Cost for diabetes mellitus care in Romania and the world in the interval

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1 Cost for diabetes mellitus care in Romania and the world in the interval CLAUDIU MORGOVAN 1, STELIANA GHIBU 2, MARIUS BOTA 3 CRISTINA FLEŞERIU 4, SMARANDA COSMA 3 1 Pharmaceutical Legislation and Marketing Department, Vasile Goldiş Western University of Arad, 1 st Feleacului Street, , Arad, ROMANIA, 2 Pharmacology, Physiology and Physiopathology Department, University of Medicine and Pharmacy Iuliu HaŃieganu, 41 Victor Babeş Street, , Cluj- Napoca, ROMANIA 3 Marketing Departement, Babeş-Bolyai University, Cluj-Napoca, 7 th Horea Street, , Cluj-Napoca, ROMANIA 4 PhD candidate Marketing Department, FSEGA, Babeş-Bolyai University, Cluj-Napoca, th Teodor Mihali Street, , Cluj-Napoca, ROMANIA claudiumorgovan@yahoo.com Abstract: This research highlights the significance of preventing, founding out and treating diabetes mellitus from early stages of on set. The late finding of diabetes mellitus leads to both medical and economic losses. The treatment of the complications of the diabetic disease raises the costs of the care and the losses due to patient missing from work cannot be neglected. The expenses with diabetes mellitus have constantly increased everywhere in the world. The highest costs for a diabetic patient raised to 13,243 USD/patient/year, in 2002, in the USA the highest ever recorded costs of this disease. A study carried out in Europe, in 1998, showed that hospitalisation costs represent 54% of the total costs of diabetes mellitus treatment, ambulatory care costs 18%, hypoglycaemia medication - 7%, while the cost for associated pathologies is about 21%. In Romania, the treatment of diabetes mellitus is free of charge. The funds allotted by the Ministry of Health for the Diabetes Programme in the time interval increased eight times, so that the estimates for 2010 range 360,000 thousand RON. Key-Words: pharmacoeconomy study, cost of diabetes mellitus, The National Health Insurance House, The program for the diabetes, anti-diabetic drugs 1 Introduction In the year 2007, in the world the total number of patients suffering from diabetes mellitus was estimated to 246 million [1]. In Romania, in 2007, official statistics included about 570,000 registered patients with diabetes mellitus [2]. In 1989, the Ministries of Health of the major European Union countries and the National Associations of Diabetic Patients produced the St. Vincent Declaration (Italy). The International Diabetes Federation (IDF) had the initiative of the declaration. This document underlines the amplitude of the problems generated by diabetes mellitus (DM) and the need to solve them, locally, regionally and nationally as soon as possible. The main objectives set in the statement are: finding out and treatment of DM, prevention, self-control, patient empowerment, care of diabetic children, fight against diabetic patients discrimination, and reduction of complications [3]. As The American Diabetes Association (ADA) mentions, the medical standards for the treatment of the diabetic pathology refer to: prevention, diagnostic and screening, treatment management, sugar level control, self-monitoring, nutrition, prevention and management of complications (cardiovascular diseases, neuropathies, nephropathies, retinopathies, the diabetic foot etc.), assistance of diabetics in schools and hospitals etc. [4]. Compared to other diseases, the treatment of the diabetes mellitus patients has recorded a significant increase in costs. As the illness is very complex duet o its complications too, costs related to DM can be: direct, indirect and psycho-social ones. The psychosocial costs are intangibles and can be estimated with difficulty as they are the consequence of the psychological state of the patient that leads to decreased life quality for them [5]. The increase in diabetic pathology prevalence led to increased ISSN: ISBN:

