Effective with date of service Sept. 15, 2022, the Medicaid and NC Health Choice programs cover Olipudase alfa-rpcp for injection, for intravenous use (Xenpozyme) for use in the Physician Administered Drug Program (PADP) when billed with HCPCS code J3590 - Unclassified biologics
Strength/Package Size: For injection: 20 mg of Olipudase alfa-rpcp as a lyophilized powder in a single-dose vial for reconstitution
Indicated for treatment of non–central nervous system manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients
Recommended Dose: Administer Xenpozyme via intravenous infusion every two weeks.
Adults:
a. Dose Escalation Phase:
- First dose (Day 1/Week 0) 0.1 mg/kg
- Second dose (Week 2) 0.3 mg/kg
- Third dose (Week 4) 0.3 mg/kg
- Fourth dose (Week 6) 0.6 mg/kg
- Fifth dose (Week 8) 0.6 mg/kg
- Sixth dose (Week 10) 1 mg/kg
- Seventh dose (Week 12) 2 mg/kg
- Eighth dose (Week 14) 3 mg/kg (recommended maintenance dose)
NOTE: Use actual body weight for patients with a BMI less than or equal to 30. For patients with a BMI greater than 30, calculate adjusted body weight (kg) = (actual height in m)2 x 30
b. Maintenance Phase: The recommended maintenance dosage of Xenpozyme in adults is 3 mg/kg via intravenous infusion every two weeks
Pediatrics:
a. Dose Escalation Phase:
- First dose (Day 1/Week 0) 0.03 mg/kg
- Second dose (Week 2) 0.1 mg/kg
- Third dose (Week 4) 0.3 mg/kg
- Fourth dose (Week 6) 0.3 mg/kg
- Fifth dose (Week 8) 0.6 mg/kg
- Sixth dose (Week 10) 0.6 mg/kg
- Seventh dose (Week 12) 1 mg/kg
- Eighth dose (Week 14) 2 mg/kg
- Ninth dose (Week 16) 3 mg/kg (recommended maintenance dose)
NOTE: Use actual body weight for patients with a BMI less than or equal to 30. For patients with a BMI greater than 30, calculate adjusted body weight (kg) = (actual height in m) 2 x 30
b. Maintenance Phase: The recommended maintenance dosage of Xenpozyme in pediatric patients is 3 mg/kg via intravenous infusion every two weeks
See full prescribing information for further detail.
For Medicaid and NC Health Choice Billing
- The ICD-10-CM diagnosis codes required for billing are:
- E75.240 - Niemann-Pick disease type A;
- E75.241 - Niemann-Pick disease type B;
- E75.244 - Niemann-Pick disease type A/B
- Providers must bill with HCPCS code: J3590 - Unclassified biologics
- One Medicaid and Health Choice unit of coverage is: 1 mg
- The maximum reimbursement rate per unit is: $385.67
- Providers must bill 11-digit NDCs and appropriate NDC units. The NDC is: 58468-0050-01
- The NDC units should be reported as “UN1”
- For additional information, refer to the January 2012, Special Bulletin, National Drug Code Implementation Update and 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.
Contact
NCTracks Call Center: 800-688-6696