Background

Enspryng is a humanized monoclonal antibody targeting the interleukin‑6 (IL‑6) receptor, blocking IL‑6 signaling to reduce inflammation. It's approved for neuromyelitis optica spectrum disorder (NMOSD) in adults who are AQP4-IgG seropositive.

Policy (Criteria)

Coverage of these drugs is provided when the criteria below is met and for non-preferred products there has been a trial and failure of preferred therapy (if applicable).

Satralizumab-mwge may be considered MEDICALLY NECESSARY for the following condition(s):

Neuromyelitis Optica Spectrum Disorder (NMOSD)

1. Diagnosis of neuromyelitis optica spectrum disorder (NMOSD)
2. Member is anti-aquaporin-4 (AQP4) antibody positive
3. Prescribed by or in consultation with one of the following:

• Neurologist
• Ophthalmologist

Continuation therapy is considered MEDICALLY NECESSARY when the following criteria are met:

Documentation of positive clinical response to therapy

Authorization duration: 12 months

References

1. 1. U.S. Food and Drug Administration. (2022, March). Enspryng™ (satralizumab‑mwge) injection, for subcutaneous use: Highlights of prescribing information. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761149s005lbl.pdf
2. 2. Genentech. (2023). for Enspryng ®(satralizumab‑mwge. Retrieved from https://www.genentechaccess.com/content/dam/gene/accesssolutions/pdfs/coding/ENSPRYNG-Billing-Coding-for-NMOSD.pdf

Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each Policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

"Current Procedural Terminology © American Medical Association. All Rights Reserved" 

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