Bristol Myers Scraps Cancer Drug Launch in Germany Over Pricing

Bristol Myers Squibb’s (BMS) cancer drug Opdualag will not be launched in Germany for the foreseeable future, despite its EU approval last September. The decision was made due to pricing conflicts with a 2010 drug pricing law in the nation that requires evidence that a new drug has a benefit over current alternatives. While clinical trial data showed the drug to be more effective than the standard of care in treating advanced melanoma, the endpoints used are a sticking point for the Gemeinsamer Bundesausschuss (G-BA).

According to Emily Kimber, “This would partly be due to BMS measuring Opdualag’s efficacy with progression-free survival, which is not considered a ‘patient-relevant endpoint’ by the country’s AMNOG law.”

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(Source: PM Live, March 10^th, 2023)