Subject: Radicava-Radicava ORS 1961-A SGM P2024

Drug

RADICAVA  (edaravone)

RADICAVA ORS  (edaravone)

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
          Radicava and Radicava ORS are indicated for the treatment of amyotrophic lateral sclerosis
          (ALS).

          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:
          Chart notes or medical record documentation supporting use as applicable in section IV and V.
          A.  Initial Requests:
               1.  Diagnosis of definite or probable ALS.
               2.  ALS Functional Rating Scale (ALSFRS-R) results.
          B.  Continuation Requests:
               1.  Documentation of clinical benefit from therapy with the requested medication.


   III.  PRESCRIBER SPECIALTIES

          This medication must be prescribed by or in consultation with a neurologist, neuromuscular
          specialist, or physician specializing in the treatment of amyotrophic lateral sclerosis (ALS).


   IV.  CRITERIA FOR INITIAL APPROVAL

          Amyotrophic Lateral Sclerosis (ALS)
          Authorization of 12 months may be granted for treatment of ALS when all of the following
          criteria are met:
          A.  Member has a diagnosis of definite or probable ALS (e.g., medical history and/or diagnostic
               testing including, nerve conduction studies, imaging, and laboratory values to support the
               diagnosis).
          B.  Member has scores of at least 2 points on all 12 areas of the revised ALS Functional Rating
               Scale (ALSFRS-R).
          C.  Continuous use of ventilatory support during the day and night is not required (noninvasive
               or invasive).


   V.  CONTINUATION OF THERAPY

          Authorization of 12 months may be granted for members requesting continuation of therapy
          when all of the following criteria are met:
          A.  Member has a diagnosis of definite or probable ALS.
          B.  Member has had a clinical benefit from therapy with the requested medication.
          C.  Invasive ventilation is not required.

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Radicava [package insert]. Jersey City, NJ: MT Pharma America, Inc.; November 2022.
2. EFNS Task Force on Diagnosis and Management of Amyotrophic Lateral Sclerosis; Andersen PM, et al. EFNS guidelines on the Clinical Management of Amyotrophic Lateral Sclerosis (MALS) – revised report of an EFNS task force. Eur J Neurol. 2012;19(3):360-75.
3. Writing Group, Edaravone (MCI-186) ALS 19 Study Group. Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomized, double-blind, placebo-controlled trial. Lancet Neurol. 2017; 16:505-512.

 

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.

November 03, 2024