CMS Takes Aim at Hyaluronidase Formulations; JNJ, BMY, MRK Face Negotiation Risk Under New Rule

Research evidence excerpt

CMS Takes Aim at Hyaluronidase Formulations; JNJ, BMY, MRK Face Negotiation Risk Under New Rule

CMS Takes Aim at Hyaluronidase Formulations; JNJ, BMY, MRK Face

Negotiation Risk Under New Rule

• REGN (Sector Perform) Eylea HD (higher-dose formulation): Unlike the hyaluronidase cases

above, Eylea HD was already aggregated with Eylea 2mg under existing rules, they share the

same active ingredient, route of administration, and BLA holder. The new formulation policy

does not change this aggregation. More importantly, the key protection for Eylea HD remains

fully intact: bona fide marketed biosimilars exist for Eylea 2mg (Amgen's Pavblu and others),

which excludes the entire aggregated bundle, including Eylea HD, from negotiation under

the biosimilar exclusion, now codified as binding regulation. The proposed rule's deselection

symmetry provisions explicitly confirm that biosimilar exclusion flows through to all dosage

forms and strengths in the same bundle. While it remains to be determined whether the final

rule or future guidance attempts to broaden the "new formulation" definition to encompass

higher-dose variants, the proposed regulatory text as written provides no indication of that

direction. In our view, the key threat to REGN's Eylea franchise remains market competition

from Vabysmo and biosimilars, not IRA risk.

Why We Expect Limited Impact

Despite the headline risk, we believe the practical impact will be minimal for several reasons:

1. Legal Challenge Risk: Classifying BLA products with their own payment codes and distinct

clinical value as "new formulations" appears vulnerable to legal challenge, in our view. We

think these products deliver differentiated value, convenience, reduced infusion time, and

improved tolerability.