CurrentWashington State Health Care AuthorityPolicy 85.10.25.AA-1

Antihemophilic Products - Etranacogene dezaparvovec-drlb (Hemgenix)

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This policy governs Apple Health coverage and prior authorization for etranacogene dezaparvovec-drlb (Hemgenix), a single-dose gene therapy for adults with moderately severe or severe congenital Factor IX deficiency (hemophilia B).

Policy Summary

PayerWashington State Health Care Authority

PolicyAntihemophilic Products - Etranacogene dezaparvovec-drlb (Hemgenix)

Policy CodePolicy 85.10.25.AA-1

Change TypeNo material change

Effective DateOct 1, 2024

Next Review DateN/A

Key ActionSubmit the patient's current weight and liver function tests from within the past 3 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+Minimum patient age

1 lifetime dose

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CurrentWashington State Health Care AuthorityPolicy 85.10.25.AA-1

Antihemophilic Products - Etranacogene dezaparvovec-drlb (Hemgenix)

Customize your policy alerts

Sign up for Washington State Health Care Authority Policy 85.10.25.AA-1 alerts

Get alerted when Policy 85.10.25.AA-1 changes without checking for updates manually.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Policy Summary

PayerWashington State Health Care Authority

PolicyAntihemophilic Products - Etranacogene dezaparvovec-drlb (Hemgenix)

Policy CodePolicy 85.10.25.AA-1

Change TypeNo material change

Effective DateOct 1, 2024

Next Review DateN/A

Key ActionSubmit the patient's current weight and liver function tests from within the past 3 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+Minimum patient age

1 lifetime dose

2 × 10^13 gc/kgApproved dose

>150 daysPrior Factor IX exposure

≤1:678Maximum anti-AAV5 titer

≤2%Factor IX level

Coverage Criteria

Initial Therapy

Covered when ALL of the following criteria are met:

ALL of the following

Patient is 18 years of age or older.
Hemgenix is prescribed by, or in consultation with, a hematologist or specialist in hemophilia.
Patient has not received prior gene therapy.
Patient has a diagnosis of moderately severe or severe congenital Factor IX deficiency, with Factor IX levels of ≤ 2% of normal as confirmed by blood coagulation testing.
ONE of the following
- Contraindication, intolerance, or history of failure to continuous routine Factor IX prophylaxis with greater than 150 prior exposure days to Factor IX therapy, due to current or historical life-threatening hemorrhage.
- Contraindication, intolerance, or history of failure to continuous routine Factor IX prophylaxis with greater than 150 prior exposure days to Factor IX therapy, due to a history of repeated, serious spontaneous bleeding episodes.
Documentation demonstrates that the patient is negative for Factor IX inhibitor titers.
Patient has a baseline anti-AAV5 antibody titer of ≤ 1:678 measured by ELISA.
Factor IX prophylaxis therapy will be discontinued upon achieving Factor IX levels of at least 5% following treatment.
Required documentation
- The patient's current weight is submitted.
- Liver function tests from within the past 3 months are submitted.

Continuation and Reauthorization

Hemgenix may be approved for one dose only and cannot be renewed.

Continuation therapy and reauthorization are not available.

Hemgenix is excluded for patients who have received prior gene therapy, have positive Factor IX inhibitor titers, or have a baseline anti-AAV5 antibody titer greater than 1:678 measured by ELISA.

Additional Hemgenix doses and renewal treatment are excluded.

Under the standard criteria, Hemgenix is not medically necessary when the patient does not meet all applicable coverage requirements. If all criteria are not met, the clinical reviewer may determine that there is a medically necessary need and approve the request on a case-by-case basis. The clinical reviewer may choose to use the reauthorization criteria when a patient has been previously established on therapy and is new to Apple.

