Application Detail

Status

Closed

Description of Medical Service

This service is for the genetic testing of mutations in the EGFR gene in locally advanced (stage IIIB) or metastatic (stage IV) NSCLC patients to determine eligibility for treatment with the irreversible EGFR tyrosine kinase inhibitor (TKI) afatinib.

Testing for EGFR gene mutations in patients with NSCLC requires collection of an appropriate sample of tumour tissue, preparation of the tissue sample and conducting the test. There are several techniques used to determine the presence of EGFR mutations in tumour tissue, including screening technologies which detect all EGFR mutations, e.g. direct DNA sequencing, or targeted technologies which detect known specific mutations, e.g. Qiagen®EGFR test. The medical service will involve the use of an in-vitro diagnostic test to determine eligibility for the pharmaceutical afatinib.

Description of Medical Condition

Lung cancer carries a significant morbidity and mortality burden. Approximately 70% of patients are diagnosed with locally advanced or metastatic disease. NSCLC is the most common type of lung cancer, comprising approximately 75% of all cases in Australia. The EGFR family of tyrosine kinases regulates many developmental, metabolic and physiological processes. The frequency of EGFR mutations has been estimated as approximately 27% in all lung cancer patients. EGFR mutations are more common in (but not exclusive to) patients who are never (or former light) smokers, patients with adenocarcinoma histology, females and Asians, but are uncommon in patients with squamous cell carcinoma histology. The high frequency of EGFR mutations in NSCLC has driven the development of EGFR TKIs. Afatinib is a novel irreversible EGFR TKI. It is proposed as a treatment option in patients who have EGFR mutations.

Reason for Application

-

Medical Service Type

-

Previous Application Number

Not Applicable

Associated Documentation

Application Form

-

PICO Confirmation

Final decision Analytic Protocol (PDF 985 KB)
Final decision Analytic Protocol (Word 378 KB)

Assessment Report

-

Public Summary Document

Public Summary Document - August 2013 (PDF 146 KB)
Public Summary Document - August 2013 (Word 103 KB)

Meetings for this Application

PASC

16 – 17 August 2012
13 – 14 December 2012

ESC

Not required

MSAC

1 August 2013