Authors' objectives: The following research questions are addressed: - What are the indications for NGS panel testing in haematology/oncology and what should be the characteristics of such panels (level of clinical utility, technical specifications, informed consent and reporting specifications, quality assurance,...) in order to implement this technology in routine clinical care, as an alternative method for the currently accepted single gene markers? - What is the added value of NGS panel tests compared with current practices; what is the cost for performing NGS panel tests? - What is the impact of the diagnostic accuracy of the companion diagnostic on the cost-effectiveness of the treatment from a healthcare payer perspective? - How are targeted therapy and companion diagnostics reimbursed in Belgium (and abroad)? - What could be options for financing this technology during a transitional period and which further data could be collected during such a period to support the clinical use?

Authors' recommendations: To RIZIV-INAMI, the Cancer Registry, WIV-ISP, BELAC, the healthcare professionals and their scientific associations: - NGS gene panels are a valuable and potentially budget neutral alternative to some of the current sequential gene tests in oncology and haemato-oncology provided the test quality is assured and the testing is centralized appropriately. - As the sensitivity and especially the specificity of the companion diagnostics (NGS or other technique) in routine care have a major impact on the incremental cost-effectiveness ratio of the targeted treatment, companion diagnostics should be co-evaluated during reimbursement decisions of targeted therapy. The demonstrated clinical sensitivity and specificity of the approved companion diagnostic should be identical or highly similar to the one used in the trials demonstrating the efficacy of the drug. - Targeted drugs should only be reimbursed if the companion diagnostic was approved for this purpose and performed in a laboratory that passed the yearly EQA for this test, organized by WIV-ISP. - Further standardisation of the ISO 15 189 accreditation process by BELAC in this field is recommended using test specific guidance documents (including bioinformatics) and should be fully integrated with the external quality assessment organized by WIV-ISP. A training of the technical auditors is recommended. - The involved commissions at RIZIV-INAMI should be advised by a independent multidisciplinary committee of experts (preferentially embedded in an international consortium) to define for billable immunohistochemistry or molecular tests: o the actionability (including thresholds of variant allelic fractions), o the level of evidence, including the evidence supporting ‘off-label’ (but on-target) use of targeted drugs o the specifications for test equivalence, o the need for pre-test counseling, o the test turnaround time o the adequate reporting format. - For reimbursement decisions, evaluations of effectiveness and cost-effectiveness remain essential. For the billable markers the amount reimbursed could be based on the level of test complexity, but also more global financing systems should be explored. These should include the diagnostic testing as well as the selection of a targeted therapy and the registration of the relevant results. - The results of these markers (specific immunohistochemistry and molecular tests) should automatically be made available to the cancer registry in a standard format, in collaboration with the Healthdata.be initiative. Registration of the test result at the cancer registry should be a condition for reimbursement of the test. - Education in molecular diagnostics (including NGS) of the healthcare professionals is highly recommended during the residency training as well as in a continuous and documented manner during the full professional career.

Project Status: Completed

Year Published: 2015

URL for published report: https://doi.org/10.57598/R240C

URL for additional information: http://kce.fgov.be/publication/report/cervical-cancer-screening-program-and-human-papillomavirus-hpv-testing-part-ii-up

English language abstract: An English language summary is available

Publication Type: Rapid Review

Country: Belgium

DOI: 10.57598/R240C

Organisation Name: Belgian Health Care Knowledge Centre

Contact Address: Administrative Centre Botanique, Doorbuilding (10th floor), Boulevard du Jardin Botanique 55, B-1000 Brussels, Belgium tel: +32 2 287 33 88 fax: +32 2 287 33 85

Contact Name: info@kce.fgov.be

Contact Email: info@kce.fgov.be

Copyright: <p>Belgian Health Care Knowledge Centre (KCE)</p>