Methodological issues in estimating the cost of epilepsy

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1 Epilepsy Research 33 (1999) Methodological issues in estimating the cost of epilepsy Charles E. Begley *, John F. Annegers, David R. Lairson, Thomas F. Reynolds The Uni ersity of Texas, Houston, School of Public Health, P.O. Box 20186, Houston, TX 77225, USA Received 17 February 1998; received in revised form 1 June 1998; accepted 2 June 1998 Abstract Changes in treatment alternatives and the emphasis on cost containment and managed care have increased the interest in information on the cost of epilepsy. The last comprehensive cost study in the USA was in That study estimated the national cost of epilepsy at $3.6 billion for 2.1 million cases. On a per patient basis the 1975 figure represents $7440 in 1995 US dollars, $1150 (15%) for direct treatment-related costs and $6290 (85%) for indirect employment-related costs. Since then, various cost-of-illness (COI) studies in the USA and other countries have offered estimates ranging from $6000 to $15000 per patient per year, with percentages of direct and indirect cost varying greatly. To assist those interested in interpreting or producing cost information, this paper reviews the state of research on the cost of epilepsy and discusses several methodological issues. A comprehensive study begun in 1993 to update the 1975 estimates for the USA is also described. Recommendations are provided to stimulate discussion about the best methods to use in future research Elsevier Science B.V. All rights reserved. Keywords: Economics; Costs; Methods; Review 1. Introduction The cost of medical care for persons with epilepsy is changing. New drugs have been developed that cost $2000 $3000 per year per patient, up from $400 to $1300 for the previous generation of first line medications (Cockerell, 1996; Marks and Garcia, 1998). Surgery has become an option for an increasing number of patients and an even * Corresponding author. Tel.: ; fax: larger number are undergoing pre-surgical assessment. The cost of pre-surgical evaluation and surgery has been estimated from $25000 to $100000, depending upon the complexity of the case (NIHCP, 1990; King et al., 1997). These changes in treatment and the new emphasis on cost containment and managed care are increasing the interest in the economic aspects of epilepsy. Cost estimates are increasingly required by insurance companies and government payers, government agencies and foundations involved in funding research, and advocacy groups concerned /99/$ - see front matter 1999 Elsevier Science B.V. All rights reserved. PII S (98)

2 40 C.E. Begley et al. / Epilepsy Research 33 (1999) with the allocation of scarce research and treatment dollars. They are needed to determine the consequences of having epilepsy and to specify the array of factors that determine the distribution of the burden across individuals. Cost-effectiveness and cost-benefit analysis is needed for evaluations of new treatments, for example, comparing surgery versus polytherapy for intractable cases, and evaluating alternative practice issues, such as comparing neurologists versus primary care physicians for the management of newly diagnosed patients. Economic evaluation studies combine cost analysis with health outcome data to evaluate relative efficiency. The recent appearance in the literature of several cost studies with markedly different results, methods, and objectives prompted us to prepare this methodological review for persons interested in conducting and/or evaluating such studies. In the first three sections of the paper we provide an overview of COI research, discuss key methodological issues in epilepsy cost studies, and review existing studies. In the final section, we discuss the estimation methods and the data sources being used in an on-going study to develop current estimates of the national cost of epilepsy in the USA. 2. Overview of COI research 2.1. Objecti es COI research attempts to determine the economic burden of a specific disease for a defined population. The most common approach is the human capital method in which costs are defined in terms of two components: (1) direct cost defined as the cost of medical, non-medical, and patient- or family-related resources used to prevent, diagnose, treat, or rehabilitate persons with the disease; and (2) indirect cost defined as the cost of economic output that is lost because of the effects of an illness on a person s productivity on the job and at home. An alternative approach, called the willingness-to-pay (WTP) method, may also be used in cost studies. This approach defines the cost of an illness in conceptually different terms the amount people would be willing to pay to avoid or reduce the consequences of the illness. The WTP perspective is theoretically appealing because what people would be willing to pay to avoid an illness is a more global measure of cost than the direct and indirect components of the human capital model. However, practical problems in measuring willingness-to-pay have limited the use of this approach in COI research 1. Therefore, this paper focuses on issues which arise in applying the human capital method using the standard framework that was originally developed by Cooper and Rice (1976) in the 1960s. The human capital framework views the cost of an illness as the value of resources a society gives up to treat a patient or loses because a person works less often or less productively because of the illness. This is a relatively broad view of social costs, recognizing that illness has adverse economic consequences not only in terms of the consumption of services and resources that could have been put to other uses but also in terms of losses in human capacity to contribute goods and services. As mentioned above, however, an even broader perspective is justified that recognizes psycho-social costs that are not related to resource use or productivity. These intangibles are not included in the human capital approach because of the difficulty in putting a dollar value on them. Estimates of direct cost require data on the number of persons with the illness, their use of resources, and the cost of those resources. Three broad types of resources are considered: 1. Medical care the cost of medical care services such as professional services, tests, drugs, hospital care, medical supplies, and medical equipment. 2. Non-medical services the cost of non-medical services and resources related to special education, child care, and transportation of a person to and from a clinic to receive care. 1 Detailed discussions of the features of both methods can be found in the COI research literature (Hartunian et al., 1980; Hodgson and Meiners, 1982; Scitovsky, 1982; Hodgson, 1983; Tolpin and Bentkover, 1983; Robinson, 1986; Hodgson, 1988, 1994) and a recent statement of standards in the field is available (Luce et al., 1996).

