Subject: Enspryng 4100-A SGM P2022

Drug

ENSPRYING  (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 21, 2022