Iclusig - NC Standard

• Iclusig® (ponatinib)

• For the treatment of adults with chronic phase (CP) chronic myeloid leukemia (CML) with resistance or intolerance to at least two prior kinase inhibitors.
• For the treatment of adults with accelerated phase (AP) or blast phase (BP) CML or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) for whom no other kinase inhibitors are indicated. 
• For the treatment of adults with T315I-positive CML (chronic phase, accelerated phase, or blast phase) or T315I-positive Ph+ ALL

1. The patient is currently taking the requested medication for a cancer diagnosis; AND 
   1. The patient will utilize the generic formulation of this product (if available); OR 
2. The patient is 18 years of age or older; AND 
3. The patient is being managed by or in consultation with an oncologist; AND 
4. The patient has been diagnosed with one of the following diagnoses (medical record documentation required): 
   1. Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) that is T315I-positive; OR
   2. Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) that is T315I- positive; OR 
   3. Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in chronic phase, accelerated phase, or blast phase; OR 
5. Chronic myeloid leukemia (CML) in chronic phase, accelerated phase or blast phase; AND
6. The patient has tried and failed, or has a contraindication/intolerance to a generic imatinib; AND 
7. For patients with chronic myeloid leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in chronic phase, accelerated phase, or blast phase, the patient has tried and failed, or has a contraindication/intolerance to generic imatinib and another oral tyrosine kinase inhibitor; AND
8. Indications outside of FDA labeling will be subject to medical necessity review in accordance with specific strong endorsement or support by nationally recognized compendia, when such recommendation is based on strong/high levels of evidence, and/or uniform consensus of clinical appropriateness has been reached. Medical records and references / evidence must be provided; AND 
9. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 365 days (1 year)

Quantity limitations apply to brand and associated generic products.

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND 
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND 
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR 
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).

Duration of Approval: 365 days (1 year)

All information referenced is from FDA package insert unless otherwise noted below.

June 2023: Criteria update: Criteria reviewed and formatting changes.

February 2021: Criteria change: Added new 10mg and 30mg tablets. Decreased QL on 15mg tablet to 1 tablet per day.

December 2020: Criteria update: Update to FDA Approved use section: Chronic phase (CP) chronic myeloid leukemia (CML) with resistance or intolerance to at least two prior kinase inhibitors. (Previously only for treatment only where NO other kinase inhibitors were indicated)

August 2020: Criteria update: Allow for approval if taking for a cancer diagnosis and utilizing the generic (if available).

January 2020: Criteria change: Reformatted criteria. Allow authorization if currently taking the medication for a cancer diagnosis. Added CML into diagnosis section.

October 2018: Annual review; No change

April 2017: Original utilization management criteria issued