Cost of care according to disease-modifying therapy in Mexicans with relapsing-remitting multiple sclerosis

274
-1

Published on

Miguel A. Macı´as-Islas • Isaac F. Soria-Cedillo • Merced Velazquez-Quintana •
Victor M. Rivera • Vero´nica I. Baca-Muro • Edith A. Lemus-Carmona • Erwin Chiquete

Limited data exist on the costs of care of
patients with multiple sclerosis (MS) in low- to middleincome
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 (IFNb)-1a, 6 million units (MU); (2) IFNb-1a, 12MU;
(3) IFNb-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
IFNb-1a 12MU (22.6 %), IFNb-1b 8MU (20.7 %), and
IFNb-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.

Published in: Health & Medicine
0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total Views
274
On Slideshare
0
From Embeds
0
Number of Embeds
0
Actions
Shares
0
Downloads
3
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide

Cost of care according to disease-modifying therapy in Mexicans with relapsing-remitting multiple sclerosis

  1. 1. Acta Neurol Belg DOI 10.1007/s13760-013-0200-z ORIGINAL ARTICLE Cost of care according to disease-modifying therapy in Mexicans with relapsing-remitting multiple sclerosis ´ Miguel A. Macıas-Islas • Isaac F. Soria-Cedillo • Merced Velazquez-Quintana ´ Victor M. Rivera • Veronica I. Baca-Muro • Edith A. Lemus-Carmona • Erwin Chiquete • Received: 22 January 2013 / Accepted: 16 April 2013 Ó Belgian Neurological Society 2013 Abstract Limited data exist on the costs of care of patients with multiple sclerosis (MS) in low- to middleincome 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, ´ M. A. Macıas-Islas (&) ´ ´ Jefe del Departamento de Neurologıa, UMAE, Centro Medico ´ Nacional de Occidente, IMSS, Belisario Domınguez #1000, Col. Independencia Oriente, C.P. 44340 Guadalajara, Jal, Mexico e-mail: miguelangelmacias@hotmail.com ´ M. A. Macıas-Islas Department of Neurosciences, Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, Guadalajara, Jal, Mexico I. F. Soria-Cedillo Á V. I. Baca-Muro Á E. A. Lemus-Carmona Department of Health Economics, Novartis Mexico, Mexico City, DF, Mexico M. Velazquez-Quintana Department Health Research, Hospital Regional #1, IMSS, Chihuahua, Chi, Mexico V. M. Rivera The Maxine Mesinger MS Comprehensive Care Centre, Baylor College of Medicine, Houston, TX, USA E. Chiquete Department of Neurology and Psychiatry, Instituto Nacional de ´ ´ ´ Ciencias Medicas y Nutricion ‘‘Salvador Zubiran’’, Mexico City, DF, Mexico relapses, intensive care and rehabilitation. Four groups were defined according to DMT alternatives: (1) interferon beta (IFNb)-1a, 6 million units (MU); (2) IFNb-1a, 12MU; (3) IFNb-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 IFNb-1a 12MU (22.6 %), IFNb-1b 8MU (20.7 %), and IFNb-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. Keywords Costs of care Á Glatiramer acetate Á Healthcare Á Interferon Á Multiple sclerosis Introduction Multiple sclerosis (MS) is a disabling neurodegenerative disease caused by immune-mediated destruction of myelinated central nerve fibres [1]. Most individuals experience their first symptoms between the ages 20 and 40 years [2] and as a consequence, it leads to high costs associated with lost of productivity, employment and quality of life [3–5]. On one hand, the introduction of new costly diseasemodifying therapies (DMTs) may contribute to the 123
  2. 2. Acta Neurol Belg elevated healthcare costs; but on the other hand, these highly effective interventions may diminish long-term healthcare system expenses through a reduction of disabilities, hospitalisations associated with relapses and loss of productive years. Careful evaluations of the cost-benefit ratio become essential for the formulation of efficient health policies, especially in countries where the healthcare system depends primarily on public resources [6–8]. Thus, the cost analysis of a disabling disease such as MS is an important topic around the world. Unfortunately, for most developing countries MS represents an under diagnosed disease, and therefore, information on the epidemiology as well as the economic burden of this disabling disorder is scarce [9–12]. Countries going through the economic-epidemiological transition are facing new