Post-market review of the use of biologics in the treatment of severe chronic plaque psoriasis

Page last updated: 21 December 2020

Background

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

In June 2014, the Drug Utilisation Sub-Committee (DUSC) of the Pharmaceutical Benefits Advisory Committee (PBAC) reviewed the Pharmaceutical Benefits Scheme (PBS) utilisation of bDMARDs medicines 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.

The Review was recommended by the PBAC at its December 2015 meeting and approved by the Minister for Health on 7 April 2016.

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.

The 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 Review is being carried out under the Australian Government’s post-market monitoring program, which aims to ensure the continued safe, cost-effective and quality use of medicines listed on the PBS.

Medicines included in the biologics for severe chronic plaque psoriasis Review are:

adalimumab
etanercept
infliximab
ustekinumab
secukinumab
ixekizumab

Reference Group

Name	Nominated By	Capacity of Appointment	Expertise
Professor Geoff McColl	Department of Health	Chair	Pharmaceutical Benefits Policy
Dr Debra Rowett	DUSC	Technical Expert	Drug Utilisation
Professor Nigel Stocks	Royal Australian College of GPs	Organisational Representative	General Practice
Ms Jing Jing Li	Australian Health Economics Society	Technical Expert	Health Economics
Dr Sasha Bennett	Society of Hospital Pharmacists	Organisational Representative	Hospital Pharmacy
Ms Elizabeth de Somer	Medicines Australia	Organisational Representative	Pharmaceutical Manufacturing Industry
Mr Mounir Mina as proxy for Dr Jane Cook	Therapeutic Goods Administration	Organisational Representative	Quality Use of Medicines
Ms Eileen Jerga	Consumers Health Forum of Australia	Consumer Advocate	Health consumer advocacy
Dr Andrew Miller	Australasian Medical Association	Organisational Representative	Dermatology
Dr Anita Wluka	Individual	Clinical Expert	Rheumatology /Epidemiology
Dr Jane Woods	Australasian College of Dermatologists	Organisational Representative	Dermatology

Public Consultation on the draft Terms of Reference (Closed)

Public consultation on the draft Review Terms of Reference closed on 16 May 2016. To view submissions please go to the Public Consultation page.

Final Terms of Reference

The Final Review Terms of Reference are:

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.
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.
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.
Subject to the findings from Terms of Reference 1, 2 and 3, review the cost-effectiveness of biologics for severe chronic plaque psoriasis.

Consultation on the Review

Public consultation addressing the Review and final Terms of Reference closed on 15 February 2017.

Submissions are published on the public consultation page for the post-market review of biologics for the treatment of severe chronic plaque psoriasis.

Stakeholder Forum

A Stakeholder Forum was held in Melbourne on 20 October 2017. Consumers of biological medicines listed on the PBS for severe chronic plaque psoriasis, clinicians and pharmaceutical sponsors were invited to participate. A Summary of the Stakeholder forum is provided below.

Public Consultation on the Draft Review Report

The draft Review Report on the Public Consultation page was available for public comment until 2 February 2018.

PBAC consideration of the Draft Review Report

The Draft Report, including PBAC sub-committee advice and stakeholder comments, was provided to the PBAC for consideration in April 2018. The PBAC Minutes for this item are now available. Parts of the PBAC Minutes have been redacted due to ‘commercial-in-confidence’ information.

PBAC Minutes pertaining to the Draft Review Report for the Post-market Review of the use of biologics in the treatment of severe chronic plaque psoriasis.

Considering the findings from Terms of Reference 1, 2 and 3, the PBAC recommended a review of the cost-effectiveness of biologics for severe chronic plaque psoriasis under Term of Reference 4.

Post-market Review of the use of biologics in the treatment of severe chronic plaque psoriasis – Final Report to the PBAC

The Final Report is provided in six parts, in DOCX and PDF format:

PBAC consideration of the Cost-effectiveness Review Report

The Cost-effectiveness Review Report, including PBAC sub-committee advice and stakeholder comments, was provided to the PBAC for consideration in July 2020. A Public Summary Document (PSD) for this item is now available. Parts of the PSD have been redacted due to ‘commercial-in-confidence’ information.

Plain Language Summary

A brief plain language summary (PDF 572KB) - (Word 28KB) on each of the key Terms of Reference findings from the Final Report has been created.

Review Process

This Review followed the steps in the Post-market Review Framework. This process includes public consultation on the draft Terms of Reference, an opportunity to provide submissions to the Review, and an opportunity to comment on the draft Review Report.

Further Information

Further information on post-market reviews is available on the Post-market Reviews web page.

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