OBJECTIVES:

Understanding country-specific reimbursement processes and the evidence requirements of payers and stakeholders is essential for the success of new medical devices in the European market. In this study, we analysed and evaluated the device reimbursement systems in three key markets: England, France, and Germany.

METHODS:

A comprehensive literature review was conducted to identify processes for the assessment of medical devices, clinical and economic evidence requirements, and implications for patient access in the three countries of interest.

RESULTS:

HTA agencies in England (National Institute for Health and Care Excellence [NICE]), France (Haute Autorité de Santé [HAS]) and Germany (Gemeinsame Bundesausschuss [G-BA]) are responsible for assessing medical devices, with different reimbursement pathways depending on the alignment of the device with existing diagnosis-related group (DRG) codes, and the intended patient setting.

Across all three countries, HTA agencies require a presentation of robust clinical evidence, demonstrating the benefit of the medical device or associated usage procedure versus a comparator, to support a recommendation for reimbursement. In France, the cost-effectiveness of the product should be modelled to guide the pricing negotiations, whilst a cost-minimisation approach is used in England. Patient accessibility is affected by whether the device is for inpatient or outpatient use, the reimbursement pathway followed, and the duration of the HTA process. The process can be as rapid as 3-6 months in Germany, while stricter timelines of 180 days and 38 weeks are specified in France and England, respectively.

CONCLUSIONS:

HTA processes for the assessment of medical devices across the three European markets differ in their transparency, complexity and duration. Pre-submission market access planning by manufacturers should take into account these country-specific intricacies and requirements.