Expert Elicitation Used for Early Technology Assessment to Inform on Cost-Effectiveness of Next Generation Sequencing.

PCN215 Next GeNeratioN SequeNCiNG teChNoloGy: health teChNoloGy aSSeSSmeNt, market aCCeSS treNdS aNd PoteNtial imPaCtS oN the Future oF ComPaNioN diaGNoStiC teStiNG Faulkner E.C.1, Spinner D.S.2, Ransom J.F.3, Paul A.4, Chawla A.S.5, Doyle J.J.6, Shaw W.H.2, Fitzgerald J.T.2 1Institute for Pharmacogenomics and Individualized Therapy, Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, NC, USA, 2Quintiles, Durham, NC, USA, 3Quintiles Global Consulting, Hawthorne, NY, USA, 4Quintiles Global Consulting, Durham, NC, USA, 5Quintiles Consulting, Durham, NC, USA, 6Quintiles, Hawthorne, NY, USA Objectives: Next Generation Sequencing (NGS) offers a potentially powerful platform for extremely sensitive, high-throughput, multiplex, quantitative detection of nucleic acid biomarkers. While NGS currently represents a small portion of global clinical molecular diagnostic testing, new funding and reimbursement initiatives promise to accelerate its clinical utilization. Given increasing numbers of predictive/ prognostic biomarkers but limited tissue and need for less invasive sample acuisition, NGS has the potential to transform personalized medicine (PM) and companion diagnostics. The current study characterized global NGS availability and reimbursement trends. Health technology assessments (HTAs) for NGS and other relevant multiplex/ gene panel tests were also studied for evolving evidence requirements. MethOds: Key health care provision, HTA agency, and payer websites in the EU, US, Australia and Canada were reviewed to identify NGS funding and reimbursement initiatives, and relevant HTAs. In addition, a limited number of stakeholder interviews were conducted to help further characterize the evolving global NGS landscape. Results: A number of NGS funding and reimbursement initiatives were identified, especially France, Germany, UK, US and Australia. Initiatives have been mainly centered on funding of pilot clinical utility demonstrations through research and clinical use. In Germany and US, specific initiatives are underway to develop specific NGS reimbursement codes and payment rates. A number of HTAs for NGS and other multiplex/ gene panel test platforms were identified, primarily for oncology, cardiovascular, infectious disease, inherited disease, and neuropsychiatry applications. Key HTA concerns include test clinical utility, cost-effectiveness, realworld reproducibility and equity of access given potential cost. cOnclusiOns: Payers and providers increasingly recognize NGS as enabling expanded adoption of PM approaches. As PM expands with increasing numbers of clinically actionable biomarkers, ensuring that test evidence development is aligned with expectations, and expectations with reality are key steps. Further, developing reimbursement/ funding mechanisms to support testing uptake will be critical in all markets.