Novartis challenges hospitals over copycat cancer treatment, fuelling debate on access

Pharma News: Novartis is urging Australian hospitals to halt the production of copycat alternatives to its radioligand therapy, Pluvicto.

The current intellectual property framework fails to acknowledge the substantial financial investments of billions of dollars made by pharmaceutical companies in developing innovative treatments. It acts as a disincentivise for ongoing research and investment in Australia.

Doctors at St Vincent’s Hospital in Sydney, including the Director of Nuclear Medicine, Louise Emmett, defend their compounded treatments, which cost $6,000 per dose compared to $80,000 for two doses of Pluvicto. They assert that their alternatives are both safe and effective. This disagreement has sparked a wider debate on the accessibility of life-extending cancer treatments, with Novartis allegedly threatening potential legal action.

The Australasian Association of Nuclear Medicine Specialists (AANMS) has applied to the Medical Services Advisory Committee (MSAC) for public funding of these treatments to ensure availability for all patients in need. In April, MSAC recommended that the treatment be covered by Medicare, but the final decision now lies with the federal government.

However, Novartis has cautioned MSAC that there is insufficient evidence to establish therapeutic equivalence between 177LuPSMA i&t and Pluvicto, stating that the existing data does not permit a reliable clinical comparison between these two structurally different products.

Novartis ANZ joined forces with Queensland Health and the University of Queensland to launch the “Bench to Bedside” report and host a roundtable discussion on the impact of these cutting-edge therapies on patients in Queensland and the wider radiopharmaceutical industry. Policymakers, industry leaders, academic experts, and patient advocates from the Prostate Cancer Foundation of Australia (PCFA) gathered to discuss the potential of radioligand therapies and strategies for improving cancer care.

A recently released discussion paper, developed by MTPConnect and supported by Novartis and other partners, also highlighted the nation’s readiness to lead the growing global radiopharmaceutical industry, with advanced therapies driving significant investment and expansion.

Novartis has made radiopharmaceuticals a key part of its oncology portfolio, marked by the recent Therapeutic Goods Administration (TGA) approval of Pluvicto. Despite this milestone, access remains a challenge due to the lack of government funding for wider and more equitable patient access.

Pluvicto has been hailed as a breakthrough for late-stage prostate cancer, and now shows potential for improving outcomes in earlier stages of the disease. A new study led by Peter MacCallum Cancer Centre, presented at the European Society for Medical Oncology (ESMO) Congress 2024, unveiled “remarkable” trial results, offering new hope for patients.

St Vincent’s Hospital clinicians are emphasising the urgent need for affordable treatment options, particularly for older patients with advanced prostate cancer, many of whom are already facing significant financial and health challenges.

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