Biological Therapies in Immune-Mediated Inflammatory Diseases: Can Biosimilars Reduce Access Inequities?

Abstract

Biological therapies are an effective treatment for a range of immune-mediated inflammatory diseases (IMIDs), including rheumatoid arthritis, psoriasis, and inflammatory bowel diseases. However, due to their high costs, considerable differences in their utilization exist across the world, even among the various European countries, with many countries restricting access despite professional society guideline recommendations. Adoption of biologics by healthcare providers has been particularly poor in many Central and Eastern European countries. Differences in utilization have also been observed across medical specialties, healthcare providers, and at a regional and national level. The objective of this paper is to provide an overview of the different market access policies for biologics in Europe and to investigate reasons for such differences. One of the potential solutions for providing broader access to IMID patients, where cost is the major barrier, is to encourage the use of biosimilars in place of their reference products. Biosimilars are generally less expensive alternatives to already licensed biological therapies and are approved on the basis that they are similar to the reference product in terms of quality, safety, and efficacy. Budget impact models predict considerable cost savings following the introduction of biosimilars in the next few years. These savings could be used to increase access to biologics and other innovative therapies.

Impact of Corticosteroids and Immunosuppressive Therapies on Symptomatic SARS-CoV-2 Infection in a Large Cohort of Patients with Chronic Inflammatory Arthritis

“…In addition, the iatrogenic effect generated by the use of immunomodulating drugs should also be considered [23,24]. As IMIDs are highly prevalent in Western societies (approximately 5-7%) [25], and routine use of CS, synthetic and biological disease-modifying drugs has become widespread in rheumatology, gastroenterology and dermatology [26][27][28][29][30][31], understanding the real impact of immunosuppression on COVID-19 diffusion and severity undoubtedly represents a crucial issue of inter-disciplinary relevance.…”

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].…”

“…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.…”

Prospects for Anti-B-Cell Therapy in Immuno-Inflammatory Rheumatic Diseases

“…Снижение стоимости лечения дорогостоящими ГИБП и, как следствие, увеличение доступности инновационной терапии у пациентов, живущих в странах с ограниченными экономическими ресурсами, является при- оритетной задачей здравоохранения всех стран мира. Эта проблема частично решена благодаря разработке биоаналогов (biosimilars) ГИБП, широкое применение которых в клинической практике стало возможным благодаря окончанию срока действия патентов для многих оригинальных ГИБП [335][336][337][338][339], включая РТМ [340][341][342][343] В 2001 г. в России была основана биотехнологическая компания «БИОКАД», занимающаяся производством биоаналогов и оригинальных ГИБП. В настоящее время на разных стадиях разработки находятся ряд ГИБП, предназначенных для лечения аутоиммунных заболеваний, включая РТМ [344] Хотя бы одна НЛР / серьезная НЛР (СНЛР) была зарегистрирована у 48 (44,9%) пациентов в группе Ацеллбия ® + МТ и у 22 (43,1%) в группе ПЛ + МТ (р=0,974).…”