Cost-effectiveness of four immunomodulatory therapies for relapsing-remitting multiple sclerosis: a Markov model based on data a Balkan country in socioeconomic transition.

BACKGROUND/AIM: A cost-effectiveness analyses of immunomodulatory treatments for relapsing-remitting multiple sclerosis (RRMS) in developed countries have shown that any benefit from these drugs is achieved at very high cost. The aim of our study was to compare the cost-effectiveness of five treatment strategies in patients diagnosed with RRMS (symptom management alone and in combination with subcutaneous glatiramer acetate, intramuscular interferon beta-1a, subcutaneous interferon beta-1a, or intramuscular interferon [beta-1b) in a Balkan country in socio-economic transition. METHODS: The Markov model was developed based on the literature about effectiveness and on local Serbian cost calculations. The duration of a cycle in the model was set to a month. The baseline time horizon was 480 months (40 years). The societal perspective was used for costs and outcomes, and they were discounted for 3% annually. Monte Carlo micro simulation with 1000 virtual patients was done. RESULTS: Significant gain with immunomodulatory therapy was achieved only in relapse-free years, while the time spent in health states EDSS 0.0-5.5 was longer with symptomatic therapy only, and gains in life years and QALYs were only marginal. One QALY gained costs more than a billion of Serbian dinars (more than 20 million US dollars), making each of the four immunomodulatory therapies cost-ineffective. CONCLUSION: Our study suggests that immunomodulatory therapy of RRMS in a Balkan country in socioeconomic transition is not cost-effective, regardless of the type of the therapy. Moderate gain in relapse-free years does not translate to gain in QALYs, probably due to adverse effects of immunomodulatory therapy.

Nonsteroidal antiinflammatory drugs and risk of gastrointestinal bleeding among patients on hemodialysis.

BACKGROUND: Both use of nonsteroidal antiinflammatory drugs (NSAIDs) and chronic renal insufficiency are significant independent risk factors for gastrointestinal bleeding. OBJECTIVE: The aim of our study was to investigate whether regular use of NSAIDs further increases the risk of gastrointestinal bleeding among patients with end-stage renal insufficiency on hemodialysis. METHODS: This was a case-control study. Case and control patients were selected from the lists of patients on hemodialysis during the period of 4 months (n=650), at 3 secondary care general hospitals in Serbia. Cases (n=33) were chosen from the study population if they had experienced at least 1 episode of gastrointestinal bleeding during the last 3 years. For each case, at least 1 sex- and age-matched control patient (n=45) was randomly selected from the source population. RESULTS: Among patients on hemodialysis, NSAIDs users had approximately 3 times higher risk of developing gastrointestinal bleeding, than non-users (crude odds ratio = 3.29; 95% confidence interval [95% CI], 1.28-8.45). After adjustment for potential confounders (sex, age, use of erythropoietin or parenteral iron, frequency of NSAID use, smoking, drinking alcohol, heart failure, arterial hypertension, diabetes mellitus, chronic obstructive pulmonary disease, and use of anticoagulants, antiplatelet agents, beta-blockers, angiotensin-converting enzyme inhibitors or diuretics), the only significant association that remained was between gastrointestinal bleeding and use of NSAIDs (OR adjusted = 5.8; 95% CI, 1.3-26.9; p=0.024). CONCLUSION: There is a need for development of effective strategies to prevent gastrointestinal bleeding in patients on hemodialysis who use NSAIDs.