Prior Auth Protocol

FDA Approved Indications:

For the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.

Health Net Approved Indications and Usage Guidelines:

Patient has a diagnosis of locally advanced or metastatic NSCLC that is ALK-positive

OR

Single-agent therapy for recurrence or metastasis in patients with ROS1 (receptor tyrosine kinase of the insulin receptor family)- or ALK-positive tumors of nonsquamous cell histology (NSCLC)

OR

Second-line therapy for progressive asymptomatic disease, symptomatic isolated lesions, or multiple symptomatic brain lesions (NSCLC)

OR

Activity against MET (mesenchymal-epithelial transition) amplifications in lung cancer

OR

Single agent therapy for the treatment of Inflammatory Myofibroblastic Tumor (IMT) [a type of Soft Tissue Sarcoma] with ALK translocation

OR

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:

Advanced disease is defined as recurrence or metastatic (spread of cancer to other sites).
National Comprehensive Cancer Network (NCCN) Practice Guidelines for Soft Tissue Sarcoma, Xalkori is recommended as single agent therapy for the treatment of IMT with ALK Translocation.
NCCN Practice Guidelines for NSCLC, Xalkori has a 2A recommendation as single agent therapy for recurrence or metastasis in patients with ROS1- or ALK-positive tumors of nonsquamous cell histology as first-line therapy or second-line therapy for progressive asymptomatic disease, symptomatic isolated lesions, or multiple symptomatic brain lesions. NCCN also recommends Xalkori (2A) for activity against MET amplifications in lung cancer. MET is thought to give rise to a metastatic lesion with cellular characteristics of the original tumor.
National Comprehensive Cancer Network (NCCN) Practice Guidelines for NSCLC has the following recommendations:
- Xalkori as first-line therapy for ALK-positive patients
- Tarceva or Gilotrif as first-line therapy for EGFR-positive patients
- Systemic chemotherapy regimens for first-line therapy for advanced NSCLC where ALK/EGFR mutation is negative or unknown

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
Cisplatin Carboplatin Paclitaxel Docetaxel Vinorelbine Gemzar^R (gemcitabine) Etoposide Irinotecan Vinblastine Avastin^R (bevacizumab) Alimta^R (pemetrexed)	Various doses	Number of cycles vary
Gilotrif (afatinib)*	EGFR positive disease: 40 mg PO QD	40 mg
Tarceva (erlotinib)	EGFR positive disease: 150 mg PO QD	150 mg
Zykadia (ceritinib)*	ALK positive NSCLC: 750 mg PO QD	750 mg

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Xalkori	250 mg PO BID May require reduction to 200 mg BID or 250 mg QD	Length of benefit or until disease progression

Product Availability:

Capsules: 250 mg and 200 mg

References:

1. Xalkori [Prescribing Information]. New York, NY: Pfizer; March 2015.

2. Clinical Pharmacology Web site. Available at: http://www.clinicalpharmacology-ip.com/default.aspx. Accessed June 17, 2015.

3. National Comprehensive Cancer Network. Soft Tissue Sarcoma. Version 1.2015 Available at: http://www.nccn.org/professionals/physician_gls/pdf/sarcoma.pdf. Accessed June 17, 2015.

4. 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 17, 2015.

5. National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at: http://www.nccn.org/professionals/drug_compendium. Accessed June 17, 2015.

6. DRUGDEX^R System [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed July 15, 2014.

7. American Hospital Formulary Service Drug Information. AHFS Web site. Available at: http://www.ashp.org/ahfs/index.cfm. Accessed June 17, 2015.

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