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Indian Journal of Cancer, Vol. 48, No. 4, October-December, 2011, pp. 428-437 Breast - Original Article Expenditure audit of women with breast cancer in a tertiary care hospital of Delhi S Pakseresht1, GK Ingle2, S Garg2, MM Singh2 1 Department of Obstetrics, Guilan University of Medical Sciences, Rasht, Iran Code Number: cn11121 PMID: 22293256 Abstract Background: Breast cancer is associated with substantial medical and economic burden. This study assisted the expenditure incurred by the subjects on diagnosis and treatment till the period of follow-up. Keywords: Breast cancer, cost, women Introduction Worldwide, around 10 million individuals develop cancer each year; this figure is expected to increase to 15 million in 2020. [1] The present communication attempts to provide a scenario for cancer in India during the year 2001 and its likely change by 2016 for all sites of cancer as well for selected leading sites. During the year 2001, nearly 0.80 million new cancer cases were estimated in the country and this can be expected to increase to 1.22 million by 2016 as a result of change in size and composition of population. [2] For all cancers, the total economic burden of this disease worldwide was projected by the authors to be in the range of $US 300-400 billion in 2001 (about $US 100-140 billion as direct costs and the remainder as indirect costs [morbidity and mortality). [1] Breast cancer inflicts large costs on the population, both direct and indirect, but the costs have been difficult to measure. [1] Direct medical cost estimates based on the National Medical Expenditure Survey and National Hospital Discharge Survey address inpatient care only. [3] Breast cancer is associated with substantial medical and economic burden. The management of breast cancer accounts for a large percentage of health care budget. [4],[5] There is a limitation about this, the aim of this study was to estimate expenditure audit of women with breast cancer in a tertiary care hospital in Delhi. Definition Direct medical cost, the types of direct medical cost include physician fees, laboratory tests, radiological procedures, rehabilitation, medical equipment and long-term care. Indirect medical cost, expenditures such as food, transportation, lodging, family care, home aides and clothing are results of an illness but do not involve purchasing medical services. [4] Materials and Methods The present prospective study was conducted in a 1600 bedded hospital attached to a medical college in India. The hospital provides services to more than one million patients per year from Delhi and neighboring states. [6] A case series of patients studied at the time of diagnosis and all women with primary breast cancer, detected in surgery Out Patient Department (OPD), were included in the study and they were followed up for 6 months after getting various treatment modalities such as surgery, chemotherapy and radiotherapy. Patients with past history or recurrence of breast cancer, having metastasis at the time of diagnosis, reconstructive surgery, with severe psychiatric illness, any other cancer was excluded of study. The study was started from January 2006 to December 2007. Period of data collection was 2 years. From 1st January 2006 to 31st May 2007 baseline data was collected (at the time of diagnosis). From 1st July 2006 to 30th November 2007 post-treatment data was collected (6 months after treatment). Data collection The diagnosis of breast cancer was made by the surgeon on the basis of physical examination and fine needle aspiration cytology (FNAC)/core biopsy report. After the diagnosis, the informed consent was taken from each of the patient and was interviewed using pretested, prestructured questionnaire. Then the questionnaire which one was made by authors validate by 12 people of medical college members. This constituted the baseline data (at the time of diagnosis).The investigator has taken the help of a trained person who could communicate in local language with the subjects. Interview of each patient took approximately 45-60 minutes to complete the questionnaire. Depending on the type of treatment required, these subjects were referred to surgery, chemotherapy and radiotherapy department by the surgeon for further management. They were reinterviewed 6 months after the treatment. The initial interview was carried out for all 172 study subjects and baseline data was collected. During the study period 69 (33.7%) study subjects were lost to follow-up (11 due to death and 58 for their preference to other hospitals located in other cities and other technical difficulties). All the possible efforts including repeated phone calls and visits to other hospitals (they were referred because radiotherapy in this hospital was out of order temporarily) were made to contact the study subjects when they did not come for follow-up. In spite of multiple attempts, finally, the after treatment data could be collected from 103 study subjects