Australian Government - Department of Health

Medical Services Advisory Committee (MSAC)

1293- Codependent with PBAC- EGFR testing in Patients with Locally Advanced or Metastatic Non Small-Cell Lung Cancer to determine eligibility for afatinib

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Application Number1293
Application NameEpidermal Growth Factor Receptor (EGFR) testing to determine eligibility for afatinib treatment in patients with locally advanced or metastatic non-small-cell lung cancer.
Description of Medical ServiceThis 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. QiagenŽEGFR test. The medical service will involve the use of an in-vitro diagnostic test to determine eligibility for the pharmaceutical afatinib.
Description of Medical ConditionLung 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.
ProtocolsPDF version of Consultation Decision Analytic Protocol
Word version of Consultation Decision Analytic Protocol (Word 632 KB)

PDF version of Final decision Analytic Protocol
Word version of Final decision Analytic Protocol (Word 378 KB)
ConsultationConsultation Protocol out from 2 October 2012 – 9 November 2012
MSAC OutcomesPDF version Public Summary Document - August 2013 (PDF 146 KB)
Word version Public Summary Document - August 2013 (Word 103 KB)

Meetings for this Application

Meeting TypeDate
PASC16 – 17 August 2012
13 – 14 December 2012
ESC Not required
MSAC 1 August 2013

Page currency, Latest update: 20 April, 2015