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ASCO’s bright line

Why patients, docs say ASCO’s approval standards would reduce treatment options

A policy recommendation by the American Society of Clinical Oncology to raise the bar on cancer drug approvals as a means to combat high drug prices ignores the historical fact that big survival gains have been knitted together from incremental gains, and could lead to fewer therapeutic options, according to patient and physician groups who spoke to BioCentury.

In a July 19 position statement on affordability in cancer care, ASCO recommended that FDA approve drugs only if they produce “clinically meaningful” benefits as defined by tumor experts, “rather than focusing on small benefits that achieve statistical significance in trials.”

A higher bar for approval would ensure the development of “high value drugs” that could be priced and/or reimbursed via value-based payment models, the group said.

Blase Polite, a medical oncologist at The University of Chicago Medical Center who spoke to BioCentury on behalf of ASCO, said too many drugs that provide marginal benefits are approved, only to be launched at high list prices.

“We understand that FDA can’t consider costs and any likelihood that this would change in the future is low. But one way to get at this is for the agency to stop approving things that are small tweaks in standard of care,” Polite told BioCentury.

“We can’t be producing drugs with small improvements, approving them and then having them come to market at $10,000 per month,” he said.

“When you look at the value equation, which this entire thing is centered around, a key element is outcomes and a meaningful hazard ratio. If you can’t achieve that,

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