CurrentBaylor Scott & White Health PlanPolicy 312

Etranacogene dezaparvovec (Hemgenix) coverage

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This policy governs medical necessity and prior authorization for etranacogene dezaparvovec (Hemgenix) for adults with hemophilia B. It applies across lines of business unless otherwise indicated, subject to the member's benefit plan, applicable Medicare or Medicaid requirements, and federal or state rules.

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyEtranacogene dezaparvovec (Hemgenix) coverage

Policy CodePolicy 312

Change TypeMinor formatting changes

Effective DateSep 1, 2026

Last ReviewAug 27, 2026

Next Review DateAug 27, 2027

Key ActionPrior authorization is required for etranacogene dezaparvovec (Hemgenix).

SourceLink

POLICY UPDATE CHANGES

The 2026 policy history reports minor formatting changes.

18+Minimum member age

≤ 2%Maximum baseline FIX level

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CurrentBaylor Scott & White Health PlanPolicy 312

Etranacogene dezaparvovec (Hemgenix) coverage

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Sign up for baylor_scott_and_white_health_plan Policy 312 alerts

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Policy Summary

PayerBaylor Scott & White Health Plan

PolicyEtranacogene dezaparvovec (Hemgenix) coverage

Policy CodePolicy 312

Change TypeMinor formatting changes

Effective DateSep 1, 2026

Last ReviewAug 27, 2026

Next Review DateAug 27, 2027

Key ActionPrior authorization is required for etranacogene dezaparvovec (Hemgenix).

SourceLink

POLICY UPDATE CHANGES

The 2026 policy history reports minor formatting changes.

18+Minimum member age

≤ 2%Maximum baseline FIX level

Required FIX exposure history

1 lifetimeMaximum treatment administrations

< 1:678AAV5 eligibility threshold

PA requiredUtilization management

Coverage Criteria

Diagnosis, age, and specialist requirement

Covered when ALL of the following are met.

Diagnosis and age
- Member has a diagnosis of hemophilia B (congenital factor IX deficiency).
- Member is 18 years or older.Age ≥ 18 years
Specialist prescribing: Etranacogene is prescribed by or in consultation with a physician who specializes in hemophilia.

Disease severity

The member must meet all of the following.

Disease severity: Member has documented moderately severe or severe hemophilia B, evidenced by a baseline FIX level without FIX replacement therapy of ≤ 2% of normal.FIX ≤ 2% of normal

Qualifying treatment or bleeding history

The member must meet at least one pathway; each pathway requires both listed elements.

Qualifying FIX treatment or bleeding history

Routine prophylaxis pathway
- Documentation of receiving routine prophylaxis with FIX therapy continuously for at least 2 months.At least 2 months
- According to the prescriber, member has at least a 150-exposure-day history of FIX therapy.At least 150 exposure days
Life-threatening hemorrhage pathway
- Member has a history of life-threatening hemorrhage.

Liver function

Adequate liver function requires ONE of the following.

Laboratory criteria
- Alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase are less than 2 times the upper limit of normal.ALT, AST, and ALP < 2 × ULN
- Bilirubin is less than 1.5 times the upper limit of normal.Bilirubin < 1.5 × ULN
Sustained enzyme elevation pathway: In the presence of sustained liver enzyme elevations, a consulting hepatologist attests that the member is eligible to receive Hemgenix.

HIV status

The member must meet one of the following HIV-status criteria.

HIV negative: Patient is not HIV positive.
HIV positive and suppressed: Patient is HIV positive and is virally suppressed.< 200 copies of HIV per mL

Exclusion criteria

The member must NOT meet any of the following exclusion criteria.

No exclusion conditions

AAV5 antibody titer is less than 1:678; a titer ≥ 1:678 excludes coverage.AAV5 antibody titer < 1:678
Member does not have FIX inhibitors.
Member does not have an active infection with hepatitis B or C virus at screening.
Member is not currently using antiviral therapy for hepatitis B or C.
Member has no prior gene therapy.

Coverage is excluded when the member has an AAV5 antibody titer of ≥ 1:678. Eligibility requires an AAV5 antibody titer below 1:678.

Coverage is excluded when the member has factor IX (FIX) inhibitors.

Coverage is excluded when the member has an active hepatitis B or hepatitis C infection at screening.

Coverage is excluded when the member is currently receiving antiviral therapy for hepatitis B or hepatitis C.

Coverage is excluded when the member has received prior gene therapy.

Repeat administration of etranacogene dezaparvovec is considered experimental and investigational because the effectiveness of repeat treatment has not been established. Only one treatment per lifetime is considered medically necessary.

