CurrentCignaPolicy IP0535

Hemgenix

Cigna drug coverage policy defining prior authorization, medical necessity criteria, dosing (one-time per lifetime), documentation and kit/NDC mapping for Hemgenix for treatment of adults with hemophilia B.

Policy Summary

PayerCigna

PolicyHemgenix

Policy CodePolicy IP0535

Change TypeCriteria revisions and operational updates

Effective DateMar 12, 2026

Next Review Date

Key ActionSubmit prior authorization with required documentation and ensure prescribing hemophilia specialist confirms no prior gene therapy; approval duration is 90 days.

SourceLink

POLICY UPDATE CHANGES

Removed requirement that after Hemgenix infusion the physician attest to weekly liver enzyme testing for first 3 months and periodic thereafter, weekly Factor IX activity monitoring for first 3 months, and specified abdominal ultrasound/AFP monitoring for patients at risk of hepatocellular carcinoma.

Specialist requirement changed to 'hemophilia specialist physician.'

Moved current body weight requirement to its own criterion (obtain within 30 days).

Dosing clarified with emphasis that Hemgenix is given as a 'single dose.'

Verification wording changed to 'prescribing physician confirms' when claims history is not available for prior Hemgenix/Beqvez receipt.

Factor IX inhibitor requirement reworded to state patient is negative for Factor IX inhibitors; timing requirement for testing standardized to within 30 days.

Renal function criterion changed from requiring both estimated creatinine clearance ≥ 30 mL/min AND creatinine ≤ 2x ULN to meeting ONE of these elements.

Conditions Not Covered: Prior Receipt of Gene Therapy was added as an exclusion.

Approval duration of 90 days was added to Policy Statement to allow for preparation and administration of one dose.

Documentation instruction added that all documentation must include patient-specific identifying information.

Coverage Summary

Cigna coverage policy for Hemgenix (etranacogene dezaparvovec-drlb) defines prior authorization, medical necessity criteria, dosing as a one-time (per lifetime) single dose, documentation requirements, and kit/NDC mapping for treatment of adults with hemophilia B.

Hemgenix is indicated as an AAV vector-based one-time gene therapy for adults with moderately severe or severe hemophilia B to increase Factor IX activity.

Initial Therapy Criteria (FDA-Approved Indication)

FDA-Approved Indication - Hemophilia B

Approve a one-time (per lifetime) single dose if the patient meets ALL of the following (A through O):

A: Patient is male *

B: Patient is ≥ 18 years of ageAge >= 18 years

C: Patient has not received a gene therapy for hemophilia B in the past

[verification in claims history required]

D: Patient has moderately severe or severe hemophilia B as evidenced by a baseline (without Factor IX replacement therapy) Factor IX level ≤ 2% of normalBaseline Factor IX <= 2%

[documentation required]

E. Meets ONE of the following

E.i: According to the prescribing physician, the patient has a history of use of Factor IX therapy for ≥ 150 exposure daysFactor IX exposure days >= 150
E.ii
- E.ii.a: Patient has a history of life-threatening hemorrhage
- E.ii.b: On-demand use of Factor IX therapy was required for this life-threatening hemorrhage
E.iii
- E.iii.a:

F. Factor IX inhibitor testing

F.i: Factor IX inhibitor titer testing has been performed within 30 daystesting within 30 days
[documentation required]
F.ii: Patient is negative for Factor IX inhibitors
[documentation required]

G. Hepatitis status

G.i: Patient does not have an active infection with hepatitis B virus or hepatitis C virus
[documentation required]
G.ii: Patient is not currently receiving antiviral therapy for a prior hepatitis B virus or hepatitis C virus exposure
[documentation required]

H: According to the prescribing physician, the patient does not have uncontrolled human immunodeficiency virus infection

I. Liver function testing within 30 days

I.i: Alanine aminotransferase level is ≤ two times the upper limit of normalALT <= 2x ULN (within 30 days)
[documentation required]
I.ii: Aspartate aminotransferase level is ≤ two times the upper limit of normalAST <= 2x ULN (within 30 days)
[documentation required]
I.iii: Total bilirubin level is ≤ two times the upper limit of normalTotal bilirubin <= 2x ULN (within 30 days)
[documentation required]

J: Patient does not have evidence of advanced liver impairment and/or advanced fibrosis

K: Within 30 days, the platelet count was ≥ 50 x 10^9 /LPlatelet count >= 50 x 10^9/L (within 30 days)

[documentation required]

L. Renal function (within 30 days)

L.i: Patient has an estimated creatinine clearance ≥ 30 mL/minCreatinine clearance >= 30 mL/min (within 30 days)
[documentation required]
L.ii: Creatinine level is ≤ two times the upper limit of normalCreatinine <= 2x ULN (within 30 days)
[documentation required]

