Análisis de costes y resultados en salud del tratamiento de la esclerosis múltiple en el área sanitaria de guadalajara

Abstract

Multiple Sclerosis (MS) is an autoimmune, inflammatory and disabling disease. Although many disease-modifying drugs (DMDs) have been approved since the 1980s, MS has no cure to date. The objective of this research work is to analyze the costs associated with MS in the Integrated Management Area (IMA) of Guadalajara and to study the health outcomes achieved with the different DMDs with real life data. A retrospective observational study of the overall cost of MS treatment and health outcomes of patients treated at Guadalajara IMA was made from 2012 to 2016. In addition, the quality of life of patients with MS during 2016-2017 was prospectively analyzed. The direct and indirect costs of the disease were calculated: drugs, analytical tests, Temporary Disability and Permanent Disability. On the other hand, the cost of MS relapses treatment was analyzed by comparing intravenous methylprednisolone (MP) with a formulation of oral high-dose MP prepared at the Hospital Pharmacy Service. The cost of the treatment of gait disturbances in patients treated with fampridine was also analyzed. The overall costs of the disease were analyzed according to the drug and degree of disability. Regarding the quality of life, a self-prepared survey was conducted to patients and caregivers. In addition, the validated questionnaire MSQoL-54 was used. Finally, the annualized relapse rate (ARR) and the persistence of the different DMDs were analyzed. Results showed that the overall cost of MS in the IMA of Guadalajara increased from € 1.7 million in 2102 (146 patients) to € 2.5 million in 2016 (179 patients). Within the direct costs of the disease, DMDs represented the largest amount (€ 1.5 million in 2012 and € 2.1 million in 2016). The overall cost of Temporary Disability was € 275.816 (47 patients) and the Permanent Disability € 404.814 (12 patients). Cost-minimisation analysis showed that high-dose oral MP formula was 91% cheaper (p <0.001) than intravenous MP for the treatment of MS relapses, achieving a saving of € 60.000 in 5 years. The use of fampridine allowed to reduce in 4 seconds (p <0.018) the time necessary to perform the 25-foot test. The self-prepared survey showed that the economic situation of the patients underwent a statistically significant change (p <0.001) after the diagnosis of the disease. The quality of life analyzed according to the MSQoL-54 questionnaire showed statistically significant differences in the physical (p <0.003) and mental subscale (p <0.01) of the patients with mild (EDSS: 0-3,5) and moderate disability (EDSS: 4-6,5). First line DMDs produced a decrease in the ARR of 0.37 (95% CI: 0.234 to 0.585) p=0.001. Second line DMDs produced a greater decrease in the ARR (0.65), although without statistical significance (p = 0.137). IM interferon β-1a was the DMD with the highest persistence 147 months (95% CI: 123 to 171). In patients with EDSS <4, persistence with first line DMDs was 122 months (95% CI: 95-148), higher than for second line DMDs: 94 months (95% CI: 75-112). Just the opposite happend in patients with EDSS> 4: persistence with second line DMDs was 87 months (95% CI: 67-107), greater than with first line DMDs 50 months (95% CI: 20-80). Finally, we can conclude that It is essential to treat patients with MS early to slow the progression of the disease and to reduce relapses. High-dose oral MP formula is a cost-effective alternative to IV MP for the treatment of MS relapses. The use of fampridine improves walking ability, decreases spasticity and fatigue with a favorable adverse effects profile. The selfprepared survey shows how MS negatively affects the quality of life of patients (work situation, leisure time and holiday habit). DMDs produce a decrease in the ARR and slow the progression of disability. Naive patients have greater persistence with DMDs compared to pre-treated patients.