1293- Codependent with PBAC- EGFR testing in Patients with Locally Advanced or Metastatic Non Small-Cell Lung Cancer to determine eligibility for afatinib
|
Assessment No | 1293 |
| Application Name | Epidermal Growth Factor Receptor (EGFR) testing to determine eligibility for afatinib treatment in patients with locally advanced or metastatic non-small-cell lung cancer. |
| Expected to be Submission based | |
| 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. QiagenŽEGFR test. The medical service will involve the use of 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. |
| Pre Assessment Meeting | February 2012 |
| Stage 2 – Suitability for Assessment | May 2012 |
| Proposed DAP Received | May 2012 |
| Stage 3 - 1st PASC (Draft DAP considered) | 16-17 August 2012 |
| Stage 3 – Release for Public Comment (Consultation DAP) | 2 October - 9 November 2012 Date of released for comment 3 October 2012 Consultation Decision Analytic Protocol (DAP) (While every effort will be made to ensure that comments received by the close date would be provided to PASC, this could not necessarily be guaranteed.) |
| Stage 3 - 2nd PASC (Final DAP) | 13-14 December 2012 Final decision Analytic Protocol (DAP) |
| Stage 4 - Submission of Collated Evidence | 13 February 2013 |
| Stage 5 - ESC evaluation | Not required |
| Stage 6 - MSAC Appraisal | August 2013 |
| Stage 6 - MSAC advice |  |
| Stage 7 - Noting by Minister | |
| Stage 8 - Implementation | |
Page currency, Latest update: 09 April, 2013
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