Prior Auth Protocol

FDA Approved Indications:

For the treatment of adult patients with chronic, accelerated, or blast phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML) with resistance or intolerance to prior therapy.

Health Net Approved Indications and Usage Guidelines:

Patient has diagnoses of chronic, accelerated, or blast phase Ph+ chronic myelogenous leukemia

AND

Failure or clinically significant adverse effects to Sprycel^R, Tasigna^R or Gleevec^R

OR

Patient has a diagnosis of relapsed/refractory Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL) with E255K/V, F317/L/V/I/C, F359V/C/I, T315A, or Y253H mutations

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:

Per NCCN compendia recommendations (2A), Bosulif can be used as a single-agent salvage therapy for relapsed/refractory Philadelphia chromosome-positive ALL with E255K/V, F317/L/V/I/C, F359V/C/I, T315A, or Y253H mutations.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
Gleevec^R (imatinib)*	Chronic phase newly diagnosed Ph+ CML: 400 mg PO QD Blast or accelerated phase Ph+ CML: 600 mg PO QD	800 mg/day
Sprycel^R (dasatinib)*	Chronic phase newly diagnosed Ph+ CML: 100 mg PO QD Blast or accelerated phase Ph+ CML: 140 mg PO QD	180 mg/day
Tasigna^R (nilotinib)*	Newly diagnosed chronic phase Ph+ CML: 300 mg PO BID Resistant or intolerant accelerated or chronic phase Ph+ CML: 400 mg PO BID	800 mg/day (divided in twice daily dosing)

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Bosulif	500 mg PO QD with food. Consider dose escalation to 600 mg daily in patients who do not reach complete hematologic response by week 8 or complete cytogenetic response by week 12 and do not have Grade 3 or greater adverse reactions.	Length of Benefit

Product Availability:

Tablets: 100 mg and 500 mg

References:

1. Bosulif [Prescribing Information] New York, NY: Pfizer Pharmaceuticals; November 2014.

2. National Comprehensive Cancer Network. Chronic Myelogenous Leukemia Version 1.2015. Available at http://www.nccn.org. Accessed June 10, 2015.

3. Micromedex Healthcare Series. Micromedex Web site. Available at http://www.thomsonhc.com. Accessed June 10, 2015.

4. Clinical Pharmacology. Available at: http://www.clinicalpharmacology-ip.com/Default.aspx. Accessed June 10, 2015.

5. American Hospital Formulary Service Drug Information. AHFS Web site. Available at: http://www.ashp.org/ahfs/index.cfm. Accessed June 10, 2015.

6. National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at http://www.nccn.org/professionals/drug_compendium. Accessed June 10, 2015.

Interim Guidelines; Final Review and Approval by the P&T Committee Pending