Subject: Acthar 3171-A RI eSGM P2021

Drug

ACTHAR GEL  (repository corticotropin injection)

Policy:

       I.  INDICATIONS

           The Restricted Indication Enhanced Specialty Guideline Management
           (RI eSGM) program provides coverage for specific, but not all FDA
           labeled or compendial supported drug uses based on plan design and
           the scope of the pharmacy benefit. This program provides coverage for
           Acthar Gel for the treatment of infantile spasms if all of the approval
           criteria are met.

           Infantile spasms: as monotherapy for the treatment of infantile
           spasms in infants and children under 2 years of age

           The use of Acthar for the treatment of all other indications listed in the
           FDA product labeling has not been proven to be superior to
           conventional therapies (e.g., corticosteroids, immunosuppressive
           agents) and has a significantly higher cost than the standard of care
           agents. Use of Acthar for these conditions is considered not medically
           necessary and is not a covered benefit.
 
          A.  Multiple Sclerosis: treatment of acute exacerbations of multiple
               sclerosis in adults
          B.  Rheumatic Disorders: as adjunctive therapy for short-term
               administration (to tide the patient over an acute episode or
               exacerbation) in: psoriatic arthritis; rheumatoid arthritis, including
               juvenile rheumatoid arthritis; ankylosing spondylitis
          C.  Collagen Diseases: during an exacerbation or as maintenance
               therapy in selected cases of: systemic lupus erythematosus,
               systemic dermatomyositis (polymyositis)
          D.  Dermatologic Diseases: severe erythema multiforme, Stevens-
               Johnson syndrome
          E.  Allergic States: serum sickness
          F.  Ophthalmic Diseases: severe acute and chronic allergic and
               inflammatory processes involving the eye and its adnexa such as:
               keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis,
               optic neuritis, chorioretinitis, anterior segment inflammation
         G.  Respiratory Diseases: symptomatic sarcoidosis
         H.  Edematous State: to induce a diuresis or a remission of proteinuria
               in nephrotic syndrome without uremia of the idiopathic type or that
               due to lupus erythematosus

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

    II. CRITERIA FOR INITIAL APPROVAL

         Infantile Spasms
         Authorization of 4 weeks may be granted for treatment of infantile
         spasms in members who are less than 2 years of age.

 III. CONTINUATION OF THERAPY

        Infantile Spasms
        Authorization of 3 months may be granted to members requesting Acthar
        Gel for continuation of therapy when the member has shown substantial
        clinical benefit from therapy.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Acthar Gel [package insert]. Hazelwood, MO: Mallinckrodt Pharmaceuticals, Inc.; March 2021.
2. Pellock JM, Hrachovy R, Shinnar S, et al. Infantile spasms: A U.S. consensus report. Epilepsia. 2010:51:2175-2189.
3. Go CY, Mackay MT, Weiss SK, et al. Evidence-based guideline update: Medical treatment of infantile spasms: Report of the Guideline Development Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society. 2012;78:1974-1980.
4. Hancock EC, Osborne JP, Edwards SW. Treatment of infantile spasms. Cochrane Database Syst Rev. 2013;6:CD001770.
5. Riikonen R. Recent advances in pharmacotherapy of infantile spasms. CNS Drugs 2014; 28:279-290.
6. Pavone P, et al. Infantile spasms syndrome, West Syndrome and related phenotypes: what we know in 2013. Brain & Development 2014; 739-751.

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 09, 2021