Hadlima — CareFirst (Caremark)

Initial criteria

• Authorization may be granted for adult members for treatment of moderately to severely active rheumatoid arthritis when both of the following criteria are met:
• 1. Member meets either of the following biomarker conditions:
• • Member has been tested for either rheumatoid factor (RF) or anti-cyclic citrullinated peptide (anti-CCP) and the test was positive OR
• • Member has been tested for ALL of the following biomarkers: RF, anti-CCP, and C-reactive protein (CRP) and/or erythrocyte sedimentation rate (ESR).
• 2. Member meets ONE of the following treatment history criteria:
• • Has failed to achieve low disease activity after a 3-month trial of methotrexate monotherapy at a titrated dose ≥15 mg/week and meets any of the following:
• – Inadequate response to methotrexate in combination with at least one other conventional synthetic drug (hydroxychloroquine and/or sulfasalazine) after a 3-month trial at maximum tolerated dose(s).
• – Experienced intolerable adverse event to hydroxychloroquine or sulfasalazine.
• – Has contraindication to hydroxychloroquine and sulfasalazine (e.g., porphyria, intestinal or urinary obstruction).
• – Has moderate to high disease activity.
• OR has been unable to tolerate methotrexate trial and meets any of the following:
• – Inadequate response to methotrexate in combination with another conventional synthetic drug (leflunomide, hydroxychloroquine, and/or sulfasalazine).
• – Stopped methotrexate and had inadequate response to another conventional synthetic drug alone or in combination (leflunomide, hydroxychloroquine, and/or sulfasalazine).
• – Experienced intolerable adverse event to leflunomide, hydroxychloroquine, or sulfasalazine.
• – Has contraindication to leflunomide, hydroxychloroquine, and sulfasalazine (e.g., porphyria, intestinal or urinary obstruction).
• – Has moderate to high disease activity.
• OR Member experienced intolerable adverse event or contraindication to methotrexate and meets any of the following:
• – Inadequate response to another conventional synthetic drug (leflunomide, hydroxychloroquine, and/or sulfasalazine) alone or in combination.
• – Experienced intolerable adverse event to leflunomide, hydroxychloroquine, or sulfasalazine.
• – Has contraindication to leflunomide, hydroxychloroquine, and sulfasalazine.
• – Has moderate to high disease activity.

Reauthorization criteria

• Continuation requests require chart notes or medical record documentation supporting positive clinical response.

Approval duration

12 months