KEVZARA (sarilumab)

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).

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)
  • For continuation of prior Kevzara therapy, defined as no more than a 45-day gap in therapy.

*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:

• 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. 

Coverage Duration:

RA, PMR:

• Initial: 1 year
• 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.

References:

1. Kevzara prescribing information. Sanofi-Aventis U.S. LLC. Bridgewater, NJ. April 2018. 
2. 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. 
3. 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.
4. 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.