CMS TransmittalOncology

FDA Approval: YERVOY (IPILIMUMAB) — Type 1 - New Molecular Entity

FDA-BLA125377

Document details

Document type
CMS Transmittal
Issuing body
Centers for Medicare & Medicaid Services
Document ID
FDA-BLA125377
Published
June 17, 2026
Effective date
March 25, 2011
MAC region
National

Summary

Yervoy (ipilimumab) is an injectable drug that may be assigned a J-code for Medicare billing, as it qualifies for Part B coverage due to its injectable nature. It is an orphan drug, which could indica

New injectable drug Yervoy impacts Medicare billing.

Affected specialty

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Source document

http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125377s0000lbl.pdf

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