3 C.E. Begley et al. / Epilepsy Research 33 (1999) Patient- or family-related the imputed cost of a patient s or care giver s time devoted to accessing care or providing care. Indirect costs also have three components including: 1. Employment-related the lost earnings associated with reduced output when people withdraw from the work place due to morbidity or premature mortality caused by the illness Productivity-related for those who continue to work with an illness, the reduced earnings from absence and reduced productivity due to morbidity. 3. Household-related the lost value of household production when people alter the time they devote to household work due to morbidity or premature mortality. Studies vary in terms of the time and population perspective that is taken in estimating the costs of an illness. Annual prevalence-based cost studies estimate the costs associated with prevalent cases over a 1-year period. The short-term nature of this type of study makes it most appropriate for determining the social burden of acute illnesses, for obtaining a cross-sectional measure of the cost of a long-term chronic disease, or for estimating the cost-savings of a new technology or program that has short-term benefits. Lifetime incidence-based studies, on the other hand, estimate costs from the time of diagnosis to cure or death associated with incidence cases. This perspective is appropriate when evaluating the costsavings of interventions which prevent new cases, or prevent or ameliorate the future course of a disease. The incidence-based perspective is rarely adopted because of the difficulty of measuring the costs of illness over time. 2 Lost work may not be a cost to society if a sick person s work (at the workplace or at home) is covered by others, or in the case of a short term absence, made up upon their return. Violations of this assumption have lead some to exclude this component of indirect costs from COI studies. Clearly, there is a need to count some of these costs, however, more research is required showing the exact relationship between illness and productivity losses, particularly during times of high unemployment (Koopmanschap and Rutten, 1993) Estimation methods Direct costs There are three distinct approaches in the estimation of resources used to treat an illness: (1) self-reported treatment data from providers or patients, (2) medical chart and/or billing data obtained from providers who treat individual patients, or (3) hypothetical use based on disease modeling. The choice of approach depends on the study objectives, the required precision of the estimates, and the resources available for the research. In most studies combinations of more than one approach are used. In the USA general-purpose provider surveys, such as the National Hospital Discharge Survey and the National Ambulatory Medical Care Survey, and population surveys, such as the National Health Interview Survey and the National Medicaid Expenditure Survey, provide nationally representative estimates of health resource use. Standard methods are available with these surveys to classify health resource use by disease-specific diagnosis. More detailed and reliable data on resource use can be obtained from reviewing medical charts and/or billing data maintained by providers for individuals with a specific illness. This approach allows for more accurate case ascertainment and more accurate and detailed information on use. However, obtaining these data may be difficult for patients receiving services from multiple providers, if record-keeping is not centralized. Another problem is the generalizability of results when selected samples of cases are studied. Because of the time and resources involved in obtaining actual data, using surveys or chart and billing records, cost studies are often based on models of disease prognosis and treatment. This is particularly true for longitudinal cost studies. Modeling may be quantitative, for example, a Markov model, in which prognosis is characterized as a sequence of particular states of health over time with statistically determined probabilities of transition from one state to the next, or qualitative, i.e. when different states and transition probabilities are based on expert opinion of the natural history of a disease. The obvious

