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    v1.0.28
    OpenPayerPolicy UpdatesAllergy/Clinical ImmunologyMHN remibrutinib (Rhapsido) Coverage Prior Auth | …
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    CurrentmhnPolicy CP.PHAR.756

    Remibrutinib (Rhapsido) — Coverage and Medical Necessity Criteria for Chronic Spontaneous Urticaria

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    Coverage and medical necessity criteria for remibrutinib (Rhapsido) for treatment of chronic spontaneous urticaria (CSU) in adults; governs Commercial, HIM, and Medicaid lines of business for the payer.

    Policy Summary
    Payermhn
    PolicyRemibrutinib (Rhapsido) — Coverage and Medical Necessity Criteria for CSU
    Policy CodePolicy CP.PHAR.756
    Change TypeMinor / no material changes
    Effective DateDec 1, 2025
    Next Review Date
    Key ActionPrior authorization required with documentation that approval criteria are met; approvals granted for 12 months.
    SourceLink
    POLICY UPDATE CHANGES

    No material clinical or coverage changes in this revision.

    25 mgtablet strength available

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    50 mg/daymaximum daily dose
    12 moapproval duration
    ≥18min age

    Coverage Criteria for Remibrutinib (Rhapsido)

    Initial Therapy

    Covered when ALL of the following are met

    Initial CSU: 1. Diagnosis of chronic spontaneous urticaria (CSU).
    Initial CSU: 2. Prescribed by or in consultation with a dermatologist, immunologist, or allergist.
    Initial CSU: 3. Age ≥ 18 years.

    Initial CSU - Step therapy requirement

    • a: For Illinois HIM requests only: Failure of one antihistamine at maximum indicated doses used for ≥ 2 weeks, unless clinically significant adverse effects are experienced or all are contraindicated.

    • b

      • i: Two antihistamines (including one second‑generation antihistamine, e.g., cetirizine, levocetirizine, fexofenadine, loratadine, desloratadine) at maximum indicated doses, each used ≥ 2 weeks.
      • ii: A leukotriene receptor antagonist (LTRA) in combination with an antihistamine at maximum indicated doses for ≥ 2 weeks.
    Initial CSU: 5. Rhapsido (remibrutinib) is not prescribed concurrently with Dupixent® (dupilumab) or Xolair® (omalizumab).
    Initial CSU: 6. Dose does not exceed 50 mg (2 tablets) per day.dose <= 50 mg/day

    Approval duration: 12 months

    Continuation Therapy

    Covered when ALL of the following are met

    Continuation CSU

    • a: Currently receiving medication via Centene benefit or member has previously met initial approval criteria.
    • b: Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations.
    Continuation CSU: 2. Member is responding positively to therapy.
    Continuation CSU: 3. Rhapsido (remibrutinib) is not prescribed concurrently with Dupixent or Xolair.

    Other Indications

    Other Diagnoses/Indications: 1. If the drug label has changed within the last 6 months and the change is not yet reflected in this policy, refer to the applicable formulary/no-coverage or non‑formulary policies for the relevant line of business (see policy references).
    Other Diagnoses/Indications: 2. If the requested use (diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off‑label use policy for the relevant line of business (commercial, health insurance marketplace, or Medicaid).

    Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid), or unless coverage is provided via the member’s evidence of coverage documents.

    When state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, state Medicaid coverage provisions take precedence. Refer to the applicable state Medicaid manual or addendum for any state‑specific coverage requirements that supersede this policy.

    Remibrutinib (Rhapsido) must not be prescribed concurrently with Dupixent® or Xolair®. Additionally, dosing above a maximum of 50 mg per day (2 tablets) is not allowed; requests for doses that exceed this threshold are considered not medically necessary under this policy.

