CurrentUnitedHealthcarePolicy N/A

Icatibant (Firazyr, Sajazir) prior authorization

Prior authorization criteria and program rules for icatibant products (Firazyr, Sajazir) for treatment of acute hereditary angioedema (HAE) attacks in adults; applies to UnitedHealthcare pharmacy benefits and affected members/providers.

Policy Summary

PayerUnitedHealthcare

PolicyIcatibant (Firazyr, Sajazir) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMay 1, 2026

Next Review DateFeb 2, 2026

Key ActionObtain prior authorization showing diagnosis of hereditary angioedema and that icatibant is prescribed for an acute HAE attack.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+age requirement (adults 18 years and older)

12 moauthorization duration issued

2products covered (Firazyr, Sajazir)

PAprogram type

Coverage Criteria for Icatibant (Firazyr, Sajazir)

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Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met:

Initial Authorization: Member has a diagnosis of hereditary angioedema (HAE)

Indication: Icatibant (Firazyr or Sajazir) is prescribed for the treatment of an acute HAE attack

Combination therapy exclusion: Icatibant is not used in combination with other products indicated for the acute treatment of HAE attacks (e.g., Berinert, Ekterly, Kalbitor, Ruconest)

Firazyr and Sajazir are generally not covered under standard benefit provisions. Firazyr (brand) and Sajazir are typically excluded from coverage; however, UnitedHealthcare may perform coverage reviews and consider coverage when required by applicable law or when the member’s specific benefit plan mandates review or coverage. State mandates, federal requirements, or member-specific benefit plan language may supersede the exclusion and affect coverage determinations.

Initial Therapy

Initial therapy — initial coverage criteria

Initial coverage criteria:

Diagnosis of hereditary angioedema (HAE)

Prescribed use: Prescribed for the treatment of an acute HAE attack

Combination exclusion: Not used in combination with other products indicated for acute HAE attacks (e.g., Berinert, Ekterly, Kalbitor, Ruconest)

Provider Actions, Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Firazyr (icatibant) or Sajazir (icatibant). Requests will be approved only when documentation demonstrates a diagnosis of hereditary angioedema (HAE) and the medication is prescribed for treatment of an acute HAE attack. Authorization will be issued for up to 12 months. State mandates, federal requirements, and the member's benefit plan may affect coverage.

Drug names: Firazyr (icatibant), Sajazir (icatibant)
Approval duration: up to 12 months

Prior Authorization

Approval Conditions

Approval requires all of the following: 1) documented diagnosis of hereditary angioedema (HAE); and 2) prescribed for the treatment of acute HAE attacks. Requests that do not meet both criteria will not be approved.

Required: diagnosis of HAE (ICD-10 documentation)
Required: indication documented as treatment of an acute HAE attack

Denial Risk

Combination Therapy Exclusion

Firazyr/Sajazir will not be approved when used in combination with other products indicated for acute HAE treatment.

Combination therapy exclusion: Berinert, Ekterly, Kalbitor, Ruconest (and other acute HAE products)

Step Therapy

Step Therapy / Automated Approvals

There is no step therapy requirement for initial approval. UnitedHealthcare may use automated approval and re-authorization processes based on prior claim/medication history, diagnosis codes, and claim logic where applicable.

No step therapy required
Automated approval/re-approval may be used per program or therapeutic class

Re-authorization / Continuation Criteria

Re-authorization — continuation and re-authorization criteria

Re-authorization and continuation:

Duration: Authorization will be issued for 12 months12 months

UnitedHealthcare may use prior claim/medication history, diagnosis codes, and automated processes for re-authorization; state mandates and member-specific benefit plan conditions may apply

Step	Requirement / Note
No explicit step-therapy steps specified	UnitedHealthcare may approve initial and re-authorization based solely on previous claim/medication history, diagnosis codes (ICD-10), and/or claim logic; use of automated approval and re-approval processes varies by program and/or therapeutic class. Supply limits may be in place.

Background

Icatibant is a bradykinin B2 receptor antagonist indicated for treatment of acute attacks of hereditary angioedema (HAE) in adults. The policy applies to icatibant products including Firazyr and Sajazir and notes that the indication is limited to adults 18 years and older. Authorization for icatibant, when granted, is issued for 12 months, and applicable state or federal mandates and member benefit plan provisions may affect coverage.

Definitions

HAE definition and treatment context

DefinitionHereditary angioedema (HAE) is a genetic condition characterized by recurrent episodes of localized edema (acute HAE attacks)

Pathophysiology / targetAcute HAE attacks are mediated by the bradykinin pathway; icatibant is a bradykinin B2 receptor antagonist used to treat these attacks

Age requirementIndicated for treatment of acute HAE attacks in adults 18 years of age and older

Relevant medicationsIcatibant products: Firazyr (icatibant) and Sajazir (icatibant)

Treatment contextIcatibant is used for acute, on‑demand treatment of HAE attacks rather than as chronic prophylaxis