CurrentUnitedHealthcarePolicy N/A

Rhapsido (remibrutinib) prior authorization

Prior authorization and medical necessity criteria for Rhapsido (remibrutinib) for treatment of chronic spontaneous urticaria in adults; applies to prescribers, pharmacists, and utilization management staff administering UnitedHealthcare Clinical Pharmacy Programs.

Policy Summary

PayerUnitedHealthcare

PolicyRhapsido (remibrutinib) prior authorization

Policy CodePolicy N/A

Change TypeNew program / Added

Effective DateMay 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with documented diagnosis of chronic spontaneous urticaria and evidence of required prior antihistamine trials or documented contraindications/intolerance.

SourceLink

POLICY UPDATE CHANGES

New prior authorization program for Rhapsido (remibrutinib) with initial and reauthorization clinical criteria.

12 monthsauthorization duration

Adults with CSUindicated population

≥2 weeksantihistamine trial

Allergist/Derm/Immunprescriber limit

Coverage and Medical Necessity Criteria

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Initial Authorization Criteria

Approved when ALL of the following are met

Initial Authorization - top: Initial authorization requires all listed criteria

Diagnosis of chronic spontaneous urticaria

Prior antihistamine therapy options: One of the following: (1) Patient remains symptomatic despite at least a 2-week trial of, or history of contraindication or intolerance to, two H1-antihistamines OR (2) Patient remains symptomatic despite at least a 2-week trial of, or history of contraindication or intolerance to both agents taken in combination: a second-generation H1-antihistamine AND one of a different second-generation H1-antihistamine, a first-generation H1-antihistamine, an H2-antihistamine, or a leukotriene modifier.>= 2 weeks

Examples in policy: second-generation H1s (fexofenadine, loratadine, cetirizine); first-generation H1s (diphenhydramine, chlorpheniramine, hydroxyzine); H2-antagonists (famotidine, cimetidine, ranitidine); leukotriene modifier (montelukast).

Concomitant therapy exclusion: Patient is not receiving Rhapsido in combination with Dupixent (dupilumab) or Xolair (omalizumab) for treatment of the same indication.

Prescriber specialty: Prescribed by an Allergist, Dermatologist, or Immunologist.

Reauthorization Criteria

Approved when ALL of the following are met

Reauthorization - top: Reauthorization requires all listed criteria

Authorization will be issued for 12 months.

Clinical response: Documentation of positive clinical response to Rhapsido therapy (e.g., reduction in exacerbations, itch severity, hives).

Concomitant therapy exclusion: Patient is not receiving Rhapsido in combination with Dupixent (dupilumab) or Xolair (omalizumab) for treatment of the same indication.

Prescriber specialty: Prescribed by an Allergist, Dermatologist, or Immunologist.

Rhapsido (remibrutinib) is not indicated for other forms of urticaria. Coverage and clinical use of Rhapsido under this policy are limited to the treatment of chronic spontaneous urticaria (CSU) as defined in the criteria; requests for Rhapsido to treat alternative urticaria subtypes do not meet the policy’s coverage criteria and may be denied.

Provider Requirements, Prior Authorization, and Denial Risks

Prior Authorization

Prior Authorization Required

Prior authorization is required before initiating Rhapsido for chronic spontaneous urticaria. Submit clinical documentation showing diagnosis, prior step-therapy trials (see step therapy callout), prescriber specialty, and confirmation that Rhapsido will not be used concurrently with Dupixent (dupilumab) or Xolair (omalizumab) for the same indication.

Affected therapy: Rhapsido for chronic spontaneous urticaria
Prescriber specialties required: Allergist, Dermatologist, or Immunologist
Authorization duration: 12 months

Step Therapy

Step Therapy Requirements

Before Rhapsido is authorized, the member must have tried and had inadequate response to specified antihistamine therapy per the step therapy criteria. Document dates, doses, duration (at least 2 weeks each), and reason for discontinuation if applicable. FDA‑labeled alternatives count if supported by labeling.

Option 1: At least a 2-week trial of, or contraindication/intolerance to, two H1-antihistamines (examples: fexofenadine, diphenhydramine, loratadine)
OR Option 2: At least a 2-week trial of, or contraindication/intolerance to, a combination that includes a second-generation H1-antihistamine plus one of: another second-generation H1-antihistamine, a first-generation H1-antihistamine, an H2-antihistamine, or a leukotriene modifier (e.g., montelukast)
Notes: Each trial should be documented (drug name, dose, dates, and reason for failure).

Documentation Required

Required Clinical Documentation

Include the following clinical documentation with initial and reauthorization requests to avoid delay or denial: diagnosis, prior medication trials, prescriber specialty, and evidence of clinical benefit for reauthorization.

Initial requests: diagnosis of chronic spontaneous urticaria; documentation of required antihistamine trials (drug names, doses, start/end dates, and reason for failure or intolerance); prescriber specialty (Allergist, Dermatologist, or Immunologist); statement that Rhapsido will not be used with Dupixent or Xolair for the same indication.
Reauthorization requests: documentation of positive clinical response to Rhapsido (examples: reduction in exacerbations, decreased itch severity, fewer hives), and ongoing medication adherence.
Administrative: include member identifiers, prior authorization number (if available), and relevant chart notes or visit summaries.

Denial Risk

Grounds for Denial / Missing Documentation

Claims or prior authorization requests may be denied if key documentation or criteria are missing. Confirm all required items are provided to reduce risk of denial.

Common reasons for denial: missing documentation of required antihistamine trials (including duration and reason for failure), absence of diagnosis of chronic spontaneous urticaria, prescriber not in an approved specialty, concurrent use with Dupixent (dupilumab) or Xolair (omalizumab) for the same indication, or lack of evidence of clinical benefit on reauthorization.
Administrative denials: incomplete member identifiers, missing prior authorization form fields, or absent supporting chart notes.

OpenPayer

Rhapsido (remibrutinib) prior authorization

Coverage and Medical Necessity Criteria

Coding and Key Values

Provider Requirements, Prior Authorization, and Denial Risks

Background and Therapeutic Context

Definitions and Clinical Terms