CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Icatibant for acute hereditary angioedema (HAE)

Covers use of icatibant subcutaneous injection for treatment of acute HAE attacks in adults when approval criteria are met and no member exclusions apply.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyIcatibant for acute hereditary angioedema (HAE)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateDec 12, 2018

Next Review DateJul 1, 2025

Key ActionObtain prior authorization for up to 6 months and document required clinical information including prescriber specialty and diagnostic confirmation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+Member age requirement (yrs)

6 monthsAuthorization duration

9 mL/30dQuantity limit

≤3 doses/24hOn-hand dosing limit

Coverage Criteria for Icatibant

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Age and indication: Patient is 18 years of age or older AND treatment is for an acute attack of hereditary angioedema (HAE)age >= 18

Includes FDA‑approved adult indication

Prescriber: Medication is prescribed by, or in consultation with, an allergist/immunologist or a physician who specializes in the treatment of HAE or related disorders

Attack characteristics: Documentation of history of moderate to severe cutaneous attacks (without concomitant hives) OR abdominal attacks OR mild to severe airway swelling attacks of HAE (e.g., debilitating cutaneous/gastrointestinal symptoms OR laryngeal/pharyngeal/tongue swelling)

On-hand medication limit: Documentation that the cumulative amount of medications the patient has on hand for acute HAE will not exceed the maximum recommended dose of 30 mg every 6 hours, for a maximum of 3 doses in 24 hours<= 3 doses/24h

Quantity limit also specified separately

Diagnostic confirmation

C1‑INH deficiency/dysfunction: C1‑INH antigenic level below the laboratory lower limit OR normal antigenic level with low C1‑INH functional level (functional C1‑INH <50% or below laboratory lower limit)
Laboratory confirmation required
Normal C1‑INH pathway: Either pathogenic gene mutation confirmed by genetic testing (e.g., F12, ANGPT1, PLG, KNG1, HS3ST6, MYOF) OR documented family history of angioedema with angioedema refractory to a trial of high‑dose antihistamine for at least 1 month
Genetic testing or family history plus antihistamine trial required

Concomitant therapy exclusion: Patient will not use icatibant concomitantly with other medications used for acute HAE treatment (e.g., Berinert, Kalbitor, Ruconest)

Concurrent acute HAE products prohibited

Rule out other causes: Other causes of angioedema (e.g., ACE inhibitor–induced, estrogen‑related, allergic angioedema) have been ruled out

Continuation therapy

Continuation of therapy covered when ALL of the following are met

Meets initial criteria: Documentation that the member continues to meet the criteria for initial approval

Clinical benefit: Documentation that the member has experienced a reduction in severity and/or duration of attacks when icatibant was used to treat acute attacks

Use of icatibant for any indication other than the treatment of acute hereditary angioedema (HAE) attacks in adults is considered experimental/investigational and is not medically necessary. This includes requests that do not align with the FDA-approved adult HAE indication and may be denied.

Requests for indications outside the approved adult acute HAE population should be accompanied by documentation supporting a covered indication; absent that documentation, coverage will not be provided.

Provider Requirements, Authorization, and Documentation

Prior Authorization

Prior Authorization and Quantity Limit

Prior authorization may be granted for up to 6 months when all approval criteria are met. Quantity is limited to icatibant 9 mL per 30 days.

Prior authorization duration: up to 6 months when criteria met
Quantity limit: icatibant 9 mL per 30 days

Documentation Required

Antihistamine Trial for HAE with Normal C1‑INH

For patients with HAE with normal C1-INH, a documented trial of high‑dose antihistamine for at least one month is required unless genetic testing confirms an F12, ANGPT1, PLG, KNG1, HS3ST6, or MYOF gene mutation, or there is other documented qualifying evidence.

Documented trial of high‑dose antihistamine (e.g., cetirizine) for ≥1 month required for HAE with normal C1‑INH unless genetic testing confirms a pathogenic mutation or there is documented family history with antihistamine-refractory angioedema.

Denial Risk

Concomitant Acute HAE Therapies

Icatibant will not be authorized for use in combination with other products indicated for acute treatment of HAE attacks. Concurrent use with other acute HAE therapies (e.g., Berinert, Kalbitor, Ruconest, Ekterly) is not permitted and may result in denial of the request.

Concurrent use with other acute HAE treatments (Berinert, Kalbitor, Ruconest, Ekterly, etc.) is not permitted

Background

Hereditary angioedema (HAE) is a disorder characterized by recurrent episodes of localized, non‑pitting swelling that can affect the skin, gastrointestinal tract, or airway. Acute attacks may produce debilitating cutaneous or abdominal symptoms and can be life‑threatening when airway structures (larynx, pharynx, tongue) are involved. Treatment of acute attacks aims to relieve symptoms rapidly and prevent progression to airway compromise.

Definitions and HAE Types

HAE type I or II — Laboratory confirmation criteria for C1‑INH deficiency or dysfunction

Lab confirmation requiredC1 inhibitor deficiency or dysfunction confirmed by laboratory testing

Antigenic C1-INH lowC1-INH antigenic level below the lower limit of normal as defined by the testing laboratory

Functional C1-INH lowNormal C1-INH antigenic level with low functional C1-INH (functional C1-INH <50% or below lab lower limit)

Age requirementPatient is 18 years of age or older (per overall coverage criteria)

Documentation of attacksHistory of moderate to severe cutaneous (without hives), abdominal, or airway swelling attacks documented

HAE with normal C1‑INH — Diagnostic definition and required confirmation

Genetic mutation confirmationPathogenic gene mutation confirmed by genetic testing (examples: F12, ANGPT1, PLG, KNG1, HS3ST6, MYOF)

Family history plus antihistamine trialDocumented family history of angioedema AND angioedema refractory to a trial of high‑dose antihistamine (e.g., cetirizine) for ≥1 month

Laboratory normal C1‑INH requiredLaboratory testing confirming normal C1 inhibitor levels prior to using the normal‑C1‑INH diagnostic pathway

Rule out other causesOther causes of angioedema should be ruled out (e.g., ACE‑I–induced, estrogen‑related, allergic angioedema)