• Treatment of patients with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. This indication is approved under accelerated approval based on tumor response rate and duration of response.

• Diagnosis of NSCLC

AND

• ALK-positive as detected by an FDA-approved test

OR

• Prescribed by an Oncologist

AND

• Failure or clinically significant adverse effect to Xalkori

• 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.

• According to National Comprehensive Cancer Network (NCCN) Practice Guidelines, treatment of ALK-positive metastatic NSCLC who have progressed on Xalkori^R or are intolerant to Xalkori^R (with category 2A NCCN recommendation) is as follows: 1) switch to Zykadia^TM or Alecensa^R, 2) consider local therapy and continue Xalkori^R if appropriate, or 3) switch to a first-line systemic therapy regimen for either non-squamous or squamous cell NSCLC.
• In the pivotal trial, Alecensa showed central nervous system (CNS) objective response rate of 61% with a median duration of response of 9.1 months in ALK-positive NSCLC metastatic patients with CNS involvement who failed on Xalkori. However, in the pivotal trial for Zykadia, there is no data to support its use in patients with CNS lesions.
• Alecensa is currently being studied for first-line treatment of ALK-positive advanced NSCLC.
  

Capsule: 150 mg

1. Alecensa [Prescribing Information]. South San Francisco, CA: Genentech USA, Inc. December 2015.
2. National Comprehensive Cancer Network. Non-Small Cell Lung Cancer. V3.2016, accessed from http://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf, on December 23, 2015.