PMID- 29937385 OWN - NLM STAT- MEDLINE DCOM- 20190318 LR - 20190318 IS - 1938-0690 (Electronic) IS - 1525-7304 (Linking) VI - 19 IP - 5 DP - 2018 Sep TI - Ventana ALK (D5F3) in the Detection of Patients Affected by Anaplastic Lymphoma Kinase-positive Non-Small-cell Lung Cancer: Clinical and Budget Effect. PG - e735-e743 LID - S1525-7304(18)30132-3 [pii] LID - 10.1016/j.cllc.2018.05.012 [doi] AB - BACKGROUND: To ensure identification of anaplastic lymphoma kinase-positive (ALK(+)) patients, the Italian Drug Agency suggested a testing algorithm based on the use of fluorescence in situ hybridization (FISH) and/or immunohistochemistry. The aim was to evaluate the clinical and economic effects of adopting an immunohistochemical test (Ventana ALK D5F3) as an option for detecting ALK protein expression in advanced non-small cell lung cancer (NSCLC) patients. MATERIALS AND METHODS: A budget impact model was developed by adopting the Italian National Health Service (NHS) perspective and a 5-year period to compare 2 scenarios: the current use of D5F3 (28%; current scenario) and increased use of D5F3 (60%; alternative scenario). The testing cost and the number and cost of the identified ALK(+) patients were evaluated. RESULTS: A more extensive use of D5F3 in the alternative scenario showed a decrease in diagnostic costs of approximately euro468,000 compared with current scenario when considering all advanced NSCLC patients. If these savings were allocated to test more NSCLC patients (75% vs. 53%), an incremental cost per identified ALK(+) patient of euro63 would be required, leading to an overall survival gain for the alternative scenario compared with the current scenario (32.4 vs. 27.1 months; relative increase, 20%). CONCLUSION: The use of D5F3 would provide a cost savings for the NHS owing to a lower acquisition cost than FISH and a comparable detection rate. The savings could be reinvested to test a greater number of patients, leading to more efficient identification, use of targeted therapy, and improvement in clinical outcomes of ALK(+) patients. CI - Copyright (c) 2018 The Author(s). Published by Elsevier Inc. All rights reserved. FAU - Paolini, Davide AU - Paolini D AD - Roche Diagnostic SpA, Monza, Italy. Electronic address: davide.paolini@roche.com. FAU - Tiseo, Marcello AU - Tiseo M AD - University Hospital of Parma, Parma, Italy. FAU - Demma, Federica AU - Demma F AD - Health Economics and Outcome Research Department, EBMA Consulting, Milan, Italy. FAU - Furneri, Gianluca AU - Furneri G AD - Health Economics and Outcome Research Department, EBMA Consulting, Milan, Italy. FAU - Dionisi, Matteo AU - Dionisi M AD - Roche Diagnostic SpA, Monza, Italy. FAU - Akkermans, Marlene AU - Akkermans M AD - Roche Diagnostics International, Ltd, Rotkreuz, Switzerland. FAU - Marchetti, Antonio AU - Marchetti A AD - Center of Predictive Molecular Medicine, Center of Excellence on Aging University-Foundation, Chieti, Italy. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20180531 PL - United States TA - Clin Lung Cancer JT - Clinical lung cancer JID - 100893225 RN - 0 (Antibodies, Monoclonal) RN - 0 (Biomarkers, Tumor) RN - EC 2.7.10.1 (ALK protein, human) RN - EC 2.7.10.1 (Anaplastic Lymphoma Kinase) SB - IM MH - Adenocarcinoma/diagnosis/economics MH - Anaplastic Lymphoma Kinase/*analysis/genetics MH - Antibodies, Monoclonal/*immunology MH - Biomarkers, Tumor/*analysis MH - Carcinoma, Non-Small-Cell Lung/*diagnosis/*economics MH - Carcinoma, Squamous Cell/diagnosis/economics MH - Follow-Up Studies MH - Gene Rearrangement MH - Humans MH - Immunohistochemistry/*methods MH - In Situ Hybridization, Fluorescence MH - Lung Neoplasms/diagnosis/economics MH - Prognosis MH - Survival Rate OTO - NOTNLM OT - ALK OT - Budget OT - FISH OT - IHC OT - NSCLC EDAT- 2018/06/26 06:00 MHDA- 2019/03/19 06:00 CRDT- 2018/06/26 06:00 PHST- 2018/01/16 00:00 [received] PHST- 2018/05/02 00:00 [revised] PHST- 2018/05/17 00:00 [accepted] PHST- 2018/06/26 06:00 [pubmed] PHST- 2019/03/19 06:00 [medline] PHST- 2018/06/26 06:00 [entrez] AID - S1525-7304(18)30132-3 [pii] AID - 10.1016/j.cllc.2018.05.012 [doi] PST - ppublish SO - Clin Lung Cancer. 2018 Sep;19(5):e735-e743. doi: 10.1016/j.cllc.2018.05.012. Epub 2018 May 31.