CurrentCareSourcePolicy N/A

Hemgenix (etranacogene dezaparvovec) — Coverage Criteria

Defines prior authorization and medical necessity criteria for Hemgenix (etranacogene dezaparvovec) for adult members with Hemophilia B under CareSource pharmacy/medical benefit in Arkansas.

Policy Summary

PayerCareSource

PolicyHemgenix (etranacogene dezaparvovec) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMar 1, 2024

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of male sex, age ≥18, documented Hemophilia B with Factor IX activity ≤2%, current weight, evidence of prophylaxis use or qualifying bleeding history, and absence of listed contraindications.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

single IV infusiondosage/administration

18+min age

FIX ≤2%severity

3 monthsauth length

Coverage Criteria for Hemgenix (etranacogene dezaparvovec)

Initial Therapy

Covered when ALL of the following are met for initial authorization:

Initial criteria: Member is male and at least 18 years of age; AND medication is prescribed by or in consultation with a hematologist; AND documented diagnosis of Hemophilia B; AND severe or moderately severe disease as indicated by Factor IX activity ≤2% (or <2 IU/dL); AND member is currently using Factor IX prophylaxis OR has current or historical life‑threatening hemorrhage OR has repeated serious spontaneous bleeding episodes; AND current weight is provided for dose calculation; AND member does not have any of the following exclusions: Factor IX inhibitors (≥0.6 Bethesda units/mL) or history of inhibitors, active hepatitis B or C or advanced liver fibrosis, uncontrolled HIV, prior gene therapy; AND dosage is limited to a single‑use IV infusion of 2 x 10^13 genome copies per kg.

If all the above requirements are met, the medication will be approved for 3 months

COVERAGE CRITERIA — Additional Requirements

Supporting inclusion/exclusion criteria and clinical restrictions:

Exclusion criteria (member must NOT have any)::

Policy Summary

PayerCareSource

PolicyHemgenix (etranacogene dezaparvovec) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMar 1, 2024

Next Review DateN/A

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.

Factor IX inhibitors or history of inhibitors (≥0.6 Bethesda units/mL); active hepatitis B or C or advanced liver fibrosis; uncontrolled HIV (HIV positive and uncontrolled on antiviral therapy); prior gene therapy.

These contraindications must be documented and excluded prior to approval.

Clinical history requirement (at least ONE):: Currently using Factor IX prophylaxis; OR current or historical life‑threatening hemorrhage; OR repeated serious spontaneous bleeding episodes.

Documentation of prophylaxis use or bleeding history is required.

Administrative/clinical documentation requirements:: Medication prescribed by or in consultation with a hematologist; documented diagnosis of Hemophilia B; member sex and age (male ≥18 years); recent Factor IX activity level showing ≤2% (<2 IU/dL); current weight for dose calculation.

Provide clinical records and labs supporting each item.

Reauthorization

Reauthorization rules:

Reauthorization: Hemgenix is a one‑time single infusion and will not be reauthorized.

No continuation or repeat dosing is available; requests for additional doses will be denied.

Initial therapy (Hemgenix)

Initial coverage requires meeting ALL of the following:

Initial authorization nodes: Male ≥18 years of age; documented Hemophilia B; medication prescribed by or in consultation with a hematologist; Factor IX activity ≤2% (or <2 IU/dL); currently using Factor IX prophylaxis OR current/historical life‑threatening hemorrhage OR repeated serious spontaneous bleeding episodes; current weight provided for dose calculation; absence of contraindications (Factor IX inhibitors ≥0.6 BU/mL, active hepatitis B or C or advanced liver fibrosis, uncontrolled HIV, prior gene therapy); single IV infusion dose 2 x 10^13 genome copies per kg.

If all requirements met, medication approved for 3 months

Continuation Therapy

Continuation: No continuation or repeat dosing: single administration only; not eligible for reauthorization.

Hemgenix is a one‑time single infusion and will not be reauthorized.

CareSource considers use of Hemgenix (etranacogene dezaparvovec) for any indication not listed in this document to be not medically necessary. Providers should refer to the plan's Off‑Label policy for requests outside the covered indications.

