CurrentEmblemHealthPolicy MG.MMPH.380

Hemgenix (etranacogene dezaparvovec-drlb) intravenous suspension

Medical policy governing one-time gene therapy Hemgenix for adults with Hemophilia B; defines clinical criteria, dosing, authorization limits, coding, and required pre-treatment assessments for EmblemHealth members.

Policy Summary

PayerEmblemHealth

PolicyHemgenix (etranacogene dezaparvovec-drlb) intravenous suspension

Policy CodePolicy MG.MMPH.380

Change TypeCriteria clarified and monitoring language removed

Effective Date

Next Review Date

Key ActionObtain prior authorization and submit clinical evidence that the member meets all specified criteria for one-time Hemgenix administration.

SourceLink

POLICY UPDATE CHANGES

Replaced requirement 'Patient has not received Hemgenix in the past' with 'Patient has not received a gene therapy for hemophilia B in the past'.

Removed prior monitoring schedule and mandatory documentation requirements (weekly liver enzyme and Factor IX monitoring language and several attestations).

Clarified renal function requirement timeframe to 'within the past 30 days'.

1dose per lifetime authorized

2 x 10^13dose (gc/kg)

>=18minimum age

<2%

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>50min platelet count

Coverage Criteria for Hemgenix (etranacogene dezaparvovec-drlb)

Initial Therapy

Approve a one-time per lifetime dose if ALL of the following are met

Eligibility core criteria

Demographics: Patient is male AND age >= 18 years
Disease severity: Moderately severe or severe Hemophilia B evidenced by Factor IX level < 2% of normal< 2% of normal
No prior gene therapy: Patient has not received a gene therapy for hemophilia B in the past; verify claims history and if no Hemgenix claim present prescriber must attest no prior Hemgenix
Claims verification plus prescriber attestation when no claim exists
Clinical history qualifying events (one required): Patient currently uses Factor IX prophylaxis therapy OR has repeated serious spontaneous bleeding episodes OR has a history of life-threatening hemorrhage
Exposure days or bleeding history: History of use of Factor IX therapy for at least 150 exposure days OR life-threatening hemorrhage requiring on-demand Factor IX OR repeated serious spontaneous bleeding episodes requiring on-demand Factor IX>= 150 exposure days (if using exposure days pathway)
Inhibitor and infection status: Factor IX inhibitor testing performed within 30 days before receipt of Hemgenix; no current inhibitor and no history of inhibitors; no active hepatitis B or C infection; not currently receiving antiviral therapy for prior hepatitis B or C exposure
HIV-positive patients controlled on ART with CD4 >200/µL or viral load <200 copies/mL may qualify; no uncontrolled HIV
Liver and laboratory assessments: Within 30 days: ALT and AST < 2x ULN, total bilirubin < 2x ULN, alkaline phosphatase < 2x ULN, platelets > 50 x10^9/L, adequate renal function (estimated creatinine clearance > 30 mL/min and creatinine < 2x ULN), and current body weight documented
Prescriber specialty: Medication must be prescribed by a physician who specializes in hemophilia

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title

Initial Therapy

Patient has received a gene therapy for hemophilia B in the past; prior receipt of any gene therapy for hemophilia B precludes approval. Verify claims history for prior Hemgenix exposure and, if no Hemgenix claim exists, obtain prescriber attestation that the patient has not previously received Hemgenix.

Use beyond one dose per lifetime (more than one kit) is not supported. Dosing limit: one dose per lifetime.

Coding: Procedure, Diagnosis, and Drug Codes

Applicable Procedure CodesHCPCSCovered

J1411

Injection, etranacogene parvovec-drlb

ICD-10 DiagnosesICD-10Covered

D67	Hereditary factor IX deficiency

Applicable NDCsNDC

00053-0410-41	Hemgenix
00053-0440-44	Hemgenix
00053-0150-15	Hemgenix
00053-0140-14	Hemgenix
00053-0420-42	Hemgenix
00053-0130-13	Hemgenix
00053-0390-39	Hemgenix
00053-0310-31	Hemgenix
00053-0240-24	Hemgenix
00053-0320-32	Hemgenix

