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PHARMACOECONOMIC EVALUATION OF ANTI-DIABETIC THERAPY AT BTGH, GULBARGA

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ABOUT AUTHORS:
Shujauddin Hashmi*,P. Neelkant reddy, S. hafiz ali, B. Kalyani, K. Karna, S. S.Biradar, Abdul kareem
Department of pharmacy practice
H.K.E Society’s Matoshree Taradevi Rampure Institute of Pharmaceutical Sciences,
MR medical College Road, Gulbarga -585105

ABSTRACT
Diabetes mellitus is a chronic and potentially disabling disease which is like a sleeping giant that is ready to awaken and literally sink our health care system. The present study “Pharmacoeconomic evaluation of anti-diabetic therapy” was carried out with an objective to assess estimated direct medical cost of diabetes and its complications. A hospital based prospective observational study was conducted using a prevalence based ‘cost of illness’ method focusing on estimated direct health care cost of diabetes and its complications. A total of 108 type 2 DM patients were enrolled into the study out of which 68 (62.96%) were males and 40 (37.04%) patients were females. The results revealed that, the average cost was the highest for the age group 45-60 years. The costs for patients with complications were substantially higher than those without complications and the costs were found to increase progressively with the increase in number of complications. The study concludes that Diabetes with complications resulted about 2.5 times higher cost, therefore the burden of diabetes and its complications was significant for individual and families, keeping in mind the burden of the disease on individuals as well as the society, the health policy makers should emphasize on initiatives to prevent the disease prevalence, care and counseling to diabetes patients should be done continuously to prevent the progression of the disease and its devastating complications.

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Reference Id: PHARMATUTOR-ART-1299

INTRODUCTION:

Need for the study:
A growing diabetes pandemic is unfolding with rapid increase in the prevalence of type 2 diabetes1. The global increase in the prevalence of diabetes is due to population growth, aging, urbanization and an increase in obesity and physical inactivity. Healthcare expenditures on diabetes are expected to account for 11.6% of the total healthcare expenditure in the world in 2010. Estimated global healthcare to treat and prevent diabetes and its complications was expected to be at least 376 billion US Dollars in 2010. By 2030 this number is projected to exceed some 490 billion US Dollars2

The global burden and India:
It has been estimated that the Global burden of Type-2 Diabetes Mellitus (DM) for 2010 would be 285 million people which is projected to reach 438 million in 2030. (International Diabetes Federation IDF) that is 65% increase, similarly for India this increase is estimated to be 58% from 51 million people in 2010 to 87 million people in 20303. The Global morbidity and mortality associated with diabetes is closed to 4 million deaths in the age group of 20-79 years in 2010 (IDF report 2009). The total amount needed for India to treat Type-2 DM is estimated around US $ 2.2 billion and the health care budget of the government of India is a meager 2% comparing to 14% for defense (Indian budget 2010: http://indianbudget.nic.in/)4. As Indian population is 1.2 billion the economic impact of this increase in diabetes population could be devastating to India. India being a emerging economy projections show that in the next decade, India will lose US $ 237 billion in National income due to diabetes, stroke, heart disease. Although India accounts for approximately 15% of the global burden of diabetes it contributes only 1 % of the World’s diabetes research5.

Patients with diabetes use higher health care resources. The high cost is related to late Diabetes Complications (DC), the economic loss is due to Lost Man-Days (LMD) or Lost Economic Opportunity (LEO). Due to lack of health insurance policies, awareness and institutions providing financial help, Indians social support system is centered around the nuclear and extended relatives of family, which supports medical calamities, either by providing loan money, or help by working to balance the family income, hence the illness affecting the earning of active member of the family as well as others. Diabetes related complications accounts for 60% of diabetes related health care costs (Direct Costs- DC) and almost 80-90% of Indirect Cost (IC). There is emerging evidence that diabetes education awareness and improving motivation for self care improves care, reduces complications, and may thus reduces overall Economic Costs of Diabetes (ECOD) 6. Assal JP showed that simple measures like patient education and awareness about foot problems can bring about a remarkable reduction in amputation rates. They calculated that the cost of nine below knee amputations can pay the annual salary of 13 hospital staff members responsible for the care of 400 patients7.

