Kevzara (sarilumab)
Indications for Prior Authorization
Kevzara (sarilumab)
-
For diagnosis of 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). -
For diagnosis of Polyarticular Juvenile Idiopathic Arthritis (PJIA)
Indicated for treatment of active polyarticular juvenile idiopathic arthritis (PJIA) in patients who weigh 63 kg or greater. -
For diagnosis of 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.
Criteria
Kevzara
*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 review process only: Refer to the table in the Background section for carrier-specific formulary adalimumab products
Prior Authorization (Initial Authorization)
Length of Approval: 6 Month(s)
For diagnosis of Rheumatoid Arthritis (RA)
- Diagnosis of moderately to severely active rheumatoid arthritis (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 [2, 3]:
- methotrexate
- leflunomide
- sulfasalazine
- 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)
- One formulary adalimumab product**
- Simponi (golimumab)
- Rinvoq (upadacitinib)
- Xeljanz/XR (tofacitinib/ER)
- Trial and failure, contraindication, or intolerance to BOTH of the following:
- Actemra (tocilizumab)
- Orencia (abatacept)
- For continuation of prior therapy, defined as no more than a 45-day gap in therapy
Kevzara
Prior Authorization (Reauthorization)
Length of Approval: 12 Month(s)
For diagnosis of Rheumatoid Arthritis (RA)
- Patient demonstrates positive clinical response to therapy as evidenced by at least one of the following [1-3]:
- Reduction in the total active (swollen and tender) joint count from baseline
- Improvement in symptoms (e.g., pain, stiffness, inflammation) from baseline
Kevzara
*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 review process only: Refer to the table in the Background section for carrier-specific formulary adalimumab products
Prior Authorization (Initial Authorization)
Length of Approval: 6 Month(s)
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 [4]:
- leflunomide
- methotrexate
- 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)
- One formulary adalimumab product**
- Rinvoq/LQ (upadacitinib)
- Xeljanz (tofacitinib)
- Trial and failure, contraindication, or intolerance to BOTH of the following:
- Actemra (tocilizumab)
- Orencia (abatacept)
- For continuation of prior therapy, defined as no more than a 45-day gap in therapy
Kevzara
Prior Authorization (Reauthorization)
Length of Approval: 12 Month(s)
For diagnosis of Polyarticular Juvenile Idiopathic Arthritis (PJIA)
- Patient demonstrates positive clinical response to therapy as evidenced by at least one of the following [1, 4]:
- Reduction in the total active (swollen and tender) joint count from baseline
- Improvement in symptoms (e.g., pain, stiffness, inflammation) from baseline
Kevzara
Prior Authorization (Initial Authorization)
Length of Approval: 6 Month(s)
For diagnosis of Polymyalgia Rheumatica (PMR)
- Diagnosis of polymyalgia rheumatica (PMR) AND
- One of the following:
- Patient has had an inadequate response to corticosteroids (e.g., prednisone) OR
- Patient cannot tolerate tapering of corticosteroids (e.g., prednisone)
- Prescribed by or in consultation with a rheumatologist
Kevzara
Prior Authorization (Reauthorization)
Length of Approval: 12 Month(s)
For diagnosis of Polymyalgia Rheumatica (PMR)
- Patient demonstrates positive clinical response to therapy as evidenced by at least one of the following [1, 5]:
- Improvement in symptoms (e.g., pain, stiffness) or lab values (e.g., C-reactive protein) from baseline
- Reduced need for corticosteroids (e.g., prednisone)
P & T Revisions
2024-12-04, 2024-12-04, 2024-08-02, 2024-06-24, 2024-05-30, 2024-04-23, 2024-03-06, 2023-10-03, 2023-06-30, 2023-04-09, 2023-02-26, 2023-01-31, 2022-10-23, 2022-03-02, 2021-03-02, 2020-09-15, 2020-02-04, 2019-10-23
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.
Revision History
- 2024-12-04: Dec P&T: Added Cimzia as an additional preferred alternative for PJIA. Aug P&T: Update to remove manufacturer information from "one formulary adalimumab product"; updated background table
- 2024-12-04: Update to remove manufacturer information from "one formulary adalimumab product"; updated background table
- 2024-08-02: Addition of criteria for PJIA
- 2024-06-24: No criteria changes; updated background table to specify BI manufacturer for adalimumab-adbm
- 2024-05-30: Updated background table to include CalPERS formulary; no criteria changes
- 2024-04-23: Updated verbiage in the step to say, "One formulary adalimumab product manufactured by AbbVie, Amgen, BI, or Sandoz"; added table to background section detailing preferred adalimumab products; Annual review - no additional criteria changes
- 2024-03-06: Updated verbiage in the step to say, "One formulary adalimumab product manufactured by AbbVie, Amgen, BI, or Sandoz"; added table to background section detailing preferred adalimumab products; Annual review - no additional criteria changes
- 2023-10-03: Program update to standard reauthorization language. No changes to clinical intent
- 2023-06-30: Addition of Cyltezo, Hyrimoz, and brand Adalimumab-adaz as preferred step options for RA
- 2023-04-09: Addition of criteria for PMR
- 2023-02-26: Annual review - no criteria changes
- 2023-01-31: Addition of Amjevita as another preferred step option
- 2022-10-23: Addition of Enbrel as another preferred step option; further clinical detail added
- 2022-03-02: Annual review - no criteria changes
- 2021-03-02: Annual review - Removal of drug name from reauthorization criteria; background updates
- 2020-09-15: Formulary strategy update to remove Simponi Aria as a preferred step option for RA
- 2020-02-04: Annual review - no clinical changes
- 2019-10-23: Added Rinvoq (upadacitinib) as a step option for RA.
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