Antimicrobial resistance (AMR) is a global public health threat which is the cause of numerous deaths and medical complications. One major driver for AMR is the inappropriate use of antibiotics, such as in the treatment of community-acquired acute respiratory tract infections (CA-ARTI). Several measures, including AMR stewardship programs and incentives for research of novel antibiotics, have been discussed and implemented to address AMR. One important tool to tackle AMR is diagnostic testing, e.g., rapid point-of-care tests (POCT) applied in primary health care, such as in the practices of general practitioners, to identify if the infection is caused by a virus or a bacteria, and consequently to determine whether or not prescribing of an antibiotic is justified and needed. The European VALUE-Dx project under the “Innovative Medicines Initiative” (IMI) framework, aims to foster the use of diagnostic tests to improve the quality of antibiotic prescribing. Its Work Package 5 (Economic Value, Policies and Innovative Funding Models) is aimed to demonstrate the value of diagnostic tests which support doctors in their prescribing decisions related to antibiotics. Previous research and practice have identified a potential to encourage uptake of CA-ARTI POCT (pointof-care tests in community-acquired acute respiratory tract infections) and suggested possible barriers related to existing pricing and funding policies applied for these diagnostics (e.g., high prices of POCT compared to antibiotics). However, little evidence was available as to which policies in the so-called perilaunch phase (i.e., between the CE mark certification and placing the diagnostic on the market) have been implemented for POCT in European countries, and what their possible implications might be. In the VALUE-Dx project, the authors shed light into this under-researched area and explore how perilaunch policies can contribute to appropriate use of CA-ARTI POCT with a view to optimising antibiotic prescribing and thus reducing AMR. This document presents recommendations for policy action related to HTA, pricing and procurement, and funding, to facilitate the outpatient use of CA-ARTI POCT. The development of the recommendations was based on previous work, including a literature search and a mapping exercise of existing HTA, pricing and reimbursement policies applied for medical devices in general and for diagnostic tests in the outpatient sector in 17 European countries (cross-country comparative findings are presented in a separate VALUE-Dx technical report and a scientific article). In
addition, expert interviews were conducted to identify factors with facilitating or hindering impact with regard to the uptake of diagnostics. The barriers and facilitators were analysed in the context of the health system and country setting and formed the basis for the development of fit for purpose policy recommendations with the potential to improve CA-ARTI POCT uptake. In addition to the involvement of experts from national public authorities when collecting the evidence base for the development of the recommendations, a broad review process was carried out to consider the perspectives of relevant stakeholders (e.g., policy-makers, which are the target group of the recommendations, or CA-ARTI POCT suppliers), including their assessment of feasibility of the measures. The review process included expert meetings to present and discuss the recommendations. A total of fifteen recommendations targeted at policy-makers are proposed; ten of them have been
clustered in the policy areas of HTA, pricing and procurement, and funding. Five additional recommendations refer to overarching aspects that are conducive to the successful implementation of peri-launch policies.