Jefferies not seeing significant impact to Merck, Bristol from draft guidance

Jefferies analyst Akash Tewari notes that new Medicare Part B & D draft guidance has been released and that Merck (MRK) and Bristol Myers (BMY) are trading down due to updated language on single source qualifying drugs. The updated language on single source qualifying fixed dose combo products in the draft makes it seem as if subcutaneous Keytruda/Opdivo will be eligible for negotiation in 2028, but “We’re not sure this is true,” says the analyst, who is not seeing a significant impact to Merck and Bristol. The firm thinks subQ Keytruda/Opdivo may be exempt from IRA negotiation on biosimilar entry, similar to HD Eylea, and believes changes may create an opening for Merck to settle with some biosimilars before Keytruda’s ’28 loss of exclusivity and “therefore be EXCLUDED from IRA negotiation.” Since subQ and IV Keytruda are now both “considered the same drug,” theoretically subQ Keytruda “may never get IRA negotiated,” the analyst added.