4 42 C.E. Begley et al. / Epilepsy Research 33 (1999) weakness of the modeling approach is that the model s predictions rest on many assumptions, some of which may not be verifiable. The cost of the resources which are used to treat an illness must be estimated in terms of their value to society. The standard method is to use nationally representative payment rates such as Medicare fees or hospital DRG rates, Medicaid, or private insurance company payments 3. By combining resource use and payment rate data, cost estimates for different types of services (i.e. hospital care, physician services, nursing home care, etc.) can be made and then summed across services to derive total costs Indirect costs Measures of indirect cost which are estimated in COI studies include the dollar value of: (1) excess unemployment, (2) sick days lost at work or at home, and (3) reduced productivity at work or at home that is attributed to morbidity and mortality caused by the illness. Morbidity-related excess unemployment, workplace-related sick days, and reduced productivity are estimated based on population surveys, or inferred from related literature. For example, the National Health Interview Survey provides information on unemployment and the number of sick days for persons with specific illnesses. There is also national survey data on reductions in work productivity due to disability. However, estimates of illness-specific productivity losses are not readily available from these surveys. Consequently, such estimates must be made by the researcher based on related studies or obtained directly by questioning individuals with an illness. The amount of time spent on housekeeping activity that is lost to illness is also not readily available from existing surveys and must be estimated for the reference population or obtained from existing literature. 3 COI studies typically assume that payment rates are an accurate reflection of the cost of medical resources. This assumption is based on the theory that medical markets are reasonably competitive, e.g. that prices reflect the value of resources had they been used to produce some other commodity besides medical care. The dollar value of the work-related indirect cost components are estimated by applying national age and sex-specific average earnings data available from the Bureau of Census and the Bureau of Labor Statistics to the excess amounts of these items that occur among individuals with illness, as compared to the general population. The result is the expected earnings lost due to a specific illness. The dollar value of the housekeeping activity-related items is typically imputed based on the wages of household workers. Studies on disease-specific excess mortality are combined with average earnings data and household wages data to estimate indirect costs. Data on illness-specific mortality is obtained from epidemiologic literature, or from vital records maintained by state and federal governments. 3. Issues in estimating the cost of epilepsy There are several methodological issues that arise in estimating the direct and indirect cost of epilepsy. Awareness of these issues should be helpful in planning new studies and/or judging the quality of existing studies Choosing types of cost to measure Because epilepsy can be a devastating disease for some, a broad spectrum of medical, non-medical, and patient and family-related direct cost items should be considered. There is also considerable evidence of the relevance of all the indirect cost components as well, including mortality-related costs for persons with poorly controlled epilepsy. In practice, however, studies are not able to capture all the components of cost that are indicated by experience with a given illness. Recognizing the trade-off between being comprehensive and being practical, it is necessary to prioritize, with a focus on those items that are most likely to have a significant affect on costs. An effort should be made to justify the items selected for study and to indicate possibly important items that are not addressed. From what is known about the medical treatment of epilepsy (Marks and Garcia, 1998), im-

5 C.E. Begley et al. / Epilepsy Research 33 (1999) portant direct cost items that should be addressed include: anti-epileptic drugs (AEDs), hospital care, major diagnostic procedures, physician visits, and treatment for injuries and adverse consequences of AEDs, e.g. dental care. The list of non-medical direct cost items is not as clear. Possibly important items are assistive and protective equipment, use of legal services to obtain appropriate housing, jobs, and school placements, and the use of rehabilitative training and special education. In addition, epilepsy can require the care of members of the household. The amount of care-giver time, and the respite care that is needed to permit the care-giver to recover from the demands of assistance are important items. Non-medical cost items that have been estimated in existing epilepsy cost studies have included special education, vocational training, residential care (institutional and communitybased), social support, and transportation costs 4. Existing evidence on indirect costs has focused on employment losses. Both the occurrence and severity of epilepsy appear to be negatively related both to the probability of employment and to the productivity of those employed (Famulari, 1992). Epidemiological studies indicate excess mortality risk for persons with epilepsy, with the greatest increase in the younger age groups and for more severe epilepsy (Hauser et al., 1980) Defining cases to estimate incidence and pre alence Epilepsy is defined as a condition characterized by recurrent unprovoked seizures. However, based on perceptions of resource use, arguments have been made for more inclusive definitions of cases ranging from all suspect epilepsy, to all seizures, to all unprovoked, to only epilepsy. Different definitions lead to different estimates of the number of people for which costs are counted, with more inclusive definitions leading to higher total costs and lower average costs. An argument for including all persons with a single unprovoked seizure appears to have merit. Early diagnosis of epilepsy can be difficult and be delayed, or may never occur. Substantial costs occur as part of the evaluation to detect underlying causes of an initial seizure (Marks and Garcia, 1998). If cost studies are limited to persons with recurrent seizures, costs prior to diagnosis that are related to the initial evaluation would not be captured Identifying reliable and alid sources of data Ideally, in estimating the cost of individuals with epilepsy, random samples should be drawn from the population and detailed follow-up of resource use and cost should be obtained. However, such sampling is not possible because there is no registry of persons with epilepsy, or of providers who treat epilepsy. Since cost data are more readily available for persons undergoing treatment in special epilepsy clinics or hospitals, cost estimates have often been based on data from these sites. However, since such sites attract patients with more severe disease or who have other associated problems, national costs based on these providers and populations may not be representative. As indicated earlier, there are a number of general population surveys that may be used which are based on nationally representative samples of providers and/or the general population. However, several features of these surveys make it difficult to obtain valid and reliable data for persons with epilepsy including: 1. The relatively small number of epilepsy cases captured in the surveys. 2. The limited number of direct and indirect cost items that are captured in the surveys. 3. The lack of detailed information on diagnosis and utilization. 4. The possibility of error from self-report and from the reliance on primary diagnosis codes 5. Despite these problems, the survey data are useful for generating rough estimates of certain direct cost items, but when possible such estimates should be validated with more detailed data obtained from medical charts and billing records. 4 More discussion of these studies is provided later in the paper. 5 A brief description of the major surveys in the USA are provided as an appendix to further illustrate these limitations.

