Ponatinib (Iclusig®)

Self administration- Oral

Indications for Prior Authorization

  • Treatment of adult patients with chronic, accelerated, or blast phase chronic myeloid leukemia (CML)
  • Treatment of adult patients with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL)

Patients must meet the following criteria for the indication(s) above.

Patient is resistant or intolerant to prior tyrosine kinase inhibitor therapy

  • CML: Gleevec, Sprycel, Tasigna and Bosulif
  • Ph+ ALL: Gleevec and Sprycel

For ALL, patients must undergo genetic testing to confirm Ph+ status

Patient must not be pregnant or planning on becoming pregnant

The Following Conditions Do Not Meet the Criteria for Use as Established by the WHA P & T Committee.

  • All non-FDA approved uses not listed in the approved indications

Recommended Dosing

  • 45 mg orally once a day

Approval

One year or until disease progression or intolerable side effects

  • Box warnings for: arterial/venous thrombosis, hepatotoxicity, congestive heart failure, pancreatitis, cardiac arrhythmias and myelosuppression.

Western Health Advantage Pharmacy and Therapeutics Committee

Approved/Revised: March 2013 Reviewed: December 2013