Prior Auth Protocol

FDA Approved Indications:

Treatment of adult patients with T315I-positive chronic myeloid leukemia (chronic phase, accelerated phase, or blast phase) or T315I-positive Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL).
Treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia or Ph+ ALL for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated.

Health Net Approved Indications and Usage Guidelines:

Patient has diagnosis of T315I-positive chronic myeloid leukemia (CML) (chronic phase (CP), accelerated phase (AP), or blast phase (BP)) or T315I-positive Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL)

OR

AND

OR

AND

Failure or clinically significant adverse effects to all of the following: Gleevec, Tasigna^R, Bosulif^R and Sprycel (patients with blast phase CML do not need to have tried Tasigna^R)

Coverage is Not Authorized For:

Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.

General Information:

The optimal dose of Iclusig has not been identified. In clinical trials, the starting dose of Iclusig was 45 mg administered orally once daily. However, 59% of the patients required dose reductions to 30 mg or 15 mg once daily during the course of therapy.
Black box warnings include: Arterial and venous thrombosis and occlusions have occurred in at least 27% of Iclusig treated patients, including fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and the need for urgent revascularization procedures. Patients with and without cardiovascular risk factors, including patients less than 50 years old, experienced these events. Heart failure, including fatalities, occurred in 8 % of Iclusig-treated patients. Hepatotoxicity, liver failure and death have occurred in Iclusig-treated patients.
National Comprehensive Cancer Network (NCCN), 2A recommendation, includes Iclusig as a treatment option for post-transplant relapse in CML patients with T315I mutation-positive CML or who have not responded to two or more tyrosine kinase inhibitor therapies

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
Gleevec^R (imatinib)	Adults with Ph+ CML-CP: 400 mg PO QD Adults with Ph+ CML-AP or blast crisis (BC): 600 mg PO QD Pediatrics with Ph+ CML-CP: 340 mg/m²PO per day Adults with Ph+ ALL: 600 mg PO QD Pediatrics with Ph+ ALL: 340 mg/m² PO per day	800 mg/day
Sprycel^R (dasatinib)	Ph+CML-CP: 100 mg PO QD Ph+CML-AP, myeloid or lymphoid Ph+CML-BP, or Ph+ ALL: 140 mg PO QD	180 mg/day
Tasigna^R (nilotinib)*	Newly diagnosed Ph+ CML-CP: 300 mg PO BID Resistant or intolerant Ph+ CML-CP and Ph+CML-AP: 400 mg PO BID	800 mg/day
Bosulif^R (bosutinib)*	Chronic, accelerated, or blast phase Ph+ CML: 500 mg PO QD	600 mg/day
Synribo^R (omacetaxine)*	CML-CP or CML-AP Induction Dose: 1.25 mg/m² SC BID for 14 consecutive days of a 28-day cycle. Maintenance Dose: 1.25 mg SC BID for 7 consecutive days of a 28-day cycle.	2.5 mg/m²/day

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Iclusig	Starting dose 45 mg PO QD (30 mg PO QD if taken with a strong CYP3A4 inhibitor). Consider reducing the dose of Iclusig for CML-CP and CML-AP patients who have achieved a major cytogenetic response.	Treatment continues until no longer clinically beneficial or until unacceptable toxicity occurs. Consider discontinuing Iclusig if response has not occurred by 3 months (90 days) Length of Benefit

Product Availability:

Tablets: 15 mg and 45 mg

References:

Iclusig [Prescribing Information] Cambridge, MA: Ariad Pharmaceuticals, Inc.; July 2014.
National Comprehensive Cancer Network. Chronic Myelogenous Leukemia Version 1. 2015. Available at http://www.nccn.org. Accessed, May 27, 2015.
National Comprehensive Cancer Network. Acute Lymphoblastic Leukemia Version 2.2014. Available at http://www.nccn.org. Accessed, May 27, 2015.
Clinical Pharmacology Web site. Available at: http://cpip.gsm.com/. Accessed May 27, 2015.
DRUGDEX. System [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed May 27, 2015.
Iclusig. American Hospital Formulary Service Drug Information. Available at: http://www.medicinescomplete.com/mc/ahfs/current/. Accessed May 27, 2015.
National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at : http://www.nccn.org/professionals/drug_compendium. Accessed May 27, 2015.