Subject: Rasuvo 2018-A SGM P2023

Drug

RASUVO  (methotrexate injection)

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
           A.  Rheumatoid Arthritis (RA) including Polyarticular Juvenile
                Idiopathic Arthritis (pJIA)
                Rasuvo is indicated in the management of selected adults
                with severe, active rheumatoid arthritis (RA) or children with
                active polyarticular juvenile idiopathic arthritis (pJIA), who
                have had an insufficient therapeutic response to, or are
                intolerant of, an adequate trial of first-line therapy including
                full dose non-steroidal anti-inflammatory agents (NSAIDs).
           B.  Psoriasis
                Rasuvo is indicated in adults for the symptomatic control of
                severe, recalcitrant, disabling psoriasis that is not
                adequately responsive to other forms of therapy, but only
                when the diagnosis has been established, as by biopsy
                and/or after dermatologic consultation. It is important to
                ensure that a psoriasis “flare” is not due to an undiagnosed
                concomitant disease affecting immune responses.

                Limitations of use: Rasuvo is not indicated for the treatment
                of neoplastic diseases.

                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:

           A.  Chart notes, medical record documentation, or claims
                history supporting previous use of generic oral methotrexate
                and inadequate response or intolerance to therapy.
           B.  Chart notes or medical record documentation of member’s
                inability to prepare and administer generic injectable
                methotrexate.

   III.  CRITERIA FOR INITIAL APPROVAL

          Authorization of 12 months may be granted for treatment of
          rheumatoid arthritis (RA), polyarticular juvenile idiopathic
          arthritis (pJIA), or psoriasis when BOTH of the following criteria
          are met:
          A.  Member has had an inadequate response or intolerance to
               generic oral methotrexate.
          B.  Member has an inability to prepare and administer generic
               injectable methotrexate.

   IV.  CONTINUATION OF THERAPY

          Authorization of 12 months may be granted for all members
          (including new members) who meet ALL initial authorization
          criteria and achieve or maintain a positive clinical response after
          at least 3 months of therapy with Rasuvo as evidenced by low
          disease activity or improvement in signs and symptoms of the
          condition.

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Rasuvo [package insert]. Chicago, IL: Medexus Pharma Inc.; March 2020.
2. Fraenkel L, Bathon JM, England BR, et al. 2021American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2021;73(7):924-939.
3. Smolen JS, Landewé R, Billsma J, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update. Ann Rheum Dis. 2020;79:685-699.
4. Ringold S, Angeles-Han S, Beukelman T, et al. 2019 American College of Rheumatology recommendations for the treatment of juvenile idiopathic arthritis: Therapeutic approaches for non-systemic polyarthritis, sacroilitis, and enthesitis. Arthritis Care Res. 2019;71(6):717-734.
5. Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 4: Guidelines of care for the management and treatment of psoriasis with traditional systemic agents. J Am Acad Dermatol. 2009;61:451-485. 

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.

April 11, 2023