healthcare challenges unrecognised in the previous decades. The aim of this study was to determine the economic burden associated with care of Mexican patients with relapsing-remitting MS, in a representative sample of the largest institution of the Mexican healthcare system. revised 2005 McDonald criteria, and treated at least for 12 months with one of the first-line DMTs (IFNb-1a 6 MU, IFNb-1a 12 MU, IFNb-1b 8 MU or glatiramer acetate). The costs of institutional resources were determined according to the Unitary Costs per Level of Medical Attention (the lower the level, the higher the Institutional costs, with lower patient’s economic participation) and Diagnosis-Related Groups (DRG). The cost of each relapse was established according to DRGs, which consider the mean cost of institutional resources use per patient. Costs are expressed in US Dollars (US $) and Euro (€) at a currency exchange rate of (Mexican pesos) MXN $13.28 per US $1.00, and €0.70 per US $1.00. To estimate the institutional burden of disease in a standardised fashion, direct costs on individual patient data were used to construct an economic simulation (using TreeAge Pro 2010, TreeAge Software Inc, Williamstown, MA, USA) of the patterns of resource usage in a standardised time frame of 12 months. Patients with similar disease states were grouped for a comparable analysis of resources usage. For each health state (group of patients) the following formula was employed: Methods In this retrolective observational study, we directly analysed individual clinical records of patients with relapsingremitting MS pertaining to the Mexican Social Security Institute (Instituto Mexicano del Seguro Social, IMSS), the largest institution of the Mexican public healthcare system. The Institutional Review Board of IMSS hospitals approved the present analysis. Individual patient data were recorded from January 2009 to February 2011, in a standardised structured case report form (CRF), especially designed for the purpose of this study. For each patient, we registered the use of medical resources such as diagnostic tests, DMTs, drugs for symptoms control, outpatient medical revisions, patientday hospitalisations associated with relapses, patient-day intensive care unit hospitalisations and rehabilitation care. Four DMT alternatives were evaluated in the present report: (1) interferon beta (IFNb)-1a, 6 million units (MU); (2) IFNb-1a, 12 MU; (3) IFNb-1b, 8 MU; and (4) glatiramer acetate. These alternatives are the most commonly used in the Mexican Social Security Institute. The pattern of resources use and direct costs were recorded for a sample of 492 relapsing-remitting MS patients of Mexican hospitals pertaining to the Mexican Social Security Institute. Only certified neurologists with experience in MS diagnosis and management were responsible for the healthcare of patients pertaining to this cohort. The main study measures were institutional use of resources, costs of care and annualised relapse rate. We included patients aged 18–70 years, with relapsing-remitting MS according to 123 TCj ¼ n XÀ Á Qij à Ci ; i¼1 where TC total costs during the simulated time frame, Q resource units during the simulated time frame, and C unitary cost of resource Q. Statistical analysis Parametric continuous variables are expressed as minimum and maximum geometric means. Non-parametric continuous variables are expressed as medians. Categorical variables are expressed as percentages. To compare quantitative variables distributed between two groups, Student’s t test was performed in parametric distributions. Chi square statistics (i.e., Pearson’s Chi square or Fisher’s exact test, as corresponded) were used to compare nominal variables in bivariate analyses, among two or more nominal categories. Spearman’s test was used for the evaluation of class correlations. All P values are two-sided and considered significant when P 0.05. SPSS v 17.0 software for windows (SPSS, Inc, Chicago, IL, USA) was used for all statistical calculations. Results A total of 492 patients (67 % women) with confirmed diagnosis of relapsing-remitting MS were studied (Table 1). All patients were treated with a DMT for at least
