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. 

Last review date: June 1, 2023

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