COVERAGE-WITH-EVIDENCE-DEVELOPMENT (CED) IN GERMANY- STATUS QUO
Author(s)
Molnar S, Kreis J, Angelescu K, Sauerland S
Institute for Quality and Efficiency in Health Care (IQWiG), Cologne, Germany
Presentation Documents
BACKGROUND: For many novel medical devices (MD) and other non-drug interventions high-quality clinical studies are scarce. The German coverage-with-evidence-development (CED) regulation allows three different pathways to generate evidence on non-drug interventions. OBJECTIVES: We describe how the German CED regulation (including the new legislation on mandatory assessment of novel high-risk MD) works. Further, we summarise which topics have been selected for clinical studies until now by the Federal Joint Committee (G-BA), the highest decision-making body regarding reimbursement. METHODS: Information on regulatory framework was collated from the law and the rules of procedure at G-BA. Information on medical topics under assessment was systematically searched using the websites of G-BA and IQWiG. RESULTS: The German CED model aims at testing the effectiveness of promising interventions. IQWiG usually assesses whether an intervention is promising (i.e. has ‘potential’). Clinical trials then can be started on topics a) that have been put under scrutiny by G-BA itself, b) that a MD manufacturer has applied for, or c) that have come under scrutiny because an invasive, novel, high-cost MD is involved. So far, 10 interventions have been proposed for CED, but a directive on starting a trial has been issued only for 2. Further, 6 methods are currently being discussed by the G-BA. For 2 interventions, CED was not started due to diverse reasons. Clinical study costs have to be borne by manufacturer or G-BA, or can be split between the two. LIMITATIONS: As no clinical trial has yet been started, it remains to be seen whether the German CED approach is successful. No information on unsuccessful manufacturers’ applications is published. CONCLUSIONS: The German CED regulation offers a promising pathway to generate evidence, but the speed of the process is constrained by regulatory complexity.
Conference/Value in Health Info
2017-11, ISPOR Europe 2017, Glasgow, Scotland
Value in Health, Vol. 20, No. 9 (October 2017)
Code
PHP142
Topic
Health Policy & Regulatory
Topic Subcategory
Reimbursement & Access Policy
Disease
Multiple Diseases