Subject: Rasuvo 2018-A SGM P2024

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. Clinical Consult. CVS Caremark Clinical Programs Review: Focus on Rheumatology Clinical Programs. November 2014.
6. 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.
7. Clinical Consult. CVS Caremark Clinical Programs Review: Focus on Dermatology Programs. October 28, 2016.

 

 

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 14, 2024