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May 8, 2023

Educational Article J1411 Hemgenix (esranacogene dezaparvovec-drlb)

Esranacogene dezaparvovec-drlb is an FDA approved gene therapy treatment of hemophilia B (congenital factor IX deficiency/ICD10= D67) in adults who currently use factor IX prophylaxis therapy, or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes. Further investigation is ongoing for this agent. Claims for this agent are subject to review on case-to-case basis to ensure all FDA requirements have been met for coverage.

To file a claim for Hemgenix (esranacogene dezaparvovec-drlb) submit the following claim information:

  • HCPCS® Code J1411
  • Enter Unit of service (UOS) given
  • Select an appropriate ICD-10-CM code for the reason the drug was given to the patient.

Documentation requirements include:

All requirements outlined in the FDA label have been met.

  • Patient disease course including severity of disease and confirmatory laboratory studies and history of past and current treatments and hospitalizations.
  • Care is being provided by or in consultation with a hematologist.
  • There is no contraindications or exclusions as outlined in the clinical trials which includes known history of inhibitor, active hepatitis B or C, uncontrolled HIV, advanced liver disease or uncontrolled co-morbidity and laboratory/imaging studies to support evaluation of candidacy for drug.
  • Duration of factor IX prophylaxis consistent with enrollment in clinical trials (>150 previous exposure days of treatment with factor IX protein)

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