CurrentBlue Cross Blue Shield - IowaPolicy 05.04.88

Wellmark Blue Cross and Blue Shield Drug Policy - Hemgenix

Defines coverage criteria, prior authorization documentation, dosing limits, and billing codes for Hemgenix gene therapy in adults with Hemophilia B within Wellmark Blue Cross and Blue Shield plans.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyWellmark Blue Cross and Blue Shield Drug Policy - Hemgenix

Policy CodePolicy 05.04.88

Change TypeReviewed (Oct 2024); Revised Apr 2023

Effective DateDec 1, 2023

Next Review Date

Key ActionProvider must submit chart notes and lab documentation including FIX level (≤2%), absence of FIX inhibitors, proof of current Factor IX prophylaxis, and history of life‑threatening hemorrhage or repeated serious spontaneous bleeds to initiate PA review.

POLICY UPDATE CHANGES

Policy reviewed October 2024 with prior revisions in April 2023; current effective date listed as December 2023.

1Lifetime treatments allowed

18-75Covered age range (years)

<2%FIX activity threshold

>150Exposure days required

Coverage Summary

Policy number 05.04.88: Hemgenix (etranacogene dezaparvovec-drlb) gene therapy is covered with criteria for adults with Hemophilia B in accordance with the FDA-approved labeling. Coverage is limited to members who meet the policy’s clinical criteria (including age, sex assignment at birth, severity of Factor IX deficiency, current prophylaxis or history of life‑threatening/repeated serious bleeding, absence of anti‑AAV antibodies, sufficient Factor IX exposure days, liver health assessment, and infectious disease status) and when treatment is prescribed by or in consultation with a hematologist or hemophilia specialist. Approvals are limited to one lifetime dose per member and dosing is subject to FDA‑label limits (minimum recommended dose 2 x 10^13 genome copies (gc) per kg).

Quick Eligibility & Thresholds

Plasma Factor IX activity<2%

Exposure days>150

Age range18-75 years

Lifetime treatments allowed1

Minimum recommended dose2 x 10^13 genome copies (gc)/kg

Provider Actions / Prior Authorization Requirements

Prior Authorization

Prior authorization submission required

Prior authorization submission is required. Providers must submit chart notes and lab documentation including FIX level (≤2%), documentation of absence of FIX inhibitors, proof of current Factor IX prophylaxis, history of life‑threatening hemorrhage or repeated serious spontaneous bleeding episodes, and supporting chart notes and labs to initiate PA review.

FIX level ≤2% (severe or moderately severe hemophilia B)
Absence of Factor IX inhibitors (lab test results)
Proof of current Factor IX prophylaxis therapy
History of life‑threatening hemorrhage or repeated serious spontaneous bleeding episodes
Chart notes and lab documentation

Documentation Required

Specialist prescribing requirement

Medication must be prescribed by or in consultation with a hematologist or a prescriber who specializes in hemophilia B; documentation of specialist involvement is required.

Prescriber: hematologist or hemophilia specialist (or documented consultation)

Documentation Required

Pre-treatment liver evaluation

Providers must document a pre-treatment liver health assessment including enzyme testing and imaging prior to treatment.

Alanine aminotransferase (ALT)
Aspartate aminotransferase (AST)
Alkaline phosphatase (ALP)
Total bilirubin
Hepatic ultrasound
Elastography

Documentation Required

Anti-AAV antibody testing

Providers must document absence of anti‑adeno‑associated virus (anti‑AAV) antibodies (titers) prior to therapy.

Document anti-AAV antibody titers demonstrating absence of antibodies

Documentation Required

Infectious disease status

Providers must document the member's infectious disease status, including HIV status (negative or controlled) and absence of active hepatitis B and hepatitis C infection prior to treatment.

HIV negative or controlled HIV infection
No active hepatitis B infection
No active hepatitis C infection

Clinical Evidence & References

Evidence summary: Hemgenix is FDA-approved for treatment of adults with Hemophilia B meeting specified clinical criteria. Refer to the Hemgenix package insert: Hemgenix [package insert], CSL Behring LLC; November 2022. The safety and efficacy of repeat dosing have not been studied; repeat treatment is considered investigational and evidence is insufficient to determine effects on net health outcomes.

Background

Background: Hemgenix (etranacogene dezaparvovec-drlb) is an adeno‑associated virus (AAV) vector–based gene therapy indicated for adults with Hemophilia B who currently use Factor IX prophylaxis or who have current or historical life‑threatening hemorrhage or repeated, serious spontaneous bleeding episodes. This policy aligns coverage with FDA labeling, FDA guidance, evidence-based practice standards, and published guidelines and requires documentation to support prior authorization (including FIX activity level, absence of FIX inhibitors, proof of current Factor IX prophylaxis, history of life‑threatening or repeated serious bleeding, anti‑AAV antibody testing, liver health assessment, and infectious disease status). Treatment must be prescribed by or in consultation with a hematologist or prescriber who specializes in hemophilia B.

Key Definitions

Severe or moderately severe hemophilia BPlasma Factor IX (FIX) activity level <2% of normal

Exposure day (definition)A day on which the patient received Factor IX product

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyWellmark Blue Cross and Blue Shield Drug Policy - Hemgenix

Policy CodePolicy 05.04.88

Change TypeReviewed (Oct 2024); Revised Apr 2023

Effective DateDec 1, 2023

Next Review Date

On This Page

OpenPayer

Wellmark Blue Cross and Blue Shield Drug Policy - Hemgenix

Coverage Summary

Initial Therapy Criteria (Authorization)

Continuation of Therapy and Treatment Limits

Provider Actions / Prior Authorization Requirements

Applicable Codes

Clinical Evidence & References

Background

Revision History