CurrentSecurity Health Plan of Wisconsin, Inc.Policy IC-0688

Hemgenix (etranacogene dezaparvovec-drlb) for Hemophilia B

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This policy governs prior authorization, medical necessity, dosing, administration, and billing for Hemgenix intravenous gene therapy in adults with moderately severe or severe congenital factor IX deficiency. Authorization is limited to one dose and cannot be renewed.

Policy Summary

PayerSecurity Health Plan of Wisconsin, Inc.

PolicyHemgenix (etranacogene dezaparvovec-drlb) for Hemophilia B

Policy CodePolicy IC-0688

Change TypeNo material clinical or coverage changes

Effective DateN/A

Last ReviewJan 6, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with supporting clinical documentation for the requested single intravenous dose.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 doseInitial authorization validity

1 unitMaximum billable unit

18+ yearsMinimum patient age

≤2%Maximum factor IX activity

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CurrentSecurity Health Plan of Wisconsin, Inc.Policy IC-0688

Hemgenix (etranacogene dezaparvovec-drlb) for Hemophilia B

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Policy Summary

PayerSecurity Health Plan of Wisconsin, Inc.

PolicyHemgenix (etranacogene dezaparvovec-drlb) for Hemophilia B

Policy CodePolicy IC-0688

Change TypeNo material clinical or coverage changes

Effective DateN/A

Last ReviewJan 6, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with supporting clinical documentation for the requested single intravenous dose.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 doseInitial authorization validity

1 unitMaximum billable unit

18+ yearsMinimum patient age

≤2%Maximum factor IX activity

≤1:678 or ≤1:898

Anti-AAV5 titer threshold

2 × 10^13 gc/kgRecommended Hemgenix dose

Coverage Criteria

Initial therapy for hemophilia B

Covered when all of the following criteria are met:

Initial Hemgenix therapy criteria

Patient is at least 18 years of age.
Patient has moderately severe or severe congenital factor IX deficiency, confirmed by blood coagulation testing, with factor IX activity ≤2% of normal circulating factor IX, and is receiving continuous routine factor IX prophylaxis unless contraindicated or intolerant.
Continuous routine prophylaxis means the intent to treat with an a priori defined frequency of infusions, as documented in the medical records.
Patient has not received prior hemophilia AAV-vector-based gene therapy.
At least one qualifying treatment-history criterion
- Patient currently uses factor IX prophylaxis therapy.
- Patient has current or historical life-threatening hemorrhage.
- Patient has repeated, serious spontaneous bleeding episodes.
  Examples include intramuscular hematomas requiring hospitalization, hemarthrosis, central nervous system or intracranial bleeding, pulmonary hemorrhage, life-threatening gastrointestinal hemorrhage, and umbilical cord bleeding.
Patient has a negative factor IX inhibitor titer (<0.6 Bethesda Units) and no prior history of inhibitors.
If the initial test is positive, repeat testing is required in approximately two weeks. If repeat testing is also positive, Hemgenix should not be given.
Factor IX activity will be monitored periodically, and factor IX inhibitors will be monitored if bleeding is not controlled.
Patients will continue to require exogenous factor IX until response to Hemgenix occurs.
Patient will discontinue factor IX prophylaxis therapy upon achieving a factor IX level of 5% from etranacogene dezaparvovec treatment.
ALL of the following
- Acceptable anti-AAV5 antibody titer
  - Anti-AAV5 antibody titer is ≤1:678 when using the 7-point assay.
  - Anti-AAV5 antibody titer is ≤1:898 when using the 9-point assay.
Baseline liver function will be assessed before therapy and after therapy according to the monitoring schedule in the product labeling, with corticosteroids administered in response to elevations.
Patients with preexisting risk factors for hepatocellular carcinoma will receive abdominal ultrasound screening and regular monitoring, such as annual monitoring, for alpha-fetoprotein elevations after administration.
Risk factors include cirrhosis, advanced hepatic fibrosis, hepatitis C or B, non-alcoholic fatty liver disease, chronic alcohol consumption, non-alcoholic steatohepatitis, and advanced age.

