Reimbursement Pathways for New Diabetes Technologies in Europe: Top-Down Versus Bottom-Up

Abstract

Reimbursement by payers (policy makers and budget holders) is critical for the uptake and use of new diabetes technologies. The purpose of this article is to describe the different reimbursement pathways that exist for new diabetes technologies in five selected European countries using examples of recent reimbursement decisions. Countries can be grouped into one of three categories: "top-down" (where reimbursement decisions are usually made by policy makers, eg, France), "bottom-up" (where reimbursement decisions are usually made by budget holders, eg, Italy and Spain) and "mixed" (where reimbursement decisions can be made by both policy makers and budget holders, eg, Germany and England). Whatever category a specific country falls into will have different implications from a market access perspective.

Improving patient self-care using diabetes technologies

“…There are mixed results from studies regarding cost-effectiveness depending on the setting, the healthcare structure, the endpoints and methodology used. 19,46–49 However, several studies have shown reduced incremental cost-effectiveness per quality-adjusted life year (QALY) gained at different HbA1c thresholds. Results for all HbA1c thresholds were below the willingness-to-pay threshold of US$100 per QALY for people living with diabetes.…”

“…However, very different approaches and rates of coverage have been achieved depending on the country's healthcare system structure and resources. 16,17 Large transatlantic registry comparisons have shown differences in metabolic outcomes, in spite of similar population characteristics, partly in relation to the different frequencies of use of diabetes technologies. 18 Cost-effectiveness of diabetes technologies has also shown differences depending on the type of technology, setting, healthcare system structure and the endpoints considered.…”

Use of insulin pumps and closed‐loop systems among people living with diabetes: A narrative review of clinical and cost‐effectiveness to enable access to technology and meet the needs of payers

“…They are interested in clinical and cost‐effectiveness; however, budget holders are mostly interested if new technology can help them achieve their budget targets. Most regions expect manufacturers to generate short‐term real‐world evidence for new technologies with a significant budget impact 70 …”

“…Nevertheless, in most countries, it is unlikely that a new diabetes technology will reach widespread use without being reimbursed/funded by payers. 70 As the ultimate decision makers on reimbursement, the payers/ budget holders need to make a comprehensive assessment of several factors, such as clinical efficacy, safety and effectiveness (clinical evidence), along with the direct and indirect costs and quality-of-life (QoL) improvements (economics/humanistic evidence), in order to determine the coverage and funding for a new medical technology. 71 For any new treatment to be reimbursed, these key value drivers of payers need to be properly addressed.…”

“…If this does not hold true for all these stakeholders, the technology's uptake and the use of the devices can be threatened. Nevertheless, in most countries, it is unlikely that a new diabetes technology will reach widespread use without being reimbursed/funded by payers 70 …”