No association between price and efficacy of cancer drugs — four-nation study

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In general, for Switzerland, Germany, Britain and the US, there is no association between clinical benefit of a cancer drugs and their prices, found a study by the universities of Zurich and Harvard.

A growing number of new cancer drugs have come on the market in recent years, yet the cost of therapies in Europe and the US have risen. This is driving up healthcare costs, which poses a challenge not only for the Swiss social insurance system, but for patients all over the world. But are the high prices of cancer drugs justified? Does the cost correspond to the particular drug's effectiveness in combating the disease? An international research team from the University of Zurich and Harvard Medical School carried out a study to examine these questions.

The scientists – led by Kerstin Noëlle Vokinger, professor at UZH – analysed the costs of cancer drugs in Switzerland, Germany, England, France and the US. The prices of 65 new oncology drugs to treat solid tumours and various types of blood cancer were adjusted to calculate the monthly treatment costs for a standard patient.

In a second stage, the researchers investigated whether there is a link between monthly treatment costs and the clinical benefit of cancer drugs for solid tumours. The effectiveness of the drugs, which had been approved by the US and European licensing authorities (the US Food and Drug Administration and European Medicines Agency, respectively), was calculated using two well-established systems for evaluating the clinical benefit of cancer therapies: the American Society of Clinical Oncology Value Framework, and the European Society of Medical Oncology Magnitude of Clinical Benefit Scale.

"Our study clearly shows that, in general, for Switzerland, Germany, England and the US, there is no association between clinical benefit of a cancer drugs and their prices," explains lead author, Kerstin Vokinger. Only for France a correlation could be found based on one of the clinical benefit assessment systems. "It's also clear that the prices of cancer drugs in the US are significantly higher than in the four European countries, with Americans paying on average approximately twice as much for the same drug."

This is because drug pricing in the US is dictated by the free, unregulated market. In Europe, on the other hand, national authorities negotiate prices with manufacturers. From the European countries analysed in the study, Switzerland has the second-highest prices after England, while the same drugs are cheaper in Germany and France. It must be kept in mind, however, that NHS England benefits from non-public discounts on certain drugs, so the actual prices may be lower than the official list prices.

"The pricing of cancer drugs is only partially justified. Drugs that are less effective should be cheaper than those with high efficacy," the UZH professor says. "National authorities should take greater account of the clinical benefits of drugs when negotiating prices, and therapies that provide high clinical benefit should be prioritized in price negotiations." Vokinger firmly believes that this is crucial in order to guarantee patients access to key cancer drugs since countries have only limited financial resources.

Background: Increasing cancer drug prices are a challenge for patients and health systems in the USA and Europe. By contrast with the USA, national authorities in European countries often directly negotiate drug prices with manufacturers. The American Society of Clinical Oncology (ASCO) and the European Society for Medical Oncology (ESMO) developed frameworks to evaluate the clinical value of cancer therapies: the ASCO-Value Framework (ASCO-VF) and the ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS). We aimed to assess the association between the clinical benefit of approved cancer drugs based on these frameworks and their drug prices in the USA and four European countries (England, Switzerland, Germany, and France).

Methods: For this cost–benefit analysis, we identified all new drugs with initial indications for adult cancers that were approved by the US Food and Drug Administration between Jan 1, 2009, and Dec 31, 2017, and by the European Medicines Agency up until Sept 1, 2019. For drugs indicated for solid tumours, we assessed clinical benefit using ASCO-VF and ESMO-MCBS. We compared monthly drug treatment costs between benefit levels using hierarchical linear regression models, and calculated Spearman's correlation coefficients between costs and benefit levels for individual countries.
Findings: Our cohort included 65 drugs: 47 (72%) drugs were approved for solid tumours and 18 (28%) were approved for haematological malignancies. The monthly drug treatment costs in the USA were a median of 2·31 times (IQR 1·79–3·17) as high as in the assessed European countries. There were no significant associations between monthly treatment costs for solid tumours and clinical benefit in all assessed countries, using the ESMO-MCBS (p=0·16 for the USA, p=0·98 for England, p=0·54 for Switzerland, p=0·52 for Germany, and p=0·40 for France), and for all assessed countries except France using ASCO-VF (p=0·56 for the USA, p=0·47 for England, p=0·26 for Switzerland, p=0·23 for Germany, and p=0·037 for France).
Interpretation: Cancer drugs with low or uncertain clinical benefit might be prioritised for price negotiations. Value frameworks could help identify therapies providing high clinical benefit that should be made rapidly available across countries.
Funding: Swiss Cancer Research Foundation (Krebsforschung Schweiz).

Kerstin N Vokinger, Thomas J Hwang, Thomas Grischott, Sophie Reichert, Ariadna Tibau, Thomas Rosemann, Aaron S Kesselheim

University of Zurich material

The Lancet Oncology abstract

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