October National Health Committee. Epidermal Growth Factor Receptor Mutation Testing: Supplement to Recommendation Update

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1 October 2015 National Health Committee Epidermal Growth Factor Receptor Mutation Testing: Supplement to Recommendation Update

2 National Health Committee (NHC) The National Health Committee (NHC) is an independent statutory body charged with prioritising new and existing health technologies and making recommendations to the Minister of Health. It was re-formed in 2011 to establish evaluation systems that would provide the New Zealand people and the health sector with greater value for money invested in health. The NHC Executive is the secretariat that supports the Committee. The NHC Executive s primary objective is to provide the Committee with sufficient information for it to make decisions regarding prioritisation and reprioritisation of interventions and services. They do this through a range of evidence-based products chosen according to the nature of the decision required and timeframe within which decisions need to be made. The New Zealand Government has asked that all new diagnostic and treatment (non-pharmaceutical) services, and significant expansions of existing services, are to be referred to the NHC. In August 2011 the NHC was appointed with new Terms of Reference and a mandate to establish the capacity to assess new and existing health technologies. Its objectives (under Section 4.2 of its Terms of Reference include contributing to improved value for money and fiscal sustainability in the health and disability sector by: providing timely advice and recommendations about relative cost-effectiveness based on the best available evidence; providing advice and recommendations which influence the behaviour of decision makers including clinicians and other health professionals; providing advice and recommendations which are reflected in resource allocation at national, regional and local levels; and contributing to tangible reductions in the use of ineffective interventions and improved targeting to those most likely to benefit. In order to achieve its objectives under Section 4.2 and to achieve Value for Money, the NHC has adopted a framework of four assessment domains Clinical Safety & Effectiveness; Economic; Societal & Ethical; and Feasibility of Adoption in order that assessments cover the range of potential considerations and that the recommendations made are reasonable. It is intended that the research questions asked will fall across these domains to ensure that when the Committee comes to apply its decision-making criteria, it has a balanced range of information available to it. When the NHC is setting those questions they will have the decision-making criteria in mind. The 11 decision-making criteria will assist in the determination of the NHC work programme and in the appraisal and prioritisation of assessments.

3 Supplement to Recommendation Update The National Health Committee s recommendations on EGFR mutation testing 1 were provided to the sector as a guide while further research on the prevalence of the EGFR mutation was completed, and the utility of existing assay to test for the mutation were assessed. In this supplement the recommendations are updated with the results obtained from the Health Innovation Partnership (HIP) research project (recommendation 16), presented to the Committee in February The rest of the report remains current. The evidence included in Section 3 of the EGFR Testing in New Zealand: Final Recommendations is included in this update (Table 1). Table 1: Updated EGFR testing recommendations EGFR Testing in New Zealand Rec 1: EGFR mutation testing should be provided by New Zealand laboratories in more than one centre. Eligibility for EGFR Mutation Testing Rec 2: EGFR mutation testing should be offered to patients with non-small cell lung cancer (NSCLC), with all histological diagnoses except confidently-diagnosed squamous cell carcinoma. EGFR Testing Pathway Rec 3: Rec 4: Rec 5: Rec 6: Eligible patients should have only a single EGFR mutation test during the course of their illness. Ideally, this should be undertaken on the first diagnostic biopsy, and should only be performed on the resection specimen if no previous EGFR mutation test has been undertaken. EGFR mutation testing should form part of the standard Pathology reporting process for eligible patients (who have not previously had an EGFR test). Current evidence does not support repeat biopsy or EGFR mutation testing at the time of relapse in patients who are able to or have had an EGFR test performed on their primary tumour. Accurate clinical information including disease stage, prior biopsy procedures and individual patient history (particularly in relapsed disease) should be included with any lung cancer pathology request to avoid test duplication. Sample Acquisition and Quality Rec 7: Rec 8: Rec 9: The largest amount of tissue, at the least risk to the patient, should be obtained at initial diagnosis. Endobronchial ultrasound (EBUS) guided biopsy is preferred to blind transbronchial needle aspiration (TBNA), and transthoracic core biopsy is preferred to fine needle aspirate (FNA) for sample acquisition wherever available and safe. Where biopsy material is inadequate for EGFR mutation testing this should be fed back to the diagnostic clinician, and the primary treating clinician should consider re-biopsy on a case-bycase basis. Pathology Processes for Testing Rec 10: A testing approach used must identify at least 90% of mutations known to predict for response to EGFR tyrosine kinase inhibitors (TKIs), and should be able to identify mutations

