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

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Table of Submission


Author Name

Document Link

Date received


Janssen-Cilag Pty-Ltd

Submission 1



Australasian College of Dermatologists

Submission 2




Submission 3