[Budget impact analysis of the first-line treatment of relapsing remitting multiple sclerosis in Spain].
ABSTRACT To assess the budget impact of the treatment for relapsing remitting multiple sclerosis (RRMS), interferons, and glatiramer acetate, from the National Health System perspective in Spain.
A budget impact model was designed to compare the cost of RRMS treatment in different settings, using a five year time-horizon, considering different percentages of administration of each medication. A reference setting o base case using all the available first line treatments (interferons and glatiramer acetate) was compared with five alternatives scenarios excluding each one of these treatments. The cost analysis (euros, year 2010) includes direct medical resources (drugs, administration, visits, disease management, diagnostic tests). Unitary cost data was obtained from the health costs database e-Salud and drugs catalogue.
Considering a cohort of 22 255 patients with RRMS, the mean global budget impact per year would be 260 775 470 euros in the base case. The setting that excluded glatiramer acetate increases the budget impact in a 3.23% (372 euros per patient per year). Pharmacological costs were the key drivers of total cost (90%).
The use of glatiramer acetate in the first-line-treatment of RRMS patients is a cost-saving strategy, which may decrease the budget impact from the National Health System perspective in Spain.
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ABSTRACT: BACKGROUND: Fingolimod is an innovative drug with a significant budget impact in the treatment of MS in Spain. The aim of this study was to calculate the direct cost comparison of glatiramer acetate and fingolimod for the treatment of patients with relapsing-remitting multiple sclerosis (RRMS) in Spain. METHODS: A cost analysis model was developed to compare glatiramer acetate and fingolimod, based on a 1-year time horizon. In addition to the pharmacological costs, resource use was estimated for glatiramer acetate (1 hour of training with nursing staff in self-injection techniques for subcutaneous administration) and fingolimod (vaccination for varicella-zoster virus in 5% of patients, 3 complete blood counts per year, 3 ophthalmology visits for prevention of macular edema, 3 transaminase tests to monitor liver function, and cardiovascular monitoring consisting of 1 ECG before the first fingolimod dose and at 6 hours; 1 day outpatients-hospital visit for cardiological monitoring during 6 hours on the day of the first fingolimod dose, with follow-up of blood pressure and heart rate every hour). The pharmacological costs were calculated based on the ex-factory price of the drugs evaluated, using the doses recommended in the respective Summary of Products Characteristics (SmPC). Total invoicing volume was discounted by 7.5%, as laid down in Spanish Royal Decree 8/2010. Unit costs were obtained from the e-Salud database and the drug catalog. Costs in the model are expressed in [euro sign]2012. RESULTS: The cost of annual treatment was [euro sign]9,439.42 for glatiramer acetate and [euro sign]19,602.18 for fingolimod, yielding a cost difference of [euro sign]10,162.76. Assuming a fixed budget of [euro sign]100,000.00, approximately 10 patients could be treated with glatiramer acetate, compared to 5 with fingolimod. CONCLUSIONS: Fingolimod therapy requires twice the investment as glatiramer acetate.Health economics review. 05/2013; 3(1):13.
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ABSTRACT: Limited data exist on the costs of care of patients with multiple sclerosis (MS) in low- to middle-income nations. The purpose of this study was to describe the economic burden associated with care of Mexican patients with relapsing-remitting MS in a representative sample of the largest institution of the Mexican public healthcare system. We analysed individual data of 492 patients (67 % women) with relapsing-remitting MS registered from January 2009 to February 2011 at the Mexican Social Security Institute. Direct costs were measured about the use of diagnostic tests, disease-modifying therapies (DMTs), symptoms control, medical consultations, relapses, intensive care and rehabilitation. Four groups were defined according to DMT alternatives: (1) interferon beta (IFNβ)-1a, 6 million units (MU); (2) IFNβ-1a, 12MU; (3) IFNβ-1b, 8MU; and (4) glatiramer acetate. All patients received DMTs for at least 1 year. The most frequently used DMT was glatiramer acetate (45.5 %), followed by IFNβ-1a 12MU (22.6 %), IFNβ-1b 8MU (20.7 %), and IFNβ-1a 6MU (11.2 %). The mean cost of a specialised medical consultation was 74.90 (US $107.00). A single relapse had a mean total cost of 2,505.97 (US $3,579.96). No differences were found in annualised relapse rates and costs of relapses according to DMT. However, a significant difference was observed in total annual costs according to treatment groups (glatiramer acetate being the most expensive), mainly due to differences in unitary costs of alternatives. From the public institutional perspective, when equipotent DMTs are used in patients with comparable characteristics, the costs of DMTs largely determine the total expenses associated with care of patients with relapsing-remitting MS in a middle-income country.Acta neurologica Belgica. 05/2013;
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ABSTRACT: Several cost-effectiveness models of disease-modifying treatments (DMTs) for multiple sclerosis (MS) have been developed for different populations and different countries. Vast differences in the approaches and discrepancies in the results give rise to heated discussions and limit the use of these models. Our main objective is to discuss the methodological challenges in modelling the cost effectiveness of treatments for MS. We conducted a review of published models to describe the approaches taken to date, to identify the key parameters that influence the cost effectiveness of DMTs, and to point out major areas of weakness and uncertainty. Thirty-six published models and analyses were identified. The greatest source of uncertainty is the absence of head-to-head randomized clinical trials. Modellers have used various techniques to compensate, including utilizing extension trials. The use of large observational cohorts in recent studies aids in identifying population-based, 'real-world' treatment effects. Major drivers of results include the time horizon modelled and DMT acquisition costs. Model endpoints must target either policy makers (using cost-utility analysis) or clinicians (conducting cost-effectiveness analyses). Lastly, the cost effectiveness of DMTs outside North America and Europe is currently unknown, with the lack of country-specific data as the major limiting factor. We suggest that limited data should not preclude analyses, as models may be built and updated in the future as data become available. Disclosure of modelling methods and assumptions could improve the transferability and applicability of models designed to reflect different healthcare systems.PharmacoEconomics 05/2013; · 2.86 Impact Factor