ModifiedEmblemHealthPolicy MG.MM.PH.34

Medical Policy: Firazyr (icatibant) injection solution

Defines medical necessity criteria, dosing limits, procedure/NDC/ICD-10 codes, authorization duration and renewal criteria for Firazyr (icatibant) for acute treatment of hereditary angioedema (HAE) in adults.

Policy Summary

PayerEmblemHealth

PolicyMedical Policy: Firazyr (icatibant) injection solution

Policy CodePolicy MG.MM.PH.34

Change TypeDosing limit revision (substantive)

Effective Date

Next Review Date

Key ActionTreating physician must submit clinical evidence that the member meets criteria (age, avoidance of causative medications, specialist involvement/consult, qualifying attack history, laboratory or genetic evidence of HAE subtype) for preauthorization or post-payment review.

SourceLink

POLICY UPDATE CHANGES

Updated dosing limits: removed '30 billable units per dose up to 3 times in a 24‑hour period once per week' and replaced with '360 billable units per 28 days'.

Increased coverage duration to 6 months and removed requirement for H. pylori negativity; updated HAE clinical presentation table.

Typo fix in title only with no criteria changes.

Annual review with no criteria changes.

18+Minimum age for coverage (years)

360 UDosing limit (per 28 days)

6 monthsInitial approval duration

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Authorized on-hand quantity planning

Coverage Summary

Firazyr (icatibant) is a bradykinin B2 receptor antagonist indicated for treatment of acute hereditary angioedema (HAE) attacks in adults 18 years and older.

EmblemHealth coverage stance: covered_with_criteria; medical necessity criteria and authorization parameters were established based on clinical evidence and guideline review.

Key authorization and dosing highlights: Max dose = 360 billable units per 28 days; initial approvals are granted for 6 months and may be renewed per renewal criteria; authorizations provide sufficient quantity to permit the member to have on‑hand medication to treat up to 4 acute attacks per 4 weeks for the duration of the authorization.

Key coverage limits

Minimum age18+ years

Dosing limit360 billable units per 28 days

Initial approval duration6 months

Authorized on-hand quantity planningQuantity to treat up to 4 attacks per 4 weeks

Medical Necessity Criteria

Initial therapy — Medical necessity for Firazyr (icatibant) for acute HAE attacks

Firazyr (icatibant) is considered medically necessary when ALL of the following are met:

ALL of the following

Patient is 18 years of age or older
Confirmation that member is avoiding medications known to cause angioedema (e.g., ACE inhibitors, oral contraceptives, hormone replacement therapy, DPP‑IV inhibitors, Neprilysin inhibitors)
Firazyr is prescribed by, or in consultation with, a specialist in allergy, immunology, hematology, pulmonology, or medical genetics
Member has a history of moderate to severe cutaneous OR abdominal attacks OR mild to severe airway swelling attacks of HAE (i.e., debilitating cutaneous/gastrointestinal symptoms or laryngeal/pharyngeal/tongue swelling)

Applicable Codes

Applicable Procedure Codes (medical benefit)HCPCSCovered

J1744

Injection, icatibant, 1 mg

Applicable NDCsNDCCovered

54092-0702-03	Firazyr 30mg/3mL Solution Injection, Icatibant, 1 mg
54092-0702-02	Firazyr 30mg/3mL Solution Injection, Icatibant, 1 mg

Applicable ICD-10 Diagnoses (supported indication)ICD-10Covered

D84.1

Defects in the complement system

Provider Actions & Authorization Requirements

Prior Authorization

Clinical documentation required for authorization

Treating physician must submit clinical evidence that the member meets criteria for Firazyr authorization, including: confirmation the patient is ≥18 years old; documentation that the member is avoiding medications known to cause angioedema (e.g., ACE inhibitors, oral contraceptives, hormone replacement therapy, DPP‑IV inhibitors, neprilysin inhibitors); evidence of specialist involvement or consultation (allergy, immunology, hematology, pulmonology, or medical genetics); history of qualifying attack severity (moderate–severe cutaneous or abdominal attacks or any airway swelling); and laboratory or genetic evidence supporting the HAE subtype per guidelines (e.g., C1‑INH antigenic/functional levels, C4, C1q, or known HAE‑causing mutation). Authorization and post‑payment review require this documentation. Affected codes: J1744, D84.1.

Patient age ≥18 years (see diagnostic criteria).
Documentation member is avoiding listed causative medications.
Specialist prescribing or documentation of consultation.
History of qualifying HAE attack severity (cutaneous/abdominal or airway).
Laboratory/genetic evidence consistent with HAE subtype.
Affected codes: J1744 (icatibant injection) and D84.1 (complement defects).

