ICLUSIG (ponatinib)

ICLUSIG (ponatinib)

Self-Administration - oral tablets

Diagnosis considered for coverage:

• Chronic Myeloid Leukemia (CML): Indicated for the treatment of adult patients with chronic phase (CP) chronic myeloid leukemia (CML) with resistance or intolerance to at least two prior kinase inhibitors. Limitations of Use: Iclusig is not indicated and is not recommended for the treatment of patients with newly diagnosed CP-CML.
• Accelerated phase (AP) or blast phase (BP) Chronic Myeloid Leukemia (CML) or Philadelphia  chromosome positive acute lymphoblastic leukemia (Ph+ ALL): Indicated for the treatment of adult patients with Accelerated phase (AP) or blast phase (BP) Chronic Myeloid Leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) for whom no other kinase inhibitors are indicated.
• T315I-positive Chronic Myeloid Leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL): Indicated for the treatment of adult patients with T315I-positive CML (chronic phase, accelerated phase, or blast phase) or T315I-positive Ph+ ALL.
   

Coverage Criteria:

For diagnosis of CML or ALL: 

• One of the following:
  • Diagnosis of chronic myelogenous leukemia (CML), OR
  • Diagnosis of Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL)

Reauthorization Criteria:

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

Dosing:

• 45 mg orally once a day

Coverage Duration:

• Initial: 1 year
• Reauthorization: 1 year

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: 

• Resistance in CP-CML while on prior TKI therapy, was defined as failure to achieve either a complete hematologic response (by 3 months), a minor cytogenetic response (by 6 months), or a major cytogenetic response (by 12 months). Patients with CP-CML who experienced a loss of response or development of a kinase domain mutation in the absence of a complete cytogenetic response or progression to AP-CML or BP-CML at any time on prior TKI therapy were also considered resistant. Resistance in AP-CML, BP-CML, and Ph+ALL was defined as failure to achieve either a major hematologic response (by 3 months in AP-CML, and by 1 month in BP-CML and Ph+ALL), loss of major hematologic response (at any time), or development of a kinase domain mutation in the absence of a complete major hematologic response while on prior TKI therapy. Intolerance was defined as the discontinuation of prior TKI therapy due to toxicities despite optimal management in the absence of a complete cytogenetic response in patients with CP-CML or major hematologic response for patients with APCML, BP-CML, or Ph+ALL.
   

Policy Updates:

• 12/02/2013 – Policy creation.
• 06/01/2024 – Policy update for Iclusig approved by WHA P&T Committee. (P&T, 05/21/2024)
   

References:

1. Iclusig Prescribing Information. ARIAD Pharmaceuticals, Inc. Cambridge, MA. February 2022.