The outdated PBS: Future life expectancy hinges on wallet size

Pharma News: Australians with life-threatening illnesses are being made to wait more than 18 months for access to new medicines, with new research revealing an average ‘patient access gap’ of 591 days, and up to three years for the listing of some life-saving drugs.

Prostate Cancer Foundation of Australia (PCFA) has called for reform, with thousands of men impacted by the delays.

The Australian Patient Access Gap Report analysed the time to listing of every TGA approved medicine between January 2021 and April 2024, finding patients waited on average 591 days to access novel medicines proven to be superior to existing medicines.

For applications made on a basis of cost-effectiveness, more than 80 per cent required multiple attempts to secure a listing, whereas applications made on a basis of cost-minimisation were more likely to secure listing on the first attempt, and within a shorter timeframe (488 days v 638 days).

Alarmingly, more than 40 new medicines recommended to the government for listing by Australia’s Pharmaceutical Benefits Advisory Committee were still waiting to be funded more than 1,000 days after being recommended for subsidisation.

Prostate Cancer Foundation of Australia CEO, Anne Savage, called for action ahead of the Federal Election.

“In almost every instance, Australians are being denied access to new medicines that can extend and save their lives, simply because our approval systems have not kept up with the pace of change.

“In relation to prostate cancer, applications typically undergo two or three rounds of review before achieving a positive recommendation, while 10 men die a day from the disease.

“It’s simply not good enough,” Savage emphasised.

PCFA’s Chief of Mission and Head of Research, Professor Jeff Dunn, said that while a number of new drugs have been listed for men with prostate cancer over recent years, more needs to be done.

“Australia is falling behind the rest of the world, demanding high discount rates without considering international harmonisation. As a result, we’re often the last jurisdiction in the world to approve new medicines and therapies, including life-saving nuclear medicines for men with prostate cancer, such as Lutetium PSMA.

“We have made it hard for pharmaceutical companies to do business in Australia, despite the significant funding they dedicate to clinical trials and patient access schemes.

“The same is true when it comes to manufacturing – we should be leading the world, but continue to fall behind while other jurisdictions move ahead with more progressive regulatory and pricing regimes.”

Examples include Bayer’s Nubeqa (darolutamide) which was listed in 2020 after a seven year gap in listings of new medicines for prostate cancer.

“Without government support, Australians will continue to die before their time while they await new medicines,” Savage said. “Many of these drugs cost upwards of $35,000 per year without PBS listing, placing them completely out of reach for Australian men and families.

She added, “Without rapid reform to modernise Australia’s pharmaceutical benefits scheme, we’re looking at a future where the life expectancy of men and women will be limited by what they can afford to buy.”

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