Use of etranacogene dezaparvovec for indications other than hemophilia B is considered experimental and investigational because the effectiveness of this use has not been established.

Coding and Clinical Thresholds

CPT CodesCPT

96365	Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour
96366	Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); each additional hour (List separately in addition to code for primary procedure)

HCPCS CodesHCPCS

J1411

Injection, etranacogene dezaparvovec-drlb, per therapeutic dose

ICD-10 CodesICD-10Covered

D67	Hereditary factor IX deficiency

ICD-10 Not coveredICD-10Not Covered

No codes listed

Baseline factor IX level

Required baseline levelFactor IX (FIX) level must be ≤ 2% of normal.

Measurement conditionThe baseline level is measured without FIX replacement therapy.

Qualifying conditionThis level documents moderately severe or severe hemophilia B.

Continuous FIX prophylaxis

Minimum durationRoutine FIX prophylaxis must be received continuously for at least 2 months.

Therapy typeThe qualifying therapy is routine prophylaxis with FIX therapy.

Authorization and Provider Requirements

Prior Authorization

Obtain prior authorization before treatment

Prior authorization is required for etranacogene dezaparvovec (Hemgenix). Submit the request for clinical review; all requests are reviewed by a clinical pharmacist and medical director.

Documentation Required

Submit complete clinical documentation

Submit documentation confirming that all coverage criteria are met, including the diagnosis, age, specialist prescribing or consultation, disease severity, qualifying FIX treatment or bleeding history, liver function, HIV status when applicable, and absence of exclusion conditions.

Hemophilia B diagnosis and age of at least 18 years
Prescription by or consultation with a physician who specializes in hemophilia
Baseline FIX level of ≤ 2% of normal without FIX replacement therapy
Qualifying FIX treatment history or qualifying bleeding history

Clinical Background

Hemophilia B is an inherited X-linked bleeding disorder caused by mutations in the F9 gene, resulting in deficient coagulation factor IX (FIX). Etranacogene dezaparvovec is an adeno-associated virus serotype 5 gene-transfer therapy that delivers a functional F9 variant encoding FIX-Padua to the liver. This policy addresses its use in adults with moderately severe or severe hemophilia B who meet specified treatment-history, bleeding-history, liver-function, infection, and immunologic requirements.

Policy Definitions

Hemophilia B

ConditionHemophilia B is a congenital inherited bleeding disorder.

Underlying deficiencyThe disorder is caused by factor IX deficiency.

Policy diagnosisThe member must have a diagnosis of hemophilia B, also described as congenital factor IX deficiency.

Moderately severe or severe hemophilia B

FIX activity thresholdFactor IX activity must be ≤ 2% of normal.

Severity classificationThis level evidences moderately severe or severe hemophilia B.

Testing condition

Initial Hemgenix Treatment

Initial Hemgenix treatment

Initial treatment may be considered medically necessary when ALL core criteria are met, including at least one qualifying FIX-treatment or bleeding-history pathway and no exclusion condition.

Initial Hemgenix eligibility

Diagnosis, age, and specialist requirement
- Member has a diagnosis of hemophilia B (congenital factor IX deficiency).
- Member is 18 years or older.Age ≥ 18 years
- Etranacogene is prescribed by or in consultation with a physician who specializes in hemophilia.

Treatment Quantity Limits

Etranacogene dezaparvovec (Hemgenix)

Covered treatmentEtranacogene dezaparvovec (Hemgenix) is limited to one treatment per lifetime.

Repeat administrationRepeat administration is considered experimental and investigational.

Reason for limitationThe effectiveness of repeat administration has not been established.

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyEtranacogene dezaparvovec (Hemgenix) coverage

Policy CodePolicy 312

Change TypeMinor formatting changes

Effective DateSep 1, 2026

Last ReviewAug 27, 2026

Next Review DateAug 27, 2027

Key ActionPrior authorization is required for etranacogene dezaparvovec (Hemgenix).

SourceLink

On This Page

On-demand use of FIX therapy was required for the life-threatening hemorrhage.

Serious spontaneous bleeding pathway

Member has a history of repeated, serious spontaneous bleeding episodes.
On-demand use of FIX therapy was required for the serious spontaneous bleeding episodes.

Pathway requirementThis is one element of the qualifying FIX-treatment history pathway.

FIX exposure history

Minimum exposure historyThe member must have at least 150 exposure days of FIX therapy.

Documentation sourceThe exposure-day history must be supported according to the prescriber.

Pathway relationshipThe exposure history is required together with at least 2 months of continuous routine FIX prophylaxis under this pathway.

ALT, AST, and ALP

Alanine aminotransferase (ALT)Less than 2 times the upper limit of normal (ULN).

