CurrentCignaPolicy IP0535

Hemgenix

Cigna coverage policy for Hemgenix, defining prior authorization, detailed medical necessity criteria for a one-time (per lifetime) single intravenous dose for adults with moderately severe or severe hemophilia B, dosing kit/NDC mapping, documentation and specialist prescribing requirements, and exclusions.

Policy Summary

PayerCigna

PolicyHemgenix

Policy CodePolicy IP0535

Change TypeCriteria revisions and clarifications (multiple)

Effective DateMar 27, 2025

Next Review Date

Key ActionPrior Authorization is recommended; submit documentation (labs, chart notes, claims) and ensure prescribing by a hemophilia specialist for one-time dosing approval when all criteria are met.

POLICY UPDATE CHANGES

Removed prior requirements for post-infusion monitoring (weekly liver enzyme testing and weekly Factor IX activity testing for first 3 months, and specified HCC ultrasound/AFP monitoring).

Specialist physician requirement changed to 'hemophilia specialist physician.'

Moved requirement that current patient body weight be obtained within 30 days to a separate criterion.

Dosing clarified emphasizing Hemgenix is given as a 'single dose.'

Verification wording changed to 'prescribing physician confirms' regarding prior receipt of Hemgenix or Beqvez when claims history is not available.

Factor IX inhibitor testing timing wording changed: 'within 30 days' retained but phrase 'before receipt of Hemgenix' removed.

Requirement for renal function changed from needing both CrCl ≥30 mL/min AND creatinine ≤2x ULN to meeting ONE of these elements.

Condition 'Patient with a History of Factor IX Inhibitors' added to Conditions Not Recommended for Approval.

Changed criterion to require patient has not received 'a gene therapy for hemophilia B' (includes Hemgenix and newly approved Beqvez).

One-time dose allowed per lifetime

≥18Minimum age (years)

≤2%Baseline Factor IX threshold (%)

≥150Exposure days to Factor IX (option)

Coverage Summary

Cigna coverage policy for Hemgenix (etranacogene dezaparvovec-drlb) covers a one-time (per lifetime) single intravenous dose of 2 x 10^13 genome copies/kg for adults with moderately severe or severe hemophilia B. The policy defines prior authorization and detailed medical necessity criteria that must all be met for approval, including that the patient is male, is ≥ 18 years of age, has a baseline Factor IX level of ≤ 2% of normal, and other specified documentation, laboratory, and specialist prescribing requirements.

Initial Therapy Criteria (Medical Necessity)

Dosing

Recommended dosing

Hemgenix is given as a one-time (per lifetime) single dose of 2 x 10^13 genome copies per kg of body weight by intravenous infusion2 x 10^13 genome copies/kg

Note: Criteria node O references kit size and NDC mapping for approval; Table 1 in the Coding/Indication section provides the Hemgenix multi-vial kit sizes and corresponding NDCs for each patient weight range to select the appropriate kit.

Not Medically Necessary / Exclusions

Applicable Codes

Drug J-code considered medically necessary when criteria metHCPCSCovered

J1411

Injection, etranacogene dezaparvovec-drlb, per therapeutic dose

Hemgenix kit NDCs (by patient weight ranges)NDC

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

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Provider Actions & Authorization Requirements

Prior Authorization

Prior authorization required

Prior Authorization is recommended for benefit coverage. Approvals are provided for a one-time (per lifetime) single dose when all criteria are met.

J1411

Documentation Required

Documentation and verification requirements

Documentation (chart notes, labs, claims records, etc.) is required for many criteria. Required documentation and verification items include:

Baseline Factor IX level (without replacement therapy) showing ≤ 2% of normal [documentation required]
Factor IX inhibitor testing performed within 30 days and documentation that patient is negative for inhibitors [documentation required]

Clinical Evidence

54HOPE-B trial participants (adult males, Factor IX ≤2%)

1.9 vs 4.1Annualized bleeding rate Months 7-18 vs lead-in

+34.3%Mean increase in Factor IX activity at 18 months

The HOPE-B pivotal trial evaluated a single intravenous dose of Hemgenix in 54 adult males with moderately severe or severe hemophilia B (Factor IX ≤ 2%). Results showed a reduction in estimated mean annualized bleeding rate to 1.9 bleeds/year during months 7–18 versus 4.1 bleeds/year during the lead-in period, and a mean increase in Factor IX activity of 34.3% at 18 months.