2 awareness of the need to treat the diabetic illness and consequently to more funds allocated for DM throughout in the world. Direct costs concern pharmacotherapy (OAD, insulins), medical services provided by consultation, hospitalisation, ambulatory or nursing services, medical equipments and laboratory and paraclinic investigations as well. [5-8]. They also include the home care of diabetic children and their transport to medical offices for the periodical check-ups [5, 6] and other services (dentistry, kinesitherapy etc.) [7, 8]. Indirect costs are related to the days off of the diabetic patient from work (care of disabled people and early retirement included), as well as early mortality. 2 Material and method The acts and norms concerning DM issued by health authorities from more countries in the period , as well as information published in various financial journals were investigated. As work methods we used: logical analysis and comparison. 3 Results and discussion a) World level costs related to diabetes mellitus In Sweden, in 1978, the total cost of diabetes mellitus was 291 million USD, i.e. 1.5% of the Health budget. In 1994 it reached 2.1%, i.e. 744 million USD. [5] In France, the direct cost per DM type 2 patient raised from 2,350 Euro (1998) to 3,914 Euro (2002) and for the year 2010 the estimate reaches 5,173 Euro, and in ,624 Euro. Then, it was established that minor complications lead to a 10-20% increase as compared to the situation in which complications do not exist, and the addition of cardio-vascular complications raises expenses 2.89 times.[9] Another study made in France in the same interval ( ) indicates that 31.4% of the DM cost is brought by the cure of complications. [10] In Canada, DM prevalence is approximately 5%. The budget allocated in 1993 was 1.1 billion USD, in over 1.6 billion. In 1998, the direct costs represented 0.4 billion (25%) including only expenses with hospitalisation and medication. The indirect costs duet o poor labour capacity, disability and even premature death could not be appreciated. [11, 12] In USA, in 1998, total cost (direct and indirect) was 98 billion USD; in 2002 it went to 132 billion USD, meaning 13,243 USD/patient/year. In USA too, costs for ambulatory services and hospitalisation grew as time went on, the weigh of pharmacotherapy being reduced from 14% (in 1973) to 3% (in 1992) of the total allotted budget. [5, 13, 14] The study named Cost of Diabetes in Europe-type 2 (CODE-2) is a research performed in eight EU countries in 1998, on a cohort of 7,000 patients. The study shows that the largest part in DM costs is related to hospitalisation (54%) and ambulatory medical assistance (18%). Hypoglycaemia inducing drugs represent only 7%, and the treatment of associated pathologies represents 21% of the total costs. [5] In another study named Cost of Diabetes in Latin America and the Caraibes, Barcelo A. And his team indicate that for the year 2000, lasses tot o early retirement (under 65 years) reached 3 billion USD, those for permanent disabilities of diabetic persons over 50 billion USD, and those for temporary disabilities over 763 million USD. The drugs cost 4.72 billion USD, hospitalisation cost 1.01 billion USD, consultations 2.51 billion USD, and complications cure 2.48 billion USD, in the year 200 in that region under investigation. In this way, total annual costs were estimated at billion USD, of which only 16% (10.72 billion) as direct costs. The budget allocated per patient in Ecuador, Guatemala and Jamaica were 491 USD, in Bolivia USD, in Trinidad Tobago and Barbados USD, in Chile and Mexico USD. [7] In Japan, in 1997, DM prevalence was 6% (6, 9 million Japanese), for which 8 billion USD (4%) were allotted from the Health Ministry. The Kumamoto study performed in Japan between 1988 and 1998, to assess the cost of the intensive insulin treatment DM type 2 patients, used to recommend the intensive administration of insulin to patients of this kind in order to increase life expectation, life quality, and last, but not least, to reduce risk of complications and additional costs related to the former. The overall cost of the conventional therapy with insulin for one patient, all along the time of the research, ranged around 36,685 ± 12,985 USD/patient [15]: The cost of the treatment valued 21,121 USD, of which only 14,444 USD for insulin, the rest being for self-monitoring, medical visits and tests; The cost of the complications reached 15,565 USD; including expenses with hospitalisation, eye specific care, drugs for additional complications. In Germany, a research on the costs for anti-diabetic medication performed between 1994 and 2004, by W. Rathmann and his team shows that in 1994, the average annual cost for the treatment was of 372 ISSN: ISBN:

3 Euro/patient, while in 2004 it increased by about 60%, to 559 Euro/patient.[16] The Kusnik-Joinville research demonstrates that, if in 2000, in France, the average annual/patient amount, paid to pay for DM treatment was 237 Euro, of which 78 for insulins, in 2005, the amount increased with 12.2%, reaching 312 Euro, of which 126 for insulins. Moreover, from the total cost of a diabetic patient with cardio-vascular disorders, the anti-diabetic medication represented 44% in 2000, and only 41.1% in [17] b) Costs for diabetes mellitus care in Romania In Romania, the treatment of diabetes mellitus is free of charge for all the patients. The drugs are prescribed by the diabetologists or other doctors having competence in working with diabetic people. The drugs are released, beginning with October 2006 in all pharmacies with open to public circuit complying Order MSP no. 1061/425. [18] After five years, the system was decentralised and the antidiabetic drugs are no more distributed in close circuit pharmacies. The evolution of amounts allotted by the National Unique Fund of Social Health Insurance (FNUASS) for the national health programs during (table 2) presents a rising tendency, showing the importance of prevention and treatment of chronic diseases. The amount provided for 2008 (1,816.5 million RON) shows an increase with over 500 million RON compared to the amount for 2007 and a 22.5 times increase in comparison with the year 1999 [19, 20]. Table 1 Evolution of fund allotted by FNUASS for health programs during [19-20] Year FNUASS funds (thousand RON) 80, , , , , , ,100 1,152,900 1,310,900 1,816,500 FNUASS Found Growth (%) % 60.26% 32.75% 47.10% 13.90% 9.90% 40.41% 13.70% 38.57% Index of inflation (%) 45,8% 45.70% 34.50% 22.50% 15.30% 11.90% 9.00% 6.56% 4.84% 7.85% Real growth (growth - inflation) (%) % 25.76% 10.25% 31.80% 2.00% 0.90% 33.85% 8.86% 30.72% As for the funds allotted by FNUASS the diabetes program in Romania, table 3 gives valuable in formation. It is found that in 9 years, the budget allotted increased over 9.5, from 32,053 thousand RON to 306,243 thousand RON. The main objective of the Ministry of Public Health (MSP) and National House of Health Insurance (C.N.A.S.) that allocate these funds consists in providing the treatment with oral anti-diabetic drugs (OAD) and insulins. As program 3.6. for the treatment of diabetes mellitus is more complex, besides the FNUASS budget, MSP also allocated additional funds. From the graphical representation (figure 1) of the way funds allotted in the interval [19, 20] were spent to prevent and treat DM in Romania, in Figure 2 we simulated an evolution of funds to be allocated for the period s According to the calculations, in 2010, the amount allotted should be around 360,000 thousand RON, i.e. a ten times increase for the interval This amount should be reached as the factors to influence in the future the evolutions in diabetic pathology should not be too different than those in previous years According to the equation related to the straight line y = 3298x the correlation coefficient R is , the determination coefficient R 2 is , and this proves that the two variables (time and allotted funds) are in good correlation. Table 2 Diabetes mellitus funds during [19-21] Year No Diabet Program Funds (thousand 1 RON) 32,053 64,637 80, , , , , , ,243 Diabet Funds vs. 2 FNUASS Funds (%) 15.29% 19.24% 18.03% 20.03% 23.82% 23.59% 18.36% 20.47% 16.86% Index of inflation % 34.50% 22.50% 15.30% 11.90% 9.00% 6.56% 4.84% 7.85% Diabet Program Funds Growth (%) Real growth (%) Drugs values (thousand RON) Drugs values growth (%) Other cost (t housand RON) Drugs volum (units) Drugs volum growth (%) *not available Fonduri (miiron) 450, , , , , , , ,000 50, % 24.41% 63.33% 35.50% 8.82% 9.28% 26.79% 14.12% 5 = % 1.91% 48.03% 23.60% -0.18% 2.72% 21.95% 6.27% 6 30,569 53,833 73, , , , , , , % 76.10% 36.25% 37.12% 68.05% -3.00% 16.29% 9.07% 30.76% 8 = 1-6 1,484 10,804 7,068 30,773 8,964 29,736 21,007 60,414 34, ,426,309 3,968,623 3,045,210 3,050,216 4,277,626 5,020,141 5,786,089 6,509,831 * % 15.83% % 0.16% 40.24% 17.36% 15.26% 12.51% y = 33879x R 2 = ,416 64,637 32, , , , , , , Timp (an) Figure 1 Funds allotted in Romania for the diabetes mellitus prevention and control during (thousand RON) For the year 2007, these amounts were of 35,375 thousand RON and they were spent for: selfmonitoring, annual assessment of glicated haemoglobin, equipping the Diabetes County Centres with computers (2,150,000 RON) and treating patients requiring insulin pumps [22-24]. The expenses with the drugs needed for the treatment of DM patients in program 3.6. at national level, for the interval presented by CNAS in 2007 are given in Figure 2. Comparing the data presented in Figure 2, one can notice that, in 2008, the amount spent for the anti-diabetic drugs was highest: 297,334 thousand RON (124,255 ISSN: ISBN:

4 thousand + 152,971 thousand + 18,100 thousand). [19] In 2005, the funds allotted were smaller; representing 96% of the budget for 2004, while in 2006 they increased by 3% compared to For the interval , allotted funds exceeded expenses in all the years in question (Figure 2). This can be explained by the payment of debts from previous years. As from October 2006, the diabetes program meant the release of OAD in open circuit pharmacies, in 2006, expenses with OAD were divided into hospital related expenses and ambulatory expenses. 300, , , , ,000 50, ,108 90,152 86,688 23,399 70,642 90,152 23,337 75,222 98,283 Figure 2 Expenses with medicines and materials in 2004 and 2005 [22] According to Figure 3, the distribution of expenses with OAD, between pharmacies and hospitals is in a 1:3 ratio, for the 3 months program when open circuit pharmacies were introduced in it, in One can state that the expenses with anti-diabetic drugs along 2006 were uniformly distributed. 19,381,425, 25.77% hospital ambulatory Figure 3 Structure of expenses with OAD in 2006 [22] 18, , , Insulin OAD OAD + Insulin 55,840,511.91, 74.23% In 2007, in Romania, according to MSP Order no. 570/116/2007, it was estimated that 400,000 individuals would benefit from the anti-diabetic treatment, with a total therapy cost of 267,625,000 RON. The analysis of the medication costs shows that the highest monthly costs (over 10 Euros) are registered with the recently introduced products for oral therapy, belonging to new structural classes: Repaglinide, Acarbose, Pioglitazone or modern pharmaceutical systems (Glipizid GITS - gastrointestinal therapeutic system), with higher level pharmacological properties. Though costly, the treatment with Repaglinide exhibits less disadvantages than other anti-diabetic drugs [26]. The highest costs for 1 UI insulin occur with the insulin analogue-based preparations (Glargine, Aspartat, Lispro), their combinations (Humalog Mix and Novo Mix) and prefilled devices (Opti Set, Novolet, Flex Pen) [27]. 4 Conclusion The improper DM treatment or its absence can lead to complications with disastrous effects upon the individual, in particular, and society, in general. It is extremely important to avoid such additional expenses in the budget of health insurance that can arise from extra care, hospitalisation, early mortality etc, but also in the budget of social insurance, which are affected by days off and early patient retirement. Everywhere in the world costs with DM have constantly increased. The highest cost sever were recorded in the USA, in 2002, when they were USD/patient/year. A study made in France for the interval has shown that 31, 4% of DM costs are represented by the treatment of complications. Another research from 1998, on a lot of 7000 patients from eight EU countries concluded that most DM expenses can be divided as follows: 54% for hospitalisation, 18% for ambulatory care, 7% for medication and 21% for the treatment of DM associated pathologies In Romania, the treatment of diabetes mellitus is free of charge. The funds allotted in Romania for DM prevention and control goes on increasing. Thus, from thousand RON, in 2000, in 2007, the amount of thousand RON was reached and the estimates for the years to come forecast increases too, so that in thousand RON will be paid for this disease.. References: 1. *** Diabet Altas, IDF, 3rd edition, online available at docs/background_opening_pc.pdf, date accessed *** Medicii sunt îngrijorańi de aparińia diabetului de tip II la copii, Mediafax, , online available at date accessed *** Diabetes Care and Research in Europe. The St. Vincent Declaration (1989), online available at ISSN: ISBN:

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