Background, Evidence & Definitions

Firazyr (icatibant) is indicated for treatment of acute HAE attacks in adults 18 years and older. EmblemHealth developed clinical review criteria to determine medical necessity for Firazyr based on regulatory indication, peer‑reviewed evidence, and guideline recommendations.

The criteria require documentation of patient age (≥18 years), avoidance of medications that can cause angioedema (for example ACE inhibitors, oral contraceptives, hormone replacement therapy, DPP‑IV inhibitors, neprilysin inhibitors), prescribing or consultation by a relevant specialist (allergy, immunology, hematology, pulmonology, or medical genetics), and a history of qualifying HAE attack severity (moderate to severe cutaneous or abdominal attacks or any airway swelling).

Laboratory or genetic confirmation consistent with HAE subtype (HAE I, HAE II, or HAE with normal C1‑INH) is required as described in the guideline. Applicable codes and identifiers for administration and billing include HCPCS J1744 and NDCs 54092-0702-03 and 54092-0702-02; the ICD‑10 diagnosis supporting the indication is D84.1 (defects in the complement system).

Authorization considerations: approvals are for 6 months, with renewal contingent on continued meeting of criteria, clinical benefit, and absence of unacceptable toxicity; the cumulative on‑hand quantity will be managed to allow treatment of up to 4 attacks per 4 weeks. The policy was updated 4/08/2025 to revise dosing limits (replacing prior per‑dose/week language with a 360 billable units per 28 days limit).

Source	Reference
Package insert
Firazyr [package insert], Shire Orphan Therapies LLC; December 2015
Guideline citations
Multiple HAE management guidelines and consensus documents (WAO, HAEA, international consensus) — see listed references in policy
Applicable NDCs
54092-0702-03; 54092-0702-02 — Firazyr 30mg/3mL Solution Injection, icatibant, 1 mg

Firazyr: Bradykinin B2 receptor antagonist indicated for treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.

Revision History

2025-04-08dosing_revisionLatest

Updated dosing limits: removed '30 billable units per dose up to 3 times in a 24‑hour period once per week' and replaced with '360 billable units per 28 days'.

2024-02-05typo_fix

Typo fix in title only with no criteria changes.

2023-06-29annual_review

Policy Summary

PayerEmblemHealth

PolicyMedical Policy: Firazyr (icatibant) injection solution

Policy CodePolicy MG.MM.PH.34

Change TypeDosing limit revision (substantive)

Effective Date

Next Review Date

SourceLink

On This Page

Member has one of the following clinical presentations consistent with HAE subtype

HAE I (C1‑inhibitor deficiency)
- Low C1‑INH antigenic level (below laboratory lower limit of normal)
- Low C4 level (below laboratory lower limit of normal)
- Low C1‑INH functional level (below laboratory lower limit of normal)
- ANY of the following
  - Member has a family history of HAE
  - Normal C1q level
HAE II (C1‑inhibitor dysfunction)
- Normal to elevated C1‑INH antigenic level
- Low C4 level (below laboratory lower limit of normal)
- Low C1‑INH functional level (below laboratory lower limit of normal)
HAE with normal C1‑INH (HAE III)
- Normal C1‑INH antigenic level
- Normal C4 level
- Normal C1‑INH functional level
- ANY of the following
  - Member has a known HAE‑causing mutation (e.g., F12, angiopoietin‑1, plasminogen)
  - Member has a family history of HAE

Billing Rule

Authorization quantity rule

Authorization will provide sufficient quantity for the member to have on‑hand medication to treat up to 4 acute attacks per 4 weeks for the duration of the authorization. The cumulative on‑hand amount of HAE medication(s) will be considered when authorizing. Applicable codes include J1744 and the listed NDCs for Firazyr.

Quantity authorized supports up to 4 attacks per 4 weeks for the authorization period.
Cumulative on‑hand amount will be taken into account.
Affected codes: J1744 and NDCs 54092-0702-03, 54092-0702-02.

Documentation Required

Specialist prescribing or consultation required

Firazyr must be prescribed by, or in consultation with, a specialist in allergy, immunology, hematology, pulmonology, or medical genetics. Documentation of the specialist's involvement or a consult must be provided with the request.

Specialist types: allergy, immunology, hematology, pulmonology, or medical genetics.
Provide consult notes or documentation of specialist prescribing/involvement.

Billing Rule

Approval duration

Approval will be granted for 6 months. Coverage may be renewed if the renewal criteria are met (member continues to meet initial criteria, has sustained improvement in attack severity/duration, and has no unacceptable toxicity).

Initial approval duration: 6 months.
Renewal requires meeting stated renewal criteria (clinical benefit and tolerability).

Annual review with no clinical policy changes.

2018-07-25material_revision

Increased coverage duration to 6 months and removed requirement for H. pylori negativity; updated HAE clinical presentation table.