Prior Auth Protocol

FDA Approved Indications:

For the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation positive non-small cell lung cancer (NSCLC), as detected by an FDA approved test, who have progressed on or after EGFR TKI therapy

Health Net Approved Indications and Usage Guidelines:

Patient has a diagnosis of NSCLC

AND

Patient has an EGFR T790M mutation as detected by an FDA-approved test

AND

Failure or clinically significant adverse effects to Gilotrif, Tarceva, or Iressa

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:

The National Comprehensive Cancer Network recommendation is 2A for: 1. subsequent threapy as a single agent for EGFR T790M mutation-positive metastatic disease following progression on erlotinib, afatinib, or gefitinib for asymptomatic disease or symptomatic systemic lesions 2. for progression on tyrosine kinase inhibitor therapy
Use in patients with metastatic EGFR T790M mutation positive NSCLC was approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
Gilotrif (afatinib)	NSCLC EGFR mutation: 40 mg PO QD	40 mg/day
Tarceva (erlotinib)	NSCLC EGFR mutation: 150 mg PO QD	150 mg/day
Iressa (gefitinib)	NSCLC EGFR mutation: 250 mg PO QD	250 mg/day

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug	Dosing Regimen	Authorization Limit
Tagrisso	40 mg to 80 mg PO QD	Length of Benefit

Product Availability:

Tablets: 40 mg. 80 mg

References:

1. Tagrisso [Prescribing Information] Wilmington, DE. AstraZeneca Pharmaceuticals LP, November 2015.
2. National Comprehensive Cancer Network. Non-Small Cell Lung Cancer. V2.2016. http://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed December 7, 2015.