European Med Tech and IVD Reimbursement Consulting Ltd. used its in-house expertise to identify and provide an overview of the innovative payment schemes for medical devices and in-vitro diagnostic tests in European countries. The availability of innovative payment schemes was studied in Austria, Belgium, Denmark, England, Finland, France, Germany, Italy, the Netherlands, Norway, Spain, Sweden and Switzerland.

Two types of schemes were considered: coverage with evidence development (funding with requirement to perform a clinical study to bridge the evidence gaps) and innovation funding (funding with no requirements to perform a study).

Out of 13 studied countries, 7 countries (Austria, Belgium, England, France, Germany, the Netherlands and Switzerland; 54%) had innovative payment schemes in place. On average, there were 2 innovative payment schemes per country. The largest number was available in France (n=4) and England (n=3); Austria, Belgium and Switzerland each had one program in place.

In total, 14 schemes were identified:

• Austria: Provisional procedure codes for new diagnostic or therapeutic methods (NUB);

• Belgium: Restricted Clinical Application for invasive medical devices and implants (Application Clinique Limité);

• England: Innovation Technology Payment (ITP), Innovation and Technology Tariff, and Commissioning through Evaluation;

• France: Hospital Program of Clinical Research (PHRC), Health Economic Research Program (PRME), Innovation Package (forfait innovation) and List of biological and anatomocytopathology innovative acts outside the nomenclature (RIHN);

• Germany: New diagnostic or therapeutic methods (Neue Untersuchungs- und Behandlungsmethoden, NUB) and Government-co-sponsored studies according to the §137e of the German Social Code Book V;

• Netherlands: Conditional funding of medical technologies within Basic Health Insurance (Voorwaardelijke toelating tot het basispakket) and small-scale experiments for the introduction of innovations (Innovatie voor kleinschalige experimenten);

• Switzerland: Provisional reimbursement of medical procedures (Leistungen in Evaluation).

Most of the schemes (n=11, 79%) are focused on coverage with evidence development. Three schemes (21%) are innovative funding programs with no requirements to generate evidence during the coverage period.

All but one program are focused primarily on medical technologies. One program (RIHN) is focused exclusively on in-vitro diagnostic tests.

Critical review of every innovative payment program is provided in the report