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Cost of New Cancer Drugs ‘Inappropriate’ for Many
New chemotherapy medications approved in the past decade prolong life in adults with cancer by merely a few weeks or months, suggesting their 6-figure sums for many patients “may be inappropriate,” argues Peter Wise, a former consultant physician at London’s Charing Cross Hospital, in an analysis column in The BMJ.
“The approval of drugs with such small survival benefits raises ethical questions, including whether recipients are aware of the drugs’ limited benefits, whether the high cost:benefit ratios are justified, and whether trials are providing the right information,” Wise writes.
For reduced costs as well as truly ethical cancer treatment, stricter drug approval criteria and improved consent processes are necessary, according to the column. For example, surrogate endpoints in cancer drug trials — such as overall response rate, early tumor shrinkage, and progression-free survival (vs overall survival) — allow earlier approval of new drugs but are not necessarily accurate indicators of survival benefit.
“Many drugs approved on the basis of better progression-free survival have been subsequently found not to produce better overall survival than the comparator drug,” Wise writes. “Some of these drugs are logically withdrawn but others remain inexplicably on the market.”
Furthermore, marginal responses in carefully controlled clinical trials may not be applicable to the majority of patients in the community, he writes. The column also touches on the US Food and Drug Administration’s “breakthrough” category, introduced in 2012, which Wise says “compounds the risks of premature approval on limited evidence.”
Studies show that patients often overestimate the benefits of cancer chemotherapy drugs, he points out, highlighting the need for better informed consent for cancer treatment.
"Good cancer care demands empowerment of patients with accurate, impartial information followed by genuinely informed consent in both the clinical trial and therapeutic settings. Ethical impediments to sound practice need to be addressed and corrected,” he writes.
"Above all, the threshold for approval of new and existing cancer drugs needs to be raised — using more meaningful disease-specific criteria of risk-benefit and cost-benefit.”
—Jolynn Tumolo
References:
Wise PH. Cancer drugs, survival, and ethics. The BMJ. 2016;355:i5792.
