Author: GDIT, (800) 688-6696
Effective with date of service Feb. 3, 2020, the Medicaid and NC Health Choice programs cover antihemophilic factor (recombinant), glycopegylated-exei lyophilized powder for solution, for intravenous use (Esperoct®) for use in the Physician Administered Drug Program (PADP) when billed with HCPCS code J7199 - Hemophilia clotting factor, not otherwise classified.
Strength/Package Size(s): Lyophilized powder in single-dose vials of dosage strengths at 500, 1000, 1500, 2000 and 3000 IU per vial.
Indicated for use in adults and children with hemophilia A for:
- On-demand treatment and control of bleeding episodes
- Perioperative management of bleeding
- Routine prophylaxis to reduce the frequency of bleeding episodes
Esperoct® is not indicated for the treatment of Von Willebrand disease.
Recommended Dose:
- On-demand treatment/control of bleeding episodes: In adolescents / adults, 40 IU/kg body weight for minor/moderate bleeds and 50 IU/kg body weight for major bleeds; children (<12 years), 65 IU/kg body weight for minor/moderate/major bleeds.
- Perioperative management: For minor/major surgery: In adolescents / adults: pre-operative dose of 50 IU/kg body weight; in children (<12 years), pre-operative dose of 65 IU/kg body weight. Frequency of administration is determined by the treating physician.
- Routine prophylaxis: In adolescents/adults, 50 IU/kg every 4 days; in children (<12 years), 65 IU/kg twice weekly. A regimen may be individually adjusted to less or more frequent dosing based on bleeding episodes.
- Esperoct® also may be dosed to achieve a specific target Factor VIII activity level, depending on the severity of hemophilia, for on-demand treatment/control of bleeding episodes or perioperative management. To achieve a specific target Factor VIII activity level, use the following formula: Dosage (IU) = Body Weight (kg) × Desired Factor VIII Increase (IU/dL or % normal) × 0.5 (IU/kg per IU/dL).
See full prescribing information for further detail.
For Medicaid and NC Health Choice Billing
- The ICD-10-CM diagnosis code(s) required for billing is/are: 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
- The maximum reimbursement rate per unit is: 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 NDCs and appropriate NDC units. The NDCs is/are: 00169-8500-01, 00169-8501-11, 00169-8100-01, 00169-8101-11, 00169-8150-01, 00169-8151-11, 00169-8200-01, 00169-8201-11, 00169-8300-01, 00169-8301-11
- 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 PADP, refer to the PADP Clinical Coverage Policy 1B, Attachment A, H.7 on Medicaid's website.
- Providers shall bill their usual and customary charge for non-340B drugs.
- PADP 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 PADP is available on Medicaid's PADP web page.