Medicare Part B applicability

Medicare coverage is governed by applicable Medicare requirements:

Medicare Part B coverage framework

For outpatient Medicare Part B drug coverage, apply the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50, Drugs and Biologicals.
Comply with applicable National Coverage Determinations, Local Coverage Determinations, and Local Coverage Articles for coverage, claims payment, and benefit eligibility.
Additional indications, including the preceding policy information, may be applied at the health plan's discretion.
The preceding policy information is intended for non-Medicare coverage determinations.

Hemgenix should not be administered to a patient with a repeat-positive factor IX inhibitor test or a history of prior hemophilia AAV-vector gene therapy. If an initial factor IX inhibitor test is positive, repeat testing is required in approximately two weeks; Hemgenix should not be given if the repeat test is also positive.

Coding and Dosage Details

HCPCS CodeHCPCSCovered

J1411

Injection, etranacogene dezaparvovec-drlb, per therapeutic dose; 1 billable unit = 1 kit

Hemgenix Kit NDCsNDCCovered

00053-0100-10	10 vials; patient weight 46-50 kg; total volume 100 mL
00053-0110-11	11 vials; patient weight 51-55 kg; total volume 110 mL
00053-0120-12	12 vials; patient weight 56-60 kg; total volume 120 mL
00053-0130-13	13 vials; patient weight 61-65 kg; total volume 130 mL
00053-0140-14	14 vials; patient weight 66-70 kg; total volume 140 mL
00053-0150-15	15 vials; patient weight 71-75 kg; total volume 150 mL
00053-0160-16	16 vials; patient weight 76-80 kg; total volume 160 mL
00053-0170-17	17 vials; patient weight 81-85 kg; total volume 170 mL
00053-0180-18	18 vials; patient weight 86-90 kg; total volume 180 mL
00053-0190-19	19 vials; patient weight 91-95 kg; total volume 190 mL

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Covered Diagnosis CodesICD-10Covered

D67	Hereditary factor IX deficiency

Factor IX activity

Threshold≤2% of normal circulating factor IX

Applies toModerately severe or severe congenital factor IX deficiency

ConfirmationBlood coagulation testing

Factor IX inhibitor titer

Negative-result threshold<0.6 Bethesda Units

Initial positive testRetest within approximately 2 weeks

Repeat-positive result

Authorization and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Hemgenix® (etranacogene dezaparvovec-drlb) when medical necessity criteria are met. Initial authorization is limited to one intravenous dose.

Prior Authorization

Prior Authorization Factors

Prior authorization is considered using NQTL factors, including the drug’s indication, safety and efficacy, potential for misuse or abuse, and cost. The policy identifies indication and drug cost as factors supporting consideration of prior authorization; safety and efficacy and misuse/abuse are not identified as PA priorities.

Step Therapy

Factor IX Prophylaxis Requirement

The patient must be receiving continuous routine factor IX prophylaxis, unless a contraindication or intolerance is documented. Continuous routine prophylaxis means an a priori defined infusion frequency documented in the medical record, such as twice weekly or once every two weeks.

Background

Hemgenix (etranacogene dezaparvovec-drlb) is an intravenous AAV-vector gene therapy for adults with moderately severe or severe congenital hemophilia B caused by factor IX deficiency. Treatment requires factor IX inhibitor testing, anti-AAV5 antibody assessment, and liver-function monitoring; patients continue exogenous factor IX support until a response to treatment occurs, as hemostatic improvement may take several weeks after infusion.

Definitions

Continuous routine factor IX prophylaxis

DefinitionIntent to treat with an a priori defined frequency of infusions

Frequency examplesTwice weekly or once every two weeks

DocumentationThe infusion schedule must be documented in the medical records

Moderately severe or severe hemophilia B

DefinitionModerately severe or severe congenital factor IX deficiency

Factor IX activity2% or less of normal circulating factor IX

ConfirmationBlood coagulation testing

Policy Summary

PayerSecurity Health Plan of Wisconsin, Inc.

PolicyHemgenix (etranacogene dezaparvovec-drlb) for Hemophilia B

Policy CodePolicy IC-0688

Change TypeNo material clinical or coverage changes

Effective DateN/A

Last ReviewJan 6, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with supporting clinical documentation for the requested single intravenous dose.

