Prosperini Luca, Brescia Morra Vincenzo Brescia, Fornari Carla, Santoni Laura, Perini Daria, Bergamaschi Roberto, Cortesi Paolo Angelo
Department of Neurosciences, MS Centre, S. Camillo-Forlanini Hospital, Rome, Italy.
Multiple Sclerosis Unit, Policlinico Federico II University Hospital, Naples, Italy.
Pharmacoeconomics. 2025 Sep 18. doi: 10.1007/s40273-025-01539-3.
Advances in the availability and regimen optimization of highly effective disease-modifying treatments (DMTs) for relapsing-remitting multiple sclerosis (RRMS) have led to questions about their comparative worth.
This study evaluates the costs and effects of natalizumab versus other highly effective DMTs and the impact, in terms of times and costs, of the new subcutaneous natalizumab formulation versus the intravenous formulation in patients with RRMS in Italy.
This is a cost-consequence analysis from the Italian national health service and societal perspectives. A Markov model was developed to assess clinical and cost outcomes related to disease and DMTs. The model simulated two scenarios: one comparing natalizumab extended-dose regimen and ofatumumab and ocrelizumab, focusing on efficacy outcomes and costs, and one comparing intravenous and subcutaneous natalizumab with a focus on administration resource consumption, times, and costs. Model input data came from the literature.
DMTs had similar clinical and social outcomes: natalizumab slightly reduced disease progression, increased quality-adjusted life-years, and reduced the impact on days of productivity loss and informal care. Natalizumab also resulted in statistically significant 5-year cost reductions compared with ocrelizumab and ofatumumab. Subcutaneous natalizumab improved resource consumption compared with intravenous natalizumab, saving the time of healthcare professionals, patients, and caregivers and reducing administration costs. The subcutaneous formulation was associated with statistically significant total direct and indirect cost reductions at 5 years.
6-week dosing regimen of natalizumab showed a slight improvement of clinical and social outcomes and a statistically significant cost reduction compared with ocrelizumab and ofatumumab over a 5-year simulation. Moreover, subcutaneous administration reduced administration times and costs.
复发缓解型多发性硬化症（RRMS）高效疾病修正治疗（DMT）的可用性和方案优化取得进展，引发了关于其相对价值的问题。
本研究评估那他珠单抗与其他高效DMT的成本和效果，以及意大利RRMS患者中新型皮下那他珠单抗制剂与静脉制剂相比在时间和成本方面的影响。
这是一项从意大利国家卫生服务和社会角度进行的成本后果分析。开发了一个马尔可夫模型来评估与疾病和DMT相关的临床和成本结果。该模型模拟了两种情景：一种比较那他珠单抗延长剂量方案与奥法妥木单抗和奥瑞珠单抗，重点关注疗效结果和成本；另一种比较静脉注射和皮下注射那他珠单抗，重点关注给药资源消耗、时间和成本。模型输入数据来自文献。
DMT具有相似的临床和社会结果：那他珠单抗略微降低了疾病进展，增加了质量调整生命年，并减少了对生产力损失天数和非正式护理的影响。与奥瑞珠单抗和奥法妥木单抗相比，那他珠单抗在5年时的成本也有统计学显著降低。与静脉注射那他珠单抗相比，皮下注射那他珠单抗改善了资源消耗，节省了医护人员、患者和护理人员的时间，并降低了给药成本。皮下制剂在5年时与直接和间接总成本的统计学显著降低相关。
在5年的模拟中，与奥瑞珠单抗和奥法妥木单抗相比，那他珠单抗6周给药方案显示出临床和社会结果略有改善，成本有统计学显著降低。此外，皮下给药减少了给药时间和成本。