1–10 of 38

1/4

inv-07: Platelet count — minimum lab threshold required

Minimum platelet count> 50 x 10^9/L (evaluated within the past 30 days)

Assessment timeframePlatelet count must be measured within the last 30 days prior to dosing

Related liver assessmentPlatelet requirement is part of the liver health assessment bundle (see ALT/AST, bilirubin, alkaline phosphatase)

inv-08: Estimated creatinine clearance — minimum renal function threshold

Estimated creatinine clearance threshold> 30 mL/min (measured within the past 30 days)

Additional renal criterion

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required — Hemgenix is a one-time per lifetime administration and requires prior authorization and approval when all specified clinical criteria are met.

One-time per lifetime administration
Prior authorization required before administration

Documentation Required

Clinical Evidence Submission

The treating physician or primary care provider must submit clinical evidence that the member meets the criteria for treatment. EmblemHealth will not be able to properly review the request (preauthorization or post-payment review) without this documentation.

Clinical evidence must be submitted by the treating physician or primary care provider
Required for preauthorization and post-payment review

Background on Hemgenix

Hemgenix is an adeno-associated virus (AAV) vector–based gene therapy indicated for treatment of adults with congenital Factor IX deficiency (Hemophilia B). It is intended as a one-time treatment option for eligible adults with moderately severe or severe disease to address Factor IX deficiency.

Definitions

inv-16: Definition — Hemgenix

DefinitionHemgenix is an adeno-associated virus vector-based gene therapy indicated for treatment of adults with Hemophilia B (congenital Factor IX deficiency).

Indicated population examplesPatients who currently use Factor IX prophylaxis therapy, or have repeated serious spontaneous bleeding episodes, or have current or historical life‑threatening hemorrhage

Dose policy contextHemgenix is administered as a one-time per lifetime dose when coverage criteria are met

Policy Summary

PayerEmblemHealth

PolicyHemgenix (etranacogene dezaparvovec-drlb) intravenous suspension

Policy CodePolicy MG.MMPH.380

Change TypeCriteria clarified and monitoring language removed

Effective Date

Next Review Date

Key ActionObtain prior authorization and submit clinical evidence that the member meets all specified criteria for one-time Hemgenix administration.

SourceLink

On This Page

Serum creatinine must be < 2 times the upper limit of normal (within the past 30 days)

Assessment timeframeRenal function requirements must be documented within 30 days before dosing

inv-09: ALT and AST — hepatic enzyme thresholds

Alanine aminotransferase (ALT)< 2 x upper limit of normal (measured within the last 30 days)

Aspartate aminotransferase (AST)< 2 x upper limit of normal (measured within the last 30 days)

Assessment contextALT and AST are part of the required liver health assessment performed within 30 days prior to dosing

inv-10: Total bilirubin — hepatic function threshold

Total bilirubin< 2 x upper limit of normal (measured within the last 30 days)

Part of liver health assessmentTotal bilirubin requirement is included with ALT/AST and alkaline phosphatase within 30 days

Related exclusionNo evidence of advanced liver impairment or advanced fibrosis as part of liver assessment

Denial Risk

Documentation Submission Required

Failure to submit the required clinical evidence will prevent EmblemHealth from properly reviewing the request and may result in denial of authorization or claim payment.

Omission of documentation may lead to denial of request or post-payment recovery

Documentation Required

Prior Therapy / Clinical History Documentation

Provider must confirm and include documentation of prior therapy and clinical history per criteria (e.g., current Factor IX prophylaxis use or documented history of repeated serious spontaneous bleeding episodes, exposure days to Factor IX therapy). Include any applicable attestation (e.g., no prior gene therapy or Hemgenix claim) and recent inhibitor and viral testing results as specified in the clinical criteria.

Document current Factor IX prophylaxis or history of repeated serious spontaneous bleeding episodes
Document exposure days to Factor IX therapy (as applicable)
Attestation or claims verification that patient has not previously received Hemgenix
Include Factor IX inhibitor titer testing performed within 30 days and viral status documentation