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Bristol Myers axes German launch of new cancer drug, citing pricing hurdles:

Following its European approval last September, Bristol Myers Squibb has decided not to launch Opdualag, an infusion of the pharma giant’s Opdivo and new antibody relatlimab, in Germany due to pricing pressures. The drug won approval to treat advanced melanoma in adults and adolescents aged 12 years and older.

Per a Bristol Myers spokesperson, Opdualag won’t be marketed in Germany “for the foreseeable future,” as the country’s drug pricing law from 2010 makes it so that the pharma giant “sees no possibility to achieve a benefit rating from the G-BA [Gemeinsamer Bundesausschuss] for Opdualag.”

Not including that benefit rating from the G-BA means the price regulator does not think Opdualag has any additional benefit over its appropriate comparator (“preferably a therapy for which endpoint studies are available and which has proved beneficial in practical use,” the German regulator’s English website says), so the drug’s yearly treatment costs cannot be higher than what it is being compared to.

Part of the reason is due to BMS’ use of progression-free survival (PFS) in measuring Opdualag’s efficacy. A BMS spokesperson said that while the combo drug demonstrated statistically-significant PFS over anti-PD-1 monotherapy in patients with advanced melanoma, the AMNOG law does not consider PFS a “patient-relevant endpoint.”

Bristol Myers added:

Our goal is to make Opdualag available to appropriate adult and adolescent advanced melanoma patients in countries around the world where it is approved for use. We are disappointed that this is not possible in Germany at this time due to the current benefit assessment system and recent GKV-FinStG reforms. We remain open to reconsidering should that change in the future.

According to the Munich-based lawyer Gabor Kiss, last November, the new GKV Financial Stabilization Act (GKV-FinStG) law came into effect, and one of its provisions also set an additional 20% rebate for drugs that are used as a combination regimen and that fulfill certain criteria. BMS’ Opdualag could have potentially fulfilled those criteria if the company had gone through the process.

BMS Germany’s general manager Neil Archer said in an email, “Pharmaceutical innovation needs long-term planning horizons. And long-term planning horizons need stable framework conditions.” Archer added that Germany is a location where “pharmaceutical innovation and investment is recognized has deteriorated significantly.”

https://endpts.com/bristol-myers-axes-german-launch-of-new-cancer-drug-citing-pricing-hurdles/