In India because of growing pressure on the health care budget, appropriate justification of current expenditures and future investments in public health care are becoming priority. There is only sparse data available from developing countries on the expenditure on diabetes care. In developing countries like India, which lacks a comprehensive health care system, availability of uniform documentation of medical details, especially cost of treatment is limited4. India is witnessing a rising incidence of non-communicable diseases (NCDs) and old age diseases. This rise is occurring in a setting where health expenditures are growing rapidly led by an unregulated private sector and where health insurance and pension coverage are still limited. These financial concerns are further exacerbated by the emerging evidence that the India’s poor are at heightened risk of acquiring NCDs owing to high rates of smoking and tobacco use, occupational risks, and living conditions. According to a World Bank report, it is estimated that Indians spent nearly Rs. 84,600 crores out of pocket on health care expenses (year 2004), amounting to 3.3 per cent of India’s Gross Domestic Product  (GDP) for that year. If we consider only those who are working, the annual income loss to households associated with NCDs is estimated to be Rs. 28,000 crores8.  Compared with non-diabetics, patients with diabetes have increased risk of morbidities involving multiple organ systems. There is 25 times increased risk of renal failure, 20-fold risk of blindness, 40-fold risk of amputation, threefold risk of stroke and fivefold risk of myocardial infarction. Expected lifespan is reduced by an average of 15 years. In the developed world, diabetes is the leading cause of blindness, end-stage renal disease and amputation. Compounded with the others factors of metabolic syndrome, the risk is increased several fold9. Besides morbidity and mortality, these disorders impact the socio-economic status of individuals as well as the state10. The Bangalore Urban District Diabetes Study (BUDS) estimated the annual direct cost for routine care of diabetes in Bangalore city among lower socio-economic patients in 1998 to be about US$ 191, while cost per hospitalization was US$ 20811. Similar estimates have also been provided from North India12. The Cost of Diabetes in India (CODI) study involving upper socio-economic status patients at multiple centers in the country estimated mean total annual cost of diabetic management to be Rs 21,408, with direct annual cost for out-patient diabetes care being Rs 4724. For a developing country like India with only 5% of its GDP being spent on healthcare, diabetes, especially with complications has a major impact on the socio-economic status13.

From the available information it is clear that diabetes will pose a severe burden on the already fragile and under resourced health care system of India, in the future. The per capita-expenditure on health care in India is only 6.4% of the average World spending6.

The rising prevalence of DM poses a major clinical, economical and societal burden in India with its dubious distinctions of being called “The Diabetic Capital of the World”. This means that every fifth diabetic in the World would be Indian. The cost of diabetes care is high and is escalating World-wide. Pharmacoeconomics (PE) analysis is one means of justifying and minimizing these expenditures. Health care professionals must be able to create a balance between the needs and desires of individual’s patients, with the needs and desires of a society at large. Comparing the expected benefits of a medical intervention against the expected cost of that intervention along with the health care benefits, many times it is difficult to interpret, in such a scenario Pharmacoeconomics (PE) studies helps to ensure that society allocates minimal health care resources wisely, fairly, and efficiently. To help decision making regarding a drug therapy, the Pharmacoeconomic (PE) evaluation should include an assessment of the economic, clinical and humanistic outcomes (Echo methods)14.

The health care system is clearly in a state of rapid revolution. Traditional approaches to health care decisions are no longer sufficient; therefore new tools will be needed. Medical ethical and societal concerns about costs, access and quality care are causing health care practitioners to consider a more comprehensive model for medical decision making. These trends let to the evaluation of Pharmacoeconomics15.

Pharmacoeconomics (PE) is a established sub-discipline of health economics concerned with the evaluation of pharmaceutical products in terms of their value for money16. It is defined as the “Description analysis of the cost of drug therapy to health care system and society”. It identifies measures, compares the costs (resources) consequences (clinical, economical and humanistic) of pharmaceutical products and services, with in this frame work are included, the research method related to cost-minimization, cost-effectiveness, cost-benefits, cost of illness, cost-utility, cost-consequences and decision analysis, as well as quality of life and other humanistic outcomes. Pharmacoeconomics (PE) analysis is a comparison between two or more pharmacotherapy options or strategies in terms of the costs and outcomes. Analysis is termed as partial when only costs are assessed, and complete when both costs and outcomes assessed17.

