New studies question whether novel anti-cancer drugs are worth their extra cost .

Many new anti-cancer medicines add little value for patients compared to standard treatment and are rarely worth the extra cost, according to results of two studies investigating links between clinical benefit and pricing in Europe and the USA, reported at the ESMO Congress 2019

The studies looked to see if monthly treatment costs of medicines introduced in the last 10-15 years for solid tumors were associated with clinical benefit scores showing improved outcomes such as survival, quality of life and/or treatment complications versus standard treatment.

In one study, almost half of new drugs approved in Europe between 2004 and 2017 for treatment of solid tumours had low added value scores on the ESMO Magnitude of Clinical Benefit Scale (ESMO-MCBS), and over two thirds had low added value on the Added Therapeutic Benefit Ranking (ASMR) scale used by French drug regulators. Forty-eight percent and 70% of drugs had low added value according to ESMO-MCBS and ASMR, respectively. The mean monthly price for new drugs and comparators were 4,616 and 2,314 euros, respectively and increased during the observation period. 

Prices were obtained from the French Official Journal. Rating for added therapeutic value were obtained from the HAS Added Therapeutic Benefit ranking (ASMR 1 being the highest benefit, and 5 the lowest) and the v1.1 ESMO-Magnitude of Clinical Benefit Scale (MCBS, 5 being the highest and 2 being the lowest). 

A second unrelated study examined drugs approved for adult solid tumors in four European countries and the United States between 2009-2017. There was no link between drug cost and clinical benefit measured by ESMO-MCBS and the American Society of Clinical Oncology Value Framework (ASCO-VF). Overall, median cancer drug prices in Europe were less than half US prices. The median monthly cost for drugs with low benefit scores on ESMO-MCBS ranged from USD 4,361 - 5,273 in the European countries compared to USD 12,436 in the USA.

Both studies concluded that drug prices had little correlation with added value or clinical benefit. 

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