Public Consultation on the Post-market Review of Biologics for severe chronic plaque psoriasis

Page last updated: 19 December 2016

Public Submissions: 4 January 2017 to 15 February 2017

Background

Biologics are a group of anti-inflammatory and immune-suppressing agents that are used to treat rheumatoid arthritis and other autoimmune diseases including severe chronic plaque psoriasis, Crohn’s disease, ankylosing spondylitis and psoriatic arthritis.

In June 2014, the Drug Utilisation Sub-Committee (DUSC) of the Pharmaceutical Benefits Advisory Committee (PBAC) reviewed the Pharmaceutical Benefits Scheme (PBS) utilisation of biological Disease-Modifying Anti-rheumatic Drugs (bDMARDs) and referred the matter to the PBAC for information.

In March 2015, the PBAC considered the submission for secukinumab for severe chronic plaque psoriasis and noted that etanercept was the main comparator for the current PBS biological Disease Modifying Anti-Rheumatic Drugs (bDMARDs) psoriasis listings. PBAC noted that there is emerging evidence of variation in response to Tumour Necrosis Factor-alpha (TNF-α) inhibitors in psoriasis, with etanercept appearing to be less effective than other agents. The PBAC recommended to the Minister that a cost-effectiveness review of the bDMARDs for severe chronic plaque psoriasis be undertaken.

At its August 2016 meeting, the PBAC endorsed the final Terms of Reference (ToR) 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.

This Post-market Review will re‑assess the cost-effectiveness of biologics used in the treatment of severe chronic plaque psoriasis, in the context of the latest available evidence and best clinical practice.

The Department is inviting submissions from interested organisations and individuals addressing the Review and Final Terms of Reference for the Post‑market Review of biologics used in the treatment of severe chronic plaque psoriasis from Wednesday 4 January 2017. The public submission process will be open for six weeks. Submissions must be lodged by 5pm Wednesday 15 February 2017.

Lodgement

To ensure the successful lodgement of your submission please follow these steps:

  1. Complete and attach the Biologics Review Submission Cover Sheet (Word 25KB) to your submission.
  2. Provide your submission in a Microsoft Word or PDF format.
  3. Please email your comments to the Biologics Review Secretariat between 4 January 2017 to 15 February 2017.

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.