Author: GDIT Call Center, (800) 688-6696
Effective with date of service Dec. 17, 2018, the North Carolina Medicaid and NC Health Choice programs cover levoleucovorin for injection, for intravenous use (Khapzory) for use in the Physician Administered Drug Program when billed with HCPCS code J3490 - Unclassified drugs.
Khapzory is available as 175 mg and 300 mg of levoleucovorin lyophilized powder in a single-dose vial for reconstitution.
It is indicated for:
• Rescue after high-dose methotrexate therapy in patients with osteosarcoma.
• Diminishing the toxicity associated with overdosage of folic acid antagonists or
impaired methotrexate elimination.
• Treatment of patients with metastatic colorectal cancer in combination with
fluorouracil.
Khapzory is not indicated for the treatment of pernicious anemia and megaloblastic anemia secondary to lack of vitamin B12 because of the risk of progression of neurologic manifestations despite hematologic remission.
Recommended Dose:
Rescue After High-Dose Methotrexate Therapy:
• 7.5 mg as an intravenous infusion every six hours
• Dose can be increased up to 75 mg by intravenous infusion every three hours until
methotrexate level is less than one micromolar; then 7.5 mg by intravenous infusion
every three hours until methotrexate level is less than 0.05 micromolar.
• See package insert for dosage adjustments and duration based on laboratory findings.
Overdosage of Folic Acid Antagonists or Impaired Methotrexate Elimination:
• Administer Khapzory as soon as possible after an overdosage of methotrexate or
within 24 hours of methotrexate administration when methotrexate elimination is
impaired.
• 7.5 mg as an intravenous infusion every six hours
• Dose can be increased to 50 mg/m2 by intravenous infusion every three hours until
the methotrexate level is less than 0.05 micromolar.
• See package insert for dosage adjustments and duration based on laboratory findings .
In Combination with Fluorouracil for Metastatic Colorectal Cancer:
• 100 mg/m2 by intravenous injection over a minimum of three minutes, followed by
fluorouracil at 370 mg/m2, once daily for five consecutive days OR 10 mg/m2 by
intravenous injection, followed by fluorouracil at 425 mg/m2 once daily for five
consecutive days
• The five-day course may be repeated every four weeks for two courses, then every
four to five weeks, if the patient has recovered from toxicity from prior course.
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:
- C18.0 - Malignant neoplasm of cecum;
- C18.1 - Malignant neoplasm of appendix;
- C18.2 - Malignant neoplasm of ascending colon;
- C18.3 - Malignant neoplasm of hepatic flexure;
- C18.4 - Malignant neoplasm of transverse colon;
- C18.5 - Malignant neoplasm of splenic flexure;
- C18.6 - Malignant neoplasm of descending colon;
- C18.7 - Malignant neoplasm of sigmoid colon;
- C18.8 - Malignant neoplasm of overlapping sites of colon;
- C18.9 - Malignant neoplasm of colon, unspecified;
- C19 - Malignant neoplasm of rectosigmoid junction;
- Providers must bill with HCPCS code: J3490 - Unclassified drugs
- One Medicaid and NCHC unit of coverage is: one mg
- The maximum reimbursement rate per unit is: $4.32
- Providers must bill 11-digit National Drug Codes (NDCs) and appropriate NDC units. The NDCs are: 68152-0112-01, 68152-0114-01
- 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 PADP, refer to the PADP, Attachment A, H.7 on NC 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 Physician Administered Drug Program is available on NC Medicaid's PADP web page.