Subject: glatiramer-Copaxone-Glatopa 1841-A SGM P2024

Drug

COPAXONE  (glatiramer acetate)

GLATOPA

glatiramer acetate

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
          Indicated for the treatment of patients with relapsing forms of multiple sclerosis (MS), to include
          clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive
          disease, in adults.

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


    II.  PRESCRIBER SPECIALTIES

          This medication must be prescribed by or in consultation with a neurologist.


   III.  CRITERIA FOR INITIAL APPROVAL

          A.  Relapsing forms of multiple sclerosis
               Authorization of 12 months may be granted to members who have been diagnosed with a
               relapsing form of multiple sclerosis (including relapsing-remitting and secondary progressive
               disease for those who continue to experience relapse).

          B.  Clinically isolated syndrome
               Authorization of 12 months may be granted to members for treatment of clinically isolated
               syndrome of multiple sclerosis.


   IV.  CONTINUATION OF THERAPY

          For all indications: Authorization of 12 months may be granted for members who are
          experiencing disease stability or improvement while receiving Copaxone, Glatopa, or
          glatiramer acetate.


    V.  OTHER

          Members will not use Copaxone, Glatopa, or glatiramer acetate concomitantly with other
          disease modifying multiple sclerosis agents (Note: Ampyra and Nuedexta are not disease
          modifying).

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Copaxone [package insert]. Parsippany, NY: Teva Pharmaceuticals USA, Inc.; November 2023.
2. Glatopa [package insert]. Princeton, NJ: Sandoz Inc.; December 2023.
3. Glatiramer acetate 20mg/mL [package insert]. Morgantown, WV: Mylan Pharmaceuticals Inc.; January 2024.
4. Glatiramer acetate 40mg/mL [package insert]. Morgantown, WV: Mylan Pharmaceuticals Inc.; January 2024.
5. IBM Micromedex [database online]. Ann Arbor, MI: IBM Watson Health. Updated periodically. www.micromedexsolutions.com [available with subscription]. April 14, 2024.
6. AHFS DI (Adult and Pediatric) [database online]. Hudson, OH: Lexi-Comp, Inc.; http://online.lexi.com/lco/action/index/dataset/complete_ashp [available with subscription]. Accessed April 14, 2024.
7. The Multiple Sclerosis Coalition. The use of disease-modifying therapies in multiple sclerosis: principles and current evidence. https://ms-coalition.org/wp-content/uploads/2019/06/MSC_DMTPaper_062019.pdf. Accessed March 01, 2024.

 

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 30, 2024