CurrentAetnaPolicy N/A

Berinert (C1 esterase inhibitor, human) precertification request form

Covers the information and clinical requirements a provider must submit to Aetna to request precertification for Berinert for hereditary angioedema (HAE) treatment, including acute attacks, prophylaxis, and short-term preprocedural use. Affects prescribers, dispensing providers, and patients seeking coverage.

Policy Summary

PayerAetna

PolicyBerinert precertification request form

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionPrecertification must be requested from Aetna using the Berinert precertification form; phone and fax contact numbers are provided for submission and inquiries.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2 pagesform length

Requireddiagnostic evidence fields

acute/prophylaxis/preprocindications covered

phone/faxcontact points

Coverage Criteria for Berinert

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Medical necessity criteria

Covered when documentation supports one of the following indications and required diagnostic or clinical criteria:

Indication group: One of the following indications must be documented: acute hereditary angioedema (HAE) attack treatment; prophylaxis for recurrent/severe attacks or when attack frequency/severity and quality of life warrant prophylactic therapy; or short-term preprocedural prophylaxis prior to surgical or major dental procedures.

HAE with C1-INH deficiency or dysfunction

A C1-INH antigenic level below the lower limit of normal as defined by the laboratory performing the test (document lab report).
OR a normal C1-INH antigenic level with a low C1-INH functional level (functional C1-INH <50% or below the laboratory lower limit of normal).C1-INH functional <50% or below lab lower limit

HAE with normal C1-INH or genetic HAE

Genetic testing demonstrating a mutation such as F12, angiopoietin-1, plasminogen, KNG1, HS3ST6, or MYOF.
Alternatively, documentation of both: 1) angioedema refractory to a trial of high-dose antihistamine therapy (e.g., cetirizine 40 mg/day or equivalent for ≥1 month) AND 2) a family history of angioedema.

Prior therapy and alternative considerations: When applicable, documentation that prior therapies were tried, were ineffective, contraindicated, or not tolerated (e.g., Ruconest), and whether prophylactic treatment was considered; provide rationale if prophylaxis not considered.

Coding and Diagnostic Codes

Administration CPT CodesCPT

administration code(s) (CPT)

Field for CPT administration codes as applicable

Diagnosis ICD CodesICD-10

Primary ICD Code	Field for primary ICD diagnosis code
Secondary ICD Code	Field for secondary ICD diagnosis code
Other ICD Code	Field for other ICD diagnosis codes

High-dose antihistamine trial — inv-05

Required trialTrial of high-dose antihistamine: cetirizine 40 mg per day (or equivalent) for at least 1 month

PurposeDocuments angioedema refractory to standard-dose antihistamines prior to genetic workup or alternative diagnoses

Documentation expectedDate range and medication/dose details for the 1-month trial should be provided on the precertification form

C1‑INH functional level — inv-06

ThresholdC1‑INH functional level less than 50% or below the laboratory lower limit of normal

Alternate lab criterionNormal C1‑INH antigenic level with low C1‑INH functional level qualifies (functional <50% or below lab lower limit)

Source for testingFunctional and antigenic C1‑INH results as defined by the performing laboratory must be reported on the form

Provider Actions, Submission & Documentation Requirements

Prior Authorization

Precertification submission

Precertification for Berinert must be requested from Aetna using the Berinert precertification form. Contact Aetna Precertification Notification by phone at 1-866-752-7021 (general) or 1-866-503-0857 (Medicare Advantage Part B) and fax to 1-888-267-3277. For Medicare Advantage Part B requests, use the Medicare request form. Complete all required fields on the two-page form, including start/continuation dates and precertification requester contact information.

Use the Berinert Medication Precertification Request form (2 pages).
Provide start of treatment date or date of last treatment for continuation requests.
Include precertification requester name, phone and fax.

Step Therapy

Prior therapy and alternatives

The precertification form requires documentation of prior therapy and alternatives. Indicate whether the patient had an ineffective response, contraindication, or intolerance to Ruconest and whether prophylactic treatment has been considered. For acute HAE attacks, state if the medication will be used in combination with other acute therapies and whether the patient is currently receiving samples or assistance programs. Provide rationale if prophylactic treatment was considered or not.

Document if patient had ineffective response/contraindication/intolerance to Ruconest.
Record if prophylactic treatment has been considered and provide rationale when applicable.
Indicate concurrent use with other acute HAE medications (e.g., Firazyr, Kalbitor, Ruconest).
State current receipt of samples or manufacturer assistance if applicable.

Documentation Required

Required Documentation

Submit a completed precertification form with all patient demographics, insurance and prescriber information, dispensing provider/administration details, requested product (Berinert), dose, frequency, ICD diagnosis codes, and required clinical documentation demonstrating HAE diagnosis and relevant laboratory or genetic testing. The plan may request additional information or clarification if needed to evaluate requests.

Completed two-page Berinert precertification form with all fields legible.
Patient demographics (name, DOB, contact, weight, height, allergies).
Insurance information (Aetna member ID, group #, other coverage, Medicare/Medicaid IDs).
Prescriber details (name, specialty, NPI, license, phone, fax) and signature/date.
Dispensing provider and place of administration details (site, pharmacy, infusion center, CPT administration codes if applicable).
Requested product, dose, and frequency.
Primary and any secondary ICD codes and supporting clinical documentation.
Clinical evidence of HAE diagnosis (C1-INH antigenic and/or functional levels, genetic testing where applicable) and documentation of prior treatments/trials.

Denial Risk

Fraud/False Information

Any person who knowingly provides materially false information or conceals material information on the precertification form may be subject to denial of the request and to criminal and civil penalties for fraudulent insurance acts. The plan may verify information and request additional documentation.

Knowingly filing false or misleading information is a fraudulent insurance act and may result in criminal and civil penalties.
Providing materially false information or concealing material facts can lead to denial of authorization.

Background

Hereditary angioedema (HAE) is the primary indication addressed on the Berinert precertification form, with checkboxes to specify use for acute HAE attacks, prophylaxis when attack frequency, severity, comorbidities, or quality of life warrant it, and short-term preprocedural prophylaxis. The form also requests confirmation of HAE subtype by laboratory testing (C1‑INH antigenic below lab lower limit or C1‑INH functional less than 50% or below the laboratory lower limit) or documentation of HAE with normal C1‑INH, and asks whether the patient has had prior therapies (for example, ineffective response or intolerance to Ruconest) and whether prophylactic treatment has been considered.

Definitions and Diagnostic Criteria

HAE with C1 inhibitor deficiency or dysfunction — inv-12

DefinitionHereditary angioedema (HAE) with C1 inhibitor deficiency or dysfunction confirmed by laboratory testing

Laboratory criteria (antigenic)C1‑INH antigenic level below the lower limit of normal as defined by the laboratory performing the test

Laboratory criteria (functional)C1‑INH functional level less than 50% or below the laboratory lower limit of normal

HAE with normal C1 inhibitor — inv-13

DefinitionHereditary angioedema (HAE) with normal C1‑INH confirmed by laboratory testing and/or genetic testing

Genetic mutations listedF12, angiopoietin‑1, plasminogen, kininogen‑1 (KNG1), HS3ST6, MYOF

Alternate pathwayPatients with normal antigenic and functional C1‑INH but with a qualifying gene mutation meet the definition