6 44 C.E. Begley et al. / Epilepsy Research 33 (1999) Case ascertainment and resource use are better documented in medical charts and billing records. Medical record numbers as identifiers, detailed diagnostic information, and itemized services and procedures received by patients is available. However, it is more expensive and time-consuming to obtain this data when carried out well, and when done for local or regional populations the findings may not be generalizable to the country as a whole (Famulari, 1992). A reasonable compromise may be to develop cost estimates based on detailed studies of individuals in various treatment settings, i.e. some from regional treatment centers and others being managed in the community at large. The generalizability of the estimates can be determined by comparison with national survey data Separating epilepsy and co-morbidity costs This is an important issue for epilepsy because of the high prevalence of comorbidities, especially other neurological conditions, trauma, stroke, or brain tumor, that may be associated with and/or the cause of epilepsy. The question arises whether all direct and indirect costs experienced by a person with epilepsy should be attributed in whole or in part to epilepsy or to another accompanying condition, and on what basis attribution should be determined Direct cost attribution When relying on survey data, questions can be worded precisely to address this issue, increasing the likelihood that respondents only list epilepsyspecific use. In provider surveys, where detailed diagnostic coding is used to identify illness-specific use, algorithms can be developed to include or exclude items based on different combinations of primary and secondary codes. However, it is not known how valid this approach would be for epilepsy given the questionable accuracy of these codes. When using chart and billing data, there are two possible ways to address the attribution problem: 1. Review each resource used and determine causality for each using diagnostic information; or 2. Compare the total cost of care for epilepsy patients with the cost of care of a matched control group of individuals without epilepsy (a positive difference would be interpreted as the extra resource utilization that occurred due to epilepsy). The choice of which method is a balance between data quality gained versus the extra time, costs, and effort required. The validity of the review method depends on the accuracy of the coding. The validity of the case-control approach requires that the range of non-epilepsy related determinants of cost be included in matching individuals with epilepsy and their controls. Neither approach is completely adequate Indirect cost attribution For indirect costs, practical techniques for separating epilepsy-related losses from other possible causes include: (1) ask survey questions that specify illnesses or disabilities that have caused an individual to be unable to work or carry out other productive activities; or (2) adopt the comparison approach in which the work behavior of persons with epilepsy and other disabilities are compared to similar people with a disability only. Again, the choice of method involves a trade-off between data quality and available time and resources. Another problem arises when using the comparison method to estimate productivity-related indirect costs. Because of the high fraction of persons with epilepsy who withdraw from the job market, those who remain are likely to be more motivated or determined, or have more labor market skills, than the population as a whole (Famulari, 1992). Thus, those who choose to work even with a seizure disorder are more likely to have higher earnings than the average person with the condition. Therefore, comparing the wages of persons with epilepsy to those without epilepsy will understate the effect of epilepsy. A statistical correction for this bias is available which needs to be applied (Heckman, 1976) Determining costs by se erity Experience suggests that the cost of epilepsy varies enormously with the nature, severity, and

