Australia To Seek Stakeholder Input On Terms Of HTA Review
Executive Summary
The review of the health technology assessment system will look at the use of adaptable and flexible approaches to managing future health care technologies, early and equitable access for patients, as well as the possibility of international work-sharing initiatives and comparisons of purchasing practices.
The Australian government has set out the terms of reference for the forthcoming review of the health technology assessment (HTA) system and says that the first round of stakeholder consultations will kick off on 11 April. A workplan for stakeholder involvement in the review will be made available at the same time.
The review, which is due to conclude at the end of this year, will aim to identify which policies and methods are working well and which ones might be acting as barriers to early and equitable access or detracting from “person-centeredness.”
Among other things, the terms of reference (ToR) say the review will look at specific issues such as how best to capture the value of medicines, identify patient-relevant outcomes and select appropriate comparator products.
It will also examine how to encourage the launch of first-in-class technologies, make the most efficient use of limited HTA resources, and manage future advances in health care by using adaptable HTA approaches and flexible decision-making.
International work-sharing initiatives and comparisons of purchasing practices in other jurisdictions are also on the agenda, as is equitable access for specific patient groups.
The government said there would be “multiple opportunities for stakeholders to give input during the HTA Review.”
Industry group Medicines Australia said the review had to ensure “equitable, timely, safe and affordable access to innovative medicines.”
For Elizabeth de Somer, CEO of Medicines Australia and newly appointed member of the HTA Review Reference Committee, the review was “an opportunity to improve our health and medicine system so it is fit-for-purpose and realizes the government’s National Medicines Policy vision of providing the world’s best health care for all Australians.”
The 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,” de Somer said.
Any 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 declared.
The Terms Of Reference
The publication of the ToR follows a 13 February meeting of the review reference committee at which it examined amendments made to the terms based on stakeholder feedback, which had been discussed by the committee at an earlier meeting in January. (Also see "Australian HTA Review Preparations Gather Pace" - Pink Sheet, 10 Feb, 2023.)
The final terms set out the background to the review, its objectives, and the areas under consideration, and take into account feedback from patients, consumers, industry, advisory bodies and Commonwealth and state and territory governments.
They confirm that the review will cover all medicines and vaccines, highly specialized therapies (such as gene and cell therapies), other health technologies such as pathology tests or imaging that could improve health outcomes, as well as “foreseeable changes in health care that may influence the need, accessibility, effectiveness or cost-effectiveness of new health technologies.”
Specific topics to be covered include:
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Identifying the place of a technology in care and selection of comparators.
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Identifying patient-relevant outcomes.
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Augmenting primary clinical evidence with data to capture the value of health technologies from the patient perspective.
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Using direct input from patients, clinicians and others with “professional or lived expertise” for HTA evaluations.
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Increasing transparency in HTA decision-making.
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Managing clinical, economic, financial and other uncertainties throughout a technology’s lifecycle, including “better capture of necessary data on duration of effectiveness and safety events."
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Assessing technologies such as those for rare and ultra-rare diseases where there is a high unmet need together with clinical and economic uncertainty. This would include using evidence from sources other than randomized controlled trials where such trials are not feasible, and arrangements for post-market assessment and decision making.
The review will also look at funding and approval pathways, including the feasibility of international work sharing for the evaluation of technologies that are within the scope of the review, and purchasing practices used by comparable international jurisdictions.
More Focus On Patients And Earlier Access
Medicines Australia said it welcomed changes that had been made to the ToR to “strengthen the focus on patients,” noting in particular the reference to additional groups of Australians who have problems with equity of access, 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-centered approach’,” de Somer said.
She stressed the importance of transparency in the review process that allowed “appropriate space and time to listen to the views, experiences and challenges of all stakeholders.”
The association said it was looking forward to the “prompt public release” of the review workplan and any discussion papers prepared by the independent HTA expert that would help stakeholders to engage with the review.
The expert, who has yet to be named, will be responsible for leading the evaluation of current HTA policies and methods, overseeing public consultation processes, and preparing the final report and recommendations.
Health technology assessments in Australia are used to inform government decisions as to whether to fund health technologies through programs such as the Pharmaceutical Benefits Scheme, the Medicare Benefits Schedule, the National Immunisation Program, and the Life Saving Drugs Program.
The review is among the main commitments made under the 2022-27 Strategic Agreement between the Commonwealth and Medicines Australia. Following the completion of the review in December 2023, its recommendations are to be implemented within 12 months.