OBJECTIVES: Next-generation sequencing (NGS) is a massively parallel sequencing technology that can provide results for multiple genomes with high accuracy and sensitivity using relatively minimal tissue. Broad testing ensures that a wider range of genomic alterations are identified facilitating patient selection for precision medicines (PM). Currently in the USA reimbursement of NGS is widespread, however there are challenges associated with EU reimbursement. This research was completed to identify current and evolving public funding considerations for NGS in France, Germany, Italy, Spain, and UK.

METHODS: A web-based survey was administered through Rapid Payer Response™ online portal (RPR®) to 15 payers with experience in reimbursement decision-making for oncology diagnostics (3 payers per market). Responses were collected through RPR® in 5 days and analysed via Microsoft™ Excel.

RESULTS: In some markets, there is a lack of a clear framework for NGS testing reimbursement. There is large variation in NGS access and uptake due to the different reimbursement pathways in France i.e. hotspots vs large panels. In Spain and Italy, there is a significant variation in access to NGS across regions because of the different coverage guidelines and referral pathways. In many cases, PM manufacturer sponsorship may also be required. However in Germany and the UK, the centralized systems permit infrastructure investment and these markets demonstrate greater uptake of NGS. As the number of targetable mutations increase, access pathways are expected to evolve to enable broader reimbursement and uptake of NGS testing in all markets.

CONCLUSIONS: For manufacturers, the key challenge is to ensure that once EMA approves a PM, its reimbursement is followed by the timely reimbursement of the related NGS test. They must learn how to navigate through the existing complex frameworks for public coverage of NGS tests relating to their EMA approved PMs and anticipate future policy changes.