Public Consultation on the Post-market Review of the use of biologics in the treatment of severe chronic plaque psoriasis

Page last updated: 9 June 2017

The public submission process on the Post-market Review of the use of biologics in the treatment of severe chronic plaque psoriasis closed on 15 February 2017.

The Department appreciates the contribution of all organisations and individuals who made a submission.

Final Terms of Reference

The Final Review Terms of Reference are:

  1. Review current clinical guidelines for the treatment of severe chronic plaque psoriasis and compare to the Pharmaceutical Benefits Scheme (PBS) restrictions for use of biologics in this indication.
  2. Review and evaluate recent clinical evidence on the efficacy and safety of biologics used in the treatment of severe chronic plaque psoriasis and compare to the evidence considered by Pharmaceutical Benefits Advisory Committee (PBAC) in previous sponsor submissions.
  3. Review the utilisation of PBS biologics for the treatment of chronic plaque psoriasis including time on treatment and discontinuation from treatment, and compare this with that observed in the clinical trial evidence considered by the PBAC.
  4. Subject to the findings from Terms of Reference 1, 2 and 3, review the cost-effectiveness of biologics for severe chronic plaque psoriasis.

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Privacy

Unless otherwise requested, all submissions to the Review will be 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 will be 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 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 biologics 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 submissions addressing the draft Terms of Reference

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 Pty Ltd

Submission 3

16/05/2016

Table of submissions addressing the Review

Submission

Author Name

Document Link

Date received

Date Updated

1

Individual

Submission 1

6 February 2017

-

2

Janssen-Cilag Pty Ltd

Not for publication

14 February 2017

5 May 2017

3

Eli Lilly Pty Ltd

Not for publication

15 February 2017

9 May 2017

4

Abbvie Pty Ltd

Not for publication

15 February 2017

-

5

Pfizer Australia

Submission 5

15 February 2017

1 May 2017

6

The Australasian College of Dermatologists

Submission 6

27 February 2017

-