Public Consultation on the draft Terms of Reference for the Post-market Review of biologics to treat Severe Chronic Plaque Psoriasis

Page last updated: 19 August 2016

At its August 2016 meeting, the PBAC endorsed the final Terms of Reference and altered the name of the Review from ‘bDMARDs’ to ‘biologics’ in response to stakeholders’ comments that these drugs are not anti-rheumatic drugs, but biological drugs for the treatment of psoriasis and psoriatic arthritis.  

Public Submissions

The public consultation on the draft Terms of Reference for the Post-market Review of biological Disease Modifying Anti-Rheumatic Drugs (bDMARDs) to treat Severe Chronic Plaque Psoriasis closed on 16 May 2016.

The Department appreciates the contribution of all organisations and individuals who made a submission commenting on the Review’s draft Terms of Reference. 

Draft Terms of Reference

The draft Review Terms of Reference are:

  1. Review current clinical guidelines for the treatment of severe chronic plaque psoriasis and compare to the PBS restrictions for use of bDMARDs in this indication.
  2. Review and evaluate recent clinical evidence on the efficacy and safety of bDMARDs used in the treatment of severe chronic plaque psoriasis and compare to the evidence considered by PBAC in previous sponsor submissions.
  3. Review the utilisation of PBS bDMARDs for the treatment of chronic plaque psoriasis and compare the patient response in practice to those observed in the clinical trial evidence considered by the PBAC. Compare the efficacy in practice among the listed bDMARDs in terms of time on treatment and discontinuations from treatment.
  4. Subject to the findings from terms of reference 1, 2 and 3, review the cost effectiveness of bDMARDs for severe chronic plaque psoriasis.

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Privacy

Unless otherwise requested, all submissions to the Review have been published on this page.

The Department of Health will 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.

Submissions and contact details are stored in accordance with the Australian Privacy Principles from Schedule 1 of the Privacy Amendment (Enhancing Privacy Principles) Act 2012 and the Archives Act 2012.  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 bDMARDS Review 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 on 02 6289 5773 and, if unsatisfied with the response, you may submit a complaint to the Office of the Australian Information Commissioner.

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.
Table of Submission

Submission

Author Name

Document Link

Date received

1

Janssen-Cilag Pty-Ltd

Submission 1

16/05/2016

2

Australasian College of Dermatologists

Submission 2

16/05/2016

3

AbbVie

Submission 3

16/05/2016