Aspartate aminotransferase (AST)Less than 2 times the ULN.

Alkaline phosphatase (ALP)Less than 2 times the ULN.

Bilirubin

Bilirubin thresholdBilirubin must be less than 1.5 times the ULN.

Liver-function pathwayThe bilirubin threshold is part of the laboratory criteria for adequate liver function.

Paired laboratory requirementThe bilirubin criterion applies together with ALT, AST, and ALP values less than 2 times the ULN.

HIV viral load

HIV-negative pathwayThe member may qualify if the patient is not HIV positive.

HIV-positive pathwayIf HIV positive, the patient must be virally suppressed.

Viral-load thresholdViral suppression means fewer than 200 copies of HIV per mL.

AAV5 antibody titer

Qualifying titerAAV5 antibody titer must be less than 1:678.

Exclusion thresholdAAV5 antibody titer ≥ 1:678 excludes coverage.

Antibody typeAAV5 antibodies are directed against the adeno-associated virus serotype 5 vector.

Liver-function laboratory results or, when applicable, hepatologist attestation

HIV status and viral suppression documentation when HIV positive

Documentation that the member has no listed exclusion conditions

Documentation Required

Include hepatologist attestation for elevated enzymes

If sustained liver enzyme elevations are present, submit an attestation by a consulting hepatologist documenting the member’s eligibility to receive Hemgenix.

Denial Risk

Avoid noncovered indications and exclusion conditions

Requests are denied or considered experimental and investigational when Hemgenix is requested for an indication other than hemophilia B, when repeat administration is requested, or when a listed exclusion condition is present.

Only one treatment per lifetime is medically necessary; repeat administration is experimental and investigational because effectiveness has not been established.
Noncovered indications include conditions other than hemophilia B.
Exclusions include an AAV5 antibody titer ≥ 1:678, FIX inhibitors, active hepatitis B or C infection at screening, current antiviral therapy for hepatitis B or C, or prior gene therapy.

Denial Risk

Document every medical necessity criterion

Coverage requires documentation of all applicable medical necessity criteria. Requests are at risk for denial when age, specialist prescribing, disease severity, qualifying treatment or bleeding history, liver function, HIV status, or exclusion criteria are not established.

Member must be at least 18 years old and have hemophilia B.
Baseline FIX level must be ≤ 2% of normal without FIX replacement therapy.
At least one qualifying FIX-treatment or bleeding-history pathway must be documented.
Adequate liver function must be shown by laboratory criteria or consulting hepatologist attestation.
The member must be HIV negative or, if HIV positive, virally suppressed at < 200 copies of HIV per mL.
None of the listed exclusion conditions may be present.

The activity level is measured without FIX replacement therapy.

AAV5 antibodies

Antibody definitionAAV5 antibodies are antibodies directed against the adeno-associated virus serotype 5 vector.

Eligible titerA titer less than 1:678 meets the policy threshold.

Exclusion titerA titer of 1:678 or greater is an exclusion under the policy.

Disease severity: Member has documented moderately severe or severe hemophilia B, evidenced by a baseline FIX level without FIX replacement therapy of ≤ 2% of normal.FIX ≤ 2% of normal

Qualifying treatment or bleeding history

Routine prophylaxis pathway
- Documentation of receiving routine prophylaxis with FIX therapy continuously for at least 2 months.At least 2 months
- According to the prescriber, member has at least a 150-exposure-day history of FIX therapy.At least 150 exposure days
Life-threatening hemorrhage pathway
- Member has a history of life-threatening hemorrhage.
- On-demand use of FIX therapy was required for the life-threatening hemorrhage.
Serious spontaneous bleeding pathway
- Member has a history of repeated, serious spontaneous bleeding episodes.
- On-demand use of FIX therapy was required for the serious spontaneous bleeding episodes.

Adequate liver function

Laboratory criteria
- Alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase are less than 2 times the upper limit of normal.ALT, AST, and ALP < 2 × ULN
- Bilirubin is less than 1.5 times the upper limit of normal.Bilirubin < 1.5 × ULN
Sustained enzyme elevation pathway: In the presence of sustained liver enzyme elevations, a consulting hepatologist attests that the member is eligible to receive Hemgenix.

HIV status

Patient is not HIV positive.
Patient is HIV positive and is virally suppressed.< 200 copies of HIV per mL

No exclusions

AAV5 antibody titer is less than 1:678; a titer ≥ 1:678 excludes coverage.AAV5 antibody titer < 1:678
Member does not have FIX inhibitors.
Member does not have an active infection with hepatitis B or C virus at screening.
Member is not currently using antiviral therapy for hepatitis B or C.
Member has no prior gene therapy.