HTA Review gets underway with the release of Terms of Reference

Pharma News: Medicines Australia and Patient Voice Initiative (PVI) have acknowledged the Health Technology Assessment (HTA) Review Terms of Reference (ToR) released yesterday and will continue to advocate for bold policy reform to speed up access to innovative medicines.

CEO of Medicines Australia – and newly appointed HTA Review Reference Committee member – Elizabeth de Somer said that the release of the Terms of Reference kickstarts the HTA Review process, which must deliver equitable, timely, safe and affordable access to innovative medicines for all Australians.

“The Australian medicines access system has not seen this type of review in 30 years and rapid advances in health, medicine, and technology require reform, so Australians don’t miss out,” Ms de Somer said.

“The HTA Review is an opportunity to improve our health and medicine system, so it is fit-for-purpose and realises the government’s National Medicines Policy vision of providing the world’s best healthcare for all Australians. Reforms must remove the barriers in current policies, methods and decision-making systems that are stopping patients from having rapid access to innovative medicines, vaccines and treatments,” she said.

Patient Voice Initiative (PVI) welcomed the clearer statement about how the review will interact with parallel work to improve consumer engagement and the focus on time to earliest possible access and equitable access of novel therapies.

The organisation pointed to other highlights. “The person-centred perspective which we see as thinking about the wider lives and needs of patients is critical, the inclusion of policies and methods for the use of patient-based evidence (patient preference studies, PROMs and PREMS, qualitative research) and integration of patient input and other expertise is also welcomed.

“Also, the commitment to improving meaningful transparency is very important. Additionally, the consideration of funding and approval pathways to bring innovative treatments to patients equitably – the right patient at the right time whoever they are and wherever they are.

“We look forward to seeing further information about how the patient community can contribute its knowledge to this important review,” said PVI.

Rare Voices Australia (RVA) was also pleased to contribute to the ToR consultation as the national peak body for Australians living with a rare disease.

“RVA is pleased that it is noted within the ToR that the Enhanced Consumer Engagement Process (ECEP) will be informed by the existing Conversations for Change work led by the Department of Health and Aged Care which involves RVA and rare disease organisation group leaders with an active interest in HTA,” the organisation said.

Medicines Australia said the ToR strengthened the focus on patients and noted the specific mention of additional groups of Australians who experience access equity issues, such as First Nations people.

“After advocacy from Medicines Australia, there is now a stronger focus on having ‘earliest possible access’ to medicines, as well as a ‘person-centred approach’,” Ms de Somer said.

“The Terms of Reference are broad enough to consider system-level policy reforms and will allow all stakeholders to put their issues on the table.

“But this is just the beginning. Health reform like the HTA Review must make lasting, impactful change. Moving forward, the HTA Review must be transparent and create appropriate space and time to listen to the views, experiences and challenges of all stakeholders.

“The House of Representatives Health Committee’s inquiry and The New Frontier report [in November 2021] shows groundswell of support for bold reform and everyone involved in that inquiry should have the opportunity to put forward their ideas. The government, medicines industry, patients and health experts must work together that ensure all Australians have better access to innovative medicines,” she said.

The ToR also pointed to the areas that are out of scope for the HTA Review. This includes the fact that the government has agreed to funding parameters that allow the Minister for Health and Aged Care to approve the PBS listing of a new medicine up to $20M in any year. “Beyond this cost, the PBS listing would require Cabinet approval. The government has given a high priority to funding new medicines recommended by the PBAC. It can do this because the processes of the PBAC ensure value for spending on medicines. However, this decision making occurs in the broader context of the government and Cabinet health and economic decision making. This broader policy setting and decision making is outside the terms of reference for this review,” the ToR stated.

Medicines Australia looks forward to the prompt public release of the HTA Review workplan and any discussion papers prepared by the HTA Expert to provide greater understanding for stakeholders and how everyone can engage.

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