Clinical benefit of cancer drugs approved in Switzerland 2010–2019

Over time, the number of cancer drugs approved by the Food and Drug Administration (FDA) has increased. This has been attributed to advances in cancer drug research but also to faster approvals which are often based on preliminary data and intermediate primary endpoints instead of overall survival (OS). While it is desirable to make treatments available on the market in a shorter time, this should not happen at the expense of effectiveness or safety of the approved substances and must therefore be approached with caution. There are concerns that faster drug approval may be associated with lower drug efficacy and worse patient safety, possibly also partly due to the high amount of approvals based on intermediate endpoints whose correlation to long-term outcomes like OS and Health related quality of life (HRQoL) was low in studies.

Effective treatments should prolong survival time and/or improve HRQoL. Previous studies have argued that certain cancer drugs approved by the FDA and the European Medicines Agency (EMA) show questionable clinical benefit. In Switzerland, approval for new drugs is granted by the Swiss national authorisation and supervisory authority Swissmedic. In the authorisation process of medical products, Swissmedic takes into account pharmacological and clinical data on efficacy and safety as well as HRQoL. The price of a medicinal product is not assessed by Swissmedic and is determined after authorisation either by the authorisation holder or, in the case of an application for health insurance coverage, by the Swiss Federal Office of Public Health.