CurrentAvMedPolicy N/A

Hemgenix (etranacogene dezaparvovec-drlb) gene therapy prior authorization

This document is AvMed's medical prior authorization form and clinical criteria for coverage of Hemgenix (etranacogene dezaparvovec-drlb) for members receiving medical benefit (J1411). It governs authorization requirements, clinical eligibility criteria, dosing/quantity limits, and documentation expectations for providers requesting one lifetime infusion.

Policy Summary

PayerAvMed

PolicyHemgenix (etranacogene dezaparvovec-drlb) gene therapy prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit the signed prior authorization form and supporting documentation (labs, factor IX baseline, inhibitor testing, liver/renal tests, weight, exposure/bleeding history, and claims verification) to AvMed for review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1infusion permitted per lifetime

2 x 10^13 gc/kgrecommended dose

≤ 2%baseline factor IX level for eligibility

≥50required platelet threshold (within 30 days)

Medical Necessity / Approval Criteria

Policy Summary

PayerAvMed

PolicyHemgenix (etranacogene dezaparvovec-drlb) gene therapy prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

SourceLink

On This Page

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.

Medical Necessity / Approval Criteria

All criteria must be met for approval. To support each checked item, documentation including labs and chart notes must be provided.

ALL of the following

Member is male (biological male defined regardless of gender identity)
Member is 18 years of age or older
Medication is prescribed by a hemophilia specialist physician
Member has NOT received a prior gene therapy for hemophilia B (verification via claims or prescriber attestation)
ALL of the following
- Member has moderately severe or severe hemophilia B as evidenced by a baseline (without Factor IX replacement) Factor IX level ≤ 2% of normal
Demonstration of clinically significant bleeding or exposure
- History of use of Factor IX therapy for ≥ 150 exposure days (per prescribing physician)
- ALL of the following
  - History of life-threatening hemorrhage
  - On-demand use of Factor IX therapy was required for this life-threatening hemorrhage
- ALL of the following
  - History of repeated, serious spontaneous bleeding episodes
  - On-demand use of Factor IX therapy was required for these serious spontaneous bleeding episodes
ALL of the following
- Factor IX inhibitor titer testing has been performed within 30 days
  submit documentation
- Member is negative for Factor IX inhibitors
- Member does NOT have a history of Factor IX inhibitors
ALL of the following
- Prophylactic therapy with Factor IX will NOT be given after Hemgenix administration once adequate Factor IX levels have been achieved
  Episodic Factor IX for bleeds or surgeries is acceptable per specialist
ALL of the following
- Member does NOT have an active infection with hepatitis B or hepatitis C
- Member is NOT currently receiving antiviral therapy for prior hepatitis B or hepatitis C exposure
Member does NOT have uncontrolled HIV infection (per prescribing physician)
ALL of the following
- Liver function testing within 30 days with ALT ≤ 2x ULN
  submit documentation
- Liver function testing within 30 days with AST ≤ 2x ULN
  submit documentation
- Total bilirubin ≤ 2x ULN
  submit documentation
- Alkaline phosphatase ≤ 2x ULN
  submit documentation
- No evidence of advanced liver impairment and/or advanced fibrosis (e.g., liver elastography not suggestive of METAVIR Stage 3+)
Within the past 30 days, platelet count ≥ 50 x 10^9/L (submit documentation)
ANY of the following
- Within the past 30 days, estimated creatinine clearance ≥ 30 mL/min
  submit documentation
- Within the past 30 days, creatinine level ≤ 2x ULN
  submit documentation
Current body weight obtained within 30 days (submit documentation)

Eligibility Thresholds & Dosing

Eligibility thresholds

Baseline Factor IX level≤ 2% of normal (baseline without Factor IX replacement) — submit documentation

Platelet count≥ 50 x 10^9/L (within 30 days) — submit documentation

Liver enzymes and bilirubinALT, AST, total bilirubin, alkaline phosphatase each ≤ 2 x ULN (within 30 days); no evidence of advanced liver impairment/fibrosis

Renal functionEstimated creatinine clearance ≥ 30 mL/min OR creatinine ≤ 2 x ULN (within 30 days) — submit documentation

Age≥ 18 years

Dose2 x 10^13 genome copies/kg (2 mL/kg) administered once as an intravenous infusion; one infusion per lifetime; vial calculation per weight-based kit chart

1infusion permitted per lifetime

2 x 10^13 gc/kgrecommended dose

≤ 2%baseline factor IX level for eligibility

≥ 50 x 10^9/Lrequired platelet threshold (within 30 days)

What Providers Must Do

Prior Authorization

Submit completed prior authorization form and documentation

Providers must submit the signed prior authorization form with the prescriber's signature and all supporting documentation to AvMed at the fax number on the form for review. Required supporting documentation includes labs, baseline Factor IX level and inhibitor testing, liver and renal test results, current weight, history of exposures/bleeding, and verification of prior gene therapy (claims or prescriber attestation).

