What is the issue:
For the first time in nearly 30 years, the Federal Government will conduct an independent review of Australia’s Health Technology Assessment (HTA) system (planned for July 2022 – July 2023). The reform will ensure Australia’s HTA system evolves to keep pace with advances in medicines, vaccines and biotherapeutics and delivers faster access to new medicines for patients.
This HTA Reform is being conducted in parallel with the National Medicines Policy Review and comes soon after the recommendations from the House of Representatives (HOR) Inquiry into access to new drugs and novel medical technologies.
Importantly, they should all align to ensure Australians have an enduring medicine policy that is fit for the future and allows access to affordable medicines as quickly as possible.
Why is it important:
Australians will benefit from faster access to affordable breakthrough, innovative medicines.
The medicines industry will benefit from stability and certainty for investment in, and funding for, new medicines and assessment processes that remain world class and keep pace with rapid advances in medicine enabling them to be marketed and funded in Australia as they emerge.
The Australian economy will benefit from improved health outcomes, leading to increased productivity, and continued investment in research and innovation.
Recommendations:
- Patients must be at the centre of the process, so that reimbursement decisions consider the impact and benefits of medicines from the patient’s perspective
- New evaluation and funding pathways for innovative medicines are needed to ensure the value of innovation is recognised, and to ensure efficient ways of assessing treatments and therapies that do not fit neatly into the system (such as cell and gene therapies and precision medicines).
- Time to access must be improved. Currently PBAC assessments (from submission to publication of the public summary document) takes on average 33-35 weeks1. This is far longer than international standards and increases the waiting time for patients.
Background
To inform Government funding decision, HTA provides necessary information to understand the benefits and comparative value of health technologies and procedures. HTA is commonly applied to pharmaceuticals; as well as vaccines, diagnostic tests, medical devices and other public health interventions. The main bodies involved include the Pharmaceutical Benefits Advisory Committee (PBAC) and the Medical Services Advisory Committee (MSAC). Some state hospitals also do HTAs.
The HTA Review will be overseen by a Reference Committee that is independently chaired. It will elevate the patient voice by including patient representatives on the Review Committee. This will ensure recommendations are informed by patient perspectives.
Medicines Australia’s Position
Issue for Patients:
During the 2020 House of Representatives (HOR) Inquiry into access to new drugs and novel medical technologies, many submissions from patients, patient groups and carers commented on their experience of not being part of the reimbursement process. While the current process does allow consumer feedback, they believed that their voice was not being properly heard, and their opinion is asked too late in the process.
Medicines Australia Recommendation:
Patients must be at the centre of the process, so that reimbursement decisions consider the impact and benefits of medicines from the patient’s perspective.
Issue for new medical innovations:
The Current HTA system was established in 1993 at a time when the PBAC reviewed mostly ‘small molecule’ medicines and single valent vaccines. Since then, Australia has seen a plethora of ‘large molecule’ medicines (called biologics); multi-valent vaccines; many combination medicines and most recently cell and gene therapies. The PBAC and MSAC processes have had considerable uncertainty as to best determine the value these innovations bring. Uncertainty causes delays.
Medicines Australia Recommendation:
New evaluation and funding pathways for innovative medicines are needed to ensure the value of innovation is recognised, and to ensure efficient ways of assessing treatments and therapies that do not fit neatly into the system (such as cell and gene therapies and precision medicines).
Issue of time taken to get affordable access:
Australia’s average time to reimbursement from registration for innovative, new medicines is 391 days. This is in contrast to the 20 OECD countries average of 351 days2. Three OECD countries are able to achieve reimbursement within 3 months of registration (Japan, Germany, Austria). In comparison, Australia only 2% of medicines are reimbursed in that time. One possible explanation for these time differences is how these countries handle uncertainty. In Australia, if the Committees find there are too many uncertainties, the sponsor has to resubmit their application and the process starts again.
This is confirmed by another study which looked at all new medicines and all indications (which includes a new indication of an already reimbursed medicine) over a period of 2010-2017. The study concluded for medicines or indications defined as superior to a current therapy, the average time from registration to reimbursement was 820 days with an average of 2.2 PBS submissions needed3.
Medicines Australia Recommendation:
Time to access must be improved. Having the HTA Review Committee working with a problem-solving mindset should facilitate a number of the recommendations from the HOR Inquiry4 and allow the implementation of HTA improvements better aligned with other (faster) OECD countries.
These recommendations are consistent with a 2020 House of Representatives Inquiry which looked at the approval processes for new drugs and novel medical technologies4.
- http://www.medicinesaustralia.com.au/wp-content/uploads/sites/65/2020/11/Medicines-Matter-Access-Report.pdf
- https://www.medicinesaustralia.com.au/publications/medicines-matter/ – Analysis period 2014-2019
- Amgen Australia 2020 Submission to HOR Inquiry into access to new drugs and novel medical technologies.
- PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA, The New Frontier – Delivering better health for all Australians: Inquiry into approval processes for new drugs and novel medical technologies in Australia, House of Representatives Standing Committee on Health, Aged Care and Sport. Nov 2021.