The value of diagnostics to combat antimicrobial resistance by optimising antibiotic use

The main objective of this action is to understand, demonstrate, and quantify the value of diagnostics and the obstacles to their adoption and use in the framework of a Standardised Care Network in order to combat antimicrobial resistance (AMR) by optimising antibiotic use in Europe.

The overuse of antibiotics and the underuse of diagnostics occur within the entire breadth of healthcare. It is a major issue especially in the ‘community’ setting (e.g. non-hospital clinics, private physician offices, para-medical clinics) where the majority of human antibiotics are used, most of which are inappropriately and unnecessarily prescribed. It is crucial to demonstrate both the economic and clinical value of diagnostics to health systems and purchasers.

Health economic models for the use of diagnostics must be developed to:

• address the costs and benefits of the use of diagnostics and their impact on antibiotic prescribing;
• propose funding models (e.g. research incentives, reimbursement framework, adoption motivation) which would facilitate the development, introduction, deployment and use of diagnostics into routine medical care.

A global roadmap must be defined to promote the use and development of diagnostic tools that would have distinct and clearly defined objectives: (i) avoiding unnecessary antibiotic use; (ii) optimising patient treatment and antibiotic use; (iii) identifying high-risk patients and/or pathogens for targeted and personalised antibiotic therapy; (iv) using diagnostics in clinical trials for supporting the development of new anti-infective approaches (prophylactic or therapeutic); (v) boosting innovation for new diagnostic development.

The action aims at providing clinical evidence to demonstrate the medical value, healthcare benefit and economic viability of diagnostic tests for combatting antibiotic resistance and improving patient outcome in conditions such as community-acquired acute respiratory tract infection (CA-ARTI).

Huge amounts of antibiotics are prescribed and consumed unnecessarily in almost all healthcare systems. The misuse of antibiotics has created a huge global health crisis. Prudent use of antibiotics is urgently required in order to protect the efficacy of our currently available antibiotics. Diagnostics have the potential to provide more targeted, accurate use of antibiotics which is in the best interest of patients and the wider population. Diagnostics play a critical role in guiding treatment in infectious diseases. However, the value of diagnostics as a critical component of antimicrobial stewardship programmes is not fully established throughout Europe, with guidelines, funding and policy varying in each country. This hinders the adoption and use of currently available diagnostic tests by health professionals, as well as the development of advanced or innovative diagnostic tools. Therefore, a pan-European approach is required, to demonstrate the medical, economical and public health value of diagnostics for combating AMR.

Expected impact will be the reduction of antibiotic use and AMR resulting in improved patient care through better routine use of diagnostics. This would happen thanks to a raised awareness of health professionals and patients on the necessity to effectively replace empiric antibiotic therapy with targeted therapy when required, particularly for acute respiratory tract infections (ARTIs) with short-term health benefits for patients, short-term economic benefits for the healthcare system, and mid-term / long-term benefits on reducing antibiotic resistance.

The main expected impacts should be: (i) optimum use of diagnostic tests in CA-ARTI for achieving improved patient outcomes, reduction in the inappropriate use of antibiotics, and decrease in the incidence of key antibiotic-resistant pathogens; (ii) wide dissemination of evidence-based conclusions that will sensitise the medical and patient communities, as well as decision makers, to the clinical and economic value of diagnostics; (iii) incorporation of guidance using diagnostic tests and testing algorithms in national and international guidelines; (iv) assistance to regulatory bodies to facilitate adoption of diagnostic tests into wider routine practice; (v) assistance to health technology assessment (HTA) bodies to enable appropriate, fit-for-purpose assessment of the clinical value of diagnostics; (vi) reform of pricing policies (including reimbursement) related to diagnostic tests, according to the demonstrated or anticipated medical value and health outcomes.

New health economic models demonstrated through the project will lead to new pan-European guidelines and algorithms to facilitate the widespread introduction, deployment, adoption and reimbursement of existing and new diagnostics to guide appropriate antibiotic use and reduce unnecessary antibiotic prescribing. Economic models will illustrate to governments, third-party payers and healthcare providers the economic feasibility and benefits of utilising diagnostics to guide appropriate antibiotic prescribing in various healthcare settings.