CurrentCignaPolicy IP0335

Icatibant (Firazyr, Sajazir) for acute hereditary angioedema attacks

This Cigna drug coverage policy defines medical necessity, reauthorization, dosing, exclusions, authorization durations, and billing code for icatibant (Firazyr, Sajazir) for treatment of acute hereditary angioedema (HAE) attacks in adults.

Policy Summary

PayerCigna

PolicyIcatibant (Firazyr, Sajazir) for acute hereditary angioedema attacks

Policy CodePolicy IP0335

Change TypeRevised (annual)

Effective DateJan 15, 2025

Next Review Date

Key ActionAuthorization required per Cigna coverage policy; document diagnostic confirmation and prescriber specialty (allergist/immunologist or consult) for initial and reauthorization approvals up to 12 months.

SourceLink

POLICY UPDATE CHANGES

Updated review date, disclaimer, refreshed background and references, and addition of change history.

1Covered Indication (acute HAE attacks)

12Authorization Durations (months)

J1744Primary HCPCS Drug Code Listed

Coverage Summary

This policy: covered_with_criteria for icatibant (Firazyr, Sajazir) for treatment of acute hereditary angioedema (HAE) attacks in adults ≥ 18 years. This Cigna drug coverage policy defines medical necessity, reauthorization, dosing, exclusions, authorization durations, and billing code for icatibant (Firazyr, Sajazir) for treatment of acute hereditary angioedema (HAE) attacks in adults.

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Initial Therapy - Hereditary Angioedema (HAE) - Treatment of Acute Attacks

Icatibant is considered medically necessary when the individual meets ALL of the following criteria:

ALL of the following

ONE of
- Confirmed pathogenic variant in the SERPING1, F12, ANGPT1, PLG or KNG1 gene
- ALL of the following
  - Has low levels of functional C1-INH protein (less than 50% of normal) at baseline, as documented by laboratory reference values< 50% of normal
  - Has low C1-INH antigenic levels (less than 50% of normal) at baseline, as documented by laboratory reference values< 50% of normal
Icatibant will not be concomitantly administered with other FDA-approved treatments for acute HAE attacks (for example, Berinert, Cinryze, Kalbitor, or Ruconest)
Medication is prescribed by, or in consultation with, an allergist/immunologist
Non-Covered Product Criteria is met (refer to Employer Group and Individual & Family Plan Non-Covered Products and Criteria tables)

Reauthorization / Continuation Therapy

Continuation is medically necessary when ALL of the following are met:

ALL of the following

The above medical necessity criteria were met prior to the start of icatibant therapy
There is documentation of beneficial response since initiating icatibant therapy (examples: decrease in duration of HAE attacks, quick onset of symptom relief, complete resolution of symptoms, or decrease in attack frequency or severity)
Medication continues to be prescribed by, or in consultation with, an allergist/immunologist or a physician who specializes in HAE or related disorders

Conditions Not Covered (Excluded Uses)

Any other use is considered experimental, investigational, or unproven, including the following:

ANY of the following

Hereditary Angioedema (HAE) Prophylaxis — icatibant is not indicated for prophylaxis of HAE attacks
Episodes of angioedema with normal C1-inhibitor (levels and function) not related to a documented pathogenic variant in the F12, ANGPT1, PLG or KNG1 gene

Provider Actions & Billing

Prior Authorization

Prior authorization required

Prior authorization is required per Cigna coverage policy. Initial and reauthorization approvals may be granted for up to 12 months. Providers must document diagnostic confirmation and the prescriber specialty (allergist/immunologist or consult) when requesting authorization. Affected code: J1744.

Authorization duration: up to 12 months
Document diagnostic confirmation
Document prescriber specialty (allergist/immunologist or consult)
Affected code: J1744

Documentation Required

Diagnostic documentation required

Providers must document either a confirmed pathogenic variant in SERPING1, F12, ANGPT1, PLG, or KNG1 OR laboratory evidence of one C4 level below the laboratory lower limit of normal AND one of the following: low C1‑INH functional level (< 50% of normal, baseline, per laboratory reference values) or low C1‑INH antigenic level (< 50% of normal, baseline, per laboratory reference values).

Confirmed pathogenic variant in SERPING1, F12, ANGPT1, PLG, or KNG1
One C4 level below the laboratory lower limit of normal AND one of:
- C1‑INH functional level < 50% of normal (baseline), per laboratory reference values
- C1‑INH antigenic level < 50% of normal (baseline), per laboratory reference values

Denial Risk

Concomitant therapy exclusion

Claims may be denied or not authorized if icatibant is administered concomitantly with other FDA‑approved acute HAE treatments. Examples include Berinert, Cinryze, Kalbitor, and Ruconest.

Do not administer icatibant concurrently with other FDA‑approved acute HAE treatments
Examples: Berinert, Cinryze, Kalbitor, Ruconest

Billing Rule

Dosing frequency limitation

Icatibant dosing is limited to up to 30 mg per injection, administered subcutaneously, and no more frequently than three times daily. Billing and claims must reflect these dosing limits. Affected code: J1744.

Dose: up to 30 mg per injection
Route: subcutaneous
Frequency: no more frequently than three times daily
Ensure billing reflects these limits
Affected code: J1744

Covered HCPCS/Drug CodeHCPCSCovered

J1744

Injection, icatibant, 1 mg

Clinical Evidence & Guidelines

Icatibant is a synthetic decapeptide indicated for treatment of acute hereditary angioedema (HAE) attacks in adults ≥ 18 years. Guidelines recommend ready access to effective on-demand medication for all HAE attacks, and that patients carry medication for treatment of at least two attacks. First-line acute treatment options include intravenous C1-INH (plasma-derived or recombinant), ecallantide (Kalbitor), and icatibant.

Firazyr prescribing information — Takeda; October 2021.

US HAE Association guideline — Busse et al., J Allergy Clin Immunol Pract. 2021;9(1):132-150.e3.

WAO/EAACI guideline — Maurer et al., Allergy. 2022;77(7):1961-1990.

Background & Definitions

Icatibant is indicated for treatment of acute HAE attacks in adults ≥ 18 years and is used in the typical clinical context of on-demand therapy to minimize morbidity and prevent mortality from ongoing attacks; testing to confirm HAE may include C4, C1-INH antigenic and functional levels, and genetic testing as appropriate.

Term	Definition
HAE	Hereditary angioedema
C1-INH	C1 esterase inhibitor

Laboratory Thresholds for HAE Diagnosis

C1-INH functional level< 50% of normal (baseline), as documented by laboratory reference values

C1-INH antigenic level< 50% of normal (baseline), as documented by laboratory reference values

C4 levelBelow the lower limit of normal as defined by the laboratory performing the test