The cost-of-illness (COI) method was most often used to estimate the economic cost of diabetes. This method asks, “How much does a disease such as diabetes cost society. Including both direct and indirect costs?” Direct economic costs are those generated by treatment of disease, including costs related to hospital care, physician services, long-term care, and pharmacotherapy. In contrast, indirect economic costs are the present and future value of productivity lost to society as a consequence of the disease. Indirect costs (IC) are most often estimated from earnings forgone because of illness, disability, and premature death. A third category of costs is related to psychosocial aspects of illness or its effect on quality of life; this type of cost is included only occasionally because of the difficulty of measuring it. Cost-of-illness studies are typically conducted by examining costs among a prevalent sample over a finite period (for example, 1 year) or by examining costs incurred among a cohort of persons with incident cases of the disease over a specific time frame. For this latter approach, costs are often examined from diagnosis to death through the natural progression of the disease, allowing examination of potential savings that can be realized if a case of illness were prevented by implementation of a health program18.

The Karnataka burden:
In Karnataka, almost half the population is suffering from diabetes or hypertension. A Screening India’s Twin Epidemic (SITE) survey on 1,979 patients visiting general physicians in Bangalore, Mangalore and Mysore found that 49% of them suffer from diabetes, hypertension or both. Among the diabetic population, two out of three were having uncontrolled diabetes and among the hypertensive population, four out of five were having uncontrolled hypertension19.

Hence the proposed study is aimed at, finding out the economic outcome of anti-diabetic therapy using “cost of illness analysis”.

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OBJECTIVES:
Economic studies are defined as, a study how people choose to use limited resources to satisfy their unlimited wants so that the gain from the available resources can be maximized., because diabetes is costly, resources devoted to prevention and control of Diabetes are limited and the need for resources will continue to increase because of increasing prevalence of diabetes and demand for comprehensive care and new treatments2. Hence economic studies play an important role in applying the frame work for resources allocation in diabetes prevention and control.

The study is a prevalence based cost of illness study and it presented a societal perspective of cost of diabetes.  Cost of illness (COI) studies use either a Prevalence Based (PB) or incidence based approach, depending on whether a fixed time horizon or life time horizon is adopted as the conceptual paradigm. Prevalence based cost of illness studies measure the economic burden of a disease in a given period.

Therefore the proposed study is aimed at, finding out the economic outcome of anti-diabetic therapy using “cost of illness analysis “was carried out with following objectives

Objectives of the study:
1. To document various treatments being given to in-patients for treating diabetes in the dept. of medicine at BTGH Gulbarga.
2. To record all the expenses involved in the treatment of Diabetic patients, such as
3. Cost of Drug therapy, cost of various Laboratory test, and Hospital charges.
4. To apply a suitable Pharmacoeconomic Evaluation method namely “Cost of Illness” analysis to determine the total cost of illness for diabetic patients during    the study period.

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COST OF ILLNESS SAMPLE STUDIES:
R. Williams, et al carried out a retrospective 6 month study to assess the impact of complications on the costs of type 2 diabetes. Diabetes subjects were collected from four categories of complications, first with no-complication, second with one or more micro-vascular complication, third with one or more macro-vascular complication, and fourth with both micro and macro-vascular complication. The study shows that 72% of patients had at least one complication 19% having micro-vascular and 24% having both macro and micro-vascular complication. Among those with micro-vascular complication 28% had neuropathy, 20% nephropathy, 20% retinopathy and for those with macro-vascular complication 18% had peripheral vascular disease, 17% angina, 12% heart failure and 9% had myocardial infarction. The study reveals that the total cost for diabetes with complications was increased by 250%, when compared to patients without complication. The authors concluded that complications have a substantial impact on the management of type 2 diabetes hence it confirms the prevention of complications not only benefits but potentially reduce overall burden on health care cost20.