Coding and Clinical Parameters

Covered HCPCS CodesHCPCSCovered

J1411

Injection, etranacogene dezaparvovec-drlb, per therapeutic dose

Hemgenix NDCs in weight-based appendixNDC

00053-0100-10	Hemgenix multi-vial kit for patient weight 46–50 kg; total volume 100 mL
00053-0110-11	Hemgenix multi-vial kit for patient weight 51–55 kg; total volume 110 mL
00053-0120-12	Hemgenix multi-vial kit for patient weight 56–60 kg; total volume 120 mL
00053-0130-13	Hemgenix multi-vial kit for patient weight 61–65 kg; total volume 130 mL
00053-0140-14	Hemgenix multi-vial kit for patient weight 66–70 kg; total volume 140 mL
00053-0150-15	Hemgenix multi-vial kit for patient weight 71–75 kg; total volume 150 mL
00053-0160-16	Hemgenix multi-vial kit; total volume 160 mL
00053-0170-17	Hemgenix multi-vial kit for patient weight 81–85 kg; total volume 170 mL
00053-0180-18	Hemgenix multi-vial kit for patient weight 86–90 kg; total volume 180 mL
00053-0190-19	Hemgenix multi-vial kit for patient weight 91–95 kg; total volume 190 mL

1–10 of 39

1/4

Coding threshold

Factor IX levelNo more than 2% of normal, as confirmed by blood coagulation testing.

Coding threshold

Prior Factor IX exposureMore than 150 prior exposure days to Factor IX therapy.

Coding threshold

Baseline anti-AAV5 antibody titerNo more than 1:678, measured by ELISA.

Coding threshold

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Hemgenix may be approved when all applicable policy criteria are met. If criteria are not all met, a clinical reviewer may determine medical necessity and approve the request on a case-by-case basis.

Prior Authorization

Preferred Drug List Requirement

New-to-market drugs included in this class on the Apple Health Preferred Drug List are non-preferred and require prior authorization. Consult the current Apple Health Preferred Drug List when determining the applicable preferred-drug requirements.

Step Therapy

Preferred-Agent Trial

For a non-preferred agent, document an inadequate response or documented intolerance due to a severe adverse reaction or contraindication to the required preferred agents.

Background

Hemophilia B is an X-linked congenital bleeding disorder caused by Factor IX deficiency and impaired hemostasis. Disease severity is determined by the Factor IX level: severe disease is below 1 IU/dL or 1% of normal, while moderate disease is 1–5 IU/dL or 1–5% of normal. The policy covers Hemgenix for adults with moderately severe or severe congenital Factor IX deficiency; Hemgenix is administered as a single intravenous infusion intended to provide a copy of the gene encoding Factor IX, although long-term durability is not yet established and some patients may still require Factor IX treatment.

Definitions

Hemophilia BAn X-linked disorder caused by impaired hemostasis and Factor IX deficiency, predominantly affecting males.

Definitions

Severe hemophilia BFactor IX level below 1 IU/dL or below 1% of normal.

Definitions

Moderate hemophilia BFactor IX level of 1–5 IU/dL or 1–5% of normal.

Definitions

Anti-AAV5 antibody titer

Initial Therapy Criteria

Initial Therapy

Hemgenix may be approved when all clinical and documentation criteria are met.

Initial Hemgenix treatment

Clinical and documentation requirements
- Eligibility: The patient is an adult with eligible moderately severe or severe congenital Factor IX deficiency and meets all applicable clinical requirements, including specialist involvement, no prior gene therapy, qualifying Factor IX prophylaxis history, negative Factor IX inhibitor titers, and a baseline anti-AAV5 antibody titer of no more than 1:678 measured by ELISA.
- Required documentation: The request documents the patient's current weight and includes liver function tests obtained within the past 3 months.Current weight; liver function tests within 3 months

Continuation Criteria

No Renewal

Hemgenix may be approved for one dose only and cannot be renewed.

No renewal: No additional or renewal dose is authorized after the single Hemgenix treatment dose.One dose per lifetime

Step Therapy

Step	Requirement	Documentation
1	For a non-preferred agent, document an inadequate response or documented intolerance due to a severe adverse reaction or contraindication to at least two preferred agents.	If only one preferred agent exists in the class, document inadequate response to that one agent.

Step	Requirement	Documentation
2	Document a contraindication, intolerance, or history of failure to continuous routine Factor IX prophylaxis.	More than 150 prior exposure days to Factor IX therapy are required. Qualifying failure includes current or historical life-threatening hemorrhage or repeated, serious spontaneous bleeding episodes.

