August 2018 PBAC special meeting

PD-1 and  PD‑L1 checkpoint inhibitor immunotherapies: options for subsidy consideration for multiple cancer types

Page last updated: 28 September 2018

Brief outcome

In late 2017 the Hon. Minister Hunt, Minister for Health requested that the Pharmaceutical Benefits Advisory Committee (PBAC) provide advice on options for listing PD-1 and PD-L1 checkpoint inhibitors for the treatment of multiple cancer indications on the Pharmaceutical Benefits Schedule (PBS). Specifically, the PBAC was asked to advise the Minister on 1) the current status of PD-1 and PD-L1 checkpoint inhibitors for the treatment of cancer; 2) on any issues around access to medicines for people with rare cancers, particularly where there are no existing effective therapies, and 3) options that could broaden or lead to faster PBS listing for cancer indications.

The advice to the Minister was to take into consideration the existing legislative and policy framework for PBAC decision-making that requires PBS listed medicines to be safe, effective and cost-effective compared to alternative treatments. Additionally, any advice was to take into account the role of the Therapeutic Goods Administration (TGA) in approving medicines for marketing in Australia.

Following initial discussions the Committee decided to use its August 2018 Special Meeting to discuss the matter after seeking inputs from interested stakeholders.

A discussion paper was published on 25 May 2018 along with an invitation for submissions from interested parties and a total of 28 submissions from a range of stakeholders were received. These presented a range of views and some proposed different access models for consideration.

The PBAC acknowledged the considerable input received.  The PBAC found the views and information presented in the submissions to be informative and wide-ranging. Consistent with a theme across a majority of the submissions, the PBAC considered that any change in the current PBS process should not disadvantage any other consumer group, disease type or medicine class.

The PBAC noted that at the time of its August meeting there were two PD-1 checkpoint inhibitors (nivolumab, pembrolizumab) and two PD-L1 checkpoint inhibitors (atezolizumab, avelumab) registered in Australia. Submissions to PBAC have been made for seven tumour types, five of which are now subsidised, with the final two recommended for subsidy at the July 2018 PBAC meeting.

The PBAC noted that across the submissions there were different interpretations of the concept of multi-tumour listings. It noted that it was important to distinguish between medicines for indications that were approved by TGA from those where there is no such approval. It noted that some issues presented by checkpoint inhibitors were common to other cancer medicines where biomarkers might be present in multiple different tumour types. It also noted the issues raised in relation to access to medicines for rare cancers were not unique to checkpoint inhibitors.

The PBAC noted that its current assessment processes allow for flexibility in evidentiary requirements including for medicines used to treat less common and rare diseases with a high and unmet clinical need for new treatment options.  The PBAC noted it had recommended checkpoint inhibitors for three rare cancers (merkel cell carcinoma, squamous cell carcinoma of the head and neck and classical Hodgkin’s lymphoma) and confirmed it would continue to review clinical evidence with appropriate consideration of unmet need.

The PBAC was reassured that the time from registration to reimbursement for checkpoint inhibitors in Australia, which ranged from 111 to 1,055 days (median 320 days) was consistent with the average time for PBS listing of other medicines and the timelines of international bodies. The PBAC noted the Strategic Agreement between Government and Medicines Australia initiatives aimed at improving the efficiency, transparency and timeliness of PBS listing processes, and agreed this work should further improve timeliness of access.

The PBAC noted that a full report of its considerations will be prepared for the Minister.

Public Submissions

Public submissions to the August 2018 PBAC meeting regarding PD-1 and PD-L1 checkpoint inhibitor immunotherapies: options for subsidy consideration for multiple cancer types are now available.

Please direct any queries to the PBAC Secretariat via email to PBAC@health.gov.au.

The consultation process for the August 2018 PBAC special meeting - PD-1 and PD-L1 checkpoint inhibitor immunotherapies: options for subsidy consideration for multiple cancer types closed on 29 June 2018. The Department appreciates the contribution of all organisations and individuals who made a submission. 

Disclaimer

  • The views expressed in submissions published on this website are solely those of the contributing authors or organisations.
  • The Commonwealth accepts no responsibility for the completeness or accuracy of any information contained in the submissions.
  • The Commonwealth makes no representations about the suitability of the information for any particular purpose. Users of the information must make their own inquiries and assessments about those matters or seek independent advice.
  • Submissions are published on the understanding that the contributing authors or organisations have copyright in the submissions either by way of ownership or a licence. They retain their copyright, and by making submissions they licence the Commonwealth to publish the submissions, unless a party when making a submission has requested that it be kept confidential and the Commonwealth clearly agrees that the submission will be kept confidential.

Privacy

Unless otherwise requested, submissions commenting on the PBAC paper “PD-1 and PD-L1 checkpoint inhibitor immunotherapies: options for subsidy consideration for multiple cancer types; Background to invitation for submissions”, May 2018,have been published below.

The Department of Health does not publish submissions, or parts of submissions, which contain personal information, offensive language, potentially defamatory material or copyright infringing material.

Responsibility for copyright in submissions resides with the author(s), not with the Department of Health.

All submissions have been converted to Portable Document Format (PDF) for publication and may have a different appearance to the document that was submitted.

 Your submission and contact details will be stored in accordance with the Privacy Act 1988 and the Archives Act 1983.  Should you have any concerns about the storage of your submission, or if you wish to gain access to make a correction, please contact the PBAC Secretariat. A copy of the Department’s privacy policy is available on request. If you wish to make a complaint about the handling of your private information, you may contact the Department of Health Privacy Contact Officer and, if unsatisfied with the response, you may submit a complaint to the Office of the Australian Information Commissioner.