M: The medication is prescribed by a hemophilia specialist physician

N: Current body weight has been obtained within 30 days

[documentation required]

O: If criteria A through O are met, approve one dose (kit) of Hemgenix to provide for a one-time (per lifetime) single dose of 2 x 10^13 genome copies per kg of body weight by intravenous infusionDose = 2 x 10^13 gc/kg (single lifetime dose)

[verification required]

Dosing & Administration

Dosing

Recommended dosing statement:

Dosing.1: One-time (per lifetime) single dose of 2 x 10^13 genome copies per kg of body weight by intravenous infusionDose = 2 x 10^13 gc/kg (single lifetime dose)

Dosing.2: Approval duration is 90 days to allow preparation and administration of one doseApproval duration = 90 days

Dosing is intended as a single intravenous infusion given once per lifetime to deliver 2 x 10^13 genome copies per kg of body weight. Kit selection is weight-based and billed using the appropriate NDC kit mapping (Table 1) corresponding to the patient’s body weight.

Conditions Not Covered (Not Medically Necessary)

Hemgenix for any other use is considered not medically necessary including:

Exclusions

Excl.1: Prior receipt of gene therapy for hemophilia B
Excl.2: Patient with a history of Factor IX inhibitors

Material change: the policy explicitly added Prior Receipt of Gene Therapy as an exclusion/condition not covered.

Provider Actions & Operational Requirements

Prior Authorization

Prior authorization required

Prior Authorization is recommended; approval requires meeting all criteria and prescribing by a hemophilia specialist; approval duration is 90 days for kit preparation and administration.

J1411
Approval duration: 90 days

Documentation Required

Documentation requirements

Documentation required for diagnosis, baseline Factor IX level, Factor IX inhibitor testing (performed within 30 days), liver function tests (within 30 days), platelet count (within 30 days), renal function (within 30 days), current body weight (within 30 days), and claims verification for prior gene therapy; documentation must include patient-specific identifying information.

Applicable Codes

Considered Medically Necessary - J-code for HemgenixHCPCSCovered

J1411

Injection, etranacogene dezaparvovec-drlb, per therapeutic dose

Hemgenix Kit NDCs by patient weight (per Table 1)NDCCovered

0053-0100-10	46-50 kg kit, total volume 100
0053-0110-11	51-55 kg kit, total volume 110
0053-0120-12	56-60 kg kit, total volume 120
0053-0130-13	61-65 kg kit, total volume 130
0053-0140-14	66-70 kg kit, total volume 140
0053-0150-15	71-75 kg kit, total volume 150
0053-0160-16	76-80 kg kit, total volume 160
0053-0170-17	81-85 kg kit, total volume 170
0053-0180-18	86-90 kg kit, total volume 180
0053-0190-19	91-95 kg kit, total volume 190

1–10 of 39

1/4

Clinical Evidence

1.9HOPE-B mean annualized bleeding rate Months 7-18 (bleeds/year)

36.1Mean Factor IX activity at 5-year follow-up (%)

34.3Factor IX activity increase at 18 months (%)

Hemgenix is an AAV-based one-time gene therapy indicated for adults with moderately severe or severe hemophilia B to increase Factor IX activity. The pivotal HOPE-B trial (single-dose, single-arm) showed a reduction in mean annualized bleeding rate from 4.1 bleeds/year during lead-in to 1.9 bleeds/year during Months 7–18, a 34.3% increase in Factor IX activity at 18 months, and at 5 years a mean Factor IX activity of 36.1% with an annualized bleeding rate of 1.52 bleeds/year.

Background & Definitions

Operational/background context: Hemgenix uses an adeno-associated virus (AAV) vector to deliver a single dose of therapeutic genetic material and is administered as a single intravenous infusion. The Policy defines that all approvals are for a one-time (per lifetime) single dose and requires prescribing by a hemophilia specialist physician.

Definitions: Male * is defined as individuals with the biological traits of a man, regardless of the individual's gender identity or gender expression.

Revision History

2026-03-12policy_effectiveLatest

Policy effective date; material changes include removal of monitoring and corticosteroid consideration statements, clarifications to verification and Factor IX inhibitor testing timing, change to renal function criterion (AND -> OR), and addition of 'Prior Receipt of Gene Therapy' to Conditions Not Covered. Approval duration of 90 days and documentation requirements added.

2024-06-01annual_revision

Removed requirement that after Hemgenix infusion the physician attest to weekly liver enzyme testing for first 3 months and periodic thereafter; removed corticosteroid-consideration statement; removed weekly Factor IX activity monitoring and specified abdominal ultrasound/AFP monitoring for patients at risk of hepatocellular carcinoma.