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News & Trends - Pharmaceuticals

Call to accelerate access to breakthrough cell and gene therapies

Health Industry Hub | July 22, 2021 |
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Pharma News: A ground-breaking new report is launched today to call for a suite of recommendations to the nation’s decision-makers to ensure that the 2 million Australians who may benefit are not left behind when it comes to accessing these new therapies.

Cell and gene therapies provide new hope for those whose diseases have not traditionally seen innovations and breakthroughs which could significantly change outcomes for patients and their families.

If Australia does not start the conversation on cell and gene therapies now and take the steps necessary to facilitate their approval, the country risks denying access to the treatment innovations, which have the potential to deliver real change.

Unlike the United States, United Kingdom, and other European countries which have taken proactive steps to expedite access to these novel, new therapies, Australia’s Health Technology Assessment (HTA) process is not set up to quickly and equitably fund cell and gene therapies.

Report author, Renae Beardmore says “Experts are anticipating a tsunami of cell and gene therapies will require assessment in the very near future, including some of the 2,000 cell and gene therapies currently in clinical trials. With this in mind, we must act now to ensure the system can best deliver cell and gene therapies to the many patients and disease states awaiting them without delay”.

According to independent advisory committee member, Professor Adam Jaffe, John Beveridge Professor of Paediatrics, Head of School of Women’s and Children’s Health at the University of New South Wales, there are a number of simple steps – as outlined in the report launched today – that Australia must take now to ensure a smooth passage of access is possible for cell and gene therapies, so that Australians who may benefit most from them, do not experience delayed or limited access.

“Cell and gene therapies are not specifically a product, device or service. They can be a combination thereof. As a result, their path through reimbursement does not fit our current approach to evaluating new therapies, given they are unlike the traditional medicines the reimbursement assessment process has been traditionally set-up to cater for. If the system is not challenged and changed, this will inevitably result in delayed access for patients. Cell and gene therapies typically target rarer diseases, with small patient populations, and are truly transformative in terms of altering the course of disease. As they are so new and innovative, the challenge lies in generating strength of data which the current regulatory bodies routinely demand, when assessing new treatments,” said Professor Jaffe.

“For many Australians living with genetic and rare diseases, cell and gene therapies are seen as a positive step towards a cure rather than treatment and for this reason provide much-needed hope. Those living with a rare disease often face lengthy delays in accessing new and innovative treatments. The National Strategic Action Plan for Rare Diseases calls for ‘all Australians to have equitable access to the best available health technology.’

“Rare Voices Australia encourages all governments to work together to ensure that Australians living with a rare disease can access cell and gene therapies as soon as they have been shown to be safe and effective,” said Louise Healy, patient advocate, independent Advisory Committee member and Education and Advocacy Manager for Rare Voices Australia.

According to Richard Tew, Country President of Novartis Australia and New Zealand “Cell and gene therapies can become the cornerstone of care for many Australians with rare conditions, but in doing so we must acknowledge that our system must evolve. We have worked with the government to deliver the first access to cell and gene therapies for Australians. We want to work with them to deliver long term reform that will deliver hope for many Australians. We congratulate the work of Evohealth and the independent Advisory Committee in the development of this important, independent report, which we are proud to have the opportunity to support.”

The Cell and Gene Therapies: Rising to the Challenge report was authored by Evohealth, in collaboration with an independent advisory committee comprised of some of Australia’s most respected medical and patient voices, and supported by Novartis Australia.

A summary of the seven recommendations:

  1. Leverage recommendations from the National Strategic Action Plan for Rare Diseases (which have been accepted, but not yet actioned, by the Minister for Health in 2020)
  2. Establish an Office for Rare Diseases as a Portfolio Agency of the Department of Health
  3. Establish a cell and gene therapies expert advisory group to provide input and advice to the TGA, PBAC and MSAC
  4. Enhance the role of horizon scanning via the Health Technology Reference Group, or equivalent.
  5. The Minister for Health to establish a cross-functional working group including Departments of Health (both Federal and State/ Territory), industry, patients and academics to consider current Health Technology Assessment (HTA) processes for cell and gene therapies
  6. Develop a national strategic approach to equitable and timely clinical care for cell and gene therapies via the NHRA framework.
  7. Develop incentives for cell and gene therapies to create opportunities for trials, manufacturing and commercial success in Australia.

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