A new report by Telix says the tens of thousands of Australians could miss out on a new era of cancer treatment without action from the government to secure the viability of the nuclear medicine sector, including enforcing regulatory standards.
The report, Radiopharmaceuticals Empowering Australia’s Future, found regulatory issues are impeding the promise and broader adoption of theranostics. The report follows the Albanese Government's recent decision to fund an unapproved copy of Novartis' radioligand therapy, PLUVICTO.
Theranostics – ‘therapy’ and ‘diagnostics’ - are targeted treatments that use radioactive isotopes attached to a targeting agent to both ‘see’ and ‘treat’ cancer. Often described as the sixth pillar of cancer treatment - alongside surgery, radiation, chemotherapy, targeted therapies and immunotherapy - theranostics can be more accurate, less invasive, faster and safer than other standards of care.
The report says the problem is that multiple issues are barriers to adopting these treatments, including delayed and fragmented funding, with no clear pathway in Australia for radiopharmaceuticals. Radiopharmaceutical diagnostics are evaluated for funding through the Medical Services Advisory Committee (MSAC). The pathway for radiopharmaceuticals is less clear. The report recommends that they be evaluated through the Pharmaceutical Benefits Advisory Committee, linked to TGA approval.
It says unregulated generic products produced by hospitals compounding their own ‘home-brew’ radiopharmaceuticals without oversight from the TGA could have implications for patient safety, patient access and treatment consistency. Copyright infringement and failure to enforce intellectual property rights also creates a disincentive for industry to invest in developing new treatments or bring them to Australia.
The report includes results from a new survey of 2000 people, which reveals that 81 per cent of respondents support expanding Australia’s nuclear medicines manufacturing industry, 91 per cent believe the government should fund the most cutting-edge cancer treatments like theranostics, and 84 per cent agree that nuclear medicine therapies should only be made available in Australia if the TGA has approved them.
Due to their nature, radiopharmaceuticals begin to decay the minute they are made and must be administered to patients within hours or days of manufacture, meaning Australia must build its capability. Currently, Australia has a single nuclear medical manufacturing plant for therapeutics – ANSTO at Lucas Heights in Sydney - but based on current projections, additional manufacturing capacity is needed to meet future demand.
The report recommends five strategies to expand access and boost nuclear medicine research and manufacturing. They are enforcing regulatory oversight and approvals, streamlining funding processes, supporting the expansion of sovereign manufacturing, developing a national workforce strategy, and creating a $500 million Nuclear Medicines Fund to develop and deliver a national strategy.
Telix managing director and group CEO Dr Christian Behrenbruch said Australia is a world leader in theranostics research, but that needs to translate into improved outcomes for Australian patients.
“Every year, more than 160,000 Australians are diagnosed with cancer, and 50,000 die from their disease. However, potentially life-prolonging theranostics are not being widely adopted in Australia due to policy failures and a lack of planning. Nuclear medicine in Australia is now at an inflection point where we need to move away from 'how it was always done', and towards a system that guarantees access to as many Australians as possible. We need a nationally coordinated effort between Federal and State Governments, scientists, clinicians and pharmaceutical companies, in order to meet demand.”