Radiopharmaceuticals held back by funding failures and unregulated generics

Radiopharmaceuticals are the next breakthrough in the targeted treatment of cancer due to their high efficacy, good safety profile, and targeted mechanism of action. But in the global race to capitalise on a growing radiopharmaceutical market, is Australia keeping pace?

Unlike other drug categories, there is no clear public funding pathway for radiopharmaceuticals. While radiopharmaceutical diagnostics are funded through the Medical Services Advisory Committee (MSAC), radiopharmaceutical therapies fall through the gaps.

The Pharmaceutical Benefits Advisory Council (PBAC) should be responsible for reviewing radiopharmaceutical therapies, yet its repeated failure to recommend funding has made life-saving theranostics financially inaccessible for the majority of Australians. Linking reimbursements for radiopharmaceutical products to their approval status with the Australian Therapeutic Goods Administration (TGA) could address this gap.

Compounding the issue, some hospitals are permitted to create their own ‘home-brew’ radiopharmaceuticals without TGA oversight, raising concerns about patient safety, access, and treatment consistency.

Additionally, copyright infringement and failure to enforce intellectual property rights also creates a disincentive for industry to invest in developing new treatments. Novartis ANZ has urged Australian hospitals to halt the production of copycat alternatives to its innovative radioligand therapy, Pluvicto.

Telix Managing Director and Group Chief Executive Officer, 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.”

Given their nature, radiopharmaceuticals decay rapidly and must be administered within hours or days of manufacture. This highlights the need for Australia to strengthen its domestic capabilities. Currently, the country relies on a single nuclear medical manufacturing plant – ANSTO in Sydney’s Lucas Heights – but projections indicate that additional manufacturing capacity will be required to meet future demand.

Telix’s new report calls on regulators and governments to expand sovereign manufacturing, develop a national workforce strategy, and create a $500 million Nuclear Medicines Fund to develop and implement a national nuclear medicine strategy.

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