Prior Auth Protocol

FDA Approved Indications:

First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test

Health Net Approved Indications and Usage Guidelines:

AND

Patient has an EGFR exon 19 deletion or exon 21 (L858R) substitution mutation as detected by an FDA-approved test

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:

According to National Comprehensive Cancer Network (NCCN) Practice Guidelines, treatment of NSCLC (with category 1 NCCN recommendation) is further categorized by histological findings with gene alteration and rearrangement: 1) EGFR mutation and ALK negative - platinum-based chemotherapy (e.g. cisplatin+Alimta^R), 2) EGFR mutation positive - Gilotrif, Tarceva^R, and 3) ALK positive - Xalkori^R.
NCCN Practice Guidelines do not recommend systemic, cytotoxic chemotherapy for patients of any age with a Performance Status (PS) score of 3-4 for NSCLC except Tarceva for EGFR mutation positive patients.

ECOG Performance Status Scale

Score	Description
0	Normal Activity
1	Symptoms but nearly fully ambulatory
2	Ambulatory but bedtime required during normal daytime (< 50%)
3	Confined to bed > 50% of waking hours
4	Unable to get out of bed

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
Tarceva^R (erlotinib)*	*NSCLC - EGFR mutation* 150 mg PO QD	150 mg/day

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Gilotrif	**NSCLC - EGFR mutation** 40 mg PO QD	Length of benefit or until disease progression

Product Availability:

Tablets: 20 mg, 30 mg, 40 mg

References:

Gilotrif [Prescribing Information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc. March 2015.
Sequist LV, Yang JC, Yamamoto N, et al. Phase III study of afatinib or cisplatin plus pemetrexed in patients with metastatic lung adenocarcinoma with EGFR mutations. J Clin Oncol. 2013; Jul 1. [Epub ahead of print].
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 8, 2015.
Micromedex Healthcare Series. Micromedex Web site. Available at http://www.thomsonhc.com. Accessed June 8, 2015.
Clinical Pharmacology. Available at: http://www.clinicalpharmacology-ip.com/Default.aspx. Accessed June 8, 2015.
American Hospital Formulary Service Drug Information. AHFS Web site. Available at: http://www.ashp.org/ahfs/index.cfm. Accessed June 8, 2015.
National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at http://www.nccn.org/professionals/drug_compendium. Accessed June 8, 2015.