Prior Auth Protocol

FDA Approved Indications:

For treatment of patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.

Health Net Approved Indications and Usage Guidelines:

AND

OR

As single-agent therapy for the treatment of Soft Tissue Sarcoma - Inflammatory Myofibroblastic Tumor (IMT) with ALK translocation

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:

Zykadia was approved under accelerated approval based on tumor response rate and duration of response. An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Per the package labeling for Zykadia, Zykadia should be discontinued if the patient is unable to tolerate 300 mg daily.
Per NCCN compendia, Zykadia has a 2A recommendation for the treatment of Soft Tissue Sarcoma - Inflammatory Myofibroblastic Tumor with ALK translocation.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
Xalkori^R (crizotinib)	ALK-Positive NSCLC 250 mg PO BID May require reduction to 200 mg BID or 250 mg QD	500 mg/day

Xalkori^R (crizotinib)

ALK-Positive NSCLC

250 mg PO BID
May require reduction to 200 mg
BID or 250 mg QD

500 mg/day

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Zykadia	ALK-Positive NSCLC 750 mg PO QD on an empty stomach	Length of benefit, until disease progression, or unable to tolerate at least 300 mg daily.

Product Availability:

Zykadia Capsules: 150 mg

References:

1. Zykadia^TM [Prescribing Information]. East Hanover, NJ: Novartis; April 2014.

2. Shaw AT, Kim DW, Mehra R, et al. Ceritinib in ALK-Rearranged Non-Small-Cell Lung Cancer. N Engl J Med 2014;370:1189-1197.

3. Micromedex Healthcare Series. Micromedex Web site. Available at http://www.thomsonhc.com. Accessed June 16, 2015.

4. Clinical Pharmacology. Available at: http://www.clinicalpharmacology-ip.com/Default.aspx. Accessed June 16, 2015.

5. American Hospital Formulary Service Drug Information. AHFS Web site. Available at: http://www.ashp.org/ahfs/index.cfm. Accessed June 16, 2015.

6. National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at http://www.nccn.org/professionals/drug_compendium. Accessed June 16, 2015.

7. National Comprehensive Cancer Network. Non-Small Cell Lung Cancer. Version 6.2015. Available at: http://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed June 16, 2015.

8. National Comprehensive Cancer Network. Soft Tissue Sarcoma. Version 1.2015. Available at: http://www.nccn.org/professionals/physician_gls/pdf/sarcoma.pdf. Accessed June 16, 2015.

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