PND11 Budget Impact Analysis of First-Line Treatment for Relapsing – Remitting Multiple Sclerosis in Spain

Departamento Médico, Teva Pharma SLU, Alcobendas, Madrid, España.
Revista de neurologia (Impact Factor: 0.83). 08/2011; 53(3):129-38. DOI: 10.1016/j.jval.2011.08.477
Source: PubMed


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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    • "Pharmacological direct costs of management of this disabling disease accounts for 52% of all resources required for its management and directly impacts on the cost of each hospital [16]. The average budget impact for the cohort of patients with RRMS under treatment in Spain, considering all the options indicated for first-line treatment, represents an investment of €260 million annually, with an average cost per patient of €11,540 per year [17]. The use of the DMT in real clinical practice setting has been a topic of substantial debate for payers at hospital and CCAA level. "
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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 €2012. Results The cost of annual treatment was €9,439.42 for glatiramer acetate and €19,602.18 for fingolimod, yielding a cost difference of €10,162.76. Assuming a fixed budget of €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.
    05/2013; 3(1):13. DOI:10.1186/2191-1991-3-13
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    • "Further analyses in several countries have recently addressed the cost-effectiveness of immunomodulatory therapies for MS. A budget impact analysis of first-line treatments of RRMS considering a Spanish cohort of 22,255 patients was recently published addressing the costs of both IFNβ and GA.79 The results obtained showed a mean global budget impact per year of €260,775,470, with an average cost per patient of €11,540 per year. "
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    ABSTRACT: Glatiramer acetate (GA) represents one of the most common disease-modifying therapies for multiple sclerosis. GA is currently approved for patients at high risk of developing clinically definite multiple sclerosis (CDMS) after having experienced a well-defined first clinical episode (clinically isolated syndrome or CIS) and for patients with relapsing-remitting multiple sclerosis (RRMS). GA's efficacy and effectiveness to reduce relapse frequency have been proved in placebo-controlled and observational studies. Comparative trials have also confirmed the lack of significant differences over other choices of treatment in the management of relapse frequency, and long-term studies have supported its effect at extended periods of time. Additionally, RRMS patients with suboptimal response to interferon β may benefit from reduced relapse rate after switching to GA, and those with clinically isolated syndrome may benefit from delayed conversion to CDMS. All these results, together with its proven long-term safety and positive effect on patients' daily living, support the favorable risk-benefit of GA for multiple sclerosis treatment.
    08/2012; 4:117-33. DOI:10.4137/JCNSD.S8755
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    ABSTRACT: To evaluate the clinical effectiveness and safety of glatiramer acetate for use in routine clinical practice. A retrospective, observational study was conducted on patients with multiple sclerosis who were treated with glatiramer acetate in clinical practice. The primary outcome was the clinical effectiveness of glatiramer acetate treatment. The study included a total of 104 patients (women, 59.6%; age at onset of glatiramer acetate treatment, 39.9 ± 10.9 years; prior treatment for multiple sclerosis, 30.8%). The patients had received glatiramer acetate treatment for an average of 3.6 ± 1.9 years. During the first year of glatiramer acetate treatment, the relapse rate decreased by 60%. At this time, the number of relapses had decreased for 47 patients (45.1%), 67 patients (68.4%) had not suffered a relapse and 78 patients (75.0%) showed no signs of progression. During the second year of glatiramer acetate treatment, the relapse rate decreased by 70%. At this time, the number of relapses had decreased for 43 patients (41.3%), 63 patients (75.9%) had not suffered a relapse and 59 patients (56.7%) showed no signs of progression. There were no reported relapses or progression in 56 patients (53.8%) and 41 patients (39.4%) during the first and second years of treatment, respectively. Discontinuation of glatiramer acetate was necessary in only three patients. The most common adverse effects included fatigue (28.9%) and spasticity (7.7%). This evaluation of glatiramer acetate use in clinical practice supports the effectiveness and the safety profile observed in previously published clinical trial studies.
    Revista de neurologia 01/2012; 54(1):1-9. · 0.83 Impact Factor
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