Effective with date of service Oct. 4, 2021, the Medicaid and NC Health Choice programs cover paliperidone palmitate extended-release injectable suspension, for gluteal intramuscular use (Invega Hafyera™) for use in the Physician Administered Drug Program (PADP) when billed with HCPCS code J3490 - Unclassified drugs.
Strength/Package Sizes: Extended-release injectable suspension: 1,092 mg/3.5 mL or 1,560 mg/5 mL single-dose prefilled syringes
Indicated for the treatment of schizophrenia in adults after they have been adequately treated with:
- A once-a-month paliperidone palmitate extended-release injectable suspension (e.g., Invega Sustenna) for at least four months or
- An every-three-month paliperidone palmitate extended-release injectable suspension (e.g., Invega Trinza) for at least one three-month cycle
Recommended Dose: Invega Hafyera™ is administered as a gluteal intramuscular injection by a healthcare professional once every six months. See full prescribing information for further detail.
Switching to Invega Hafyera™ from a PP1M* Product:
- If last dose of PP1M was 156 mg, initial dose of Invega Hafyera™ is 1,092 mg.
- If last dose of PP1M was 234 mg, initial dose of Invega Hafyera™ is 1,560 mg.
*PP1M = once a month paliperidone palmitate ER injectable suspension
Note: There are no equivalent doses of Invega Hafyera™ for 39 mg, 78 mg, or 117 mg doses of a PP1M product, which were not studied.
Switching to Invega Hafyera™ from a PP3M* Product:
- If last dose of PP3M was 546 mg, initial dose of Invega Hafyera™ is 1,092 mg.
- If last dose of PP3M was 819 mg, initial dose of Invega Hafyera™ is 1,560 mg.
*PP3M = every three month paliperidone palmitate ER injectable suspension
Note: There are no equivalent doses of Invega Hafyera™ for the 273 mg or 410 mg doses of a PP3M product, which were not studied.
If needed, dosage adjustment can be made every six months between the dose of 1,092 mg to 1,560 mg based on individual response and tolerability. Because of the potential longer duration of Invega Hafyera™, the patient’s response to an adjusted dose may not be apparent for several months.
For Medicaid and NC Health Choice Billing
- The ICD-10-CM diagnosis codes required for billing are:
- F20.0 - Paranoid schizophrenia;
- F20.1 - Disorganized schizophrenia;
- F20.2 - Catatonic schizophrenia;
- F20.3 - Undifferentiated schizophrenia;
- F20.5 - Residual schizophrenia;
- F20.89 - Other schizophrenia;
- F20.9 - Schizophrenia, unspecified
- Providers must bill with HCPCS code: J3490 - Unclassified drugs
- One Medicaid and NC Health Choice unit of coverage is: 1 mg
- The maximum reimbursement rate per unit is: $11.63
- Providers must bill 11-digit NDCs and appropriate NDC units. The NDCs is/are: 50458-0611-01, 50458-0612-01
- 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 Contact Center: 800-688-6696