of Reference closed on 01 May 2020. To view submissions please go to the public consultation page

Stakeholder Forum

A Stakeholder Forum will be held via webinar for the Post-market Review of medicines for smoking cessation on Thursday 3 December 2020. Please note that attendance is by invitation only. Stakeholders who wish to attend and have not received an invitation should submit an expression of interest to by Friday 27 November 2020.

For further information please go to the go to the public consultation page.

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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