Submission number

Organisation

Category

Document link

1

Patient

Patient

Not for publication

2

Roche diagnostics

Pharmaceutical Industry

Submission 2 (PDF 566KB)

3

Patient

Patient

Submission 3 (PDF 122KB)

4

Griffith University

Research

Submission 4 (PDF 132KB)

5

Australasian College of Dermatologists

Professional organisation

Submission 5 (PDF 145KB)

6

Cancer Council Australia

Consumer organisation/research

Submission 6 (PDF 231KB)

7

Centre for Health Economics Research and Evaluation (CHERE)

Research and other - PBAC evaluation group

Submission 7 (PDF 177KB)

8

Pfizer Australia

Pharmaceutical Industry

Submission 8 (PDF 231KB)

9

Canadian Agency for Drugs and Technologies in Health (CADTH)

Government HTA agency

Submission 9 (PDF 160KB)

10

Medical Oncology Group of Australia (MOGA)

Professional organisation

Submission 10 (PDF 615KB)

11

Garvan Institute

Research

Submission 11 (PDF 265KB)

12

Patient

Patient

Not for publication

13

Bristol-Myers Squibb (BMS) Australia

Pharmaceutical Industry

Submission 13 (PDF 2MB)

14

Amgen Australia

Pharmaceutical Industry

Submission 14 (PDF 549KB)

15

National Oncology Alliance

Consumer organisation/research

Submission 15 (PDF 324KB)

16

Society of Hospital Pharmacists of Australia (SHPA)

Professional organisation

Submission 16 (PDF 238KB)

17

Patient

Patient

Submission 17 (PDF 114KB)

18

Astra Zeneca

Pharmaceutical Industry

Submission 18 (PDF 193KB)

19

South Australian Medicines Evaluation Panel (SAMEP)

Government HTA agency

Submission 19 (PDF 163KB)

20

Merck Sharp and Dohme (MSD)

Pharmaceutical Industry

Submission 20 (PDF 144KB)

21

Takeda Australia

Pharmaceutical Industry

Submission 21 (PDF 131KB)

22

Lynch Syndrome Australia

Consumer organisation/research

Submission 22 (PDF 190KB)

23

Unicorn Foundation

Consumer organisation

Submission 23 (PDF 117KB)

24

Roche  

Pharmaceutical Industry

Submission 24 (PDF 1MB)

25

Individual

Individual

Not for publication

26

Lymphoma Australia

Consumer organisation

Submission 26 (PDF 131KB)

27

Medicines Australia

Professional organisation /pharmaceutical industry

Submission 27 (PDF 268KB)

28

Council of Australian Therapeutic Advisory Groups (CATAG)

Government HTA agency

Submission 28 (PDF 536KB)

Invitation for submissions open and background paper available

The invitation for submissions to the August 2018 PBAC special meeting regarding PD-1 and PD-L1 checkpoint inhibitor immunotherapies: options for subsidy consideration for multiple cancer types, is now open, closing 5pm AEST 29 June 2018. Submissions must be made in writing and emailed to the PBAC Secretariat.

To support the development of submissions, please see the background paper (PDF 167KB) - (Word 64KB).

To assist with the review and compilation of submissions, please provide your submission in the submission template (Word 36KB) and submission template for question 13 (Word 28KB).

The outcomes of PBAC's considerations will be published through the PBS website.

Please note, all submissions received will be published on the PBS website at the conclusion of the public submission period, unless otherwise requested. Where submissions indicate commercial-in-confidence or sensitive personal information, this is redacted before publication.

Please direct any queries to the PBAC Secretariat via email.

August 2018 PBAC special meeting

Options for listing of pan-tumour indications for PDL1 cancer immunotherapies on the PBS

Page last updated: 21 February 2018

In response to interest from pharmaceutical companies and cancer patient advocacy groups, the Minister for Health, the Hon Greg Hunt MP, has requested that the Pharmaceutical Benefits Advisory Committee (PBAC) consider options for listing programmed death-ligand 1 (PDL1) cancer immunotherapies for the treatment of multiple tumours (pan-tumour indications) on the Pharmaceutical Benefits Scheme (PBS).

The PBAC has set aside a Special Meeting on 17 August 2018 to consider this matter, and to enable adequate time to seek input through submissions from industry and clinicians and patient groups.

In its initial consideration of the opportunities and challenges associated with progressing pan-tumour indications for PDL1 cancer immunotherapies the PBAC has noted that while it is likely that PDL1 inhibitors will be useful for treating a range of cancers, the limited trial results it has considered to date suggest that treatment responses are not uniform across different types of cancers, different ages and different patient populations. In addition, the results for different immunotherapies have been inconsistent as to whether it is necessary to classify patients by PDL1 tumour marker expression for effective treatment. Moreover, in most cases, results from trials were still early in terms of estimating overall and comparative benefits, factors of key importance for PBS reimbursement decision-making under the National Health Act 1953.

A short background paper is being prepared which will be made available to interested parties prior to the meeting. This will accompany an invitation for submissions to inform the PBAC’s Special Meeting discussion.

Interested parties are asked to register their interest in receiving the discussion paper and making a submission with the PBAC Secretariat via email by 30 March 2018.