Title: Access to Prostate Cancer Treatment Limited for Patients

Paul and Hillary Singleton were enjoying their retirement when Paul, now 77, received a life-altering diagnosis. Five years ago, he was told he had metastatic prostate cancer and might only have three years to live. An aggressive form of the disease led him to a groundbreaking treatment called Lutetium PSMA, which significantly extended his life. However, he now faces a new challenge: the treatment is no longer available at public hospitals.

"I just want to live with Hilary and enjoy my life, visit my family," Paul said, expressing his frustration over the situation. Lutetium PSMA is a radioligand therapy that targets prostate cancer cells with a radioactive compound, delivering a focused dose of radiation. Anne Savage, CEO of the Prostate Cancer Foundation of Australia, emphasized the importance of this treatment, stating, "We know that it can extend and save men's lives."

Paul first received Lutetium PSMA at St Vincent's Hospital in Sydney in late 2022. The treatment successfully slowed the progression of his cancer for two years. However, after needing additional rounds earlier this year, he learned that St Vincent's would no longer provide the therapy. The hospital's decision stems from legal issues surrounding the local compounding of the drug, which has ceased due to a patent dispute with a pharmaceutical company.

Professor Lee Sze-Ting, a former president of the Australasian Association of Nuclear Medicine Specialists, explained that public hospitals are avoiding the therapy due to potential legal risks. "Public and private institutions do not dare provide the locally compounded, funded version," she said. The Swiss pharmaceutical company Novartis holds key patents for Lutetium-based therapies, which it markets as Pluvicto. Legal proceedings initiated by Novartis have further complicated access to the treatment.

For the first three cycles of Lutetium PSMA, Paul faced bills of about $6,000 each, a significant burden for someone on a pension. His family helped cover the costs. To improve access to the therapy, a group of specialists applied for public funding through the Medical Services Advisory Committee (MSAC). In April 2024, MSAC approved the application, allowing patients to receive reimbursement for Lutetium PSMA therapy starting in July 2025. The government set the schedule fee at $8,000, with a potential Medicare rebate of up to $7,897.60.

Despite this progress, the cost of Novartis's version of the drug remains high, with initial expenses ranging from $20,000 to $50,000. "I don't think I'd be able to finance it," Paul said, noting that many men would struggle to pay such amounts upfront, even with the promise of reimbursement.

Novartis acknowledged the financial burden on patients, stating that the requirement to pay upfront is a significant barrier to treatment access. Medicines Australia, which represents pharmaceutical companies, advocates for a more equitable funding process that would alleviate these costs for patients.

A spokesperson for the Department of Health, Disability and Ageing explained that the current funding pathway through the MBS is appropriate for radioligand therapy, as it supports both diagnostic and therapeutic components. However, many experts, including Professor Lee, argue that the existing approval systems are inadequate for radionuclide therapies.

Savage described the situation as a "stand-off" and called for the government to establish a new approval mechanism specifically for radiopharmaceuticals. She warned that without access to treatments like Lutetium PSMA, men with aggressive prostate cancer face dire consequences. "If they cannot access this treatment, they will die," she said.