CurrentAetnaPolicy N/A

Hemgenix (etranacogene dezaparvovec-drlb) Medication Precertification Request - Coverage Criteria

Precertification form and requirements for requesting coverage of Hemgenix for Aetna members; applies to providers submitting authorization for gene therapy for Hemophilia B.

Policy Summary

PayerAetna

PolicyHemgenix precertification coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed Hemgenix precertification request form with all checklist items and supporting documentation for prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1page(s) in form

multiplerequired clinical checklist items

Aetnapayer

Coverage Criteria for Hemgenix

Initial authorization criteria

Covered when ALL of the following are documented on the precertification request:

Required items: Patient has documented diagnosis of Hemophilia B; medication will be prescribed by or in consultation with a hematologist; negative Factor IX inhibitor test within the past 30 days or a positive test followed by a negative within two weeks; patient has not previously received gene therapy; patient has severe or moderately severe Factor IX deficiency (<= 2% of normal circulating Factor IX); documentation of current use of Factor IX prophylactic therapy status; history of life-threatening hemorrhage or repeated serious spontaneous bleeding episodes when applicable; administration at an Aetna designated gene therapy treatment center when required.<= 2% (Factor IX activity)

All checklist items on the precertification form (Section G) must be completed and supported by documentation.

When submitting a Hemgenix precertification request, all items on the clinical checklist must be completed and supported by documentation. If required confirmations are not provided on the form — for example, no documented diagnosis of Hemophilia B, missing confirmation of hematology involvement, absent recent negative Factor IX inhibitor testing, prior gene therapy not addressed, or lack of documentation of disease severity (≤ 2% FIX) or treatment center — the request will not meet the stated checklist conditions and therefore will not be approved.

Policy Summary

PayerAetna

PolicyHemgenix precertification coverage criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed Hemgenix precertification request form with all checklist items and supporting documentation for prior authorization.

SourceLink

On This Page

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The form does not list separate explicit “not medically necessary” statements; instead, failure to meet the checklist conditions on the precertification request (for example, omission of a documented Hemophilia B diagnosis, absence of required inhibitor test results, or lack of documentation that the patient has ≤ 2% Factor IX activity) implies the request will not be approved as medically necessary.

Diagnosis and Administration Codes

Diagnosis and Administration Codesmixed

Primary ICD Code	Primary ICD-10 diagnosis code (to be provided on form)
Secondary ICD Code	Secondary ICD-10 diagnosis code (to be provided on form)
Other ICD Code	Other ICD-10 diagnosis code (to be provided on form)
Administration code(s) (CPT)	CPT codes for administration (to be provided on form)

Factor IX activity level — key clinical threshold

Factor IX activity level<= 2% of normal circulating Factor IX (severe or moderately severe deficiency)

Clinical significanceSpecifies severe or moderately severe Hemophilia B required for coverage consideration

Documentation requirementChecklist item must be completed on the precertification request to confirm <= 2% activity

Provider Requirements and Submission Checklist

Prior Authorization

Prior Authorization Required

Prior authorization is required for Hemgenix. Submit a completed Hemgenix precertification request form; all fields must be completed and legible for precertification review. Include start or continuation of therapy dates and contact information for the requester.

Use the Hemgenix precertification request form
Include Start of treatment or Continuation of therapy date
Precertification contact phone and fax must be provided

Step Therapy

Step Therapy / Prior Treatments

There is no formal step therapy sequence specified for Hemgenix. The checklist requests documentation of current Factor IX prophylaxis and prior treatments; ensure those items are completed on the form.

Document whether patient is currently using Factor IX prophylactic therapy
Indicate any prior gene therapy treatments

Documentation Required

Required Documentation

The following documentation must be supplied with the precertification request. A completed patient demographics section (including weight and height), prescriber information (including specialty, NPI, license), and a fully completed clinical checklist are required. The clinical checklist must document a diagnosis of Hemophilia B and relevant clinical test results.

Completed patient demographics, including DOB, address, contact numbers, weight (lbs or kgs) and height (inches or cms)
Prescriber details: name, credential (MD/DO/NP/PA), address, phone, fax, state license number, NPI, DEA (if applicable), specialty (hematologist if applicable)
Completed clinical checklist documenting diagnosis of Hemophilia B
Product information: requested drug (Hemgenix), dose and frequency

Denial Risk

Denial Triggers

Requests may be denied if required clinical information is incomplete or checklist items are not completed. Common denial triggers include missing confirmation of Hemophilia B diagnosis, absent or untimely Factor IX inhibitor test results, failure to indicate hematologist involvement, or omission of required prescriber or patient data.

Missing documented diagnosis of Hemophilia B on the clinical checklist
No negative Factor IX inhibitor test result within the past 30 days (or missing follow-up negative after a recent positive)
Checklist left incomplete for items such as current Factor IX prophylaxis, history of gene therapy, or severity of Factor IX deficiency
Incomplete prescriber information (NPI, state license) or missing patient demographics (weight/height)

Clinical Definitions and Testing Requirements

Factor IX deficiency threshold

DefinitionFactor IX deficiency ≤ 2% of normal circulating Factor IX (severe/moderately severe)

Role in criteriaRequired item on clinical checklist for initial authorization

ImplicationAbsence of documentation that FIX ≤2% may preclude approval per checklist

Recent inhibitor testing

Required test resultNegative Factor IX inhibitor test result within the past 30 days

Alternate pathwayIf an initial positive inhibitor test, a subsequent negative test within two weeks is acceptable

DocumentationMust be completed on the precertification clinical checklist to support authorization

Background

Hemgenix (etranacogene dezaparvovec-drlb) is a gene therapy product for Hemophilia B. The Hemgenix precertification request form collects the clinical information needed to confirm eligibility for coverage, including a documented diagnosis of Hemophilia B, recent Factor IX inhibitor test results, prior gene therapy history, disease severity (≤ 2% Factor IX activity), current prophylactic therapy status, bleeding history, and whether administration will occur at an Aetna designated gene therapy treatment center. All fields must be completed and legible for precertification review.