Assessing, Pricing and Funding Point-of-Care Diagnostic Tests for Community-Acquired Acute Respiratory Tract Infections-Overview of Policies Applied in 17 European Countries

Abstract

Point-of-care diagnostic tests for community-acquired acute respiratory tract infections (CA-ARTI) can support doctors by improving antibiotic prescribing. However, little is known about health technology assessment (HTA), pricing and funding policies for CA-ARTI diagnostics. Thus, this study investigated these policies for this group of devices applied in the outpatient setting in Europe. Experts from competent authority responded to a questionnaire in Q4/2020. Information is available for 17 countries. Studied countries do not base their pricing and funding decision for CA-ARTI diagnostics on an HTA. While a few countries impose price regulation for some publicly funded medical devices, the prices of CA-ARTI diagnostics are not directly regulated in any of the surveyed countries. Indirect price regulation through public procurement is applied in some countries. Reimbursement lists of medical devices eligible for public funding exist in several European countries, and in some countries these lists include CA-ARTI diagnostics. In a few countries, the public payer funds the health professional for performing the service of conducting the test. Given low levels of regulation and few incentives, the study findings suggest room for strengthening pricing and funding policies of CA-ARTI diagnostics to contribute to increased acceptance and use of these point-of-care tests.

Keywords: antibiotic; antimicrobial drug resistance; diagnostic equipment; health technology assessment; policy; pricing; reimbursement mechanisms; remuneration; respiratory tract infection.

Figure 1

Framework for studied pricing and funding policies. Source: Authors. CE: Conformité Européenne/European Conformity; Dx: diagnostic(s).

Figure 2

Study countries. MD: medical device(s); PPRI MD: Pharmaceutical Pricing and Reimbursement Information Subgroup on Medical Devices.

Figure 3

VAT rates for CA-ARTI diagnostics. CA-ARTI: community-acquired acute respiratory tract infections; Dx: diagnostic(s); MD: medical device(s); incl.: inclusive; VAT: value-added tax.