P. Clarke, et al carried out a study to assess the impact of diabetes related complications on health care costs from UK prospective diabetes study. The study reveals that the estimated costs of amputation was highest followed by non-fatal myocardial infarction, fatal myocardial infarction, fatal stroke, non-fatal stroke, ischemic heart disease, heart failure , cataract extraction and blindness in one eye. The authors concluded that annual average inpatient-cost of events in subsequent years was high for heart failure and low for extraction, where as non-inpatients macro-vascular complication costs was higher than micro-vascular complications. They also concluded that results of this study provide estimates of the immediate and long term health costs associated with diabetes related complications21.

Usa Chalikledkaew, et al carried out a study to investigate the factors affecting health care costs and hospitalization among diabetic subjects in Thai public hospitals. A retrospective study was conducted by using administrative claims data obtained from diabetic subjects for a period of one year. The study suggests that high health care costs were associated with hospitalization, patients receiving treatment from teaching hospitals. The study reveals that diabetic patients on insulin therapy and those with co-morbidities had significant risk of hospitalization and high health care costs, therefore the authors concluded that intervention should be made to improve patient management by possibly reducing future health care costs22.

Weibing wang, et al carried out a study to evaluate the direct medical costs of type 2 diabetes mellitus with or without complications, and to determine the economic impact of complications on type 2 diabetic subjects. A cross-sectional study carried out in four major cities of china, which includes 1530 out patients and 524 in-patients. With the help of face-to face interview and questionnaire, the authors revealed that an Annual direct medical cost per patient was estimated to be 4800 Chinese Yuan. The costs were high for the patients with complications comparing to the patient without complications. The authors concluded that high economic burden from diabetes challenges the Chinese health care system, therefore an urgent need of intervention is needed to prevent the development of long-terms complications among diabetic population23.

Fatma Al- Maskari, et al carried out a study to assess the direct medical costs of diabetes mellitus and its complications in the United Arab Emirates. The study included 150 diabetic subjects for a period of 12 months during 2004-2005, with the help of conventional and inference statics medical costs were measured, quantified and analyzed. The authors revealed that the total annual direct medical cost without complication was 3.2 times higher than the per capita expenditure for health care in UAE, during 2004. However, these costs were increased 2.2 times for micro-vascular complication and 6.4 times for macro-vascular complication and 9.4 times for both micro and macro-vascular complication. The study also shows that overall costs increased with age, diabetes duration and for those who were treated with insulin. Therefore authors concluded that costs was increased with the presence of complications, so efforts should be made to prevent progression of diabetes complications by implementing diabetes guidelines, screening and better management24.

METHODOLOGY:
Cost of illness estimates using a prevalence based approach indicate the economic burden of the disease at a given point of time – for the present study the time frame was the financial year 2011 (June 2011 –  February 2012). In this study the cost components consisted of direct costs (DC). The direct economic costs reflected the resources used in treating or coping with the disease, including expenditures for medical care and the treatment of illness. The direct medical cost was calculated by multiplying the quantity of medical services consumed by their unit costs.

RESULTS AND DISCUSSION:
In a recent review on cost of illness studies on diabetes, it was emphasized that there is still lack of information on cost based on clinical and economic criteria such as types of diabetes, disease duration, age, gender and types of complications2. ( Zhang, &Engelgau, 2004). The present study tried to add some knowledge into these areas. It was found that the average cost was the highest for the age group 45-60 years. Further, 79.8% of total cost of illness was attributed to the age group between 45–60 years. This estimate was more than twice of the same presented in recent diabetes study in the US. This once again confirmed that the more economically productive age group was affected in diabetes and the burden was also very high for this group. The male patients were found to have higher average cost than their female counterpart. The average cost was found to increase progressively with the duration of the disease. The present study results showed that 76.7% of the study participants were with complications and 33.3% were without complications. Reviewing medical records of the study participants following the definitions used in other diabetic studies in India. Hence, it is possible that the present study approach failed to capture all types of complications. The costs for patients with complications were substantially higher than those without complications and the costs were found to increase progressively with the increase in number of complications. Costs also differed significantly across the types of complications. The patients with both micro-vascular and macro-vascular complications were found to incur the highest average cost and M.I. (myocardial infarction) complication was highest for individuals with every hospitalization.

