Cost of Relapsing-Remitting MS with New Disease-Modifying Drugs
Cost of Relapsing-Remitting MS with New Disease-Modifying Drugs
Background and Objective: During the last decade, several agents have proven to be effective in the treatment of relapsing-remitting multiple sclerosis (RRMS), for example interferon-β (IFNβ) and glatiramer acetate. This study aimed to perform a cost-analysis of the treatment of patients with RRMS in Italy after the introduction of these new agents.
Study design: This was a retrospective observational study with systematic patient inclusion.
Methods and Results: Data gathered from 630 patients with confirmed RRMS over a 2-year period were evaluated. Overall, the direct cost over 2 years reached €11073100 thousand, corresponding to a per-patient cost of €17576 (year of costing, 2001). The cost of disease-modifying agents represented approximately 77% of the total expenditure. IFNβ accounted for 94% of the expense of disease-modifying agents, corresponding to a 2-year cost per patient of €20223. Although glatiramer acetate and immunoglobulins were also associated with a high level of expense, these were prescribed in only 3.8% and 1.1% of patients, respectively. Using regression analyses, IFNβ therapy, disability, number of days spent in hospital per year and the frequency of magnetic resonance imaging procedures were the main predictors of total costs.
Conclusion: Based on the results of this study, IFNβ treatment considerably modified the management of RRMS and was associated with a rise in cost of treatment per patient.
Multiple sclerosis (MS) is a disabling illness characterised by chronic demyelinating inflammation of the white matter of the central nervous system. The disease is more common in females, and onset usually occurs between 20 and 40 years of age. The disease can significantly impair patients' quality of life. MS may manifest itself as motor dysfunction (weakness and spasticity) and/or sensory or peripheral nervous system disturbance (bowel, bladder and sexual dysfunction); psychiatric symptoms (depression) and cognitive impairment are also common.
Approximately 90% of patients with relapsing-remitting MS (RRMS) experience acute exacerbation of neurological symptoms followed by at least partial resolution. The remaining 10% show steady progression from onset (primary progressive MS). About 50% of RRMS patients eventually enter into the secondary phase in which progressive disability arises, with or without acute exacerbations. Finally, approximately 10% develop 'benign' MS, associated with minimal functional impairment.
Disease progression leads to deterioration in the patient's functional status, which eventually renders work-related tasks as well as routine daily activities difficult to perform. Therefore, MS represents a major health problem with significant physical, economic and emotional implications.
In Italy, recent surveys focusing on MS have shown a prevalence of 69 per 100000 population (estimated in the province of Ferrara, Middle-North Italy), with the highest estimate in Sardinia (ranging from 103 to 144 per 100000) compared with the other regions. Based on the assumption that the prevalence of MS in Italy (56195973 inhabitants, excluding those resident in Sardinia) might correspond to the estimate found in Ferrara province, it was calculated that 38775 patients would be affected by MS. This number was increased to about 41000 subjects when the cases in Sardinia (1648044 residents) were also included.
Recently, a study was undertaken to evaluate the socioeconomic impact of MS in Italy prior to the introduction of new disease-modifying agents. The 3-month direct cost per patient was €1102 (€5118 total cost; year 1996), and this estimate may correspond to about €181 million per 41000 patients.
Since 1993, interferon-β (IFNβ)-1b has proved tobe an effective disease-modifying agent in RRMS. Subsequent studies demonstrated the efficacy of other drugs, such as IFNβ-1a and glatiramer acetate. All these therapeutic agents reduced the number of relapses and delayed disability progression in patients with RRMS, although with differences in the magnitude of treatment effect between molecules.
After 1996, several IFNβ and glatiramer acetate preparations became available in Italy for the treatment of patients with RRMS. However, because of their high cost, the introduction of these agents may have increased direct per-patient costs.
The aim of this study was to perform a cost-analysis of the treatment of patients with RRMS in Italy after the widespread use of new disease-modifying agents in clinical practice.
Background and Objective: During the last decade, several agents have proven to be effective in the treatment of relapsing-remitting multiple sclerosis (RRMS), for example interferon-β (IFNβ) and glatiramer acetate. This study aimed to perform a cost-analysis of the treatment of patients with RRMS in Italy after the introduction of these new agents.
Study design: This was a retrospective observational study with systematic patient inclusion.
Methods and Results: Data gathered from 630 patients with confirmed RRMS over a 2-year period were evaluated. Overall, the direct cost over 2 years reached €11073100 thousand, corresponding to a per-patient cost of €17576 (year of costing, 2001). The cost of disease-modifying agents represented approximately 77% of the total expenditure. IFNβ accounted for 94% of the expense of disease-modifying agents, corresponding to a 2-year cost per patient of €20223. Although glatiramer acetate and immunoglobulins were also associated with a high level of expense, these were prescribed in only 3.8% and 1.1% of patients, respectively. Using regression analyses, IFNβ therapy, disability, number of days spent in hospital per year and the frequency of magnetic resonance imaging procedures were the main predictors of total costs.
Conclusion: Based on the results of this study, IFNβ treatment considerably modified the management of RRMS and was associated with a rise in cost of treatment per patient.
Multiple sclerosis (MS) is a disabling illness characterised by chronic demyelinating inflammation of the white matter of the central nervous system. The disease is more common in females, and onset usually occurs between 20 and 40 years of age. The disease can significantly impair patients' quality of life. MS may manifest itself as motor dysfunction (weakness and spasticity) and/or sensory or peripheral nervous system disturbance (bowel, bladder and sexual dysfunction); psychiatric symptoms (depression) and cognitive impairment are also common.
Approximately 90% of patients with relapsing-remitting MS (RRMS) experience acute exacerbation of neurological symptoms followed by at least partial resolution. The remaining 10% show steady progression from onset (primary progressive MS). About 50% of RRMS patients eventually enter into the secondary phase in which progressive disability arises, with or without acute exacerbations. Finally, approximately 10% develop 'benign' MS, associated with minimal functional impairment.
Disease progression leads to deterioration in the patient's functional status, which eventually renders work-related tasks as well as routine daily activities difficult to perform. Therefore, MS represents a major health problem with significant physical, economic and emotional implications.
In Italy, recent surveys focusing on MS have shown a prevalence of 69 per 100000 population (estimated in the province of Ferrara, Middle-North Italy), with the highest estimate in Sardinia (ranging from 103 to 144 per 100000) compared with the other regions. Based on the assumption that the prevalence of MS in Italy (56195973 inhabitants, excluding those resident in Sardinia) might correspond to the estimate found in Ferrara province, it was calculated that 38775 patients would be affected by MS. This number was increased to about 41000 subjects when the cases in Sardinia (1648044 residents) were also included.
Recently, a study was undertaken to evaluate the socioeconomic impact of MS in Italy prior to the introduction of new disease-modifying agents. The 3-month direct cost per patient was €1102 (€5118 total cost; year 1996), and this estimate may correspond to about €181 million per 41000 patients.
Since 1993, interferon-β (IFNβ)-1b has proved tobe an effective disease-modifying agent in RRMS. Subsequent studies demonstrated the efficacy of other drugs, such as IFNβ-1a and glatiramer acetate. All these therapeutic agents reduced the number of relapses and delayed disability progression in patients with RRMS, although with differences in the magnitude of treatment effect between molecules.
After 1996, several IFNβ and glatiramer acetate preparations became available in Italy for the treatment of patients with RRMS. However, because of their high cost, the introduction of these agents may have increased direct per-patient costs.
The aim of this study was to perform a cost-analysis of the treatment of patients with RRMS in Italy after the widespread use of new disease-modifying agents in clinical practice.
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