7 C.E. Begley et al. / Epilepsy Research 33 (1999) complications of the disease, and capturing the total cost for all persons with epilepsy may mask important differences across individuals. Direct and indirect costs experienced by individuals with intractable seizures, for example, will be much greater than for those with seizures that can be effectively controlled with regular treatment. The costs for a person who has frequent grand mal seizures may be very different from the costs of a person who has occasional breakthrough simple partial seizures. Although stratification to reflect these cost differences is obviously desirable, it is not clear on what basis the stratification should be designed for costs. Prevalence studies indicate there may be at least three important groups to consider in characterizing the short-term variations in costs by severity: the highest cost group may be those with serious co-existing illnesses or neurological deficits and active epilepsy; next are persons with active epilepsy; and third are persons with inactive epilepsy but receiving treatment. There is also some evidence of important differences between different refractory groups based on seizure type and frequency (van Hout et al., 1997). When adopting the longitudinal perspective, on the other hand, two different prognostic groupings may be important, separating persons who respond to treatment from those with refractory seizures (Begley et al., 1994; Murray et al., 1996). Further subgroupings of remission groups may also be needed, based on initial responsiveness, delayed responsiveness, and relapse with treatment withdrawal (Begley et al., 1994). More studies need to be done to indicate the key determinants of cost variation within subgroups of persons with epilepsy for both annual and longitudinal costs. 4. Evidence on the cost of epilepsy To illustrate existing methods and results, national cost studies that have been published in the 1990s are compared, along with the wellknown but out-dated 1975 USA study: three are from the USA (CCEC, 1978; Begley et al., 1994; Murray et al., 1996), two from the UK (Cockerell et al., 1994), and one each from Australia (Banks et al., 1995; Beran and Banks, 1995) and Switzerland (Gessner et al., 1993). 6 These studies provide estimates of annual prevalence-based direct costs per person ranging from $2750 to $9400 in 1995 dollars, 7 and annual indirect costs ranging from $3380 to $9418. The distribution of direct and indirect costs vary widely, with estimates of the indirect proportion ranging from 35 to 75% of the total. Only two longitudinal studies exist (Begley et al., 1994; Cockerell et al., 1994), suggesting a range for initial year direct costs per person from $1995 to $3144, falling significantly in year two and thereafter. One study has estimated total lifetime costs of new cases at $ Tables 1 and 2 summarize the major methodological characteristics and results of these studies. These studies are not directly comparable because of the contextual differences in the health care and economic conditions of the different countries. Even countries of similar stages of economic development differ with respect to economic and demographic factors, which create problems both of measurement and interpretation. Such factors include differences in age structures, cultural attitudes about health and health care, public and private health insurance coverage, cost sharing, reimbursement systems, absolute and relative price structures, temporal differences in the availability of certain medical technologies, efficiency and productivity, and administrative costs (OECD, 1987). It is possible, however, to compare the studies in terms of their methodological differences, both to illustrate how the estimation issues discussed earlier have been addressed and to point to the improvements that need to be made in future studies. 6 The studies were identified through Medline searches and systematic review of articles published in this and other epilepsy-related journals since For comparison, estimates from different countries were translated into US dollars using the foreign exchange rate at the time of the study. All the figures were updated to 1995 dollars using the medical care consumer price index.

8 46 C.E. Begley et al. / Epilepsy Research 33 (1999) Table 1 Prevalence-based estimates of the annual cost of epilepsy a Reference Country/year Population Cost measures Data sources Direct cost per Indirect cost per person (US $) person (US $) Banks et al. (1995), Beran Australia/1992 All epilepsy age 5+ Direct medical, some indi- Provider and and Banks (1995) rect pop. surveys Gessner et al. (1993) Switzerland/1990 Individuals on anticonvulsants Direct medical, non-medi- Provider and cal, some indirect pop. surveys Cockerell et al. (1994) UK/1990 All active and inactive Direct medical, non-medi- Administrative epilepsy on anticonvulsants cal, some indirect records Murray et al. (1996) USA/1994 Refractory adult epilepsy Direct medical, some indirect Disease model CCEC (1978) USA/1975 All active and inactive Direct medical, non-medi- Provider and epilepsy cal, some indirect pop. surveys a In 1995 US $.

9 C.E. Begley et al. / Epilepsy Research 33 (1999) Table 2 Estimates of the longitudinal cost of epilepsy a Reference Country/year Population Cost measures Data sources Annual direct cost per person Indirect cost per person Cockerell et al. UK/1990 Individuals with un- Direct medical Administrative 917 first year, decreased to 239 in year 5 NA (1994) provoked seizures records Begley et al. USA/1990 Individuals with un- Direct medical, Disease model 2468 first year, decreased to 376 in year 5, lifetime (1994) provoked seizures indirect lifetime a In 1995 US $.