4 when tumour cells comprise 10% of the sample (analytical sensitivity). Rec 11: Rec 12: Rec 13: Rec 14: Laboratories undertaking histopathological diagnosis (but not EGFR testing) should characterise samples as eligible, before sending them to the appropriate molecular testing laboratory. Any laboratory undertaking EGFR mutation testing must have molecular diagnostics accreditation from an appropriate laboratory accreditation organisation, and participate in an EGFR mutation testing quality assurance program. The turnaround time for the mutation test should be five working days from the arrival of the sample in the molecular diagnostics laboratory. The histopathological diagnostic report should not be delayed to await the EGFR test result, which can be issued as supplementary. Registering EGFR Mutations Rec 15: EGFR mutation status and the specific mutation identified should be recorded in the New Zealand Cancer Registry. EGFR mutation rate in New Zealand NSCLC patients Rec 16: The overall mutation rate of New Zealand NSCLC patients, in the studied population, was 19.9% with higher prevalence in South East Asian and Pacific patients (39.6% and 24.4% respectively) and lower prevalence in NZ European patients and NZ Maori patients (17.6% and 10.2%. respectively) 2. It should be noted that the prevalence of EGFR mutation in the studied population is more likely an over representation than an under representation of the actual number in the whole of New Zealand population. References 1 National Health Committee Epidermal Growth Factor Receptor mutation testing for access to gefitinib in first line treatment for advanced Non-Small Cell Lung Cancer. Wellington: National Health Committee 2 The Health Research Council of New Zealand EGFR Mutation Testing. Wellington: National Health Committee.

5 National Health Committee (NHC) and Executive The National Health Committee (NHC) is an independent statutory body which provides advice to the New Zealand Minister of Health. It was reformed in 2011 to establish evaluation systems that would provide the New Zealand people and health sector with greater value for the money invested in health. The NHC Executive is the secretariat that supports the committee. The NHC Executive s primary objective is to provide the committee with sufficient information for them to make recommendations regarding prioritisation and reprioritisation of interventions. They do this through a range of evidence-based reports tailored to the nature of the decision required and timeframe within which decisions need to be made. Citation: National Health Committee Epidermal Growth Factor Receptor mutation testing: Implementation and Monitoring. Wellington: National Health Committee Disclaimer Published in May 2015 by the National Health Committee PO Box 5013, Wellington, New Zealand ISBN HP 6282 This document is available on the National Health Committee s website: The information provided in this report is intended to provide general information to clinicians, health and disability service providers and the public, and is not intended to address specific circumstances of any particular individual or entity. All reasonable measures have been taken to ensure the quality and accuracy of the information provided. If you find any information that you believe may be inaccurate, please to NHC_Info@nhc.govt.nz. The National Health Committee is an independent committee established by the Minister of Health. The information in this report is the work of the National Health Committee and does not necessarily represent the views of the Ministry of Health. The National Health Committee makes no warranty, expressed or implied, nor assumes any legal liability or responsibility for the accuracy, correctness, completeness or use of any information provided. Nothing contained in this report shall be relied on as a promise or representation by the New Zealand Government or the National Health Committee. The contents of this report should not be construed as legal or professional advice and specific advice from qualified professional people should be sought before undertaking any action following information in this report. Any reference to any specific commercial product, process, or service by trade name, trademark, manufacturer, or otherwise does not constitute an endorsement or recommendation by the New Zealand Government or the National Health Committee. October 2015