Quantifying factors which influence the value of approved biologic treatments in SLE a Multi-Criteria Decision Analysis (MCDA) approach in Spain

Abstract

Objective: The objective of the present study is to assess the value contribution of belimumab compared with anifrolumab in the treatment of adult patients with systemic lupus erythematosus (SLE) in Spain using reflective Multi-Criteria Decision Analysis (MCDA). Methodology: A literature review was conducted to complete the criteria included in the EVIDEM MCDA framework. A multidisciplinary panel of eight experts, including two rheumatologists and one internist specialized in managing patients with SLE, two regional decision-makers, and three hospital pharmacists scored each criterion of the MCDA framework used. The study was developed following the MCDA methodology, including criteria scoring, aggregate scoring, value determination, and discussion of findings. Performance scores provided by experts were analysed quantitatively and qualitatively. Results: SLE was considered a potentially severe and heterogeneous disease, with important unmet needs affecting a considerably sized population. Experts considered the absence of curative therapy, the adverse effects of conventional treatments, constitutive manifestations such as fatigue and organ damage accrual as relevant unmet needs in the management of SLE. Belimumab was perceived to have a slightly higher efficacy profile, with better safety profile and to provide improved Patient Reported Outcomes (PROs) than anifrolumab. Experts considered that belimumab and anifrolumab do not differ in terms of cost of intervention; however, belimumab’s advantage lies in its potential to generate savings by reducing both direct and indirect costs. Overall, belimumab’s therapeutic impact on patients with SLE is considered high and supported by high-quality evidence. Conclusion: Based on reflective MCDA methodology, belimumab is perceived as a value-added option for the treatment of adult patients with SLE when compared with anifrolumab. Nevertheless, it is important to consider the lack of head-to-head comparations and long-term data for anifrolumab regarding these conclusions. These findings underscore the potential benefits of belimumab for patients and the healthcare system, emphasizing its role as an add-on therapy in improving outcomes for individuals with SLE. Keywords: belimumab, systemic lupus erythematous, anifrolumab, autoimmune disease, multi-criteria decision analysis (MCDA).