Author: GDIT, (800) 688-6696
Effective with date of service Oct. 29, 2018, NC Medicaid covers Azedra for use in the Physician’s Administered Drug Program when billed with HCPCS code A9699, Radiopharmaceutical, therapeutic, not otherwise classified (therapeutic use) or A4641, Radiopharmaceutical, diagnostic, not otherwise classified (dosimetric use).
Azedra injection, containing 555 MBq/mL (15 mCi/mL) of I-131 (as iobenguane I 131) and 0.006 mg/mL of iobenguane, is a sterile, clear, colorless to pale yellow solution for intravenous use supplied in a colorless Type 1 borosilicate glass 30 mL single-dose vial. Azedra is supplied in dosimetric (2 mL) and therapeutic (22.5 mL) presentations:
- Dosimetric: 1,110 MBq (30 mCi) of iobenguane I 131 at calibration time (NDC 71258-0015-02)
- Therapeutic: 12,488 MBq (337.5 mCi) of iobenguane I 131 at calibration time (NDC 71258-0015-22)
Azedra is a radioactive therapeutic agent indicated for the treatment of adult and pediatric patients 12 years and older with iobenguane scan positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma who require systemic anticancer therapy.
Administer Azedra intravenously as a dosimetric dose followed by two therapeutic doses administered 90 days apart.
- The recommended dosimetric dose is:
- Patients greater than 50 kg: 185 to 222 MBq (5 to 6 mCi)
- Patients 50 kg or less: 3.7 MBq/kg (0.1 mCi/kg)
- The recommended therapeutic dose for each of the 2 doses is:
- Patients greater than 62.5 kg: 18,500 MBq (500 mCi)
- Patients 62.5 kg or less: 296 MBq/kg (8 mCi/kg)
- Adjust AZEDRA therapeutic doses based on radiation dose estimates results from dosimetry, if needed.
See the package insert for important safety information and full prescribing and administration information.
For North Carolina Medicaid and NC Health Choice Billing
- Providers must bill the product with HCPCS code: A9699 - Radiopharmaceutical, therapeutic, not otherwise classified (therapeutic use) or A4641, Radiopharmaceutical, diagnostic, not otherwise classified (dosimetric use).
- Providers must indicate the number of HCPCS units.
- One Medicaid and NC Health Choice unit of coverage is: 1 mL
- The maximum reimbursement rate per unit is: $4,892.40 per 1 mL
- Providers must bill 11-digit National Drug Codes (NDCs) and appropriate NDC units. The NDCs are: 71258-0015-02 (dosimetric vial) and 71258-0015-22 (therapeutic vial)
- 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.
- 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 Physician Administered Drug Program is available on DHB's PADP web page.