Cost-Minimization Analysis and Budget Impact Analysis About Subcutaneous Natalizumab in Relapsing-Remitting Multiple Sclerosis in Italy

Luca Prosperini,1 Lorenzo Pradelli,2 Laura Santoni,3 Daria Perini,3 Salvatore Cottone,4 Marco Vercellino5 1S. Camillo-Forlanini Hospital, Rome, Italy; 2AdRes Health Economics and Outcomes Resources, Turin, Italy; 3Biogen Italia, Milan, Italy; 4Department of Neurology, A.R.N.A.S. Civico, Palermo, Italy; 5AOU Città della Salute e della Scienza di Torino, Torino, 10126, ItalyCorrespondence: Lorenzo Pradelli, AdRes Health Economics and Outcomes Resources, Via Alfieri, 17, Turin, 10121, Italy, Tel +390117651239, Email [email protected]: Two analyses, a cost-minimization and a budget impact, were conducted to estimate the economic and financial impact of subcutaneous (SC) vs intravenous (IV) natalizumab in terms of administration times and costs in the Italian setting from the perspective of multiple sclerosis (MS) center, patient, and society.Patients and Methods: Cost minimization analysis (CMA) adopted a Markov model with three different states, and it is based on the results of REFINE study and its post-hoc analysis, which evaluated and demonstrated the non-inferiority of natalizumab SC vs IV formulation. The economic inputs came mainly from EASIER study, that estimated the administration time, resource consumption, and costs of natalizumab SC vs IV. A lifetime horizon was considered. Budget impact analysis (BIA) was conducted with a cost calculator approach and compared a base scenario (without SC natalizumab) with an alternative scenario (with SC natalizumab). The inputs were shared with the CMA and a 3-year time horizon was considered. A progressive increase in the number of patients treated with natalizumab SC was estimated from the 1st to the 2nd to the 3rd year after reimbursement in Italy.Results: CMA estimated that savings due to the use of SC instead of IV natalizumab would be € 2,824, € 1,137, and € 9,170 per patient from the perspectives of MS center, patient, and society, respectively, thus depicting a weak dominance (lower costs and non-inferiority efficacy). BIA estimated that the savings were approximately 3.2 million euros from the perspective of MS centers and around 10.3 million euros from the perspective of society in the first 3 years following reimbursement.Conclusion: Administering natalizumab subcutaneously rather than intravenously to treatment-eligible patients would result in administration time and cost savings thus determining a favorable impact for the MS center, the patient and the society.Keywords: intravenous natalizumab, subcutaneous natalizumab, multiple sclerosis, MS center, patient perspective, society perspective