IMBRUVICA (ibrutinib)

IMBRUVICA (ibrutinib)

Self-Administration – oral

Indications for Prior Authorization:

• Imbruvica is a kinase inhibitor indicated for the treatment of:  
  • Chronic lymphocytic leukemia (CLL) / Small lymphocytic lymphoma (SLL) 
  • Chronic lymphocytic leukemia (CLL) / Small lymphocytic lymphoma (SLL) with 17p deletion 
  • Waldenstrom’s macroglobulinemia (WM) 
  • Chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy
     

Coverage Criteria:

1.    For diagnosis of chronic lymphocytic leukemia (CLL)/ Small lymphocytic lymphoma (SLL) with or without 17p deletion: 

• Dose does not exceed 420 mg orally once daily; AND 
• Prescribed by or in consultation with a hematologist/oncologist; AND
• Diagnosis of one of the following:
  • Chronic lymphocytic leukemia 
  • Small lymphocytic lymphoma 

2.    For diagnosis of Waldenstrom’s macroglobulinemia (WM):

• Dose does not exceed 420 mg orally once daily; AND
• Prescribed by or in consultation with a hematologist/oncologist; AND
• Diagnosis of Waldenstrom’s macroglobulinemia

3.    For diagnosis of chronic graft versus host disease (cGVHD):

• Dose does not exceed 420 mg orally once daily; AND
• Patient is 1 year of age or older; AND 
• Diagnosis of chronic graft versus host disease (cGVHD); AND 
• Prescribed by or in consultation with a hematologist/oncologist or physician experienced in the management of transplant patients; AND
• Failure of one or more lines of systemic therapy (see additional information for examples)

Reauthorization Criteria:

1.    For diagnosis of Chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with or without 17p deletion, Waldenstrom’s macroglobulinemia (WM),  and Chronic graft versus host disease (cGVHD):

• Dose does not exceed the FDA maximum dose for each indication; AND 
• Patient does not show evidence of progressive disease while on therapy

Coverage Duration:

• Initial: 6 months
• Reauthorization: 6 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:
  • Dosage forms: Capsules, Tablets, Suspension
  • Hepatic Impairment:
    • Reduce dose for patients with mild or moderate renal impairment
    • Avoid use in patients with severe impairment. 
• Drug Interactions:
  • CYP3A Inhibitors: Modify Imbruvica dose when using with CYP3A inhibitors 
  • CYP3A Inducers: Avoid coadministration with strong CYP3A inducers
• Chronic graft versus host disease (cGVHD): examples of therapy per NCCN guidelines 

  • Steroids (Prednisone, Methylprednisolone)

    Targeted therapies (Jakafi, Rezurock)

    Calcineurin inhibitors (tacrolimus, cyclosporine)

    Hydroxychloroquine

    Mycophenolate mofetil

    Sirolimus

Policy Updates:

• 06/01/2023 – New policy approved by P&T

References:

• Imbruvica Prescribing Information. Pharmacyclics, Inc. Sunnyvale, CA. August 2022. 
• National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology – B-Cell Lymphoma, version 2.2023 – February 8, 2023. 
• National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology – Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma, version 2.2023 – January 25, 2023
• National Comprehensive Cancer Network (NCCN). NCCN clinical practice guidelines in oncology – Waldenstrom Macroglobulinemia/Lymphoplasmacytic Lymphoma, version 1.2023 – July 6, 2022.