RESUMO
The second author's name should be "Maria De Francesco" rather than "Maria de Fransesco".
RESUMO
BACKGROUND: Cladribine tablets have recently become available in The Netherlands for patients with relapsing-remitting multiple sclerosis (RRMS) as a disease-modifying agent that reduces the frequency and severity of relapses and delays disability progression. OBJECTIVE: The aim of this study was to evaluate the cost effectiveness of cladribine tablets, compared with alternative options, in the treatment of RRMS patients with high disease activity (HDA) and patients with rapidly evolving severe (RES) MS in The Netherlands. METHODS: A Markov model was developed simulating the costs and effects of RRMS treatment. For HDA, alemtuzumab and fingolimod were used as comparators; natalizumab was used for the RES subpopulation. The analysis included a societal perspective and a value-of-information (VOI) analysis. RESULTS: For the HDA subpopulation, treatment with cladribine tablets was the cost-effective (dominant) strategy compared with alemtuzumab and fingolimod, with 50.9% and 98.2%, respectively, probability of being cost effective at a threshold of 50,000/QALY gained and a net monetary benefit (NMB) of 10,866 and 151,115, respectively. For the RES subpopulation, treatment with cladribine tablets dominated treatment with natalizumab, with 94.1% probability of being cost effective at a threshold of 50,000/QALY gained and an NMB of 122,986. Note that these outcomes are driven by the lower costs of cladribine tablets. Efficacy differences were small, very uncertain, and likely not clinically meaningful. The probabilistic sensitivity analyses showed significant overlap in the credible intervals for total lifetime QALY outcomes and costs of cladribine tablets and all relevant comparators. The population-level VOI amounted to 19,295,441. CONCLUSIONS: The base-case analysis shows that treatment of RRMS with cladribine tablets is cost effective versus alemtuzumab and fingolimod in HDA patients, and cost effective versus natalizumab in RES patients, at a threshold of 50,000. Driven by the lower costs, cladribine tablets were cost effective (dominant) in all base-case analyses. However, given that outcomes are based on indirect comparisons and post hoc subgroup analysis, as well as the uncertainty surrounding the outcomes, the results presented in this paper should be interpreted with caution.
Assuntos
Cladribina/administração & dosagem , Cladribina/economia , Imunossupressores/administração & dosagem , Imunossupressores/economia , Esclerose Múltipla Recidivante-Remitente/tratamento farmacológico , Adulto , Análise Custo-Benefício , Feminino , Humanos , Masculino , Cadeias de Markov , Países Baixos , Anos de Vida Ajustados por Qualidade de VidaRESUMO
Osteoporotic fractures are costly in terms of both the dollar amount and healthcare utilization. The objective of this review was to systematically synthesize published evidence regarding direct costs associated with the treatment of osteoporosis-related fractures in the U.S. We conducted a systematic literature review of published studies that used claims databases and economic studies reporting costs associated with osteoporosis-related fractures in the U.S. Studies published between 1990 and 2011 were systematically searched in PubMed (primary source), Ovid HealthSTAR, EMBASE and the websites of large agencies. Data concerning study design, patient population and cost components assessed were extracted with qualitative assessment of study methods, limitations and conclusions. Cost assessment included direct medical and hospitalization (inpatient) costs. The cost differences by age and gender were examined. Of the 33 included studies, 26 reported an estimated total medical cost and hospital resource use associated with osteoporotic fractures. These studies indicated that, in the year following a fracture, medical and hospitalization costs were 1.6-6.2 higher than pre-fracture costs and 2.2-3.5 times higher than those for matched controls. Analysis of the hospitalization costs by osteoporotic fracture type resulted in hip fractures identified as the most expensive fracture type (unit cost range $US 8358-32195), while wrist and forearm fractures were the least expensive (unit cost range $US 1885-12136). Although incremental fracture costs were generally lower in the elderly than in the younger population, total costs were highest for the older (≥65 years of age) population. Total healthcare costs for fractures were highest for the older female population, but unit fracture costs in women were not consistently found to be higher than for men. The qualitative assessment of the included studies demonstrated that the design and reporting of individual studies were of good quality. However, the findings of this review and comparisons across studies were limited by differences in methodologies used by the different studies to derive costs, the populations included in the studies used and the fracture assessment. Despite the variability in estimates, the literature indicates that osteoporosis-related fractures are associated with high total medical and hospitalization costs in the U.S. The variability in the cost estimates highlights the importance of comparing the methodologies and the types of costs used when choosing an appropriate unit cost for economic modelling.