Quantity Limits

Quantity limits

Etranacogene dezaparvovec-drlb (Hemgenix)Approved dose of 2 × 10^13 genome copies (gc)/kg or 2 mL/kg; one kit per lifetime.

Site of Care

Billing Rule

Administer in an infusion center

Administer Hemgenix as a single dose by intravenous infusion in an infusion center.

Policy Summary

PayerWashington State Health Care Authority

PolicyAntihemophilic Products - Etranacogene dezaparvovec-drlb (Hemgenix)

Policy CodePolicy 85.10.25.AA-1

Change TypeNo material change

Effective DateOct 1, 2024

Next Review DateN/A

Key ActionSubmit the patient's current weight and liver function tests from within the past 3 months.

SourceLink

On This Page

Liver function testingTesting must be completed within the past 3 months.

Coding threshold

Post-treatment Factor IX levelAt least 5% following treatment.

Document inadequate response or documented intolerance to at least two preferred agents.
If only one preferred agent is available in the class, document inadequate response or documented intolerance to that one preferred agent.

Documentation Required

Factor IX Prophylaxis Failure

Document a contraindication, intolerance, or history of failure to continuous routine Factor IX prophylaxis, with more than 150 prior exposure days to Factor IX therapy.

Failure may be demonstrated by current or historical life-threatening hemorrhage.
Failure may also be demonstrated by a history of repeated, serious spontaneous bleeding episodes.

Documentation Required

Required Clinical Documentation

Submit the client’s current weight and liver function tests obtained within the past 3 months.

Current weight is required for dose calculation and quantity review.
Liver function tests must be from within the prior 3 months.

Documentation Required

Required Laboratory Results

Submit laboratory documentation confirming eligibility for treatment.

Factor IX inhibitor titers must be negative.
Baseline anti-AAV5 antibody titer, measured by ELISA, must be no higher than 1:678.

Documentation Required

Diagnosis and Treatment History

Document the diagnosis and relevant treatment history for congenital Factor IX deficiency (hemophilia B).

Document moderately severe or severe congenital Factor IX deficiency, with Factor IX levels of 5% or less of normal.
Document that the patient is at least 18 years old, has not received prior gene therapy, and is prescribed by or in consultation with a hematologist or hemophilia specialist.
Include the patient’s Factor IX prophylaxis exposure and treatment history, including more than 150 prior exposure days and the applicable prophylaxis failure history.

Documentation Required

Post-Treatment Prophylaxis Plan

Document that continuous Factor IX prophylaxis will be discontinued after treatment when Factor IX levels reach at least 5%.

Denial Risk

Failure to Meet Clinical Criteria

Requests may be denied when required clinical criteria are not met, including age, specialist involvement, prior gene therapy status, diagnosis, or disease severity.

Patient must be 18 years of age or older.
The prescriber must be a hematologist or specialist in hemophilia, or prescribe in consultation with one.
The patient must have moderately severe or severe congenital Factor IX deficiency and must not have received prior gene therapy.

Denial Risk

Laboratory or Prophylaxis Exclusions

Requests may be denied for laboratory exclusions or failure to meet the required prophylaxis history.

Positive Factor IX inhibitor titers are exclusionary.
Baseline anti-AAV5 antibody titer above 1:678 is exclusionary.
The request must document contraindication, intolerance, or failure of continuous routine Factor IX prophylaxis and more than 150 prior exposure days.

Billing Rule

Lifetime Dose Limit

Hemgenix is authorized for a single dose only. More than one dose, renewal, or reauthorization is not covered.

Quantity limit: one kit per lifetime.
The single dose must be administered within 12 months of the approval date.

Documentation Required

Incomplete Documentation

Incomplete requests may be delayed or denied. The submission must include the client’s current weight and liver function tests obtained within the prior 3 months.

Provide both required documentation elements with the initial request.
Liver function tests outside the 3-month window do not satisfy the documentation requirement.

An adeno-associated virus serotype 5 antibody measurement obtained by ELISA; the required baseline titer is no more than 1:678.

Definitions

Factor IX prophylaxisContinuous routine Factor IX replacement used to prevent bleeding.

Post-treatment plan: Factor IX prophylaxis therapy will be discontinued upon achieving Factor IX levels of at least 5% following treatment.≥5% Factor IX