10 48 C.E. Begley et al. / Epilepsy Research 33 (1999) Australia Banks et al. (1995) estimated the annual direct cost of epilepsy in Australia at $2751 per person using data from population and provider surveys. Annual rates of use of physician visits, drugs, hospital inpatient and outpatient care, surgical treatment, ambulance services, diagnostic services (EEG, blood tests, and CT scans), visits to nonphysician health professionals, and nursing home care were obtained from a combination of national and regional provider surveys, population surveys, and related literature. The authors used a prevalence of seven per 1000, based on data from national health surveys, to estimate the number of cases. An accompanying study by Beran and Banks (1995) estimated indirect costs at $3381 per person. These costs included earnings lost due to sick days and days lost in accessing medical care, and benefits paid for excess unemployment. Inferences drawn from related literature were used to derive lost days. National earnings data and government payment data were used to value the losses. This study provides estimates for a relatively comprehensive list of direct medical cost items and one non-medical direct cost item: the cost of patient time accessing medical care (incorrectly listed as an indirect cost item). Indirect cost items were more limited, with housekeeping activity and excess mortality-related costs not addressed. The authors incorrectly counted transfer payments as an indirect cost, specifically, unemployment benefit payments, which are not a social cost 8. The study fails to recognize the attribution problem in estimating costs which distorts some of the items. In particular, nursing home costs, a significant portion of direct costs, were estimated as the total annual cost of nursing home care for all persons in nursing homes with an epilepsy diagnosis. For many of these people, the need for the nursing home was more likely due to another associated condition, and, therefore, the estimated 8 Such payments are a transfer from one group in society, taxpayers, to another, the unemployed and do not meet the conceptual definition of a social cost presented earlier (Johnson and Nuwer, 1997). costs attributable to nursing home care is excessive Switzerland Gessner et al. (1993) estimated annual direct costs of epilepsy in Switzerland at $9400 per person for hospital care, physician office visits, medications, special education, and vocational training. Indirect cost was estimated at $5130 per person based on lost earnings from excess unemployment and lower wages that was attributed to epilepsy. The study relied on national and regional provider surveys for medical and non-medical service utilization data, valuing these services using payment rate data from the government. Physician utilization and medications were based on multi-year surveys of nationally representative samples of doctor offices. Epilepsy-related utilization was identified by principle diagnosis code. Hospital use was based on reports of all hospitals serving two regions of the country, enabling the researchers to obtain population-based hospitalization rates that were then applied to all persons with epilepsy. Unemployment-related indirect costs were derived in a unique way that was possible because of the centralized record keeping in the country. To estimate the number unemployed, the researchers counted all persons with epilepsy in long-term hospitals, special epilepsy hospitals, and special homes for the handicapped. The number of partially disabled epilepsy patients was then determined based on data from the Swiss Social Security Office, and an index of the degree of disability of these people (based on a 0 1 scale obtained from the SSO) was applied to national labor force participation, employment, and average earnings data to estimate disability-related unemployment and productivity losses. The estimates for those in long-term care and disabled were added to obtain total indirect costs. This study stands out for estimating a number of non-medical direct cost items, as well as a comprehensive list of medical care items. Indirect cost items that were addressed were relatively limited, however, with sick days, mortality-related

11 C.E. Begley et al. / Epilepsy Research 33 (1999) costs, and housekeeping-related costs not included. The study did not address the attribution problem, leading to inflated estimates of direct and indirect costs for persons in long-term care and with disabilities. The authors attribute all of these costs to epilepsy, when many of the individuals with epilepsy had co-morbidities. Finally, some of the calculations made in deriving indirect costs were not adequately explained or validated, namely, the assumption that all long-term care patients are unemployed and the use of the disability scale to estimate indirect costs for this population UK About 1600 patients with epilepsy, under the care of a representative sample of general practitioners in the mid-1980s, were followed for one year to estimate the national cost of epilepsy in the UK as part of the National General Practice Study of Epilepsy (Cockerell et al., 1994). This is the only existing study to obtain medical record data on actual patients as the basis for costs. Medical cost measures included inpatient and outpatient care, diagnostic investigations, drugs, and doctor visits. Services were valued using payment data from the National Health Service. Non-medical direct cost items were estimated separately, based on the cost of residential care and special education of individuals at a single site. Average annual direct cost per person was $2600. Indirect cost per person, including mortality- and unemployment-related costs, were inferred from related literature at $5989. In the related National Epilepsy Study (Cockerell et al., 1994), over 600 patients treated by the same sample of general practitioners that were newly diagnosed were identified and followed prospectively for an average of 6.6 years. Longitudinal costs for a list of direct medical care items similar to those included in the prevalence study were estimated. The prospective nature of the study design, the representativeness of the cases (drawn from a random sample of community providers), the relatively comprehensive list of direct cost items, and of the validity of case ascertainment and data follow-up distinguish this study from others in the field. The attribution issue is not addressed in estimating long-term residential care costs and special schooling. Another limitation is the lack of estimates for lost earnings from reduced productivity, sick days, and changes in housekeeping activity USA Until recently, the 1975 USA cost study conducted by the Department of Health, Education, and Welfare was the only comprehensive study available in the USA (CCEC, 1978). In this study, researchers combined provider and population survey data to estimate direct costs per person at $4407. Direct cost items included hospital and physician services and procedures, nursing home and other institutional care, drug costs, vocational rehabilitation, special education, and research. Indirect costs were estimated at $4284 per person, reflecting lost earnings for excess unemployment, lower wages due to reduced productivity, and excess mortality. This study provides the most comprehensive estimates of direct and indirect costs. However, cost estimates of many of the items were based on survey data from states and/or regions of the country, rather than national surveys (there were few national surveys available at the time). A substantial percentage of total costs for nursing home care are overstated due to the failure to consider the attribution issue. The researchers attributed all nursing home and other medical costs of persons with epilepsy in nursing homes, or waiting for admission to nursing homes, to epilepsy without considering other possible causes of their disability. In the early 1990s, Murray et al. (1996) estimated the direct and indirect cost of refractory epilepsy in adults in the USA, using a modeling approach. The study estimated direct costs per case at $2971 and indirect costs at $9418. Direct medical costs were based on routine treatment patterns defined by an expert panel of physicians. Items covered included hospital/physician services, laboratory tests, diagnostic tests, epilepsyrelated drugs, and family caretaker costs. For a

