CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Icatibant (Firazyr/Sajazir) — Coverage Criteria for Acute Hereditary Angioedema (HAE)

Covers prior authorization and medical necessity criteria for icatibant (Firazyr/Sajazir) for treatment of acute HAE attacks in adults; applies to members of Neighborhood Health Plan of Rhode Island who meet clinical and documentation requirements.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyIcatibant for acute hereditary angioedema (HAE)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization (up to 6 months) and document C1‑INH testing or relevant genetic/family history and refractory high‑dose antihistamine trial when applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+age for FDA‑approved treatment

6 monthsauthorization period

<50%C1‑INH functional threshold

≥1 monthantihistamine trial duration

Coverage Criteria for Icatibant (Firazyr/Sajazir)

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Initial Therapy

Covered when ALL of the following are met:

Initial approval

Laboratory or genetic criteria: Either: A) C1‑INH antigenic level below the laboratory lower limit of normal; OR B) Normal antigenic C1‑INH with low functional C1‑INH (functional C1‑INH <50% or below laboratory lower limit of normal); OR C) Normal C1‑INH antigenic level with a pathogenic gene mutation (F12, angiopoietin‑1, plasminogen, KNG1, HS3ST6, or MYOF) confirmed by genetic testing; OR D) Documented family history of angioedema and angioedema refractory to a trial of high‑dose antihistamine (e.g., cetirizine 40 mg/day or equivalent) for at least one month.functional C1‑INH <50%
Genetic testing listed as applicable

Continuation Therapy

Covered for continuation when ALL of the following are met:

Continuation approval: 1) Member continues to meet the initial approval criteria. 2) Chart notes document a reduction in the severity and/or duration of acute HAE attacks. 3) Consideration of prophylaxis should be based on attack frequency, attack severity, comorbid conditions, and the member's quality of life.

Authorization of up to 6 months may be granted.

Use of icatibant outside of the FDA‑approved indication is considered experimental/investigational. The FDA‑approved indication is treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older; requests for other indications fall outside this approval and may be denied as investigational.

All indications other than the FDA‑approved use for acute HAE attacks in adults are considered not medically necessary. In other words, icatibant prescribed for conditions beyond acute HAE attacks in adults ≥18 years is regarded as experimental/investigational and will not meet medical necessity criteria.

Provider Actions and Authorization Rules

Prior Authorization

Prior Authorization Duration and Continuation

Authorization of 6 months may be granted for treatment of acute HAE attacks when approval criteria are met. Continuation of therapy (renewal) may be granted for up to 6 months when the member meets the initial approval criteria and has experienced a reduction in severity and/or duration of acute attacks. Prophylaxis consideration should be based on attack frequency, severity, comorbid conditions, and member quality of life.

Authorization duration: up to 6 months for initial and continuation approvals
Continuation requires meeting initial criteria and documented clinical improvement (reduction in severity and/or duration of attacks)

Denial Risk

Indication Restriction

Use of the medication for indications other than treatment of acute HAE attacks in adults 18 years and older is considered experimental/investigational and not medically necessary.

FDA‑approved indication: treatment of acute HAE attacks in adults ≥18 years
All other indications = experimental/investigational

Documentation Required

Required Documentation

For initial authorization, submit documentation of C1 inhibitor functional and antigenic protein levels. If applicable, include genetic testing results for F12, angiopoietin-1, plasminogen, kininogen-1 (KNG1), HS3ST6, or MYOF. Chart notes confirming family history of angioedema and documentation that the angioedema was refractory to a trial of high‑dose antihistamine therapy should be provided when relevant. For continuation of therapy, provide chart notes demonstrating a reduction in severity and/or duration of attacks.

Initial authorization: C1 inhibitor functional and antigenic protein levels
Initial authorization (if applicable): genetic testing for F12, angiopoietin-1, plasminogen, KNG1, HS3ST6, or MYOF
Initial authorization (if applicable): chart notes confirming family history of angioedema and refractory to high‑dose antihistamine trial
Continuation: chart notes documenting reduction in severity and/or duration of attacks

Step Therapy

High‑Dose Antihistamine Trial

When member has normal C1‑INH antigenic level, a documented trial of high‑dose antihistamine therapy is required if there is a family history of angioedema and no identified causative gene mutation. High‑dose antihistamine is defined as cetirizine 40 mg per day (or equivalent) for at least one month.

High‑dose antihistamine trial: cetirizine 40 mg/day (or equivalent) for ≥1 month
Required when C1‑INH antigenic level is normal and family history of angioedema is documented and genetic testing is negative or not applicable

Definitions

C1 inhibitor deficiency/dysfunction

Definition (primary)C1 inhibitor deficiency/dysfunction defined by C1‑INH antigenic level below the laboratory lower limit of normal

Alternate functional definitionNormal antigenic C1‑INH with low functional C1‑INH (functional <50% or below laboratory lower limit of normal)

Genetic/family considerationNormal C1‑INH antigenic and functional levels may still be consistent with disease when a pathogenic gene mutation or positive family history is documented

Refractory to high‑dose antihistamine

Refractory definitionAngioedema that did not respond to a trial of high‑dose antihistamine for at least one month

Example regimenCetirizine 40 mg per day (or equivalent) for ≥1 month

Clinical applicationUsed to support diagnosis when member has normal C1‑INH but documented family history of angioedema

OpenPayer

Icatibant (Firazyr/Sajazir) — Coverage Criteria for Acute Hereditary Angioedema (HAE)

Coverage Criteria for Icatibant (Firazyr/Sajazir)

Coding and Referenced Drugs

Provider Actions and Authorization Rules

Background

Definitions