  3. 3. Acta Neurol Belg 1 year. The most frequently used DMT was glatiramer acetate (n = 224, 45.5 %), followed by IFNb-1a 12 MU (n = 111, 22.6 %), IFNb-1b 8 MU (n = 102, 20.7 %), and IFNb-1a 6 MU (n = 55, 11.2 %). No differences were found between groups of treatment with respect to demographic characteristics. Direct costs of each DMT option are shown in Table 2. The interclass correlation between cost of DMT and usage weight was non-significant (Spearman’s rho = 0.800, P = 0.20). The mean cost of each specialised medical consultation, which included prescription filling, was €74.90 (US $107.00), and each relapse had a mean cost of €2,505.97 (US $3,579.96). The economic burdens among DMT groups were mainly due to costs of medical consultations, medications used, hospital stay, rehabilitation costs, number of relapses, and cost of DMT option (Table 3). It is important to highlight that differences in total number of relapses between treatment groups were not necessarily a result of intrinsic drug efficacy, since medical decisionmaking about the indication of a particular therapeutic option was based on several factors, among them, patient’s preference of the injection protocols and local availability of each drug option. Figure 1 shows the proportion of patients having at least one relapse per year by DMT, age and gender. The corresponding annualised relapse rates per 100 persons-year for IFNb-1a 6 MU, IFNb-1a 12 MU, IFNb-1b 8 MU and glatiramer acetate were 45.45, 46.84, 50 and 43.75 %, respectively (P = 0.76). Annualised costs per patient for each therapeutic option are depicted in Fig. 2. The main differences in costs by treatment group were due to direct drug costs, since mean individual costs per patient did not differ with respect to relapses or use of institutional resources. Thus, the group of glatiramer acetate represented the higher mean costs per patient-year, when compared with the other therapeutic options. Discussion The most important finding of the present report is that, when equipotent DMTs are used in patients with comparable characteristics, the costs of DMTs determine the total institutional expenses associated with care of patients with Table 1 Characteristics of the 492 patients with relapsing-remitting multiple sclerosis Characteristics Option of disease-modifying therapy Glatiramer acetate (n = 224) Age, median (range), years IFNb-1a 6 MU (n = 55) IFNb-1a 12 MU (n = 111) IFNb-1b 8 MU (n = 102) 39.6 (18–63) 42.3 (22–63) 39.3 (18–68) 40.0 (18–61) B30 years, n (%) 40 (17.9) 9 (16.4) 17 (15.3) 20 (19.6) 31–40 years, n (%) 97 (43.3) 21 (38.2) 51 (45.9) 39 (38.2) 41–50 years, n (%) 50 (22.3) 8 (14.5) 30 (27.0) 27 (26.5) 51–60 years, n (%) 32 (14.3) 13 (23.6) 12 (10.8) 13 (12.7) 61–70 years, n (%) 5 (2.2) 4 (7.3) 1 (0.9) 3 (2.9) Gender Male, n (%) Female, n (%) Time since diagnosis, mean (range), years Family history of multiple sclerosis None, n (%) Mother, n (%) 74 (33.0) 21 (38.2) 32 (71.2) 35 (65.7) 150 (67.0) 34 (61.8) 79 (29.8) 67 (34.3) 3.8 (1–8) 4.3 (1–11) 6.2 (1–12) 8.7 (1–8) 236 (96.7) 53 (93.4) 109 (98.2) 98 (96.1) 1 (0.4) 0 (0) 0 (0) 0 (0) Father, n (%) 0 (0) 0 (0) 0 (0) 0 (0) Sibling, n (%)a 3 (1.2) 0 (0) 0 (0) 2 (1.9) Other, n (%) 4 (1.6) 2 (3.6) 2 (1.8) 2 (1.9) Glatiramer acetate, n (%) 2 (0.9) 28 (50.9) 36 (32.4) 2 (1.9) IFNb-1a 6 MU, n (%) 3 (1.3) 2 (3.6) 2 (1.8) 5 (4.9) IFNb-1a 12 MU, n (%) 5 (2.2) 1 (1.8) 28 (25.2) 2 (1.9) 19 (8.5) 4 (7.3) 30 (29.4) 5 (4.9) Previous disease-modifying treatments IFNb-b 8 MU, n (%) IFNb Interferon beta, MU million units a No affected twins were observed 123
  4. 4. Acta Neurol Belg Table 2 Institutional costs per patient, across alternatives of disease-modifying therapies Variable Unitary cost Units per month 30 Glatiramer acetate €40.80 (US $58.28) IFNb-1a 6 MU €132.30 (US $189.00) IFNb-1a 12 MU €68.00 (US $97.14) IFNb-1b 8 MU €76.43 (US $109.19) Costs per month of treatment Costs per year of treatment €1,223.94 (US $1,748.49) €14,687.35 (US $20,981.93) €529.21 (US $756.02) €6,350.60 (US $9,072.29) 12 €815.96 (US $1,165.66) €9,791.56 (US $13,987.95) 12 €917.17 (US $1,310.24) €11,006.02 (US $15,722.89) 4 Sale prices to the Mexican Social Security Institute (Instituto Mexicano del Seguro Social, IMSS) IFNb Interferon beta, MU million units Table 3 Annual relapses according to disease-modifying therapy