NorthWest Biotherapeutics Inc (NWBO)

[Lykiri]

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.”

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