KEVZARA (sarilumab)
Self-Administration – subcutaneous (SC) injection
Indication for Prior Authorization:
Rheumatoid Arthritis (RA): Indicated for treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs).
Polyarticular Juvenile Idiopathic Arthritis (PJIA): Indicated for treatment of active polyarticular juvenile idiopathic arthritis (PJIA) in patients who weigh 63 kg or greater.
Polymyalgia Rheumatica (PMR): Indicated for treatment of adult patients with polymyalgia rheumatica who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper.
Coverage Criteria:
For diagnosis of Rheumatoid Arthritis (RA):
- Documented diagnosis of moderately to severely active RA; AND
- Prescribed by or in consultation with a rheumatologist; AND
- Minimum duration of a 3-month trial and failure, contraindication, or intolerance to one of the following conventional therapies at maximally tolerated doses:
- methotrexate
- leflunomide
- sulfasalazine
- hydroxychloroquine; AND
- One of the following:
- Both of the following:
- Trial and failure, contraindication, or intolerance to TWO of the following, or attestation demonstrating a trial may be inappropriate*:
- Cimzia (certolizumab pegol)
- Enbrel (etanercept)
- Humira (adalimumab), Amjevita, Cyltezo, Hyrimoz (Sandoz manufacturer), or Brand Adalimumab-adaz
- Rinvoq (upadacitinib)
- Simponi (golimumab)
- Xeljanz/XR (tofacitinib/ER)
- Trial and failure, contraindication, or intolerance to BOTH of the following:
- Actemra (tocilizumab)
- Orencia (abatacept)
- Trial and failure, contraindication, or intolerance to TWO of the following, or attestation demonstrating a trial may be inappropriate*:
- For continuation of prior Kevzara therapy, defined as no more than a 45-day gap in therapy.
- Both of the following:
*Includes attestation that a total of two TNF inhibitors have already been tried in the past, and the patient should not be made to try a third TNF inhibitor.
For diagnosis of Polyarticular Juvenile Idiopathic Arthritis (PJIA):
- Diagnosis of active polyarticular juvenile idiopathic arthritis (PJIA), AND
- Patient weighs at least 63 kg, AND
- Prescribed by or in consultation with a rheumatologist, AND
- Minimum duration of a 6-week trial and failure, contraindication, or intolerance to one of the following conventional therapies at maximally tolerated doses:
- Leflunomide
- Methotrexate, AND
- One of the following:
- Both of the following:
- Trial and failure, contraindication, or intolerance to TWO of the following, or attestation demonstrating a trial may be inappropriate*:
- Enbrel (etanercept)
- Humira (adalimumab), Amjevita, Cyltezo, Hyrimoz (Sandoz manufacturer), or Brand Adalimumab-adaz
- Rinvoq/LQ (upadacitinib)
- Xeljanz (tofacitinib)
- Trial and failure, contraindication, or intolerance to BOTH of the following:
- Actemra (tocilizumab)
- Orencia (abatacept)
- Trial and failure, contraindication, or intolerance to TWO of the following, or attestation demonstrating a trial may be inappropriate*:
- For continuation of prior therapy, defined as no more than a 45-day gap in therapy
- Both of the following:
*Includes attestation that a total of two TNF inhibitors have already been tried in the past, and the patient should not be made to try a third TNF inhibitor.
For diagnosis of Polymyalgia Rheumatica (PMR):
- Documented diagnosis of PMR; AND
- Prescribed by or in consultation with a rheumatologist; AND
- One of the following:
- Patient has had an inadequate response to corticosteroids (e.g., prednisone)
- Patient cannot tolerate tapering of corticosteroids (e.g., prednisone)
Reauthorization Criteria:
For diagnosis of RA, PJIA:
- Documentation of positive clinical response to therapy as evidenced by at least one of the following:
- Reduction in the total active (swollen and tender) joint count from baseline
- Improvement in symptoms (e.g., pain, stiffness, inflammation) from baseline
For diagnosis of PMR:
- Documentation of positive clinical response to therapy as evidenced by at least one of the following:
- Improvement in symptoms (e.g., pain, stiffness) or lab values (e.g., C-reactive protein) from baseline
- Reduced need for corticosteroids (e.g., prednisone)
Dosing:
RA, PMR (adults):
- 200 mg once every two weeks, administered as a subcutaneous injection.
PJIA (children 2 years of age and older and adolescents weighting at least 63 kg):
- 200 mg once every two weeks, administered as a subcutaneous injection
Coverage Duration:
RA, PMR, PJIA:
- Initial: 6 months
- Reauthorization: 1 year
Authorization is not covered for the following:
The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.
Additional Information:
- Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with Kevzara.
Policy Updates:
- 02/18/2020 – Criteria reviewed.
- 01/01/2023 – Update prerequisite drugs for RA; remove TB requirements; add reauthorization criteria; update coverage duration of initial authorization.
- 09/01/2023 – Addition of Amjevita, Cyltezo, Hyrimoz, and brand Adalimumab-adaz as preferred options for RA. Addition of PMR criteria. (P&T 08/15/2023)
- 11/14/2023 – Update Hyrimoz preferred agent to Sandoz manufacturer only.
- 10/01/2024 – Addition of criteria for PJIA
References:
- Kevzara prescribing information. Sanofi-Aventis U.S. LLC. Bridgewater, NJ. February 2023.
- Singh JA, Saag KG, Bridges SL Jr, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care Res. 2015;68(1):1-25.
- Fraenkel L, Bathon JM, England BR, et al. 2021 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. 2021;73(7):924-939.
- Ringold S, Angeles-Han ST, Beukelman T, et al. 2019 American College of Rheumatology/Arthritis Foundation guideline for the treatment of juvenile idiopathic arthritis: therapeutic approaches for non-systemic polyarthritis, sacroiliitis, and enthesitis. Arthritis Rheumatol. 2019;71(6):846-863.
- Dejaco C, Singh YP, Perel P, et al. 2015 recommendations for the management of polymyalgia rheumatica: a European League Against Rheumatism/American College of Rheumatology collaborative initiative. 2015;74(10):1799-807.
Last review date: September 30, 2024