Are expensive cancer drugs being approved without enough proof that they work?

Recent research indicates that only half of the cancer drugs approved by the European Medicines Agency (EMA) showed benefit in patients.

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Since most cancer drugs cost about $100,000 per patient per year, it is not surprising that cancer is one of the most costly diseases to treat. The global budget for cancer treatment is around $895 billion a year. With extensive research to beat cancer, new treatments with claims of extended survival are frequently being made available. Understandably, cancer patients all want access to them so they can enjoy life for longer, yet these news drugs typically carry the highest price tags. But exactly what benefits do they provide?

A research team from King's College London and the London School of Economics set out to determine the extent of the gains achieved with new cancer drugs. They analysed approvals of cancer treatments granted by the European Medicines Agency (EMA) between 2009 and 2013.

The researchers explained:

When expensive drugs that lack clinically meaningful benefits are approved and paid for within publicly funded healthcare systems, individual patients can be harmed, important societal resources wasted, and the delivery of equitable and affordable care undermined."

A total of 68 cancer indications were approved during the 4 years investigated. Worryingly, 57% of these reached the market based on indirect, or surrogate, measures that do not necessarily indicate that a patient will live longer or feel better. However, even in cases where drugs had been shown to improve survival, the increase was only slight compared with existing treatments. The study reported that, of the 23 drugs with data demonstrating improved survival, 11 did not provide clinically meaningful benefit accordingly to the definition set by the European Society of Medical Oncology.

After a median of 5 years on the market, a further eight drug indications had shown improvements in survival or quality of life. This leaves almost half of the treatments approved (49%) with no definitive evidence that they actually extend survival or improve quality of life.

Vinay Prasad, Assistant Professor at Oregon Health & Science University, highlighted the need for more rigorous testing of new cancer treatments against the best standard of care using appropriately designed and powered randomized clinical trials. He explains "The expense and toxicity of cancer drugs means we have an obligation to expose patients to treatment only when they can reasonably expect an improvement in survival or quality of life...we may be falling far short of this important benchmark."

Dr Deborah Cohen, Associate Editor at The BMJ, commented "The fact that so many of the new drugs on the market lack good evidence that they improve patient outcomes puts governments in a difficult position when it comes to deciding which treatments to fund...But regulatory sanctioning of a comparator that lacks robust evidence of efficacy, means the cycle of weak evidence and uncertainty continues."

A similar study, published in 2015, reported that most of the cancer drugs approved by the US Food and Drug Administration (FDA) between 2008 and 2012 did not show any evidence of improving a patient's life.

It thus appears that our current regulatory drugs approval process is failing patients. The approval of drugs  without evidence of their clinical benefit is undermining the need for drug companies to provide rigorous proof that their drugs work.

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