CurrentmhnPolicy CP.PHAR.756

Remibrutinib (Rhapsido) for chronic spontaneous urticaria

Medical necessity and prior authorization criteria for remibrutinib (Rhapsido) for treatment of chronic spontaneous urticaria in covered lines of business; governs prescribing clinicians and payer authorization reviewers.

Policy Summary

Payermhn

PolicyRemibrutinib (Rhapsido) for chronic spontaneous urticaria

Policy CodePolicy CP.PHAR.756

Change TypeNo material change

Effective Date12.01.25

Next Review Date

Key ActionObtain prior authorization; approvals are granted for 12 months when coverage criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsapproval duration

50 mg/daymaximum daily dose

Adults ≥18minimum age

25 mgproduct strength

≈30%prior biologic exposure

Coverage Criteria for Remibrutinib (Rhapsido)

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Initial Therapy (CSU)

Covered when ALL of the following are met

Initial Approval - CSU: 1. Diagnosis of chronic spontaneous urticaria (CSU); 2. Prescribed by or in consultation with a dermatologist, immunologist, or allergist; 3. Age ≥ 18 years; 4. One of the following: (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; OR (b) For all other requests: failure of both (i) two antihistamines (including one second‑generation antihistamine — e.g., cetirizine, levocetirizine, fexofenadine, loratadine, desloratadine) at maximum indicated doses, each used for ≥2 weeks, AND (ii) a leukotriene modifier (LTRA) in combination with an antihistamine at maximum indicated doses for ≥2 weeks; 5. Rhapsido (remibrutinib) is not prescribed concurrently with Dupixent (dupilumab) or Xolair (omalizumab); 6. Dose does not exceed 50 mg (2 tablets) per day.dose <= 50 mg/day

Approval duration: 12 months

Continuation Therapy (CSU)

Covered when ALL of the following are met

Continuation Approval - CSU: 1. Member meets one of the following: (a) Currently receiving medication via Centene benefit or previously met initial approval criteria; OR (b) Member is currently receiving medication and is enrolled in a state/product with continuity of care regulations; 2. Member is responding positively to therapy; 3. Rhapsido (remibrutinib) is not prescribed concurrently with Dupixent (dupilumab) or Xolair (omalizumab); 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

Other Indications

Requests for other diagnoses/indications

Other Indications: 1. If the drug has undergone a label change within the last 6 months that is not yet reflected in this policy, refer to the appropriate formulary/no‑coverage or non‑formulary policy for the relevant line of business (see policy references listed in the document); OR 2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III and criterion 1 does not apply, refer to the off‑label use policy for the relevant line of business (commercial, marketplace, or Medicaid).

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

For members covered under a state Medicaid program, state Medicaid coverage provisions take precedence when they conflict with the provisions of this clinical policy. Refer to the applicable state Medicaid manual for specific coverage requirements that supersede this policy.

Requests for non‑FDA approved indications that do not include sufficient supporting documentation per the referenced off‑label use policies or evidence of coverage will be considered not authorized (NMN) under this policy.

Provider Requirements and Authorization Details

Prior Authorization

Prior Authorization Guided by Medical Necessity

Prior authorization is required for coverage and will be determined using the plan's medical necessity criteria as described in this clinical policy. Approval decisions are guided by the clinical policy and supporting documentation submitted by the provider; the policy serves as a guide to medical necessity but is not a guarantee of coverage.

Prior authorization required
Decisions guided by medical necessity criteria in this clinical policy

Denial Risk

Coverage Decision Constraints

Coverage decisions and the administration of benefits are subject to the terms, conditions, exclusions, and limitations of the member's coverage documents (e.g., evidence of coverage, certificate of coverage, policy, contract of insurance) and to applicable state and federal requirements and Health Plan-level administrative policies and procedures.

Coverage subject to member's contract terms, exclusions, and limitations
State and federal laws and Health Plan administrative policies apply

Documentation Required

Required Adherence to Coverage Documents and Documentation Requirements

Providers must follow this clinical policy, the applicable coverage documents, and applicable state and federal requirements when submitting requests. Documentation (office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria must be provided with the prior authorization request.

Submit supporting documentation with PA request (chart notes, labs, other clinical information)
Adhere to coverage documents and state/federal requirements when requesting authorization

Background

Chronic spontaneous urticaria (CSU) is characterized by the spontaneous appearance of wheals, angioedema, or both for a duration of more than six weeks without an identifiable cause. Remibrutinib (Rhapsido) is a Bruton's tyrosine kinase (BTK) inhibitor approved for the treatment of adult patients with CSU who remain symptomatic despite H1 antihistamine therapy. Clinical trials have demonstrated that remibrutinib provides significant improvement versus placebo in patients with CSU; approximately 30% of trial participants had prior exposure to anti‑IgE biologic therapy. The approved dosing for adults is up to a maximum of 50 mg per day (two 25 mg tablets), and prior authorization is required with an approval duration of 12 months when coverage criteria are met.

Definitions

Chronic spontaneous urticaria (CSU)

DefinitionChronic spontaneous urticaria (CSU) is spontaneous onset of wheals, angioedema, or both for more than 6 weeks due to an unknown cause.

Typical clinical contextOccurs in patients who remain symptomatic despite H1‑antihistamine treatment; remibrutinib trials included patients with prior anti‑IgE biologic exposure (~30%).

LimitationsCSU is distinct from other forms of urticaria; guideline placement and stepwise treatments (e.g., antihistamine escalation, LTRA, omalizumab) apply per clinical guidance.

Remibrutinib (Rhapsido)

Drug classBruton's tyrosine kinase (BTK) inhibitor.

Proprietary nameRemibrutinib (Rhapsido).

FDA‑approved indicationIndicated for treatment of chronic spontaneous urticaria (CSU) in adult patients who remain symptomatic despite H1 antihistamine treatment.

Limitation of useNot indicated for other forms of urticaria.

Provider

DefinitionProviders referred to in this clinical policy are independent contractors who exercise independent judgment and over whom the Health Plan has no control or right of control.

Employment statusProviders are not agents or employees of the Health Plan.

ResponsibilityProviders are expected to exercise professional medical judgment and are solely responsible for medical advice and treatment of members.