CMS TransmittalNeurology

FDA Approval: ENSPRYNG (SATRALIZUMAB) — Type 1 - New Molecular Entity

FDA-BLA761149

Document details

Document type
CMS Transmittal
Issuing body
Centers for Medicare & Medicaid Services
Document ID
FDA-BLA761149
Published
June 18, 2026
Effective date
August 14, 2020
MAC region
National

Summary

Enspryng (Satralizumab) is an injectable drug approved for Part B billing, likely leading to a new J-code assignment. With its status as an orphan drug, it may qualify for pass-through payment under M

New injectable drug Enspryng approved; billing updates expected.

Affected specialty

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Source document

http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761149s000lbl.pdf

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