Coverage with evidence development (CED)

On November 29, 2024, the Ministry of Health and Access to Care published an Order outlining the requirements for application files to request coverage of innovative biology or pathology procedures within the new RIHN 2.0 framework. The Order concerns the application file model and list of supporting documents for coverage requests

On December 2, 2024, the Swiss Federal Office of Public Health published the changes that will occur to the Healthcare Benefit Ordinance (KLV/OPre), which determines coverage of medical services in Switzerland. The updates will enter into force on January 1, 2025, and they relate to the list of explicitly evaluated services (Annex 1 of KLV/OPre), outpatient-before-hospital services (Annex 1a), List of Tools and Equipment (Annex 2), and the List of Analyses (Annex 3).

At the beginning of October 2024, the Ministry of Labor, Health, and Solidarity published the amounts awarded for the Health Economic Research Program (PRME) projects submitted in 2023 and selected for funding.

In July 2023, the National Institute for Health and Disability Insurance (INAMI-RIZIV) significantly updated the process to obtain reimbursement for health apps. More stakeholders, including the industry, can now submit an application to INAMI-RIZIV for temporary or permanent reimbursement. The new process will come into force on October 1, 2023.

On March 8, 2023, the Ministry of Health and Prevention published an Order in the Official Journal of the French Republic on the coverage of the INTERVAPOR system for lung volume reduction under Forfait innovation program.

Rehabilitation before or after a primary knee or hip replacement using a health app is temporarily reimbursed in Belgium under a specific agreement with the National Institute for Health and Disability Insurance (INAMI-RIZIV). Reimbursement was limited to patients participating in the clinical study. From October 01, 2022, all patients eligible for rehabilitation before and after a primary knee or hip replacement will receive it using a health app in combination with a certain minimum number of classic face-to-face physiotherapy sessions. Certain health apps must be included in the list of reimbursable mobile applications. For now, only one app (MoveUP Coach) is included.

On June 22, 2022, the list of awarded PHRC and PRME projects, submitted in 2021, was published on the website of the French Ministry of Health and Prevention.

On June 22, 2022, the French Ministry of Health and Prevention published the instruction related to the 2022 application for coverage with evidence development programs. In the instruction, the specific fields of research, the application procedures, and the deadlines for applications for different types of projects (PHRC, PRME, PREPS, PHRIP, PRT) are specified.

On July 29, 2021, the French Ministry of Solidarity and Health published the instruction related to the 2021 application for coverage with evidence development programs. In the instruction, the specific fields of research, the application procedures, and the deadlines for applications for different types of projects (PHRC, PRME, PREPS, PRT) are specified.

On June 24, 2021, the list of awarded PHRC and PRME projects, submitted in 2020, was published. A total of 137 PHRC and nine PRME projects were awarded, and they concern various technology groups, such as gynecology, nephrology, neurology, cardiovascular, etc.

On July 1, 2021, the updated version of the Swiss Services Ordinance (KLV/OPre) came into force. The changes concern the List of explicitly evaluated services (Annex 1 of KLV/OPre), the List of medical aids (Annex 2 of KLV/OPre), and the List of Analyses (Annex 3 of KLV/OPre).