    Coding and Dosage Information

    Coding notesmixed
    NDC/HCPCS not listedNo specific billing codes listed in this policy.
    inv-08: Maximum daily dose — 50 mg/day
    Maximum daily dose50 mg/day (maximum of 2 tablets per day)
    Tablet strength available25 mg tablet (25 mg PO BID regimen equals 50 mg/day)
    Dose limit for requests involving dose increaseNew dose must not exceed 50 mg/day for approval
    Consequence of exceeding limitDoses exceeding 50 mg/day are considered not medically necessary under this policy

    Provider Actions and Authorization Requirements

    Prior Authorization

    Prior authorization required; approvals for 12 months

    Prior authorization is required. Approval is granted for a 12‑month duration when documentation demonstrates that the member meets all approval criteria.

    Note

    Authorization governed by plan documents

    The clinical policy is a guide to medical necessity used to assist coverage decisions and administering benefits; authorization requirements are governed by the Health Plan's administrative policies and the member's coverage documents.

    Step Therapy

    Step therapy: antihistamine and LTRA failures required

    For most requests, the member must have failed two antihistamines (including one second‑generation) at maximum indicated doses, each used ≥2 weeks, AND failed a leukotriene modifier (LTRA) in combination with an antihistamine at maximum indicated doses for ≥2 weeks; Illinois HIM requests require failure of one antihistamine at maximum doses for ≥2 weeks.

    Background

    Chronic spontaneous urticaria (CSU) is characterized by the spontaneous appearance of wheals (hives), angioedema, or both for more than 6 weeks without an identifiable external cause. Remibrutinib (Rhapsido) is approved for adult patients with CSU who remain symptomatic despite H1 antihistamine treatment and has demonstrated improvement in signs and symptoms compared with placebo in clinical studies.

    Definitions

    inv-18: CSU — definition for chronic spontaneous urticaria (>6 weeks, unknown cause)
    Definition of CSUChronic spontaneous urticaria (CSU): spontaneous onset of wheals, angioedema, or both for more than 6 weeks due to an unknown cause.
    Typical clinical contextPatients remain symptomatic despite H1 antihistamine treatment; remibrutinib indicated for adult patients with such symptoms.
    Limitation of diagnosisNot indicated for other forms of urticaria (only CSU per FDA approval).
    Age requirement referenced in criteriaInitial approval criteria require age ≥ 18 years for CSU treatment with remibrutinib.
    Policy Summary
    Payermhn
    PolicyRemibrutinib (Rhapsido) — Coverage and Medical Necessity Criteria for CSU
    Policy CodePolicy CP.PHAR.756
    Change TypeMinor / no material changes
    Effective DateDec 1, 2025
    Next Review Date
    Key ActionPrior authorization required with documentation that approval criteria are met; approvals granted for 12 months.
    SourceLink
    On This Page
    Coverage Criteria for Remibrutinib (Rhapsido)Coding and Dosage InformationProvider Actions and Authorization RequirementsBackgroundDefinitions
    Continuation CSU: 4. If request is for a dose increase, the new dose does not exceed 50 mg (2 tablets) per day.dose <= 50 mg/day

    Approval duration: 12 months

    • Two antihistamines must include one second‑generation agent (e.g., cetirizine, levocetirizine, fexofenadine, loratadine, desloratadine).
    • Illinois HIM exception: only one antihistamine at maximum doses for ≥2 weeks is required.
    Note
    Documentation Required

    Submit supporting clinical documentation

    Providers must submit clinical documentation supporting that the member meets all approval criteria when requesting authorization.

    • Acceptable documentation includes office chart notes, laboratory results, or other clinical information.
    Note

    Provider remains responsible for medical judgment

    This clinical policy does not constitute medical advice and does not dictate care; providers retain responsibility for professional medical judgment and treatment decisions.

    • Providers are solely responsible for the medical advice and treatment of members.
    Denial Risk

    Denial triggers: missing documentation, off‑label use, contraindicated combinations, or excessive dose

    Requests may be denied for lack of documentation that the member meets all approval criteria, use for non‑FDA approved indications without sufficient evidence per off‑label policies, concurrent use with Dupixent or Xolair, or dosing above 50 mg/day.

    Note

    Coverage subject to member contract and state requirements

    Coverage determinations are subject to the terms, conditions, exclusions, and limitations of the member's coverage documents and applicable state or federal requirements; state Medicaid provisions take precedence where they conflict with this policy.