Effective with date of service Nov. 16, 2022, Medicaid and NC Health Choice programs cover tremelimumab-actl injection, for intravenous use (Imjudo) for use in the Physician Administered Drug Program (PADP) when billed with HCPCS code J9999 - Not otherwise classified, antineoplastic drugs.
Strength/Package Sizes:
- Injection: 25 mg/1.25 mL (20 mg/mL) solution in a single-dose vial;
- Injection: 300 mg/15 mL (20 mg/mL) solution in a single-dose vial.
Indicated:
- in combination with durvalumab, for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC);
- in combination with durvalumab and platinum-based chemotherapy for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.
Recommended Dose:
uHCC:
- Weight 30 kg and more: 300 mg as a single dose in combination with durvalumab 1,500 mg at Cycle 1/Day 1, followed by durvalumab as a single agent every four weeks.
- Weight less than 30 kg: 4 mg/kg as a single dose in combination with durvalumab 20 mg/kg at Cycle 1/Day 1, followed by durvalumab as a single agent every 4 weeks;
Metastatic NSCLC:
- Weight 30 kg and more: 75 mg every three weeks in combination with durvalumab 1,500 mg and platinum-based chemotherapy for four cycles, and then administer durvalumab 1,500 mg every four weeks as a single agent with histology-based pemetrexed therapy every four weeks, and a fifth dose of Imjudo 75 mg in combination with durvalumab dose 6 at week 16.
- Weight less than 30 kg: 1 mg/kg every three weeks in combination with durvalumab 20 mg/kg and platinum-based chemotherapy for four cycles, and then administer durvalumab 20 mg/kg every four weeks as a single agent with histology-based pemetrexed therapy every four weeks, and a fifth dose of Imjudo 1 mg/kg in combination with durvalumab dose 6 at week 16. See full prescribing information for further detail.
For Medicaid and NC Health Choice Billing
- The ICD-10-CM diagnosis codes required for billing are:
- Unresectable hepatocellular carcinoma (uHCC):
- C22.0 - Liver cell carcinoma;
- C22.8 - Malignant neoplasm of liver, primary, unspecified as to type;
- Metastatic non-small cell lung cancer (NSCLC):
- C33 - Malignant neoplasm of trachea;
- C34.01 - Malignant neoplasm of right main bronchus;
- C34.02 - Malignant neoplasm of left main bronchus;
- C34.11 - Malignant neoplasm of upper lobe, right bronchus or lung;
- C34.12 - Malignant neoplasm of upper lobe, left bronchus or lung;
- C34.2 - Malignant neoplasm of middle lobe, bronchus or lung;
- C34.31 - Malignant neoplasm of lower lobe, right bronchus or lung;
- C34.32 - Malignant neoplasm of lower lobe, left bronchus or lung;
- C34.81 - Malignant neoplasm of overlapping sites of right bronchus and lung;
- C34.82 - Malignant neoplasm of overlapping sites of left bronchus and lung;
- Unresectable hepatocellular carcinoma (uHCC):
- Providers must bill with HCPCS code: J9999 - Not otherwise classified, antineoplastic drugs
- One Medicaid and NC Health Choice unit of coverage is: 1 mg
- The maximum reimbursement rate per unit is: $140.40000
- Providers must bill 11-digit NDCs and appropriate NDC units. The NDCs are: 00310-4505-25, 00310-4535-30
- 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