Government takes steps to deliver on ‘key commitment’ of strategic agreement with Medicines Australia

In brief

On 6 September 2021, the Australian Government and Medicines Australia, which leads the research-based medicines industry of Australia, entered into a new strategic agreement (Strategic Agreement).

Our team summarised the key outcomes of the Strategic Agreement in The Prescription last year, which you can read here.

The Strategic Agreement commenced on 1 July 2022, following the expiry of the previous strategic agreement and the passing of the National Health Amendment (Enhancing the Pharmaceutical Benefits Scheme) Bill 2021. The bill gave effect to many of the measures contained in the Strategic Agreement by amending the National Health Act 1953.

One of the Government’s key commitments under the Strategic Agreement was that it would support and resource a review of the Health Technology Assessment (HTA) policy and methods.

What is the HTA policy and methods review?

The HTA policy and methods review is aimed at ensuring processes are in place so that Australians can have more affordable and timely access to medicines, including early access to breakthrough medicines and treatments. The Government and Medicines Australia acknowledged that this required ‘continuous evaluation and improvement^[1] of HTA methods.

Under clause 5.3 of the Strategic Agreement, the Government committed to support and resource a review of the HTA policy and methods. This includes establishing and supporting a Reference Committee to prepare terms of reference (in consultation with the Pharmaceutical Benefits Advisory Committee (PBAC) and other stakeholders, including Medicines Australia) to address:

• the selection of comparator(s)
• methods for evaluating rare diseases for reimbursement and alternative funding pathways if required
• methods for evaluating new and emerging technologies, medicines and vaccines
• use of real-world evidence including from sources other than randomised controlled trials
• managing clinical, economic, financial and other uncertainty
• the feasibility of international work-sharing for reimbursement submissions.

What is the update?

On 27 October 2022, it was announced that a Reference Committee had been appointed to oversee the HTA policy and methods review.

Consistent with clause 5.3.1 of the Strategic Agreement, the Reference Committee is made up of:

• an independent Chair
• the chair of PBAC
• a Government nominee
• a patient representative
• a member nominated by Medicines Australia.

A clinical/scientific representative and an additional patient representative have also been appointed.

Medicines Australia has nominated John Young (a former chair of the Medicines Australia Board and, more recently, Group President and Senior Advisor to the Pfizer Chief Executive Officer) as its representative.

The role of the Reference Committee will be to:

• agree on the terms of the review
• agree on the expert in HTA that will be engaged to support the review and oversee the analysis of current methods that is undertaken by the expert
• oversee public consultations and consider submissions to the review
• prepare a final report and recommendations arising from the review.

Where to now?

The Strategic Agreement contemplated that the review would be completed by June 2023. However, according to a statement from the Minister for Health and Aged Care, the deadline for completion of the review and presentation of the associated recommendations has been extended to December 2023. There has been no public statement about any extension to the targeted timing for the implementation of the findings arising from the review, but given the timing for the appointment of the Reference Committee and completion of the recommendations have both been pushed out, we may see the implementation of the recommendations similarly delayed.

The timing for stakeholder consultations has not yet been announced. As noted in our previous article about the Strategic Agreement, innovative pharmaceutical companies wishing to contribute to the HTA policy and method review should consider how they can contribute to that review, whether through Medicines Australia or in response to a call for submissions. This will be an important opportunity for the innovative medicines sector to point to other approaches to funding medicines in comparable jurisdictions which are worth considering in the Australian context.

^{[1] Clause 5.1.2 of Strategic Agreement.}