CurrentColorado Rocky Mountain Health PlansPolicy 2026 P 2392-1

Rhapsido (remibrutinib) prior authorization / medical necessity

Defines initial and reauthorization prior authorization and medical necessity criteria for Rhapsido (remibrutinib) for treatment of chronic spontaneous urticaria (CSU) in adults, including prescriber requirements, concomitant therapy exclusions, approval duration, and program notes.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyRhapsido (remibrutinib) prior authorization / medical necessity

Policy CodePolicy 2026 P 2392-1

Change TypeNew program / Prior Authorization

Effective DateMay 1, 2026

Next Review Date

Key ActionProviders must obtain prior authorization demonstrating all initial or reauthorization criteria are met, including diagnosis of CSU, prior antihistamine trials or contraindications, prescriber specialty, and that Rhapsido is not used with dupilumab or omalizumab for same indication.

POLICY UPDATE CHANGES

New program for Prior Authorization/Medical Necessity for Rhapsido (remibrutinib) established.

1Covered Indication (CSU)

12mAuthorization Duration

>=2wRequired antihistamine trial length

Coverage Summary

Policy covers Rhapsido (remibrutinib) for chronic spontaneous urticaria (CSU) in adults who remain symptomatic despite H1 antihistamine treatment. Limitations of Use: Rhapsido is not indicated for other forms of urticaria. Effective date: 2026-05-01. Policy number: 2026 P 2392-1. Source: package insert referenced in the policy.

Quick facts

Covered indicationChronic spontaneous urticaria (CSU)

Authorization duration12 months

Required antihistamine trial length>= 2 weeks

H1-antihistamine trial duration threshold badge>= 2 weeks

Initial Therapy Criteria

Continuation / Reauthorization Criteria

Authorizations (initial and reauthorization) will be issued for 12 months.

Limitations / Exclusions

Limitations of Use: Rhapsido is not indicated for other forms of urticaria. Additionally, Rhapsido must not be used in combination with Dupixent (dupilumab) or Xolair (omalizumab) for treatment of the same indication.

Applicable Codes

ICD-10 Diagnosis Relevant to CoverageICD-10

No codes listed

Drug / NDCNDCCovered

remibrutinib (Rhapsido)

Rhapsido (remibrutinib) — brand referenced in policy; specific NDCs per formulary not listed in document

Provider Actions

Prior Authorization

Prior authorization required for Rhapsido

Providers must obtain prior authorization demonstrating that all initial or reauthorization criteria are met: diagnosis of chronic spontaneous urticaria; required prior antihistamine trials or documented contraindication/intolerance; prescriber is an allergist, dermatologist, or immunologist; and Rhapsido is not being used in combination with dupilumab (Dupixent) or omalizumab (Xolair) for the same indication.

Documentation Required

Document prior therapy and response

For initial requests, document trials of the required H1-antihistamines (each trial ≥2 weeks) or a history of contraindication or intolerance to those therapies, including single-agent or specified combination regimens. For reauthorization, document a positive clinical response to Rhapsido (for example, reduction in exacerbations, itch severity, or hives).

Billing Rule

Approval duration

Authorizations for Rhapsido — both initial approvals and reauthorizations — will be issued for a 12-month duration.

12 months

Clinical Evidence & Source

Evidence: Rhapsido [package insert], Novartis Pharmaceuticals Corporation, September 2025 is the primary source cited in this policy.

Background

Rhapsido (remibrutinib) is a kinase inhibitor indicated for chronic spontaneous urticaria (CSU) in adult patients who remain symptomatic despite H1 antihistamine treatment. It is not indicated for other forms of urticaria.

Revision History

2/2026P&T Approval

New program for Prior Authorization/Medical Necessity for Rhapsido (remibrutinib) established.

2026-05-01Effective DateLatest

New program for Prior Authorization/Medical Necessity for Rhapsido (remibrutinib) established.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyRhapsido (remibrutinib) prior authorization / medical necessity

Policy CodePolicy 2026 P 2392-1

Change TypeNew program / Prior Authorization

Effective DateMay 1, 2026

Next Review Date

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