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Shedding Light on Reimbursement Policies of Companion Diagnostics in European Countries
Govaerts, Laurenz Simoens, Steven Van Dyck, Walter Huys, Isabelle
Govaerts, Laurenz
Simoens, Steven
Van Dyck, Walter
Huys, Isabelle
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Publication Type
Journal article with impact factor
Editor
Supervisor
Publication Year
2020-05
Journal
Value in Health
Book
Publication Volume
23
Publication Issue
5
Publication Begin page
606
Publication End page
615
Publication Number of pages
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Abstract
OBJECTIVES: Ensuring access to precision medicine has been an issue because in some European countries, desynchronized reimbursement decision-making occurs between the medicine and the companion diagnostic (CDx). This has resulted in cases in which precision medicine is reimbursed but not the CDx. In overcoming this issue, an alignment of the decision-making process for reimbursement between the 2 entities should be considered. As pharmaceutical reimbursement procedures are meticulously covered in the literature, we set out to systematically map in vitro diagnostic (IVD) reimbursement procedures and identify policies for aligning these procedures with the pharmaceutical reimbursement procedures.
METHODS: We selected 8 European countries for this analysis. For each country, we characterized the national benefit basket entailing the IVD medical acts in outpatient care, evaluated the procedure for inclusion, and identified alternative reimbursement practices for CDx. Targeted searches, using publicly accessible sources, were conducted to identify relevant reimbursement policies and laws.
RESULTS: We systematically describe the reimbursement process in 8 European countries. Alternative procedures for CDx reimbursement were identified in Belgium and Germany. Alternative policies attributed to the practice of precision medicine were identified in England and Italy. In France, some CDx are included in the "coverage with evidence" development program. Specifically, the health technology assessment agencies of France and England commented on the assessment of companion diagnostics and their clinical utility.
CONCLUSION: CDx reimbursement procedures have recently been implemented in some countries. This was seemingly done primarily to ensure access to the precision medicine and only secondary to the value they would provide.
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Keywords
3801 Applied Economics, 38 Economics, 4203 Health Services and Systems, 42 Health Sciences, 44 Human Society, 4407 Policy and Administration, Precision Medicine, 3 Good Health and Well Being, England, Europe, Health Policy, Humans, Insurance, Health, Reimbursement, Precision Medicine, State Medicine, Technology Assessment, Biomedical