Subject: Firdapse 2803-A SGM P2023
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 Indications
Firdapse is indicated for the treatment of Lambert-Eaton
myasthenic syndrome (LEMS) in adults and pediatric patients 6
years of age and older.
All other indications are considered experimental/investigational
and not medically necessary.
II. DOCUMENTATION
Submission of either of the following diagnostic tests is
necessary to initiate the 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:
- Firdapse [package insert]. Coral Gables, FL: Catalyst Pharmaceuticals, Inc.; May 2023.
- 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 09, 2023
