Identifying the steps required to effectively implement next-generation sequencing in oncology at a national level in Europe

Horgan, Denis (author), Čufer, Tanja (author)

Next-generation sequencing (NGS) may enable more focused and highly personalized cancer treatment, with the National Comprehensive Cancer Network and European Society for Medical Oncology guidelines now recommending NGS for daily clinical practice for several tumor types. However, NGS implementation, and therefore patient access, varies across Europe; a multi-stakeholder collaboration is needed to establish the conditions required to improve this discrepancy. In that regard, we set up European Alliance for Personalised Medicine (EAPM)-led expert panels during the first half of 2021, including key stakeholders from across 10 European countries covering medical, economic, patient, industry, and governmental expertise. We describe the outcomes of these panels in order to define and explore the necessary conditions for NGS implementation into routine clinical care to enable patient access, identify specific challenges in achieving them, and make short- and long-term recommendations. The main challenges identified relate to the demand for NGS tests (governance, clinical standardization, and awareness and education) and supply of tests (equitable reimbursement, infrastructure for conducting and validating tests, and testing access driven by evidence generation). Recommendations made to resolve each of these challenges should aid multi-stakeholder collaboration between national and European initiatives, to complement, support, and mutually reinforce efforts to improve patient care.

• Language: English
• Keywords: clinical standardization, equitable reimbursement, European Alliance for Personalised Medicine, Europe’s Beating Cancer Plan, evidence generation, governance, molecularly guided treatment options, next-generation sequencing, stakeholder awareness and education, testing infrastructure
• Work type: Article
• Typology: 1.01 - Original Scientific Article
• Organization: MF - Faculty of Medicine
• Publication status: Published
• Publication version: Version of Record
• Year: 2022
• Number of pages: 27 str.
• Numbering: Vol. 12, iss. 1, art. 72
• PID: 20.500.12556/RUL-137400
• ISSN on article: 2075-4426
• DOI: 10.3390/jpm12010072
• COBISS.SI-ID: 140518403
• Publication date in RUL: 16.06.2022

Record is a part of a journal

• Title: Journal of personalized medicine
• Shortened title: J. pers. med.
• Publisher: MDPI
• ISSN: 2075-4426
• COBISS.SI-ID: 31207641

Licences

• License: CC BY 4.0, Creative Commons Attribution 4.0 International
• Link: http://creativecommons.org/licenses/by/4.0/
• Description: This is the standard Creative Commons license that gives others maximum freedom to do what they want with the work as long as they credit the author.

Secondary language

• Language: Slovenian
• Keywords: klinična standardizacija, pravično povračilo, Evropska zveza za personalizirano medicino, Evropski načrt za premagovanje raka, pridobivanje dokazov, upravljanje, molekularno vodene možnosti zdravljenja, sekvenciranje naslednje generacije, ozaveščanje in izobraževanje deležnikov, testiranje infrastrukture