OBJECTIVES: Ofatumumab was approved by Italian Medicine Agency-AIFA as second line treatment for patients with Relapsing remitting Multiple Sclerosis (RRMS). Therefore, this study aimed at evaluating the cost-effectiveness of ofatumumab compared with ocrelizumab in patients with RRMS by the Italian National Healthcare System (NHS) perspective.

METHODS: A cohort-based multi-state Markov model was developed including 3 main clinical events related to RRMS: disability progression, relapse and death. The model included patients ranged between 0 and 6.5 Expand Disability Status Scale (EDSS) score (consistent with OPERA trial). In each cycle, the patients might experience higher, lower or stable EDSS level. The disability of patients was related to the EDSS level, while the mortality rate was influenced by age, sex and EDSS. Patients with EDSS≥7 were considered as treatment discontinuers. Clinical, quality of life, treatment, management and relapse cost data, as well as DMTs efficacy and discontinuation rate were retrieved from the literature. The analysis assumed a life time-horizon, 1-year cycle and discount rate of 3% for both costs and benefits. The model estimated cost and effectiveness (life-year (LYs) and quality-adjusted life-year (QALYs)) of ofatumumab and ocrelizumab. The cost-effectiveness ratio (ICER) was assessed using a willingness to pay (WTP) threshold of €40,000/QALY. One-way sensitivity analysis (OWSA) and probabilistic sensitivity analysis (PSA) were performed.

RESULTS: Ofatumumab resulted dominant (Δ-QALY: 0.13; Δ-costs: -45.131€) compared with ocrelizumab. As reported in the OWSA analysis, the discontinuation rate was the parameter that mostly affected the results. The PSA analysis showed that ofatumumab had a 92% probability to be cost-effective compared to ocrelizumab, considering a WTP threshold of 40,000€/QALY gained.

CONCLUSIONS: In this study, ofatumumab represents a cost-effective second line treatment for patients with RRMS. This data can help healthcare decision makers to understand the value of ofatumumab and the impact of its implementation in the Italian setting.