12 50 C.E. Begley et al. / Epilepsy Research 33 (1999) portion of the cases, the researchers added surgery, treatment of adverse drug reactions, and treatment of breakthrough seizures. Both the percentage of patients using a particular service and the frequency of use were estimated by the panel. Medicare payment rates were used to value the services. Indirect costs were estimated for excess unemployment, reduced productivity, and sick days. Estimates of each item were based on judgments from the panel and/or related literature, and valued using national earnings data. Lower wages associated with reduced productivity were assumed to be 20% less than the average hourly wage. This study provides estimates for a relatively comprehensive set of direct and indirect cost items, and is the only study to assess the costs of intractable seizures. The estimates are hypothetical and based on a number of unsubstantiated assumptions. Some key cost items were not addressed including: non-medical direct cost items other than caretaker costs, and indirect costs related to mortality and changes in housekeeping activity. The attribution problem was not addressed. The authors assumed excess unemployment and underemployment rates based on the panel s observation of patients, many of whom may have had other disabling conditions besides epilepsy. Begley et al. (1994) estimated the lifetime costs of epilepsy in the USA for 1990 incident cases using a disease modeling approach. The clinical course of the condition from onset until remission or death was developed for six prognostic groups based on studies in the literature and the judgment of a panel of experts. The distribution of incident cases among prognostic groups was inferred from epidemiological studies of prognosis in epilepsy. Direct costs were estimated by multiplying nationally representative payment rates, obtained from a variety of provider and payer surveys, by medical care utilization estimated by the panel. Indirect costs were estimated for sick days, excess unemployment, and excess mortality based on data from the National Health Interview Survey and the judgment of the panel. Sensitivity analysis was performed on the amount and type of drug therapy. This study provides hypothetical estimates. The list of direct cost items is limited by the lack of non-medical and patient- and family-related items. The indirect cost items addressed were relatively broad, excluding only productivity losses. It is the first study to estimate the cost of household activity losses. It is also the first study to deal directly with the attribution problem. The researchers counted only the medical care costs (not residential costs) of persons in nursing homes in their direct cost estimates. 5. The EFA study A cost study under way since 1993 in the USA is attempting to address many of the methodological shortcomings upon which existing estimates are based. Sponsored by the Epilepsy Foundation of America, the study has two objectives: (1) estimate a cost model of the clinical course of epilepsy from onset until remission or death for different prognostic groups using data from actual patients; and (2) use the model to estimate 1995 annual and lifetime costs. The hypothetical model developed by Begley et al. (1994), that was discussed earlier, will be combined with medical record, billing, and survey data on populationbased patients from different parts of the country to generate the estimates Direct costs As described earlier, the hypothetical model was developed for six different prognostic groups in a previous project based on expert judgment and related literature (Begley et al., 1994). The model specified the stages of treatment of people in each group, the proportion in each group who use specific medical services, and the volume of services used. Treatment stages in the model are initial evaluation, follow-up evaluation and drug treatment, treatment of relapse seizure, surgical work-up, and surgery. Retrospective longitudinal data from two population-based incidence cohorts will be used to estimate the direct cost parameters of the model. A cohort of 275 patients was identified from the