Background & Definitions

Hemgenix is an adeno-associated virus (AAV)-based gene therapy approved for the treatment of adults with hemophilia B who meet specified clinical criteria. The recommended administration is a one-time (per lifetime) single intravenous dose of 2 x 10^13 genome copies/kg. Approval requires meeting all listed criteria, documentation of baseline Factor IX level (≤ 2%), laboratory and organ function thresholds, and that the medication be prescribed by a hemophilia specialist physician.

Term	Definition
{"text":"Male *","status":""},{"text":"Individuals with the biological traits of a man, regardless of the individual's gender identity or gender expression.","status":""}

Revision History

2024-06-01removed

Removed prior requirements that after Hemgenix infusion the physician attest to weekly liver enzyme testing for first 3 months (and periodic thereafter), weekly Factor IX activity testing for first 3 months (and periodic thereafter), and specified HCC ultrasound/AFP monitoring for patients with preexisting HCC risk factors.

2024-06-01revised

Specialist prescribing requirement changed to require a 'hemophilia specialist physician.'

2024-06-01revised

Moved the requirement that current patient body weight be obtained within 30 days into a separate criterion.

Policy Summary

PayerCigna

PolicyHemgenix

Policy CodePolicy IP0535

Change TypeCriteria revisions and clarifications (multiple)

Effective DateMar 27, 2025

Next Review Date

On This Page

Liver tests within 30 days: ALT, AST, total bilirubin, alkaline phosphatase ≤ 2x ULN [documentation required]

Platelet count within 30 days ≥ 50 x 10^9 /L [documentation required]

Renal function within 30 days: estimated creatinine clearance ≥ 30 mL/min OR creatinine ≤ 2x ULN [documentation required]

Current body weight obtained within 30 days [documentation required]

Verification in claims history that patient has not received a gene therapy for hemophilia B (if no claims available, prescribing physician confirms prior gene therapy status) [verification required]

Billing Rule

One-time dosing and kit selection billing rule

Approve one kit corresponding to the patient's weight to supply the single lifetime dose of 2 x 10^13 genome copies per kg by intravenous infusion. Kit NDC selection must map to the patient's weight and dosing verification by the Medical Director is required.

0053-0100-10
0053-0110-11
0053-0120-12
0053-0130-13
0053-0140-14
0053-0150-15
0053-0160-16
0053-0170-17
0053-0180-18
0053-0190-19
0053-0200-20
0053-0210-21
0053-0220-22
0053-0230-23
0053-0240-24
0053-0250-25
0053-0260-26
0053-0270-27
0053-0280-28
0053-0290-29
0053-0300-30
0053-0310-31
0053-0320-32
0053-0330-33
0053-0340-34
0053-0350-35
0053-0360-36
0053-0370-37
0053-0380-38
0053-0390-39
0053-0400-40
0053-0410-41
0053-0420-42
0053-0430-43
0053-0440-44
0053-0450-45
0053-0460-46
0053-0470-47
0053-0480-48

Documentation Required

Specialist prescribing requirement

Hemgenix must be prescribed by a hemophilia specialist physician. Medical Director review is required for all approvals and denials.

2024-06-01clarified

Dosing clarified to emphasize Hemgenix is given as a 'single dose.'

2024-06-01revised

Verification wording changed so that if claims history is not available the prescribing physician 'confirms' the patient has not previously received Hemgenix (now expanded to confirm absence of prior gene therapy including Beqvez).

2024-06-01revised

Factor IX inhibitor testing timing wording updated: 'within 30 days' retained while the phrase 'before receipt of Hemgenix' was removed.

2025-03-27revisedLatest

Requirement for renal function changed from requiring both creatinine clearance ≥ 30 mL/min AND creatinine ≤ 2x ULN to meeting ONE of these elements (within 30 days). Effective/last review date: 2025-03-27.

2025-03-27addedLatest

Condition 'Patient with a History of Factor IX Inhibitors' explicitly added to Conditions Not Recommended for Approval. Effective/last review date: 2025-03-27.

2025-03-27revisedLatest

Changed criterion to require the patient has not received 'a gene therapy for hemophilia B' (now explicitly includes Hemgenix and Beqvez); if no claims for Hemgenix or Beqvez are present or claims are unavailable, the prescribing physician confirms no prior receipt. Effective/last review date: 2025-03-27.