SourceLink

On This Page

Hemgenix should not be given

Anti-AAV5 antibody titer — 7-point assay

AssayLuciferase-based Neutralizing Antibody (NAb) assay using the 7-point format

Acceptable threshold≤1:678

RequirementBaseline anti-AAV5 antibody titer must be within the acceptable limit

Anti-AAV5 antibody titer — 9-point assay

AssayLuciferase-based Neutralizing Antibody (NAb) assay using the 9-point format

Acceptable threshold≤1:898

RequirementBaseline anti-AAV5 antibody titer must be within the acceptable limit

Factor IX level for discontinuing prophylaxis

Factor IX level5%

Treatment sourceEtranacogene dezaparvovec treatment

Required actionDiscontinue Factor IX prophylaxis therapy upon achieving the specified FIX level

Hemgenix dose

Recommended dose2 × 10^13 genome copies (gc) per kilogram of body weight

Volume conversion2 mL/kg body weight

Dose calculationHemgenix dose in mL = patient body weight in kilograms × 2

Documentation Required

Required Supporting Documentation

Submit supporting clinical documentation with every authorization request, including records, chart notes, laboratory results, confirmatory diagnostics, diagnosis information, step-therapy history, and applicable clinical markers such as genetic or mutational testing. Documentation must be uploaded through the prior authorization web portal or submitted by fax.

Documentation Required

Clinical Eligibility Documentation

Clinical eligibility documentation must establish all applicable requirements:

Patient is at least 18 years of age.
Diagnosis is moderately severe or severe congenital factor IX deficiency, defined as ≤2% of normal circulating factor IX, confirmed by blood coagulation testing.
The patient meets the factor IX prophylaxis requirement or has a documented contraindication or intolerance.
The patient has not received prior hemophilia AAV-vector-based gene therapy.
The patient currently uses factor IX prophylaxis or has current or historical life-threatening hemorrhage or repeated serious spontaneous bleeding episodes.
Factor IX inhibitor titers are negative (<0.6 Bethesda Units), with repeat testing approximately two weeks later if initially positive; Hemgenix should not be administered if the repeat test remains positive.
Factor IX activity and inhibitor status will be monitored periodically, and exogenous factor IX will continue until response occurs.
Factor IX prophylaxis will be discontinued after treatment achieves FIX levels of 5%.
Baseline anti-AAV5 antibody titer is within acceptable limits: ≤1:678 using the 7-point assay or ≤1:898 using the 9-point assay.
Baseline liver function will be assessed before and after therapy according to product-labeling monitoring requirements, with corticosteroids administered for elevations.

Denial Risk

Missing Required Clinical Documentation

Failure to submit the required medical records and clinical documentation may result in denial because medical necessity cannot be established under the policy guidelines.

Denial Risk

Criteria Not Met

Authorization may be denied when eligibility criteria are not met, including failure to meet the minimum age or moderately severe/severe hemophilia B requirement; lack of qualifying factor IX prophylaxis or documented exception; prior hemophilia AAV-vector gene therapy; inadequate or positive inhibitor testing; unacceptable anti-AAV5 antibody results; or failure to satisfy the required bleeding history, monitoring, prophylaxis-discontinuation, or liver-function requirements.

Billing Rule

Repeat or Renewal Requests

Authorization is limited to one dose and may not be renewed. Renewal requests are not authorized once the one-dose duration or authorization limit has been reached.

Billing Rule

One-Dose Unit Limit

Billing is limited to 1 billable unit for one dose. For HCPCS J1411, one billable unit equals one kit based on the patient’s weight; billing more than one unit is outside the policy’s one-dose limit.

Negative factor IX inhibitor titer

Negative-result threshold<0.6 Bethesda Units

If initially positiveRetest within approximately 2 weeks

If repeat test remains positiveHemgenix should not be given

Non-quantitative treatment limitations

DefinitionMethods, guidelines, standards of evidence, or other conditions that can restrict how long or to what extent benefits are provided under a health plan

ExamplesUtilization review or prior authorization

ApplicationThe utilization management NQTL applies comparably, and not more stringently, to mental health/substance use disorder and medical/surgical medical benefit prescription drugs