The present study suffered from some limitations. Firstly, the cost of outpatient visit was not calculated Further, dispensing cost, other service utilization cost (such as dressing for diabetic patients) were also not included for those who visited our hospitals. Hence, the direct medical cost didn’t present the exact cost incurred in the treatment. Secondly, indirect cost was also not calculated. Thirdly, the present cost of illness estimate ignored the intangible cost such as pain and suffering from the disease.

CONCLUSION:
Hence, in the present study a total of 108 patients were identified and enrolled and the study reveals that the average Direct medical cost of type 2 DM with and without complications was Rs 2, 18,590, out of which Rs 1, 74,495 [79.80%] cost for patients with complications and Rs 44,095 [20.20%] cost for patients without complications. We found that the annual average cost per person for one time hospitalization with DM complications was Rs 2,424 and patients without complication was Rs 1,225. Diabetes with complications resulted about 2.5 times higher cost, therefore the burden of diabetes and its complications was significant for individual, further, it should be noted that the disease not only affects the individual but also the family members, friends and neighbours. Much of this cost associated with the disease is preventable through improved diet and exercise, prevention initiatives to reduce prevalence of diabetes and its complications and improved care. Keeping in mind the burden of the disease on individuals as well as the society, the health policy makers should emphasize on initiatives to prevent the disease prevalence, care and counseling to diabetes patients should be done continuously to prevent the progression of the disease and its devastating complications.

REFERENCES:
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2.    Ramachandaran A, Das AK, Joshi SR, Yajnik CS, Shah S, Prasannakumar KM. current status of diabetes in india and need of novel therapeutic agents. 2010; 58(7):7-9
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8.    Government of India, Ministry of Health and Family Welfare, Sep 2010. Available at E-mail: health.report-mohfw@nic.in
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10.    Kapur, A et al. Economic analysis of diabetes care. Indian.J. Med. Res, 2007; 125, 473–82.
11.    Rayappa. PH, Raju KNM, Kapur A, Bjork. S et al. Economic costs of diabetes care – the Bangalore Urban District Diabetes Study. Int. J. Diabetes Dev. Countries, 1999; 19, 87–96.
12.    Grover S et al. Cost of ambulatory care of diabetes mellitus: a study from north India. Postgrad.Med. J, 2005; 81, 391–95.
13.    Kapur A. Cost of diabetes in India – the CODI study. In Proceedings of the Novo Nordisk Diabetes Update, Healthcare Communications Ltd, Bangalore, 2000;  71–7.
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18. Ping Zhang, Engelgau MM, Norris LS, Gregg WE et al. Application of economic analysis diabetes and diabetes care.Ann Intern Med. 2004; 140:972-77.
19. Diabetes and Hypertentsion becoming Twin Epidemic in Karnataka study. Available at URL: thehindubusinessline.com/indusrtyandeconomy/economy/article2612131.ece
20. Williams R,  Van LG , Lucioni C. “Assessing the impact of complications on the costs of Type II diabetes” Diabetologia 2002; 45: 13–17.
21.    Clarke, P. and Gray, A. and Legood, R. and Briggs, A. and Holman, R. The impact of diabetes-related complications on healthcare costs: results from the United Kingdom Prospective Diabetes Study (UKPDS Study No. 65). Diabetic Medicine 2003; 20(6): 442-450.
22. Chaikledkaew U, Pongchareons P, Chaiyakunapruk N, Ongphiphadhanakul B. “Factors Affecting Health-Care Costs and Hospitalization among Diabetic Patients in Thai Public Hospitals” value in health 2008; 11(1).
23. Wang W, Wei Fc, Yu CP, Chen W, et al. How Do Type 2 Diabetes Mellitus-Related Chronic Complications Impact Direct Medical Cost in Four Major Cities of Urban China? value in health 2009; 12(6).
24. Maskari AF, Sadig EM,  Nagelkerke N. “Assessment of the direct medical costs of diabetes mellitus and its complications in theUnited Arab Emirates” BMC Public Health 2010; 10: 679.

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