Regulatory and clinical perspective on patient access to antidiabetic medicines in Slovenia

Abstract

Introduction/Objective Three novel classes of antidiabetic medicines have been introduced into the market in the last decade, namely dipeptidyl peptidase-4 inhibitors, glucagon-like peptide-1 receptor agonists, and sodium-glucose co-transporter 2 inhibitors. Many factors influence patient access to these medicines and their utilization in clinical practice: these need to be explored. The aim of the study was to gain an insight into patient access to antidiabetic medicines in Slovenia from a regulatory and clinical point of view.

Methods A focus group with five Slovenian experts (representatives of regulatory bodies and prescribers of antidiabetic medicines) was performed in January 2019. The discussion was audiotaped upon obtaining written consent from the experts and transformed into a verbatim transcript. Two researchers independently analyzed the content of the discussion, using NVivo 11 to identify main themes and subthemes.

Results Slovenia provides satisfactory patient access to antidiabetic medicines; however, prescribing restrictions and unequal access to diabetologists in the Slovenian regions may limit patient access to novel antidiabetic medicines. Prescribing restrictions should be aligned with the new evidence on cardiovascular benefit of some antidiabetic medicines. A national registry of patients with diabetes should be established in order to obtain reliable data on patient outcomes and improve the quality of patient care.

Conclusion Patient access to antidiabetic medicines could be significantly improved not only in Slovenia but also in other countries by changing prescribing restrictions, establishing national registries of patients with diabetes, and involving multidisciplinary teams in diabetes care.

Keywords: diabetes mellitus; antidiabetic medicines; patient access; focus groups; diabetes care