Subject: Enspryng 4100-A SGM P2023

Drug

ENSPRYNG  (satralizumab-mwge)

Policy:

      I.  INDICATIONS

          The indications below including FDA-approved indications and
          compendial uses are considered a covered benefit provided that
          all the approval criteria are met and the member has no
          exclusions to the prescribed therapy.

          FDA-Approved Indication
          Enspryng is an interleukin-6 (IL-6) receptor antagonist indicated
          for the treatment of neuromyelitis optica spectrum disorder
          (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4)
          antibody positive.

          All other indications are considered experimental/investigational
          and not medically necessary.


    II.  DOCUMENTATION

          Submission of the following information is necessary to initiate
          the prior authorization review:
          A.  For initial requests: Immunoassay used to confirm anti-
               aquaporin-4 (AQP4) antibody is present.
          B.  For continuation requests: Chart notes or medical record
               documentation supporting positive clinical response.


  III.  CRITERIA FOR INITIAL APPROVAL

          Neuromyelitis optica spectrum disorder (NMOSD)
          Authorization of 12 months may be granted for treatment of
          neuromyelitis optica spectrum disorder (NMOSD) when all of the
          following criteria are met:
          A.  Anti-aquaporin-4 (AQPR) antibody positive
          B.  Member exhibits one of the following core clinical
               characteristics of NMOSD:
               1.  Optic neuritis
               2.  Acute myelitis
               3.  Area postrema syndrome (episode of otherwise
                    unexplained hiccups or nausea and vomiting)
               4.  Acute brainstem syndrome
               5.  Symptomatic narcolepsy or acute diencephalic clinical
                    syndrome with NMOSD-typical diencephalic magnetic
                    resonance imaging (MRI) lesions
               6.  Symptomatic cerebral syndrome with NMOSD-typical
                    brain lesions
          C.  The member will not receive the requested drug
               concomitantly with other biologics for the treatment of
               NMOSD.


   IV.  CONTINUATION OF THERAPY

          Authorization of 12 months for continuation of therapy may be
          granted when both of the following criteria are met:
          A.  The member demonstrates a positive response to therapy
               (e.g., reduction in number of relapses).
          B.  The member will not receive the requested drug
               concomitantly with other biologics for the treatment of
               NMOSD.

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Enspryng [package insert]. South San Francisco, CA: Genentech, Inc.; March 2022.
2. Wingerchuk DM, Banwell B, Bennett JL, et al. International consensus diagnostic criteria for neuromyelitis optica spectrum disorders. Neurology. 2015; 85:177-189.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

October 22, 2023