Patient groups are calling for changes to fast track the approval and subsidy of cancer medicines, saying cancer sufferers haven't got time to wait for duplicate testing.
Consumer group Cancer Voices Australia has told a Senate inquiry that changes were needed to ensure Australians with cancer got the drugs they needed in a timely manner.
"Many of us can't wait for the years that our present approval process takes, nor can we afford to pay the full unsubsidised costs," the organisation's convenor, Sally Crossing, writes in its submission.
The group suggests Australia make greater use of approvals by trusted foreign regulators to speed up access to medicines, and also improve surveillance of drugs once after they have reached the market, to enable assessment of the effectiveness of drugs in real life use, as opposed to clinical trials.
In their submission, Cancer Council Australia and the Clinical Oncology Society of Australia argued evaluations between the three bodies that consider new drugs and medical services be better co-ordinated to reduce delays.
It argued the Pharmaceutical Benefits Advisory Committee, which recommends which drugs should be subsidised, needs to adopt a more flexible approach to evidence, and consider measures other than survival data, such as the response of a tumour to treatment and the duration of time before the disease progresses.
"Patients die while waiting for longitudinal survival data to show a drug is effective, even though other important evidence of efficacy has been published," the two organisations said in a joint submission.
The submission cited an analysis commissioned by the Cancer Drugs Alliance, which showed the average time between a cancer medicine being approved by the Therapeutic Goods Administration and it being listed on the Pharmaceutical Benefits Scheme has increased from 15 months to 31 months over the past decade.
In its submission, the Cancer Drugs Alliance argued the "cost-effectiveness criteria" used to decide which medicines were subsidised was out-dated and a new model should be adopted based on "an assessment of value and quality".
Rare Cancers Australia questioned the relevance of the current cost-effectiveness approach for new medicines, which were increasingly focused on small populations of patients.
"The PBS has served Australia well with its principle of 'the greatest good for the greatest number' but we need flexibility and change if we are to expand its reach to include the 'greatest number of diseases' be they rare or common," its submission says.
It said large clinical trials were considered necessary to produce quality evidence, but with rare cancers it was often difficult to mount trials on this scale.
The outgoing chair of the Pharmaceutical Benefits Advisory Committee, Suzanne Hill, told Monday's hearing the committee was concerned that consumer perceptions about the effectiveness of many of the new drugs was not supported by the evidence presented to the committee.
In its submission, the committee argued that bypassing its processes would greatly increase the cost of the PBS without any commensurate gain in health outcomes, and that a factor in new drugs becoming available in other countries before Australia was that drug companies often applied to foreign regulators many months before applying to Australian authorities.
