Access to Coverage With Evidence Development Schemes for Medical Devices and Procedures in England, France, Germany, Spain, and the USA

OBJECTIVES: Coverage with evidence development (CED) schemes are used to support the collection of data to reduce uncertainty in the clinical or cost effectiveness of a medical device (MD) or medical procedure (MP) and inform future decisions about coverage or intended use. The objective of this research is to provide an overview of access to CED schemes for MDs and MPs in Europe and the USA.

METHODS: A targeted review of national payer and health technology assessment (HTA) agency websites was conducted to identify CED schemes and eligibility criteria for the enrolment of MDs or MPs. Each website was evaluated for the number of MDs/MPs that enrolled in CED schemes in 2023. The scope was England (National Institute for Health and Care Excellence [NICE]), France (Haute Autorité de Santé [HAS]), Germany (Gemeinsamer Bundesausschuss [G-BA]), Spain (Red Española de Agencias de Evaluación de Tecnologías Sanitarias [RedETS]), and the USA (Centers for Medicare & Medicaid Services [CMS]).

RESULTS: Most agencies have developed CED schemes for MDs/MPs, including NICE, Early Value Assessment (EVA), HAS, Innovation Funding, G-BA, Testing Study, and RedETS, Monitoring Study. CMS has proposed but not implemented Transitional Coverage for Emerging Technologies (TCET). In 2023, the number of MDs/MPs enrolled in CEDs was identified for EVA (8), Innovation Funding (2), Testing Study (2), and Monitoring Study (0). Eligible interventions were selected based on early data indicative of clinical, organizational, or cost benefits. If TCET is implemented, CMS plan to enroll five Food and Drug Administration (FDA) designated breakthrough devices per annum.

CONCLUSIONS: CED schemes present an opportunity for MD/MP manufacturers with insufficient data or an inability to manage large-scale clinical trials the possibility to launch, while working towards future coverage; however, access to CED schemes proved challenging, with very few MDs/MPs enrolled in CED schemes in 2023.