Drug Therapy Guidelines Enspryng™ (satralizumab-mwge) Applicable Medical Benefit Effective: 12/15/20 Pharmacy- Formulary 1 x Next Review: 9/21 Pharmacy- Formulary 2 x Date of Origin: 12/20 Pharmacy- Formulary 3/Exclusive x Review Dates: 9/20 Pharmacy- Formulary 4/AON x I. Medication Description Satralizumab is an interleukin 6 (IL-6) receptor antagonist humanized monoclonal antibody, based on a human IgG2 framework. The exact mechanism of action by which satralizumab exerts its therapeutic effects in neuromyelitis optica spectrum disorder (NMOSD) is not known but is presumed to involve inhibition of IL-6 mediated signaling through binding to soluble and membrane-bound IL-6 receptors. II. Position Statement Coverage is determined through a prior authorization process with supporting clinical documentation for every request. III. Policy Coverage of Enspryng is available when the following criteria have been met: • Member is 18 years of age or older AND • Medication is prescribed by (or in consultation with) a neurologist or other pertinent specialist AND • Member has a documented diagnosis of Neuromyelitis optica spectrum disorder (NMOSD) AND • Documentation is provided showing the member is seropositive for anti-aquaporin-4 (AQP4) antibodies AND • Baseline Expanded Disability Status Scale score (EDSS) is reported AND • Member has a history of at least 1 attack in the last 12 months or 2 attacks in the last 24 months AND • Member will not receive concomitant treatment with mitoxantrone, tocilizumab (Actemra), alemtuzumab (Lemtrada), rituximab, eculizumab (Soliris), or therapies for prevention of multiple sclerosis relapse (e.g. interferon, natalizumab (Tysabri), glatiramer acetate, fingolimod, teriflunomide, dimethyl fumarate) IV. Quantity Limitations • Induction dosing: two prefilled syringes per initial 28 days • Maintenance dosing: one prefilled syringe per every 28 days Page 1 of 2 Drug Therapy Guidelines Enspryng™ (satralizumab-mwge) Last Review Date: 9/2020 V. Coverage Duration Initial coverage is available for 6 months and may be renewed. VI. Coverage Renewal Criteria Coverage can be renewed in 12 month intervals based upon the following criteria: • Absence of unacceptable toxicity from the drug AND • Demonstrated positive clinical response or maintenance of response from baseline (relapse rate, EDSS score, etc.) VII. Billing/Coding Information Available as 120mg/ml single-dose prefilled syringes VIII. Summary of Policy Changes • 12/15/20: new policy IX. References 1. Enspryng™ [package insert]. San Francisco, CA: Genentech, Inc.; Revised: 08/2020. 2. Traboulsee A, Greenberg BM, Bennett JL, et al. Safety and efficacy of satralizumab monotherapy in neuromyelitis optica spectrum disorder: a randomized, double-blind, multicenter, placebo-controlled phase 3 trial. Lancet Neurol. 2020;19(5):402−412. 3. Yamamura T, Kleiter I, Fujihara K, et al. Trial of satralizumab in neuromyelitis optica spectrum disorder. N Engl J Med. 2019;381(22):2114−2124. 4. Enspryng. Clinical Pharmacology powered by ClinicalKey. Tampa (FL): Elsevier. c2020- [2020 November 2]. Available from: http://www.clinicalkey.com. The Plan fully expects that only appropriate and medically necessary services will be rendered. The Plan reserves the right to conduct pre-payment and post-payment reviews to assess the medical appropriateness of the above-referenced therapies. The preceding policy applies only to members for whom the above named pharmacy benefit medications are included on their covered formulary. Members with closed formulary benefits are subject to trying all appropriate formulary alternatives before a coverage exception for a non-formulary medication will be considered. The preceding policy is a guideline to allow for coverage of the pertinent medication/product, and is not meant to serve as a clinical practice guideline. Page 2 of 2 .