Alert detail

FDA Approval: RHAPSIDO (REMIBRUTINIB) — Type 1 - New Molecular Entity

Policy ID: FDA-NDA218436Specialty: HematologyAdded: 10/10/2026Effective: September 30, 2025federal register
Routine

What changed

Oral BTK inhibitor remibrutinib routes through Part D specialty pharmacy.

Who’s affected: Hematology billing teams · Effective: September 30, 2025

Primary source: View the official CMS/MAC document ↗

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