CurrentAetnaPolicy N/A

Kalbitor (ecallantide) Medication Precertification Request - Coverage Criteria

Precertification form and requirements for Aetna coverage review of Kalbitor (ecallantide) for treatment of acute hereditary angioedema (HAE) attacks; used by prescribing and dispensing providers to request authorization or continuation of therapy.

Policy Summary

PayerAetna

PolicyKalbitor (ecallantide) Medication Precertification Request - Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrecertification must be requested via phone or fax using this form prior to administration or dispensing.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2 pagesform length

1-866-752-7021precert phone

1-888-267-3277precert fax

Part BMedicare instruction

Coverage Determinations

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Diagnosis: Documented use for treatment of acute hereditary angioedema (HAE) attacks

Form requires indication checkbox confirming use for acute HAE attacks

Diagnostic confirmation: Laboratory confirmation of HAE with C1‑INH deficiency or dysfunction (C1‑INH antigenic level below lab lower limit OR normal antigenic level with low C1‑INH functional level [functional C1‑INH <50% or below lab lower limit]) OR genetic confirmation of HAE with normal C1‑INH (documented pathogenic mutation such as F12, angiopoietin‑1, plasminogen, KNG1, HS3ST6, or MYOF)C1‑INH functional <50% or below lab lower limit

Form contains checkboxes to indicate which diagnostic criteria apply

Prescriber specialty: Prescribed by or in consultation with a clinician who specializes in management of hereditary angioedema (HAE)

Form asks whether prescriber specializes in HAE management

Prior therapy or concomitant therapy: One of the following: a) Documentation that angioedema was refractory to a trial of high‑dose antihistamine therapy (e.g., cetirizine 40 mg/day or equivalent) for at least one month and family history of angioedema, OR b) Indication that the requested drug will be used in combination with other acute HAE medications (e.g., Berinert, Firazyr, Ruconest)cetirizine 40 mg/day (or equivalent) for ≥1 month

Form asks about prior high‑dose antihistamine trial, family history, and concomitant acute HAE therapies; responses may inform coverage decisions

Continuation of therapy: For continuation requests, documentation of reduction in severity and/or duration of acute attacks and dates of prior treatment

Form includes fields asking whether attacks have decreased and requests last treatment date and outcomes

This precertification form is intended specifically for requests to use Kalbitor (ecallantide) for the treatment of acute hereditary angioedema (HAE) attacks. The form requires the requester to indicate whether the drug is being used for treatment of acute HAE attacks and includes fields for product dose, frequency, and diagnosis codes to support that indication.

The form asks for documentation that the angioedema is refractory to a trial of high‑dose antihistamine therapy (e.g., cetirizine 40 mg/day or equivalent) for at least one month and for supporting diagnostic confirmation of HAE. Requests where angioedema is not refractory to high‑dose antihistamines or where appropriate laboratory or genetic diagnostic confirmation is not provided may not meet the requirements on this form.

Billing and Diagnosis Codes

Administration codesModifier

Administration code(s) (CPT)

Form field requesting administration CPT codes

ICD diagnosis codesICD-10

Primary ICD Code	Primary diagnosis code field
Secondary ICD Code	Secondary diagnosis code field
Other ICD Code	Other diagnosis code field

High‑dose antihistamine trial — inv-06

Required trial dose and durationCetirizine 40 mg per day (or equivalent) for at least one month

Purpose of trialDocument angioedema refractory to high-dose antihistamine therapy as part of precertification assessment

Form checkbox triggerForm includes a checkbox specifically asking whether angioedema was refractory to a trial of high‑dose antihistamine therapy

Equivalency note‘Or the equivalent’ indicates other antihistamines at an equivalent high‑dose may be considered

Use in coverage decisionInformation about high‑dose antihistamine trial may be required to support medical necessity determinations

Provider Requirements & Submission Instructions

Prior Authorization

Precertification required

Precertification must be requested prior to administration or dispensing. Use the Aetna precertification phone or fax and submit this completed form when requesting authorization for Kalbitor (ecallantide).

Step Therapy

Prior trial and prophylaxis considerations

The form asks whether prophylactic treatment has been considered and documents if angioedema was refractory to a trial of high‑dose antihistamine therapy (cetirizine 40 mg/day or equivalent for at least one month); this information may be required for coverage decisions.

Indicate if prophylactic treatment was considered (Yes/No).
Document if angioedema was refractory to high‑dose antihistamine (cetirizine 40 mg/day or equivalent) for ≥1 month.

Documentation Required

Required clinical and administrative documentation

Complete patient, insurance, prescriber and dispensing provider information and product details are required; include documentation that the request is for treatment of acute HAE attacks and diagnostic confirmation (C1‑INH antigenic or functional levels or genetic testing), dates of prior treatment and response for continuation requests.

Form fields for patient name, DOB, phone and start/last treatment dates must be completed.
Indicate indication (acute HAE attacks), prescriber specialty, and required diagnostic test results (C1‑INH antigenic/functional levels or relevant genetic testing).
For continuation, document reduction in severity/duration of attacks and prior treatment dates.

Denial Risk

Incomplete or false information may lead to denial

Failure to provide complete and legible clinical information or knowingly submitting materially false or concealed information may result in denial, requests for additional information, or civil/criminal penalties.

Incomplete or illegible submissions may prompt denial or further review.
Providing materially false information may be considered fraud and carry penalties.

Clinical Background

Ecallantide (Kalbitor) is requested on this form for the management of acute hereditary angioedema (HAE) attacks. The form collects diagnostic information to confirm HAE due to C1‑INH deficiency or dysfunction (including a C1‑INH antigenic level below the laboratory lower limit of normal or a C1‑INH functional level less than 50% or below the laboratory lower limit of normal) or genetic confirmation for HAE with normal C1‑INH (specified gene mutations). The form also asks whether the prescriber specializes in HAE management and whether the drug will be used in combination with other acute HAE therapies.

Definitions

HAE with C1‑INH deficiency or dysfunction — inv-12

Diagnostic criterionC1 inhibitor (C1‑INH) antigenic level below the lower limit of normal as defined by the laboratory performing the test

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

Documentation requirementLaboratory confirmation of low antigenic or low functional C1‑INH must be indicated on the form

ApplicabilityApplies to diagnosis of HAE with C1‑INH deficiency or dysfunction

HAE with normal C1‑INH — inv-13

Genetic confirmationF12, angiopoietin‑1, plasminogen, kininogen‑1 (KNG1), HS3ST6, or MYOF gene mutation confirmed by genetic testing

Diagnostic categoryUsed to confirm diagnosis of hereditary angioedema (HAE) with normal C1‑INH

Form fieldForm contains a checkbox to indicate HAE with normal C1‑INH and to list the specific gene mutation confirmed by testing

Examples listedSpecifically lists F12, angiopoietin‑1, plasminogen, KNG1, HS3ST6, and MYOF as detectable mutations