Shedding Light on Reimbursement Policies of Companion Diagnostics in European Countries

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.

Keywords: companion diagnostics; in vitro diagnostics; precision medicine; reimbursement.