CurrentBaylor Scott & White Health PlanPolicy 312

Etranacogene dezaparvovec (Hemgenix) — Medical Coverage Policy

Defines medical necessity, prior authorization, and coverage criteria for etranacogene dezaparvovec (Hemgenix) for adults with hemophilia B for Baylor Scott & White Health Plan lines of business.

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyEtranacogene dezaparvovec (Hemgenix) — Medical Coverage Policy

Policy CodePolicy 312

Change TypeOperational and clinical updates (documentation, prescriber requirement, lifetime dosing language)

Effective DateSep 1, 2025

Next Review DateAug 11, 202659d

Key ActionSubmit prior authorization with documentation of diagnosis, baseline FIX level, treatment history, prescriber specialty, liver tests and viral status to establish medical necessity.

SourceLink

POLICY UPDATE CHANGES

Added requirement of submitted documentation and updated to standard language for indication and prescriber.

Updated lifetime treatment and experimental and investigational language.

Removed Medicare NCD/LCD Interqual statement for clarity.

1 per lifetimetreatment courses considered medically necessary

18+minimum patient age for coverage

Baseline FIX < 2%severity threshold

Prior authauthorization requirement

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Etranacogene Dezaparvovec (Hemgenix)

Initial Therapy

Covered when ALL of the following are met:

Primary eligibility: Member has a diagnosis of hemophilia B (congenital factor IX deficiency); AND member is 18 years or older; AND etranacogene dezaparvovec is prescribed by or in consultation with a physician who specializes in hemophilia; AND member has documentation of moderately severe or severe hemophilia B as evidenced by a baseline (without FIX replacement therapy) FIX level of < 2% of normal.

Bleeding history / prior therapy requirement (one of the following sets required)

Current FIX prophylaxis users: Member currently uses factor IX prophylaxis therapy (documentation of receiving routine prophylaxis with FIX therapy continuously for at least 2 months).
Life‑threatening hemorrhage history: History of life‑threatening hemorrhage AND on‑demand use of FIX therapy was required for this life‑threatening hemorrhage.
Repeated serious spontaneous bleeding episodes: History of repeated, serious spontaneous bleeding episodes AND on‑demand use of FIX therapy was required for these serious spontaneous bleeding episodes.
Alternate exposure history: According to the prescriber, has at least a 150‑exposure‑day history of FIX therapy.

Liver function requirements: Member has adequate liver function defined by ONE of the following: ALT, AST, or ALP less than 2 times the upper limit of normal; OR in the presence of sustained liver enzyme elevations, attestation by a consulting hepatologist documenting eligibility to receive Hemgenix.

HIV / AAV antibody status: Member meets one of the following: patient is not HIV positive; OR patient is HIV positive and is virally suppressed (< 200 copies/mL); OR AAV5 antibody titer as reported by the prescriber.

Source lists an AAV5 antibody titer value with unclear formatting; use reported titer per documentation.

Exclusionary conditions absent: Member does NOT have any of the following: FIX inhibitors; current use of antiviral therapy for hepatitis B or C; active infection with hepatitis B or C at screening; prior gene therapy for hemophilia B.

BSWHP considers etranacogene dezaparvovec for the treatment of all indications other than the specific hemophilia B criteria in this policy to be experimental and investigational because effectiveness has not been established.

Repeat administration beyond one treatment per lifetime is considered experimental and investigational and therefore not medically necessary, because the effectiveness of re-dosing has not been established.

Applicable Codes and Key Clinical Values

Applicable CPT/HCPCS/ICD-10 codesmixed

96365	Intravenous infusion, for therapy, prophylaxis, or diagnosis; initial, up to 1 hour
96366	Intravenous infusion, each additional hour
J1411	Injection, etranacogene dezaparvovec-drlb, per therapeutic dose
D68.2	Hereditary factor IX deficiency

Baseline FIX level — key clinical threshold

Baseline (pre-replacement) FIX level< 2% of normal

Context for measurementBaseline FIX level refers to the value measured without recent FIX replacement therapy

Severity threshold useUsed to define moderately severe or severe hemophilia B for eligibility

Prior Authorization, Documentation, and Denial Conditions

Prior Authorization

Prior authorization required

Prior authorization is required. Baylor Scott & White Health Plan (BSWHP) may consider etranacogene dezaparvovec (Hemgenix) medically necessary when documentation is submitted showing ALL specified criteria are met.

Step Therapy

Step therapy / sequencing

No additional step-therapy sequencing is required beyond demonstrating prior FIX prophylaxis or an exposure history as part of eligibility documentation.

Documentation Required

Required supporting documentation

Submit documentation demonstrating diagnosis of hemophilia B, baseline (pre-replacement) FIX level, treatment history (including routine FIX prophylaxis or exposure-day history and bleed history), prescriber specialty or consultation, liver function tests or hepatology attestation if enzymes elevated, and HIV/HBV/HCV status and related information to support medical necessity.

Key Definitions

Moderately severe or severe hemophilia B

Definition of moderately severe/severe hemophilia BHemophilia B with a baseline (without FIX replacement therapy) FIX level of < 2% of normal

Clinical significanceSeverity correlates with FIX level; lower levels associated with increased spontaneous and recurrent bleeding

Role in coverage criteriaBaseline FIX < 2% is required documentation to meet primary eligibility for Hemgenix

Etranacogene dezaparvovec (Hemgenix) — product description

Product descriptionEtranacogene dezaparvovec (Hemgenix) is a recombinant gene transfer therapy consisting of an AAV5 vector that delivers a highly functional F9 gene variant (FIX‑Padua) to the liver for FIX production.

Indication summaryIndicated for treatment of adults with hemophilia B who use FIX prophylaxis or have current/historical life‑threatening hemorrhage or repeated serious spontaneous bleeding episodes.

Clinical Background

Hemophilia B is an inherited X-linked deficiency of coagulation factor IX (FIX) that leads to prolonged bleeding; severity correlates with baseline FIX level and severe disease presents with frequent spontaneous bleeding. Etranacogene dezaparvovec (Hemgenix) is an adeno-associated virus vector–based gene transfer therapy that delivers a high-activity FIX (Padua) transgene to hepatocytes to produce FIX protein, and is intended as a one-time treatment option for adults with moderately severe or severe hemophilia B who meet the policy’s eligibility criteria.