Abstract
BackgroundNext Generation Sequencing (NGS) is expected to lift molecular diagnostics in clinical oncology to the next level. It enables simultaneous identification of mutations in a patient tumor, after which targeted therapy may be assigned. This approach could improve patient survival and/or assist in controlling healthcare costs by offering expensive treatment to only those likely to benefit. However, NGS has yet to make its way into the clinic. Health Technology Assessment can support the adoption and implementation of a novel technology, but at this early stage many of the required variables are still unknown.MethodsScenario drafting and expert elicitation via a questionnaire were used to identify factors that may act as a barrier or facilitate adoption of NGS-based molecular diagnostics. Attention was paid to predominantly elicit quantitative answers, allowing their use in future modelling of cost-effectiveness.ResultsAdequately informing patients and physicians, the latters’ opinion on clinical utility and underlying evidence as well as presenting sequencing results within a relevant timeframe may act as pivotal facilitators. Reimbursement for NGS-based testing and accompanying therapies (both general and in case of off-label prescription) was found to be a potential barrier. Competition on the market and demonstrating clinical utility may also be challenging. Importantly, numerous quantitative values for variables related to each of these potential barriers/facilitators, such as such as desired panel characteristics, willingness to pay or the expected number of targets identified per person, were also elicited.ConclusionsWe have identified several factors that may either pose a barrier or facilitate the adoption of NGS in the clinic. We believe acting upon these findings, for instance by organizing educational events, advocating new ways of evidence generation and steering towards the most cost-effective solution, will accelerate the route from bench-to-bedside. Moreover, due to the methodology of expert elicitation, this study provides parameters that can be incorporated in future cost-effectiveness modeling to steer the development of NGS gene panels towards the most optimal direction.Electronic supplementary materialThe online version of this article (doi:10.1186/s12885-016-2100-0) contains supplementary material, which is available to authorized users.
Highlights
Generation Sequencing (NGS) is expected to lift molecular diagnostics in clinical oncology to the level
We report on scenario drafting concerning the adoption and implementation of Next Generation Sequencing (NGS) gene panels in clinical oncology among professionals
Respondent characteristics In total, 29 questionnaires were completed by 14 physicians, biologists, three policy workers and one epidemiologist; from within and 17 from outside the Netherlands cancer institute (NKI) (Table 1)
Summary
Generation Sequencing (NGS) is expected to lift molecular diagnostics in clinical oncology to the level. It enables simultaneous identification of mutations in a patient tumor, after which targeted therapy may be assigned. This approach could improve patient survival and/or assist in controlling healthcare costs by offering expensive treatment to only those likely to benefit. We define a NGS gene panel as “a multiplex predictive test which explores limited regions of tumor DNA/RNA for aberrations that can be used as a molecular target for therapy”
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