Abstract

IntroductionNext-generation sequencing (NGS) can be run in-house or outsourced to an independent laboratory. It has enabled wider use of deoxyribonucleic acid/ribonucleic acid (DNA + RNA) sequencing in clinical practice. Within oncology, NGS has paved the way for more effective treatment, including personalized medicine. There are, however, large variations in access and reimbursement across Europe. The aim is to understand the European NGS landscape and barriers to access.MethodsStructured telephone interviews covered topics on NGS perception, guidelines, use-cases, benefits, costs, and future expectations. Twelve experts per country (France, Germany, Italy, Spain): two payers, five oncologists, and five pathologists were interviewed between June and August 2021. Responses were translated into English for qualitative analysis.ResultsNGS was considered most useful when there were approved, targeted treatments. Although often noted that there was a lack of published evidence to support a beneficial link, respondents perceived that NGS has the potential to improve patient quality of life (QoL) and reduce resource use through avoiding suboptimal treatment. All of the payer respondents expected the role of NGS to increase, though it may be held back by lack of reimbursement. Respondents favored in-house NGS over outsourcing in terms of clinical benefit: “Advantages of in-house NGS are turnaround time, results and lean processes” … “you build the expertise in-house. If you have urgent samples, it’s easy to prioritize them”. Reasons for not having in-house NGS included “costs, lack of personnel. Basically, organizational and financial issues.” In-house NGS was perceived to be associated with high setup-costs (acquisition, setup, training), but lower running costs (per-test costs). There was a view that in-house solutions are mainly suitable in larger centers undertaking many tests.ConclusionsNGS can save costs and provide QoL benefit through enabling optimized, personalized therapy, but published evidence establishing the outcomes link is lacking. From the hospital perspective, investing in NGS requires understanding the cost of NGS over its entire lifecycle, likely entailing a health-technology assessment including health-economic analysis.

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