Age Crude number of annual relapses Number of patients with at least 1 relapse per year Percentage of patients with at least 1 relapse per year Men Men Women Men Women Women Glatiramer acetate B30 years 10 22 8 14 3.57 6.25 31–40 years 18 38 12 31 5.35 13.83 41–50 years 6 16 6 11 2.68 4.91 51–60 years 5 14 4 8 1.79 3.57 61–70 years 0 6 0 4 0.00 1.79 B30 years 2 4 2 4 3.63 7.27 31–40 years 3 7 3 7 5.45 12.72 41–50 years 0 2 0 2 0.00 3.63 51–60 years 0 8 0 5 9.09 0.00 61–70 years 2 0 2 0 3.63 0.00 B30 years 31–40 years 13 5 4 18 8 4 4 16 7.21 3.60 3.60 14.41 41–50 years 5 10 5 9 4.50 8.11 51–60 years 1 8 1 5 0.90 4.50 61–70 years 0 0 0 0 0.00 0.00 IFNb-1a 6MU IFNb-1a 12MU IFNb-1b 8MU B30 years 3 14 3 9 2.94 8.82 31–40 years 10 16 9 14 8.82 13.72 41–50 years 3 8 1 8 0.98 7.84 51–60 years 7 2 5 2 4.90 1.96 61–70 years 0 0 0 0 0.00 0.00 No statistically significant differences were observed between treatment groups with respect to the annualised relapse rates (P = 0.76) IFNb Interferon beta, MU million units relapsing-remitting MS, in the Mexican Social Security Institute. The clinical efficacy among DMTs was highly comparable, but significant differences in annual healthcare costs were observed across treatment groups. In this study glatiramer acetate was the most commonly used DMT, but it was also the most expensive. This contrasts with information derived from developed nations [13–15], which evidences that large variations in local 123 market prices exist among countries, possibly originating significant different results of economic evaluations of MS burden for the healthcare system [16]. Nevertheless, few studies exist about the economic burden of MS in low- to middle-income countries [2], which may hamper comparisons with information derived from developed nations. Different approaches generate distinct healthcare costs when facing the MS burden [17–23]. Hence, the different
  5. 5. Acta Neurol Belg Fig. 1 Percentage of patients with at least 1 relapse per year, by age and gender, and according to disease-modifying therapy alternative. IFNb interferon beta, MU million units Fig. 2 Mean institutional costs per patient-year according to disease-modifying therapy alternative players of the healthcare system should evaluate their feedback strategies that fuel improvement. In this sense, the least costly alternatives providing the best therapeutic responses in an adequate circumstance should be privileged over the others [19]. The main limitation of this study is its retrolective nature that could overlook minor but significant institutional costs. A stratification of MS patients according to their disability (i.e., EDSS) to determine direct and indirect costs of care was not performed [18]; nonetheless, the main objective of the present report was to compare the healthcare costs according to DMTs, and the total annual cost per MS patient was primarily determined by DMT option. Since this study is not a cost-effectiveness analysis, no sensitivity analysis or willingness-to-pay thresholds were performed. Moreover, no estimations of productivity loss or impact on quality of life were done, and the apparent imbalances associated with DMTs costs were not evaluated in terms of cost-benefit ratios. Based on the present results, a cost-effective analysis taking into account the particular circumstances of the Mexican Healthcare System is warranted. In conclusion, the annual institutional expenditure of MS is mainly a function of the costs of DMT. Annual relapses across treatment alternatives are comparable; nevertheless, it is very important to evaluate the balance between costs and benefits, especially in the light of new costly but highly effective therapeutic options [24]. Acknowledgments This study received financial support by Novartis, Mexico. The company was involved in study design and analysis, but had no role in the selection of patients, data capture, assignations of costs or resources use, the final approval of this article or the decision for submission to publication. References 1. Polman CH, Reingold SC, Banwell B, Clanet M, Cohen JA, Filippi M et al (2011) Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria. Ann Neurol 69:292–302 2. Filippi M, Rocca MA (2011) The role of magnetic resonance imaging in the study of multiple sclerosis: diagnosis, prognosis 123
