Subject: Kevzara 1957-A SGM P2021a

Drug

KEVZARA  (sarilumab)

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
      Kevzara is indicated for treatment of adult patients with moderately to severely active
      rheumatoid arthritis who have had an inadequate response or intolerance to one or more
      disease-modifying antirheumatic drugs (DMARDs)

      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.  For initial requests:
            1. Chart notes, medical record documentation, or claims history supporting previous
                medications tried (if applicable), including response to therapy. If therapy is not
                advisable, documentation of clinical reason to avoid therapy.­
            2. Laboratory results, chart notes, or medical record documentation of biomarker testing
                (i.e., rheumatoid factor [RF], anti-cyclic citrullinated peptide [anti-CCP], and C-reactive
                protein [CRP] and/or erythrocyte sedimentation rate [ESR]) (if applicable).
       B.  For continuation requests: Chart notes or medical record documentation supporting positive
            clinical response.

III. CRITERIA FOR INITIAL APPROVAL
 
       Moderately to severely active rheumatoid arthritis (RA)
       A. Authorization of 12 months may be granted for members who have previously received a
           biologic or targeted synthetic DMARD (e.g., Rinvoq, Xeljanz) indicated for moderately to
           severely active rheumatoid arthritis.
 
       B. Authorization of 12 months may be granted for treatment of moderately to severely
           active RA when all of the following criteria are met:
           1. Member meets either of the following criteria:
               i. Member has been tested for either of the following biomarkers and the test was
                  positive:
                  a. Rheumatoid factor (RF)
                  b. Anti-cyclic citrullinated peptide (anti-CCP)
              ii. Member has been tested for ALL of the following biomarkers:
                  a. RF
                  b. Anti-CCP
                  c. C-reactive protein (CRP) and/or erythrocyte sedimentation rate (ESR)
           2. Member meets either of the following criteria:
              i. Member has experienced an inadequate response to at least a 3-month trial of
                 methotrexate despite adequate dosing (i.e., titrated to 15 mg/week).
             ii. Member has an intolerance or contraindication to methotrexate (see Appendix).

 IV. CONTINUATION OF THERAPY

       Authorization of 12 months may be granted for all members (including new members) who
       are using the requested medication for an indication outlined in Section III and who achieve
       or maintain a positive clinical response as evidenced by disease activity improvement of at
       least 20% from baseline in tender joint count, swollen joint count, pain, or disability.

 V.  OTHER 

      For all indications: Member has had a documented negative TB test (which can include a
      tuberculosis skin test [PPD], an interferon-release assay [IGRA], or a chest x-ray)* within 6
      months of initiating therapy for persons who are naïve to biologic DMARDs or targeted synthetic
      DMARDs associated with an increased risk of TB. 

      * If the screening testing for TB is positive, there must be further testing to confirm there is no
         active disease. Do not administer the requested medication to members with active TB
         infection. If there is latent disease, TB treatment must be started before initiation of the
         requested medication.

         For all indications: Members cannot use the requested medication concomitantly with any
         other biologic DMARD or targeted synthetic DMARD.

 
VI.  DOSAGE AND ADMINISTRATION

       Approvals may be subject to dosing limits in accordance with FDA-approved labeling, accepted
       compendia, and/or evidence-based practice guidelines.

Special Notes:

VII. APPENDIX: Examples of Contraindications to Methotrexate  
       1.  Clinical diagnosis of alcohol use disorder, alcoholic liver disease or other chronic liver
            disease
       2.  Breastfeeding
       3.  Blood dyscrasias (e.g., thrombocytopenia, leukopenia, significant anemia) 
       4.  Elevated liver transaminases
       5.  History of intolerance or adverse event
       6.  Hypersensitivity
       7.  Interstitial pneumonitis or clinically significant pulmonary fibrosis
       8.  Myelodysplasia
       9.  Pregnancy or currently planning pregnancy
     10.  Renal impairment 
     11.  Significant drug interaction 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Kevzara [package insert]. Bridgewater, NJ: Sanofi-aventis, U.S. LLC /Regeneron Pharmaceuticals, Inc.; April 2018.
2. Genovese MC, Fleischmann R, Kivitz AJ, et al. Sarilumab plus methotrexate in patients with active rheumatoid arthritis and inadequate response to methotrexate: results of a phase III study. Arthritis Rheumatol.June 2015;67(6):1424-37. 
3. StrandV, Reaney M, Chen C, et al. Sarilumab improves patient-reported outcomes in rheumatoid arthritis patients with inadequate response/intolerance to tumour necrosis factor inhibitors. RMD Open. 2017; 3: doi: 10.1136/rmdopen-2016-000416.
4. Tuberculosis (TB). TB risk factors. Centers for Disease Control and Prevention. Retrieved on November 15, 2021 from: https://www.cdc.gov/tb/topic/basics/risk.htm.
5. Smolen JS, Landewé R, Bijlsma 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.
6. Aletaha D, Neogi T, Silman, et al. 2010 Rheumatoid arthritis classification criteria: an American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum. 2010;62(9):2569-81.
7. Smolen JS, Aletaha D. Assessment of rheumatoid arthritis activity in clinical trials and clinical practice. In: UpToDate, Post TW (Ed), UpToDate, Waltham, MA. Available with subscription. URL: www.uptodate.com. Accessed March 19, 2021.
8. Fraenkel L, Bathon JM, England BR, et al. 2021 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthrit Care Res. 2021;0:1-16.

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.

March 16, 2022