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As drug costs mount, approvals process comes under scrutiny

The way drug companies argue the case for subsidised access to their medicines could change after the Federal Government announced a review of submission guidelines.

As the Commonwealth comes under increasing pressure to give patients subsidised access to innovative but hugely expensive treatments for cancer, hepatitis, diabetes and other chronic or potentially deadly ailments, Health Minister Sussan Ley has launched a review of the Pharmaceutical Benefits Advisory Committee’s submission guidelines.

It has already been proposed that medicines approved by regulators in the United States and Europe be automatically cleared for use by the Therapeutic Goods Administration, and there have been noisy complaints about the length of time taken for drugs used elsewhere to become available through the publicly-subsidised medicine system.

In order to be listed on the Pharmaceutical Benefits Scheme, drugs first have to be assessed for their efficacy and cost effectiveness by the PBAC, and Ms Ley said it was appropriate to examine the sort of evidence and other information the Committee was demanding from manufacturers.

“The PBAC Guidelines help ensure Australians have access to safe, clinically proven and cost-effective medicines as soon as possible,” the Minister said. “It [the review] is particularly timely given emerging technologies and international calls for governments to subsidise drugs based on clinical evidence, as is the case with cancer drugs.”

Early last month, Ms Ley announced $75 million had been provided to list three pharmaceuticals on the PBS – the multiple sclerosis treatment Lemtrada, pancreatic cancer medicine Afinitor, and central precocious puberty drug Lucrin.

The Government is also facing a huge $3 billion bill if it accepts a PBAC recommendation to subsidise the very expensive hepatitis C drug Sovaldi, and last month approved PBS listing of the melanoma drug Yervoy, which costs more than $120,000 for a course of treatment.

Ms Ley said the PBAC’s Guidelines were used by pharmaceutical companies in preparing their submissions, and it was important to ensure they reflected international best practise, did not impose any unnecessary regulatory burden on the industry and yet safeguarded the sustainability of the PBS.

The Health Department is calling for tenders for the review.

Adrian Rollins