Pharmacy Prior Authorization Criteria

Rhapsido (remibrutinib)

Indications for Prior Authorization

Rhapsido (remibrutinib)

• For diagnosis of Chronic Spontaneous Urticaria (CSU)
  Indicated for the treatment of chronic spontaneous urticaria (CSU) in adult patients who remain symptomatic despite H1 antihistamine treatment.

  Limitations of Use: Rhapsido is not indicated for treatment of other forms of urticaria.

Criteria

Rhapsido

For state-mandated plans in Illinois or other states where applicable: Step therapy requirements do NOT apply. Beginning January 1, 2026, step therapy requirements or use of the authorization of alternative covered medications in a manner that effectively creates a step therapy requirement will not be imposed.

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Chronic Spontaneous Urticaria (CSU)

• Diagnosis of chronic spontaneous urticaria (CSU)
AND
• Both of the following:
• Persistent symptoms (itching and hives) for at least 6 consecutive weeks despite concurrent use of a second generation H1 antihistamine (e.g., cetirizine, fexofenadine), unless there is a contraindication or intolerance to H1 antihistamines [1-3]
AND
• Minimum 2-week trial of up-dosing (e.g., up to 4x dose) of the second generation H1 antihistamine, unless there is a contraindication or intolerance to H1 antihistamines [3]
AND
• Will be used concurrently with a second generation H1 antihistamine, unless there is a contraindication or intolerance to H1 antihistamines [1-3]
AND
• Prescribed by or in consultation with one of the following:
• Allergist/Immunologist
• Dermatologist
AND
• Trial and failure, contraindication, or intolerance to one of the following:
• Dupixent (dupilumab)
• Xolair (omalizumab)
AND
• Medication will not be used in combination with another immunologic therapy (e.g., Dupixent, Xolair) for the treatment of CSU

Rhapsido

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Chronic Spontaneous Urticaria (CSU)

• Patient demonstrates positive clinical response to therapy as evidenced by a reduction from baseline in itching severity or the number of hives [1-3]
AND
• Medication will not be used in combination with another immunologic therapy (e.g., Dupixent, Xolair) for the treatment of CSU

P & T Revisions

2025-12-18

References

1. Rhapsido Prescribing Information. Novartis Pharmaceuticals Corp. East Hanover, NJ. September 2025.
2. Metz M, Gimenez-Arnau A, Hide M, et al. Remibrutinib in chronic spontaneous urticaria. N Engl J Med 2025;392:984-94.
3. Zuberbier T, Latiff AHA, Abuzakouk M, et al. The EAACI/GA²LEN/EuroGuiDerm/APAAACI guideline for the definition, classification, diagnosis and management of urticaria. Allergy. 2022 Mar;77(3):734-766.

---

Revision History

• 2025-12-18: New program

---