IMJUDO (tremelimumab-actl)

IMJUDO (tremelimumab-actl)

Medical-Administration – intravenous

Diagnosis considered for coverage:

For diagnosis of hepatocellular carcinoma:

• Dose does not exceed 300 mg per dose by intravenous infusion over 60 minutes, AND

• Patient is 18 years of age and older; AND

• Prescribed by or in consultation with a hepatologist or oncologist; AND

• Diagnosis of unresectable hepatocellular carcinoma (uHCC); AND

• Used in combination with Imfinzi (durvalumab)

For diagnosis of non-small cell lung cancer (NSCLC):

• Dose does not exceed 75 mg per dose by intravenous infusion over 60 minutes, AND

• Patient is 18 years of age and older; AND

• Prescribed by or in consultation with an oncologist, AND

• Diagnosis of non-small cell lung cancer (NSCLC); AND

• Disease is ALL of the following:

  • Metastatic

  • No sensitizing epidermal growth factor receptor (EGFR) mutations

  • No anaplastic lymphoma kinase (ALK) genomic tumor aberrations; AND

• Used in combination with Imfinzi (durvalumab) and platinum-based chemotherapy (e.g carboplatin or cisplatin)

Reauthorization Criteria:

For diagnosis of hepatocellular carcinoma:

• Dose does not exceed 300 mg, AND

• Patient does not show evidence of progressive disease while on therapy 

For diagnosis of non-small cell lung cancer (NSCLC):

• Dose does not exceed 75 mg; AND

• Patient does not show evidence of progressive disease while on therapy

Coverage Duration: 

• Initial: 12 months

• Reauthorization: 12 months

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• Dosage and Administration

  • Administer IMJUDO infusion solution intravenously over 60 minutes through an intravenous line containing a sterile, low-protein binding 0.2 or 0.22 micron filter.

  • Use separate infusion bags and filters for each drug product.

  • Observe patient for 60 minutes following completion of IMJUDO infusion, hen administer durvalumab as a separate intravenous infusion over 60 minutes.

  • If there are no infusion reactions during cycle 1, subsequent cycles of durvalumab can be given immediately after IMJUDO. The time between the end of the durvalumab infusion and the start of chemotherapy can be reduced to 30 minutes.

Policy Updates:

• 05/16/2023 – New policy approved by P&T.

References:

• Imjudo prescribing information. AstraZeneca Pharmaceuticals, LP. Wilmington, DE. October 2022.