Inequity in access to bDMARD care and how it influences disease outcomes across countries worldwide: results from the METEOR-registry

Abstract

<jats:sec><jats:title>Objective</jats:title><jats:p>To establish in a global setting the relationships between countries’ socioeconomic status (SES), measured biological disease modifying antirheumatic drug (bDMARD)-usage and disease outcomes. To assess if prescription and reimbursement rules and generic access to medication relates to a countries’ bDMARD-usage.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>Data on disease activity and drug use from countries that had contributed at least 100 patients were extracted from the METEOR database. Mean disease outcomes of all available patients at the final visit were calculated on a per-country basis. A questionnaire was sent to at least two rheumatologists per country inquiring about DMARD-prices, access to treatment and valid regulations for prescription and reimbursement.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Data from 20 379 patients living in 12 different countries showed that countries’ SES was positively associated with measured disease activity (meanDAS28), but not always with physical functioning (HAQ-score). A lower country’s SES, stricter rules for prescription and reimbursement of bDMARDs as well as worse affordability of bDMARDs were associated with lower bDMARD-usage. bDMARD-usage was negatively associated with disease activity (although not with physical functioning), but the association was moderate at best.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>Disease activity in patients with rheumatoid arthritis as well as bDMARD-usage varies across countries worldwide. The (negative) relationship between countries’ bDMARD-usage and level of disease activity is complex and under the influence of many factors, including—but not limited to—countries’ SES, affordability of bDMARDs and valid prescription and reimbursement rules for bDMARDs.</jats:p></jats:sec>

EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update

“…So when making therapeutic decisions, drugs that are less costly must be preferred over more costly ones, as long as they are similarly efficacious and safe and in line with the therapeutic paradigms 20. As mentioned in the introduction, in many countries, the high costs of treatment limit the availability of modern therapies (inequity),14 the availability of biosimilars can address this and provide significant reductions of healthcare budgets, when their price is sufficiently low and their application is then reinforced by payers or politicians 16 62. The task force voted unanimously to place this item as the last overarching principle, without a change in wording.…”

“…The increasing number of effective drugs and modes of action (MOAs) has improved the likelihood of reaching the treatment target for individuals with RA, but high drug-costs still limit widespread use and thus contribute to inequity of access to best care across various regions and countries 13–15. The approval and advent of biosimilar (bs) DMARDs has introduced price competition and led to a considerable reduction of the net costs of biological (b) DMARDs,16 although this may not be true in all countries and may require further exploration.…”

The Future of Biosimilars: Maximizing Benefits Across Immune-Mediated Inflammatory Diseases

“…Current guidelines recommend access to biologics based on disease duration, disease severity, and number of insufficient responses to conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) [69][70][71][72][73][74][75][76], although differences in expert opinion may lead to divergent interpretations of the same evidence between guidelines. In addition, high costs and poor affordability often restrict patient access to biologics [77][78][79][80][81], alongside factors such as prescription controls and limitations in access to healthcare services [81]. Furthermore, national reimbursement criteria can be more restrictive than treatment guidelines, leading to disparities in patient access to biologics among countries [77,82].…”

“…In addition, high costs and poor affordability often restrict patient access to biologics [77][78][79][80][81], alongside factors such as prescription controls and limitations in access to healthcare services [81]. Furthermore, national reimbursement criteria can be more restrictive than treatment guidelines, leading to disparities in patient access to biologics among countries [77,82]. For example, a recent study in the European region (defined as 37 European countries, plus Russia and Turkey) found that only 59% of patients eligible for biologics according to EULAR guidelines (DAS28 > 3.2 and ≥ 2 csDMARD treatment failures) remained eligible following application of national reimbursement criteria [79].…”

“…Indeed, persistently moderate elevation of DAS28 has been associated with functional deterioration in some patients [83], whereas evidence confirming the efficacy of TNF inhibitors in patients with moderate disease activity (DAS28 > 3.2 to ≤ 5.1) is emerging from studies solely evaluating this population [84]. In general, low socioeconomic status of a country is linked to stricter reimbursement criteria, although UK criteria are notably more restrictive than this would suggest [77,[80][81][82]. Biosimilars present the opportunity for more cost-effective biologic treatment, which should help to address the disparities in patient access imposed by stringent national reimbursement criteria that may diverge from clinical guidelines.…”