Darolutamide

Medicare

Part D (self-administered)

Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026).

Commercial insurance

covered with prior authorisation

Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy.

Assistance programmes

• Bayer US Patient Assistance Foundation
• PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
• HealthWell Foundation
• CancerCare Co-Payment Assistance Foundation
• Patient Advocate Foundation Co-Pay Relief

Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.

Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.

Appraised for

High-risk non-metastatic hormone-relapsed prostate cancer

Notes

With docetaxel and ADT for metastatic hormone-sensitive disease (ARASENS): TA903 (2023).

NHS England

Routinely funded for the appraised indication (or via managed access)

Sources: NICE TA660 · SMC advice: darolutamide. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.