13 C.E. Begley et al. / Epilepsy Research 33 (1999) population of HMO members served by the Kelsey Seybold Group Practice in Houston, Texas from 1988 to The Kelsey Seybold system includes 18 Houston area locations, has over 200 physicians representing 36 specialties and subspecialties, and a department of neurology with four full-time board certified neurologists. The HMO enrolled multiethnic population served by the system was in 1994, representing primarily employment-age individuals and their dependents. Individuals with unprovoked seizure disorder during the study period were identified and followed using medical chart review and detailed case criteria. Another cohort of 335 cases was drawn from the population of Rochester and Olmsted County, Minnesota from 1987 to The population of Olmsted County was in The Rochester cohort was identified in the same manner as the Kelsey Seybold cohort using centralized charts that are part of the on-going Rochester epidemiological project that has successfully conducted over 700 descriptive and analytic studies of this population. Chart abstraction and billing record data will be combined to capture itemized medical treatment services for the seizure disorder for each case from initial diagnosis until December 31, 1995, or until the case was lost to the study due to disenrollment (Kelsey Seybold), outmigration (Rochester), or death. The potential follow-up period will be eight years in the Kelsey Seybold cohort and 9 years in Rochester. Data sources for Kelsey Seybold cases include Kelsey Seybold medical charts and billing records, affiliated hospitals billing records, and Kelsey Seybold out-ofnetwork billing records. Data sources for the Rochester cohort include the Rochester Project Medical Records Linkage System, hospital database, and institutional planning database. The individual item review method will be used to address the attribution problem, separating medical services related to epilepsy from those required for other illnesses Indirect costs Indirect costs will be determined separately through a survey of over 1300 consenting patients seen over a 1-week period between October 1995 and August 1996 at 18 participating epilepsy treatment centers throughout the country and incident cases from the Rochester cohort. While the direct cost study includes persons of all ages, the indirect cost study is restricted to working ages of years. All consenting patients were contacted by phone and asked questions about their epilepsy, labor market experiences, educational attainment, and family background. As part of the consent form, patients were also asked to provide access to their medical charts to obtain information about their seizure characteristics and existence of other disabilities. To estimate the effect of epilepsy on earnings and household production, responses from individuals with epilepsy will be compared to responses from a comparison group. The comparison group will be comprised of individuals from the general population responding to the March 1996 Current Population Survey (CPS). The CPS is collected monthly by the Census Bureau to provide the Federal government with unemployment statistics for the USA. The March CPS is a commonly used source of annual data on individual employment and earnings because this survey asks households about employment and earnings for the preceding year. There are persons between the ages of 18 and 64 in the March 1996 CPS. Regression models of the earnings losses associated with excess unemployment, sick days, reduced productivity, and changes in household activity will be estimated that control for the direct effect of epilepsy and the indirect effect through educational attainment and other confounding factors. In addition, statistical techniques will be used to account for the selection bias that results from directly comparing the earnings of people with epilepsy to people without the disorder in estimating indirect costs National lifetime and annual cost estimates National estimates of the lifetime cost of epilepsy for people from the date of diagnosis of unprovoked seizure disorder in 1995 will be esti-

14 52 C.E. Begley et al. / Epilepsy Research 33 (1999) mated by applying the COI model to 1995 incidence cases. In the model, prognosis for different incidence cohorts is expressed in terms of the probability that each cohort will experience a given condition over time-remission, continued seizures with medication, or relapse seizures upon withdrawal from medication, and the associated direct costs. The cohort study will be used to validate those probabilities. The model specifies the sequence of treatment stages and outcomes for age-specific persons in each prognostic group and the major medical services used in each stage. These parameters of the model will be valued using data from the cohort studies. The indirect cost survey will be used to estimate lost earnings and household production for the cohorts that will then be applied to the cost model to estimate national indirect costs. The expected losses of individuals in the cohorts over their lifetimes will be estimated by multiplying estimated losses at each age for similar persons in the survey by the probability that the person will reach that age. A national estimate of the annual cost of epilepsy for all people with epilepsy in 1995 will be made by simulating the lifetime costs of successive incidence cohorts who contributed to the prevalence in that year. The mortality of those within each prognostic group will be considered to determine the distribution of prevalence cases by prognostic group. The treatment model will provide estimates of the stage of treatment of individuals within each prognostic group, their annual use of resources, and the associated costs. Indirect costs will be estimated by applying estimates from the indirect cost regression model to each prevalent case and summing across individuals. A sensitivity analysis will be conducted to determine how sensitive the results are to the parameters of the model. The effect on aggregate costs of a number of different assumptions about various direct and indirect cost items will be examined. 6. Discussion Existing studies provide a range of estimates of the total cost of epilepsy in different countries, the average cost per person, the distribution between direct and indirect costs, and the variability in the cost burden across different groups. The methods and data sources used in these studies are variable and limited, leading to estimates that are variable and not directly comparable. This paper adds to the review of these studies by Johnson and Nuwer (1997) by critically evaluating existing methodologies and suggesting guidelines for future research. Major areas of concern are: the variability in the types of cost that are estimated, particularly the lack of consideration of non-medical and patient- or family-related direct costs and indirect costs related to changes in household activity; the failure to adequately address the attribution problem, particularly with regard to long-term residential care; the reliance on survey data for estimates, with its inherent flaws in case identification and service information; the failure to consider costs associated with initial seizures; and the inability to determine costs across the spectrum of severity. These methodological problems are offsetting in terms of their effect on cost, so it is not clear how to interpret existing estimates. A recent UK study was the first to obtain detailed medical record and payment data on actual patients to estimate direct costs. The EFA study, described here, represents the first effort to follow this method in the USA, adding an item review technique to address the attribution problem. Using a national survey of persons with epilepsy that will be compared to a similar survey of the general population, the indirect cost component of the EFA study is the first of its kind to examine interrelated variables that may affect employment decisions for persons with epilepsy and to control for the selection bias that results from direct comparisons of earnings of persons with and without epilepsy. The EFA study will also attempt to capture the variation in cost across the spectrum of severity in epilepsy, from patients who have very limited seizures and respond to treatment quickly, to patients whose seizures persist. A

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