Xalkori

Drug - Xalkori® (crizotinib) [Pfizer]

January 2017

Therapeutic area - Oral Oncology

Initial approval criteria

Patient must be 18 years of age or older AND
Patient must have a diagnosis of metastatic non-small cell lung cancer (NSCLC) whose tumors are ALK-positive as detected by an FDA-approved test OR
Patient must have a diagnosis of metastatic NSCLC whose tumors are ROS 1-positive AND
At time of request, provide documentation of reproductive health counseling provided to female patients of reproductive potential and male patients with female partners of reproductive potential

Chart notes must be supplied at time of request showing patient has no disease progression AND
Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following:
- Severe vision loss (Grade 4 Ocular Disorder)
- Bradycardia with life-threatening consequences requiring urgent intervention
- Interstitial lung disease/pneumonitis
- QTc greater than 500ms or greater than or equal to 60ms change from baseline with Torsade de pointes or polymorphic ventricular tachycardia or signs/symptoms of serious arrhythmia
- ALT or AST elevation greater than 3 times ULN with concurrent total bilirubin elevation greater than 1.5 ULN (in the absence of cholestasis or hemolysis)

68 tablets per 34 days

MHCP Provider Call Center 651-431-2700 or 800-366-5411