Vital cancer drugs blocked

Posted: Published on March 5th, 2012

This post was added by Dr P. Richardson

Delays in regulator approval mean cancer patients may miss out on the best treatments. Photo: Louie Douvis

Australian cancer patients may be missing out on the best treatments due to delays in having them approved by regulators, according to new research.

Researchers from Melbourne's Peter MacCallum Cancer Institute have found that 43 per cent of treatment regimens used at the hospital were not included on the government's list of subsidised medicines, the Pharmaceutical Benefits Scheme.

The researchers found that 192 of the 448 regimens - a drug or combination of drugs used to treat a particular cancer - were not PBS-listed.

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The drugs' exclusion from the PBS list was due in most cases to them being used in a different way to that approved by Australia's national drug regulator, the Therapeutic Goods Administration.

This was despite the uses of the drugs being supported by established treatment guidelines and published research, according to the authors of the study published in the Internal Medicine Journal.

Study co-author Associate Professor Michael Michael said the Australian regulatory system was ''way behind the current clinical evidence for a variety of drugs'', potentially affecting treatment options for patients.

He said part of the problem was that drug companies had no obligation to go through the costly and time-consuming process of re-submitting an existing drug to the authority for approval for a different use, which might include its combination with other medicines or the way it is administered. Without going through this process, a drug cannot be listed on the PBS.

The authors wrote that the exclusions may include drugs - and applications for them - that were not TGA-approved, but had nevertheless been used over long periods and were ''generally accepted as part of standard care''.

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