Post-market Review of medicines for smoking cessation

Page last updated: 22 December 2022


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 NRT 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, the 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 re-assessed the PBS restrictions of medicines for smoking cessation in the context of the latest available evidence, best clinical practice and cost-effectiveness. The Review was 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 included in the Review were:

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

Reference Group Membership



Nominated By

Capacity of Appointment

Professor Sanchia Aranda

Department of Health


Associate Professor Nicole Pratt

Drug Utilisation Sub-Committee (DUSC)

Technical Expert

Professor Gillian Gould

Department of Health

Technical Expert

Professor Rashmi Sharma

Royal Australian College of General Practitioners

Technical Expert

Associate Professor Billingsley Kaambwa

Australian Health Economics Society

Technical Expert

Dr Angela Gowland

Therapeutic Goods Administration

Organisational Nominee

Associate Professor Richard Brightwell

Consumers Health Forum of Australia

Consumer Advocate

Yelitte Ho and Anonnya Chowdhury

Medicines Australia

Organisational Nominee

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 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 were out of scope of this PMR.

No e-cigarette products were TGA approved at the time of commencement of the PMR 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 was 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 precluded their consideration at the time 1.

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.

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.

Consultation on the Review (Closed)

Public consultation addressing the Review and final Terms of Reference closed on 1 May 2020. To view submissions please go to the public consultation page

Stakeholder Forum

A Stakeholder Forum was held via webinar on 3 December 2020. Consumers, clinicians and peak bodies who have an interest in smoking cessation, and pharmaceutical sponsors who have a current PBS medicine listing for a smoking cessation therapy, were invited to participate in the forum.

A summary of the Stakeholder Forum and the presentation slides are published on the public consultation page.

The department appreciates the contribution of all organisations and individuals who attended the forum.

Public Consultation on the Draft Review Report

The Draft Review Report on the public consultation page was available for public comment until 2 July 2021.

PBAC consideration of the Draft Review Report

The Draft Report, including PBAC Sub-Committee advice and stakeholder comments, was provided to the PBAC for consideration in May 2022. The PBAC Minutes for this item are now available. Parts of the PBAC Minutes have been redacted due to ‘commercial-in-confidence’ information.

PBAC Minutes pertaining to the Draft Review Report for the Post-market Review of medicines for smoking cessation.

Post-market Review of medicines for smoking cessation – Final Report to the PBAC

The Final Review Report is provided in six parts, in DOCX and PDF format below. In-confidence information in the Final Review Report has been redacted.

  1. Report Summary  (PDF 622KB) - (Word 147KB)
  2. Background (PDF 831KB) - (Word 202KB)
  3. Section 1 - Term of Reference 1 (PDF 1.1MB) - (Word 748KB)
  4. Section 2 - Term of Reference 2 (PDF 1.4MB) - (Word 320KB)
  5. Section 3 - Term of Reference 3 (PDF 9.5MB) - (Word 7.5MB)
  6. Section 4 - Term of Reference 4 (PDF 2.8MB) - (Word 1.3MB)

Plain Language Summary

A brief plain language summary on the key findings for each Term of Reference is provided below.

Review process

This Review followed 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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