Kalbitor (ecallantide) Medication Precertification Request - Coverage Criteria
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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.
No material clinical or coverage changes in this revision.
Coverage Determinations
Coverage criteria for Kalbitor (ecallantide)
Covered when ALL of the following are documented:
Form requires indication checkbox confirming use for acute HAE attacks
Form contains checkboxes to indicate which diagnostic criteria apply
Form asks whether prescriber specializes in HAE management
Form asks about prior high‑dose antihistamine trial, family history, and concomitant acute HAE therapies; responses may inform coverage decisions
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 code(s) (CPT) | Form field requesting administration CPT codes |
| Primary ICD Code | Primary diagnosis code field |
| Secondary ICD Code | Secondary diagnosis code field |
| Other ICD Code | Other diagnosis code field |
Provider Requirements & Submission Instructions
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).
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.
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.
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
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