Coding and Clinical Thresholds

Covered HCPCS/Billing CodesHCPCSCovered

J3590

Unclassified biologics (billing code listed for Hemgenix)

inv-06: Factor IX activity threshold — clinical definition/threshold

Factor IX activity threshold≤ 2% of normal circulating Factor IX (or <2 IU/dL)

Clinical interpretationDefines severe or moderately severe Hemophilia B for coverage eligibility

Use for eligibilityRequired documentation: recent Factor IX activity at or below this threshold to qualify for Hemgenix

Provider Requirements, Documentation, and Billing

Prior Authorization

Prior Authorization Required

Prior authorization required. Hemgenix (etranacogene dezaparvovec) is a medical benefit and must be prior authorized before administration.

Hemgenix billing code: J3590
Benefit type: Medical
Prior Authorization Required

Documentation Required

Submit required clinical documentation with the prior authorization request to avoid delays or denials.

Patient age and sex (male ≥18 years)
Documented diagnosis of Hemophilia B (congenital Factor IX deficiency)
Recent Factor IX (FIX) activity level (≤2% or <2 IU/dL)
Evidence of current FIX prophylaxis OR history of life‑threatening hemorrhage OR repeated serious spontaneous bleeding episodes
Current weight for dose calculation
Prescribing physician is a hematologist or consult documented
History/results excluding FIX inhibitors (Bethesda ≥0.6 U/mL indicates inhibitor)
Hepatitis B/C status and liver fibrosis assessment
HIV status and viral control
Prior gene therapy history

Denial Risk

Requests should be denied when eligibility or exclusion criteria are not met.

Member is not male and at least 18 years of age
No documented diagnosis of Hemophilia B
Factor IX activity is >2% (or ≥2 IU/dL)
Presence or history of Factor IX inhibitors (Bethesda ≥0.6 U/mL)
Active hepatitis B or C, or advanced liver fibrosis
Uncontrolled HIV infection on antiretroviral therapy
History of prior gene therapy

Step Therapy

Step Therapy / Specialist Requirement

No step therapy requirements are specified beyond meeting the listed eligibility and exclusion criteria. Hemgenix requires prescribing by or in consultation with a hematologist.

No step therapy required
Prescribed by or in consultation with a hematologist

Billing Rule

Billing and Operational Notes

Dose and quantity limit: single-use IV infusion of 2 x 10^13 genome copies (gc) per kg. If all eligibility criteria are met, approval is for 3 months.

Single administration dosing: 2 x 10^13 gc per kg (weight required)
Approval duration: 3 months when approved
Billing code to use: J3590 (medical benefit)

Administration and Site of Care

Note

Administration: single IV infusion (medical benefit); site not restricted

Hemgenix is administered as a single‑use intravenous infusion and is covered under the medical benefit; the policy does not restrict the site of care.

Dosage limited to a single IV infusion of 2 x 10^13 genome copies per kg
Policy notes medical benefit administration but does not specify a required site (e.g., infusion center is acceptable)

inv-16: Hemgenix (etranacogene dezaparvovec) — Quantity limits: single-use/single infusion

Quantity limitSingle-use — one IV infusion

Dose2 x 10^13 genome copies (gc) per kg (single administration)

ReauthorizationNot eligible for reauthorization — one-time gene therapy

Billing/benefit noteAdministered as a medical benefit; prior authorization required

Definitions

inv-12: Severe or moderately severe Hemophilia B — defined as circulating Factor IX activity of 2% or less of normal (or <2 IU/dL).

DefinitionCirculating Factor IX activity of 2% or less of normal (or <2 IU/dL)

Clinical significanceUsed to define severe or moderately severe Hemophilia B for coverage decisions

Documentation requirementRecent laboratory measurement of Factor IX activity at or below this value must be provided

Background

Hemophilia B is an X‑linked coagulation disorder caused by deficiency of clotting factor IX. Patients with severe or moderately severe disease have very low circulating factor IX activity and commonly require regular prophylactic factor replacement; gene therapy with Hemgenix delivers a variant of factor IX via an AAV vector as a single intravenous infusion intended to increase circulating factor IX activity and reduce bleeding episodes and need for prophylactic infusions.