  6. 6. Acta Neurol Belg 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. and understanding disease pathophysiology. Acta Neurol Belg 111:89–98 Kobelt G, Berg J, Atherly D, Hadjimichael O (2006) Costs and quality of life in multiple sclerosis: a cross-sectional study in the United States. Neurology 66:1696–1702 ¨ Henriksson F, Fredrikson S, Masterman T, Jonsson B (2001) Costs, quality of life and disease severity in multiple sclerosis: a cross-sectional study in Sweden. Eur J Neurol 8:27–35 Etgen T, Adler-Hunklinger U, Hemmer B (2012) Cognitive impairment as unusual first manifestation in late-onset relapsingremitting multiple sclerosis. Acta Neurol Belg 112:307–309 Reese JP, John A, Wienemann G, Wellek A, Sommer N, Tackenberg B et al (2011) Economic burden in a German cohort of patients with multiple sclerosis. Eur Neurol 66:311–321 Fattore G, Lang M, Pugliatti M (2012) Treatment experience, burden, and unmet needs (TRIBUNE) study—measuring the socioeconomic consequences of Multiple Sclerosis. Mult Scler 18:5–6 ´ ´ Velazquez-Quintana M, Macıas-Islas MA, Rivera-Olmos V, ´ Lozano-Zarate J (2003) Multiple sclerosis in Mexico: a multicentre study. Rev Neurol 36:1019–1022 Pugliatti M, Sotgiu S, Rosati G (2002) The worldwide prevalence of multiple sclerosis. Clin Neurol Neurosurg 104:182–191 Lana-Peixoto MA, Frota ER, Campos GB, Monteiro LP, Brazilian Committee for Treatment and Research in Multiple Sclerosis (2012) The prevalence of multiple sclerosis in Belo Horizonte, Brazil. Arq Neuropsiquiatr 70:102–107 Risco J, Maldonado H, Luna L, Osada J, Ruiz P, Juarez A et al (2011) Latitudinal prevalence gradient of multiple sclerosis in Latin America. Mult Scler 17:1055–1059 Romero M, Arango C, Alvis N, Suarez JC, Duque A (2011) The cost of treatment of multiple sclerosis in Colombia. Value Health 14:S48–S50 Noyes K, Bajorska A, Chappel A, Schwid SR, Mehta LR, Weinstock-Guttman B et al (2011) Cost-effectiveness of diseasemodifying therapy for multiple sclerosis: a population-based study. Neurology 77:355–363 ´ Sanchez-de la Rosa R, Sabater E, Casado MA, Arroyo R (2012) Cost-effectiveness analysis of disease modifying drugs 123 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. (interferons and glatiramer acetate) as first line treatments in remitting-relapsing multiple sclerosis patients. J Med Econ 15:424–433 ´ Sanchez-De la Rosa R, Sabater E, Casado MA (2011) Budget impact analysis of the first-line treatment of relapsing remitting multiple sclerosis in Spain. Rev Neurol 53:129–138 Manouchehrinia A, Constantinescu CS (2012) Cost-effectiveness of disease-modifying therapies in multiple sclerosis. Curr Neurol Neurosci Rep 12:592–600 ´ ´ ´ ˜ Carra A, Macıas-Islas MA, Gabbai AA, Correale J, Bolana C, Sotelo ED et al (2011) Optimizing outcomes in multiple sclerosis: consensus guidelines for the diagnosis and treatment of multiple sclerosis in Latin America. Ther Adv Neurol Disord 4:349–360 ´ ´ ´ ´ Casado V, Martınez-Yelamos S, Martınez-Yelamos A, Carmona O, Alonso L, Romero L et al (2006) Direct and indirect costs of Multiple Sclerosis in Baix Llobregat (Catalonia, Spain), according to disability. BMC Health Serv Res 6:143 Schoenen J, Gianni F, Schretlen L, Sobocki P (2006) Cost estimates of brain disorders in Belgium. Acta Neurol Belg 106:208–214 Oleen-Burkey M, Castelli-Haley J, Lage MJ, Johnson KP (2012) Burden of a multiple sclerosis relapse: the patient’s perspective. Patient 5:57–69 Triantafyllou N, Triantafillou A, Tsivgoulis G (2009) Validity and reliability of the Greek version of the multiple sclerosis international quality-of-life questionnaire. J Clin Neurol 5:173–177 Zwibel HL, Smrtka J (2011) Improving quality of life in multiple sclerosis: an unmet need. Am J Manag Care 17:S139–145 Hawton A, Green C, Telford CJ, Wright DE, Zajicek JP (2012) The use of multiple sclerosis condition-specific measures to inform health policy decision-making: mapping from the MSWS12 to the EQ-5D. Mult Scler 18:853–861 Agashivala N, Kim E (2012) Cost-effectiveness of early initiation of fingolimod versus delayed initiation after 1 year of intramuscular interferon beta-1a in patients with multiple sclerosis. Clin Ther 34:1583–1590

×