Kevzara

Sarilumab

• Brand(s): Kevzara
• Dosage Form/Strength: 150mg/1.14mL, 200mg/1.14mL Pre-filled Pen and Pre-filled Syringe

For the treatment of rheumatoid arthritis in adult patients meeting the following criteria:

1. Sarilumab is being used as monotherapy or in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs (DMARDs); AND

2. Patient is 18 years of age or older; AND

3. Has severe active disease (≥ 5 swollen joints and rheumatoid factor positive and/or anti-CCP positive and/or radiographic evidence of rheumatoid arthritis) despite the optimal use of various formulary disease-modifying anti-rheumatic drugs (DMARDs); AND

4. Has one of the following:
   i) fails to respond to Optimal use¹ of DMARDs (e.g., hydroxychloroquine, methotrexate, sulfasalazine, leflunomide, cyclosporine, azathioprine, penicillamine, chloroquine and gold compounds).

   ¹Optimal use of DMARDs is defined as one of the below:
   • methotrexate (20 mg/week) for at least 3 months and leflunomide (20 mg/day) for at least 3 months, in addition to an adequate trial (3 months) of at least one combination of DMARDs;
   OR
   • methotrexate (20 mg/week) for at least 3 months and leflunomide in combination with methotrexate for at least 3 months;
   OR
   • methotrexate (20 mg/week), sulfasalazine (2 G/day) and hydroxychloroquine (based on weight and up to 400 mg/day) for at least 3 months.
   
   ii) has a documented intolerance or contraindication to DMARDs in which case the nature of the contraindication(s) or intolerance(s) must be provided with the request, along with details of trials of other DMARDs or clear rationale as to why other DMARDs cannot be considered

Approval duration of Initials: 1 year
Objective evidence of at least a 20% reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year.

Approval duration of first renewal: 1 year
For renewals beyond the second year, objective evidence of preservation of treatment effect must be provided.

Subsequent Renewal Criteria: Approval duration 5 years

Recommended Dose:
The recommended dose of KEVZARA is 200 mg once every 2 weeks given as a subcutaneous injection.

A reduced dose of 150 mg once every two weeks is recommended for patients with neutropenia, thrombocytopenia, or with elevated liver enzymes.

EAP Drug Request Form:

Standard Form for EAP Drug Requests