CurrentCignaPolicy IP0771

Rhapsido (remibrutinib) for chronic spontaneous urticaria — Coverage Criteria

Defines prior authorization and medical necessity criteria for coverage of Rhapsido (remibrutinib) for adults with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine therapy; applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyRhapsido (remibrutinib) for chronic spontaneous urticaria — Coverage Criteria

Policy CodePolicy IP0771

Change TypeNew policy

Effective Date

Next Review Date

Key ActionObtain prior authorization and document specialist prescribing/consultation plus prior high‑dose second‑generation H1 antihistamine use before initiating Rhapsido.

SourceLink

POLICY UPDATE CHANGES

New coverage policy established for Rhapsido (remibrutinib) with specific prior authorization criteria.

≥18Minimum age for approval

≥6 wksMinimum urticaria duration

6 moInitial approval

1 yrContinuation approval

Coverage Criteria for Rhapsido (remibrutinib)

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FDA-Approved Indication

Approve Rhapsido for chronic spontaneous urticaria in adults when meeting one of the following:

Approval pathways: Pathway A (Initial Therapy) OR Pathway B (Currently Receiving Rhapsido)

Pathway A: Initial Therapy: Approve for 6 months if ALL of the following are met

A.i Age: Patient is >= 18 years of age

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A.ii Duration: Patient has/had urticaria for >= 6 weeks (prior to treatment with Rhapsido)>= 6 weeks

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A.iii Prior therapy: According to the prescriber, the patient has tried high-dose oral second-generation H1 antihistamine therapy (highest tolerated dose, up to 4x the FDA‑approved dose)up to 4x dose

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A.iv Prescriber specialty: Medication is prescribed by or in consultation with an allergist, immunologist, or dermatologist

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Pathway B: Currently Receiving Rhapsido: Approve for 1 year if BOTH criteria are met

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B.i Prior Rhapsido exposure: Patient has already received at least 6 months of therapy with Rhapsido>= 6 months

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B.ii Clinical response (one required): Patient has experienced a beneficial clinical response defined by one of: decreased itch severity OR decreased number of hives OR decreased size of hives1 of 3

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Rhapsido (remibrutinib) is indicated specifically for chronic spontaneous urticaria (CSU) in adults who remain symptomatic despite H1 antihistamine treatment. Rhapsido is not indicated for other forms of urticaria; use for other urticaria subtypes is considered not medically necessary.

Use of Rhapsido for any indication other than the specified FDA‑approved CSU indication is considered not medically necessary. Criteria will be updated if new published data become available.

Provider Requirements and Prior Authorization

Prior Authorization

Prior authorization required — initial 6‑month approval and specialist involvement

Prior authorization is required for Rhapsido. Initial approvals for new starts are authorized for 6 months and the medication must be prescribed by or in consultation with an allergist, immunologist, or dermatologist; initial approval also requires evidence the patient tried high‑dose oral second‑generation H1 antihistamine therapy. Continuation approvals require ≥ 6 months prior Rhapsido use and documented clinical benefit and are authorized for 1 year.

Initial approval duration: 6 months
Prescriber requirement: prescribed by or in consultation with an allergist, immunologist, or dermatologist
Initial prior therapy requirement: trial of high‑dose oral second‑generation H1 antihistamine

Step Therapy

Step therapy — trial of high‑dose second‑generation H1 antihistamine required

Patient must have remained symptomatic despite treatment with a second‑generation H1 antihistamine; the prescriber must attest the patient tried high‑dose oral second‑generation H1 antihistamine therapy (defined as up to 4× the FDA‑approved dose, i.e., the highest dose tolerated).

Step therapy: trial of high‑dose oral second‑generation H1 antihistamine (up to 4× FDA dose)
Symptomatic disease defined as itch and hives for ≥ 6 consecutive weeks prior to screening

Documentation Required

Required documentation for prior authorization — specialist involvement and therapy trials

For initial prior authorization, the medication must be prescribed by or in consultation with an allergist, immunologist, or dermatologist and the prescriber must document that the patient tried high‑dose second‑generation H1 antihistamine therapy. For continuation, document ≥ 6 months of prior Rhapsido therapy and evidence of clinical benefit (decreased itch severity, decreased number of hives, or decreased size of hives).

Initial documentation: prescriber specialty or consultation and attestation of high‑dose H1 antihistamine trial
Continuation documentation: ≥ 6 months Rhapsido use plus documented clinical response (one of decreased itch, decreased number of hives, or decreased hive size)

Denial Risk

Coding-related denials — submit covered diagnosis/procedure codes

Claims submitted for services that are not accompanied by covered diagnosis or procedure code(s) under the applicable Coverage Policy will be denied as not covered.

Use the most appropriate covered codes when billing; services billed for conditions not covered under this policy will be denied

Definitions

Chronic spontaneous urticaria (CSU)

DefinitionAppearance of wheals, angioedema, or both for > 6 weeks due to known or unknown causes

Symptom patternSigns and symptoms may be present daily/almost daily or have an intermittent recurrent course

First-line therapy noteSecond-generation H1 antihistamines taken regularly are recommended first-line treatment

High-dose second-generation H1 antihistamine therapy

DefinitionHighest dose tolerated by the patient, up to four times the FDA-approved dose

Examples of agentsCetirizine, desloratadine, fexofenadine, levocetirizine, loratadine

Clinical guidanceIncrease antihistamine dose up to 4-fold if standard doses do not eliminate signs and symptoms

OpenPayer

Rhapsido (remibrutinib) for chronic spontaneous urticaria — Coverage Criteria

Coverage Criteria for Rhapsido (remibrutinib)

Coding and Related Criteria

Provider Requirements and Prior Authorization

Definitions

Background

Revision History / Policy Changes