Prior Authorization Criteria — Rhapsido (remibrutinib) for Chronic Spontaneous Urticaria
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This document defines prior authorization requirements for Rhapsido (remibrutinib) for treatment of adult patients with chronic spontaneous urticaria (CSU) within the West Virginia Bureau for Medical Services pharmacy program.
No material clinical or coverage changes in this revision.
Coverage Criteria for Rhapsido (remibrutinib)
Initial Therapy
Covered when ALL of the following are met
Initial approval duration: 3 months
Continuation Therapy / Reauthorization
Reauthorization is granted when ALL of the following are met
Continuation of therapy will be granted for 12 months
Coverage of Rhapsido (remibrutinib) is available only when all specified prior authorization criteria are met. Key requirements include: prescription by or consultation with an M.D./D.O. or specialty-trained prescriber in allergy, immunology, or dermatology; a documented diagnosis of chronic spontaneous urticaria (CSU) with itch and hives for ≥6 consecutive weeks; the patient being within the FDA-labeled age range; and documented failure of at least 30 days of a 2nd‑generation H1 antihistamine dosed at 4× the usual recommended dose, verified by pharmacy claims. Initial approvals will be granted for 3 months. Failure to meet any of these requirements may result in denial of the request.
For reauthorization, the request must document continued compliance with therapy and provide objective documentation of symptom improvement. When these reauthorization criteria are satisfied, continuation of therapy will be granted for 12 months. Providers should ensure that records supplied with reauthorization requests clearly show adherence and measurable clinical benefit.
Key Clinical Thresholds & Coding-related Values
What Providers Must Do / Denial Risks
Prior authorization required for Rhapsido (remibrutinib)
Prior authorization is required for Rhapsido (remibrutinib) for adult patients with chronic spontaneous urticaria (CSU). Initial approval will be granted only when all listed approval criteria are met and, if approved, initial authorization is issued for 3 months.
- Prescriber must be an MD/DO or specialty-trained prescriber in allergy, immunology, or dermatology, or the request must be in consultation with such a prescriber.
- Documented diagnosis of CSU with itch and hives for ≥6 consecutive weeks is required.
- Patient must meet the FDA-labeled age range.
Step therapy: high‑dose 2nd‑generation H1 antihistamine trial required
Before Rhapsido will be approved, the patient must have a documented failure of at least 30 days of therapy with a prescribed 2nd‑generation H1 antihistamine dosed at four times the usual recommended dose, verified by pharmacy claims data.
- Trial must be ≥30 days at 4× the usual recommended dose of a prescribed 2nd‑generation H1 antihistamine.
- Pharmacy claims or other objective evidence must verify the high‑dose antihistamine trial.
Required documentation to support prior authorization and reauthorization
Include clear documentation with the prior authorization request showing prescriber specialty or consultation, the diagnosis and symptom duration, age within the FDA‑labeled range, and evidence of prior high‑dose antihistamine therapy. For reauthorization, provide documentation of continued compliance and objective evidence of symptom improvement.
- Prescriber specialty: MD/DO or specialty‑trained prescriber in allergy, immunology, or dermatology, or documentation of consultation with one.
- Diagnosis: chronic spontaneous urticaria with presence of itch and hives for ≥6 consecutive weeks.
- Age: documentation that patient is within the FDA‑recommended age range.
- Prior treatment: pharmacy claims or other records showing ≥30 days of a prescribed 2nd‑generation H1 antihistamine at 4× usual dose.
- Reauthorization: documentation of continued compliance and improvement in symptoms.
Denial triggers: missing symptom duration, antihistamine trial, or prescriber specialty
Applications may be denied if required documentation is missing or incomplete. Specifically, lack of documentation of itch and hives for ≥6 consecutive weeks, absence of a documented ≥30‑day trial of a 2nd‑generation H1 antihistamine at 4× dose, or missing prescriber specialty/consultation information are triggers for denial.
- Missing documentation of symptom duration (≥6 consecutive weeks)
- No pharmacy claims or other evidence verifying the ≥30‑day high‑dose antihistamine trial
- Prescriber is not the required specialty and no consultation with allergy/immunology/dermatology is documented
Definitions
Background
Rhapsido (remibrutinib) is a Bruton tyrosine kinase inhibitor indicated for the treatment of chronic spontaneous urticaria (CSU) in adult patients who remain symptomatic despite H1 antihistamine treatment. CSU is characterized by recurrent hives and itching persisting for six weeks or longer despite standard therapy; this policy implements the FDA‑indication criteria and defines the documentation and step‑therapy expectations required for coverage.
Revision History
Policy effective date establishing prior authorization criteria for Rhapsido (remibrutinib) including initial approval for 3 months and reauthorization for 12 months.
Established coverage criteria requiring prescriber specialty or consultation, documented CSU with itch and hives for ≥6 consecutive weeks, age within FDA label, and a ≥30-day trial of a 2nd‑generation H1 antihistamine at 4× usual dose.
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