Author: NCTracks, 1-800-688-6696
Effective with date of service Sept. 5, 2018, the Medicaid and NC Health Choice programs cover antihemophilic factor (recombinant) PEGylated-aucl, for intravenous use (Jivi) for use in the Physician's Drug Program (PDP) when billed with HCPCS code J7199-Hemophilia clotting factor, not otherwise classified. Jivi is commercially available as lyophilized powder in single-use vials containing nominally 500, 1000, 2000 or 3000 IU.
Jivi is indicated for use in previously treated adults and adolescents (12 years and older) with hemophilia A (congenital Factor VIII deficiency) for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes.
Limitations of Use
- Jivi is not indicated for use in children less than 12 years of age due to a greater risk for hypersensitivity reactions.
- Jivi is not indicated for use in previously untreated patients.
- Jivi is not indicated for the treatment of von Willebrand disease.
Recommended Dose
Dosing for control and prevention of bleeding episodes—dose until bleeding is resolved
- Minor bleed: Factor VIII level required (IU/dL): 20-40, Dose: 10-20 IU/kg, Frequency of doses: 24-48 hours
- Moderate bleed: Factor VIII level required (IU/dL): 30-60, Dose: 15-30 IU/kg, Frequency of doses: 24-48 hours
- Major bleed: Factor VIII level required (IU/dL): 60-100, Dose 30-50 IU/kg, Frequency of doses: 8-24 hours
Dosing for perioperative management
- Minor surgery: Factor VIII level required (IU/dL): 30-60 (pre and post-operative), Dose: 15-30 IU/kg, Frequency of doses: 24 hours, Duration of Therapy: At least 1 day until healing is achieved.
- Major surgery: Factor VIII level required (IU/dL): 80-100 (pre- and post-operative), Dose: 40 to 50 IU/kg, Frequency of doses: 12-24 hours, Duration of Therapy: Until adequate wound healing is complete, then continue for at least another 7 days to maintain a Factor VIII activity of 30-60 (IU/dL).
Prophylaxis dosing
- The recommended initial regimen is 30–40 IU/kg twice weekly.
- Based on the bleeding episodes, the regimen may be adjusted to 45–60 IU/kg every 5 days and may be further individually adjusted to less or more frequent dosing.
- The total recommended maximum dose per infusion is approximately 6000 IU (rounded to vial size). See full prescribing information for further detail.
For Medicaid and NCHC Billing
- The ICD-10-CM diagnosis code required for billing is D66-Hereditary factor VIII deficiency.
- Providers must bill with HCPCS code J7199-Hemophilia clotting factor, not otherwise classified.
- One Medicaid and NC Health Choice unit of coverage is 1 IU.
- Providers may contact the North Carolina Pharmacy Help Desk at 1-800-591-1183 or NCPharmacy@mslc.com and submit their invoice to establish a reimbursement rate.
- Providers must bill 11-digit National Drug Codes (NDCs) and appropriate NDC units. The NDCs are 00026-3942-25, 00026-3944-25, 00026-3946-25, 00026-3948-25, 00026-4942-01, 00026-4944-01, 00026-4946-01 and 00026-4948-01.
- The NDC units should be reported as "UN1."
- For additional information, refer to the January 2012 Special Bulletin, National Drug Code Implementation Update.
- For additional information regarding NDC claim requirements related to the PDP, refer to the PDP Clinical Coverage Policy No. 1B, Attachment A, H.7 on the NC Medicaid website.
- Providers shall bill their usual and customary charge for non-340B drugs.
- PDP reimburses for drugs billed for Medicaid and NC Health Choice beneficiaries by 340B participating providers who have registered with the Office of Pharmacy Affairs (OPA). Providers billing for 340B drugs shall bill the cost that is reflective of their acquisition cost. Providers shall indicate that a drug was purchased under a 340B purchasing agreement by appending the “UD” modifier on the drug detail.
The fee schedule for the Physician's Drug Program is on the NC Medicaid website’s PDP web page.