Subject: Ruzurgi 3073-A SGM P2021

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
Ruzurgi is indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 to less than 17 years of age.

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

II.  DOCUMENTATION 

Submission of either of the following diagnostic tests is necessary to initiate prior authorization review:
A.   Electromyography (EMG)
B.   Anti-P/Q type voltage-gated calcium channel antibody test

III. EXCLUSIONS 

Coverage will not be provided for members with a history of seizures.

IV.  CRITERIA FOR INITIAL APPROVAL 

Lambert-Eaton Myasthenic Syndrome (LEMS)
Authorization of 6 months may be granted for treatment of Lambert-Eaton myasthenic syndrome (LEMS) when all of the following criteria are met:
A.   Diagnosis is confirmed by either of the following:
      1.   EMG showing compound muscle action potential (CMAP) that increased at least 2-fold after maximum
            voluntary contraction of the tested muscle
      2.   A positive anti- P/Q type voltage-gated calcium channel antibody test
B.   Member has proximal muscle weakness
C.   For treatment-naïve members, the Quantitative Myasthenia Gravis (QMG) score is at least 5

V.   CONTINUATION OF THERAPY

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for LEMS who are responding to therapy (i.e., there is stability or improvement in symptoms relative to the natural course of LEMS).

Place of Service:

Outpatient

The above policy is based on the following references:

1. Ruzurgi [package insert]. Princeton, NJ: Jacobus Pharmaceutical Co, Inc.; April 2020.
2. A Phase 3 Study of Amifampridine Phosphate in Patients with Lambert Eaton Myasthenic Syndrome (LEMS). (2018). Retrieved from https://clinicaltrials.gov/ct2 (Identification No. NCT01377922)

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.

December 27, 2021