1407 - EGFR mutation testing to determine eligibility for access to PBS subsidised AZD9291 second line therapy in patients with locally advanced or metastatic NSCLC

Page last updated: 15 February 2019

Application Detail



Description of Medical Service

The proposed medical service is an additional EGFR mutation test for the presence of the T790M mutation in patients with locally advanced (Stage IIIB) or metastatic (Stage IV), non-squamous or not otherwise specified EGFR mutation positive NSCLC, who have received first-line EGFR TKI treatment and whose disease has subsequently progressed.

Description of Medical Condition

Lung cancer is the fourth most commonly diagnosed cancer in Australian men and women(1). Unfortunately, approximately 50% of patients with lung cancer are diagnosed when the disease is advanced and inoperable (2). Prognosis is poor with a 5-year survival rate of approximately 13% (3). In the past decade, targeted therapies for treatment of specific molecular subtypes of lung cancer have become available. There are approved and established therapies for patients with non-small cell lung cancer (NSCLC) known to have sensitising mutations of the Epidermal Growth Factor Receptor (EGFR) gene. Treatment with EGFR tyrosine kinase inhibitors (TKIs) is not curative and the disease will ultimately progress in the majority of patients within 9-13 months (4).

Reason for Application

Amendment to MBS item

Medical Service Type

Co-dependent technology

Previous Application Number

Not Applicable

Associated Documentation

Application Form


PICO Confirmation

Final Protocol (PDF 1340 KB)
Final Protocol (Word 831 KB)

Assessment Report


Public Summary Document

Public Summary Document - updated (PDF 891 KB)
Public Summary Document - updated (Word 89 KB)

Meetings for this Application


13 - 14 August 2015


5 October 2017


23 November 2017
22-23 November 2018