Rhapsido®

Drug - Rhapsido® (remibrutinib) [Novartis Pharmaceuticals Corporation]

August 2026

Therapeutic Area - Chronic spontaneous uticaria (CSU)

Initial approval criteria

  • Patient must meet an age-appropriate medically accepted indication, as defined in Section 1927 of the Social Security Act, for the requested agent; AND
  • Patient has a diagnosis of chronic spontaneous urticaria (CSU) (otherwise known as chronic idiopathic urticaria [CIU]) AND ALL of the following:
    • Patient has had hives and itching for ≥ 6 weeks; AND
    • Prescriber has evaluated the patient to determine if the patient is currently treated with medication known to cause or worsen urticaria (e.g., nonsteroidal anti-inflammatory drugs [NSAIDs]) in order to reduce urticaria risk; AND
    • Patient has ONE of the following:
      • Patient tried and had an inadequate response to the FDA labeled maximum dose of ONE second-generation H1-antihistamine (e.g., cetirizine, fexofenadine, levocetirizine, loratadine) AND ONE of the following:
      • Patient has tried and had an inadequate response to a maximally tolerated dose of ONE second-generation H1-antihistamine titrated up to 4 times above the FDA labeled maximum dose after at least a 2-week duration of therapy; OR
      • There is support that the patient cannot be treated with a second-generation H1- antihistamine at a dose above the FDA labeled maximum dose; OR
      • Patient has an intolerance or hypersensitivity to ONE second generation H1-antihistamine; OR
      • Patient has an FDA labeled contraindication to ALL second generation H1-antihistamines; AND
  • If the patient has a diagnosis of chronic spontaneous urticaria, then ONE of the following:
    • BOTH of the following:
      • Patient is currently treated with second-generation H1-antihistamine therapy (e.g., cetirizine, fexofenadine, levocetirizine, loratadine); AND
      • Patient will continue second-generation H1-antihistamine therapy in combination with Rhapsido; OR
    • Patient has an intolerance, hypersensitivity or FDA labeled contraindication to ALL second-generation H1-antihistamines; AND
  • Prescriber is a specialist in the area of the patient’s diagnosis (e.g., dermatologist, allergist, immunologist), or the prescriber has consulted with a specialist in the area of the patient’s diagnosis; AND
  • Prescriber has reviewed Rhapsido Warnings/Precautions and Drug Interactions and will monitor patient status as appropriate; AND
  • If concurrent use with other biologic immunomodulators or other targeted synthetic small molecule drugs (e.g., BTK inhibitors, JAK inhibitors) is unavoidable, prescriber attestation is required that consideration has been given to the potential for additive adverse effects (e.g., immunosuppression, infections) and lack of data supporting concurrent use.

Renewal criteria

  • Patient must continue to meet the above criteria; AND
  • Patient must have disease improvement/clinical benefit (e.g., improvement in itch and/or hives); AND
  • Patient has NOT experienced any treatment-restricting adverse effects (e.g., bleeding).

Quantity limits

  • 60 tablets/30 days (maximum dose: 50 mg per day)

Background

Rhapsido is a kinase inhibitor indicated for the treatment of chronic spontaneous urticaria (CSU) in adult patients who remain symptomatic despite H1 antihistamine treatment. Rhapsido is not FDA-approved for other forms of urticaria.

Questions

Provider Call Center: (844) 575-7887