HCPCS J1411
Supporting documentation: labs (liver, renal), Factor IX baseline level, Factor IX inhibitor testing, platelet count, weight, history of exposures/bleeding, and claims verification or prescriber attestation of no prior gene therapy

Documentation Required

Provide labs within 30 days

Submit liver function tests, platelet count, factor IX inhibitor titer, current body weight, and renal function results obtained within 30 days of the request (attach documentation).

Liver function tests: ALT, AST, total bilirubin, alkaline phosphatase (each within 30 days)
Platelet count (within 30 days)
Factor IX inhibitor titer (performed within 30 days)
Current body weight (obtained within 30 days)
Renal function: estimated creatinine clearance ≥ 30 mL/min OR creatinine ≤ 2x ULN (within 30 days)

Denial Risk

Denial if documentation incomplete or criteria unmet

Requests may be denied if required documentation is not provided or if the member does not meet clinical criteria or has disqualifying conditions.

Affected code: J1411
Missing or incomplete documentation (labs, chart notes, signed form) may lead to denial
Prior gene therapy for hemophilia B (claims or prescriber attestation of prior Hemgenix/Beqvez) is disqualifying
Active hepatitis B or hepatitis C infection or current antiviral therapy for hepatitis may lead to denial
Uncontrolled HIV infection as determined by the prescribing physician
Evidence of advanced liver impairment or fibrosis (e.g., elastography suggestive of METAVIR Stage 3+)
Failure to meet Factor IX level (baseline ≤ 2% of normal) or required bleeding/exposure history

Billing Rule

One infusion per lifetime / vial calculation

Coverage is limited to a single Hemgenix infusion per member lifetime. Dose is weight-based (2 mL/kg) with vials rounded up per the kit volume/weight chart; quantity limit is 1 kit (based on weight chart) per lifetime.

Affected code: J1411
Dose calculation: Hemgenix dose (mL) = patient weight (kg) × 2 mL/kg; vials needed = dose (mL) ÷ 10, round up to next whole vial
Quantity limit: 1 kit per lifetime (based on weight chart)

Clinical Context

Hemgenix (etranacogene dezaparvovec-drlb) is a one-time, adeno-associated virus (AAV) mediated gene therapy indicated for adults with moderately severe to severe hemophilia B to increase endogenous Factor IX activity. It is provided as a single intravenous infusion and coverage is limited to one infusion per lifetime.

Dosing is weight-based: the recommended dose is 2 x 10^13 genome copies/kg (equivalent to 2 mL/kg), with vial requirements calculated from the patient’s current body weight and kits rounded up per the manufacturer/plan kit volume chart. Quantity limits specify 1 kit (based on weight chart) per lifetime for the medical benefit (HCPCS code J1411).

Prior to administration, patients require careful pre-treatment evaluation. Documentation must include baseline Factor IX level (without replacement therapy) showing Factor IX ≤ 2% of normal for eligibility, and Factor IX inhibitor titer testing performed within 30 days demonstrating the patient is negative for inhibitors and has no history of inhibitors.

Recommended pre-treatment laboratory assessment includes liver function tests and fibrosis assessment: within 30 days, ALT and AST ≤ 2 x ULN, total bilirubin ≤ 2 x ULN, and alkaline phosphatase ≤ 2 x ULN, and no evidence of advanced liver impairment or advanced fibrosis (for example, elastography suggestive of METAVIR Stage 3+). Platelet count obtained within 30 days must be ≥ 50 x 10^9/L. Renal function within 30 days must show either an estimated creatinine clearance of ≥ 30 mL/min or a creatinine level ≤ 2 x ULN.

Infectious disease and clinical history requirements include documentation that the member does NOT have an active hepatitis B or C infection and is not currently receiving antiviral therapy for prior hepatitis B or C exposure, and that the member does NOT have uncontrolled HIV infection per the prescribing physician. Hemgenix must be prescribed by a hemophilia specialist and the member must be an adult male (biological male) aged ≥ 18 years who has not previously received gene therapy for hemophilia B.

OpenPayer

Hemgenix (etranacogene dezaparvovec-drlb) gene therapy prior authorization

Medical Necessity / Approval Criteria

Eligibility Thresholds & Dosing

Relevant Codes

What Providers Must Do

Clinical Context

Key Definitions