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)