only. Baseline data comprised of demographic and social profile of women with breast cancer and the cost incurred by the subjects on the diagnosis and treatment. Data on cost were collected at the time of diagnosis and after treatment. Self-structured questionnaire for the data collection was used. The questionnaire consisted of three parts: Part I, sociodemographic profile; Part II, obstetrical, medical and family history; and Part III, cost incurred by the subjects and by insurance on the management of breast cancer. All the questions were checked for completion of information and the responses were coded for entry in the computer. The information was transferred to a computer by using the Microsoft the statistical package for the social science (SPSS-pc) version 14.0 statistical programs. Descriptive statistics and correlation analysis were used to characterize demographical and medical direct and indirect costs of the subjects. All statistical tests were done to determine any significant difference at 5% level. The study was approved by the ethical committee of the Medical College. All study subjects were explained about the nature and purpose of study and informed verbal consents were taken prior to the administration of the study instrument. The subjects were not denied treatment if they refuse to participate. There were no coercion at any stage and she could withdraw at any stage of study. Confidentiality of the information provided by the subjects was protected. Results Estimates of cost incurred by the patient on diagnosis and various aspects of treatment, which include direct and indirect and total medical expenditures was taken into consideration. Total study subjects were 172, out of which 135 (78.5%) came directly to hospital, 37 (21.5%) first went to private setup for consultation, investigation or hospitalization. Only three persons had insurance. Hence huge range of medical costs was observed. Only 103 (75 out of the 135 and 28 out of the 37) subjects were followed from diagnosis to 6 months of treatment. [Table - 1] shows the median and range of cost variables of breast cancer before and after intervention. The median direct expenditure was Rs. 4800 (before intervention Rs. 100 and from diagnosis to 6 months of treatment Rs. 4500). The median indirect expenditure was Rs. 6300 (before intervention Rs. 1000, and from diagnosis to 6 months of treatment Rs. 5400). The median total direct and indirect expenditure was Rs. 12,100 with the range of Rs. 0-54,000 (before intervention Rs. 1300; and from diagnosis to 6 months of treatment Rs. 10000). According to stage and other risk categories some subjects also received different chemotherapy regimens. Most of the patients received standard regime of chemotherapy including 5- fluorouracil, epirubicin and cyclophosphamide (FEC), cyclophosphamide, methotrexate and adinamycin (CAM) were widely used, though it is costly. Medical care varied according to stages of breast cancer at the time of diagnosis and at the time of 6 months follow-up. Total direct and indirect costs were studied according to stages of cancer. The largest component of total direct medical costs was in stage I (median Rs. 6530), total indirect costs (median Rs. 7500) and median total cost was Rs. 17,600 [Table - 2]. [Table - 3] shows the total direct (median; Rs. 5900), total indirect costs (median; Rs. 7600) and the total expenditures (median Rs. 13,100) were the highest in younger age group (< 40). The total expenditures (median Rs. 12,100) were the second highest in the older age group (> 60years). [Table 3.1] shows that the cost before treatment (median Rs. 1600) and the cost from diagnosis to 6 months of treatment (median Rs. 11,000) was the highest in younger age group (< 40). [Table - 4] shows, the median cancer-related direct, indirect costs and total medical expenditures (Rs) was less amongst the subjects living in the state of Delhi as compared to others (Uttar Pradesh, Haryana, etc.) [Table - 5] shows the comparison of cost among study subjects with/without visiting private setup before coming to hospital before treatment. The median direct expenditure was higher in subjects who visited private setup before coming to Hospital (Rs. 2600) than those who came directly (Rs. 100). [Table 5.1] shows the comparison of cost among study subjects with/without visiting private setup before coming to hospital after the treatment. The median direct expenditure was higher in the subjects who visited private setup before coming to hospital (Rs. 8250) than those who came directly (Rs. 4500). Whereas the median indirect expenditure was higher in the subjects who came directly (Rs. 5400 verses Rs. 3350) Discussion Breast cancer accounts for 19-34% of all cancer cases among women in India. According to national and regional cancer registries, it is the most common cancer among women in Delhi, Mumbai, Ahmedabad, Kolkata and Thiruvanathpuram. In all other Indian registries, it is listed as the second leading site of cancer among women. The age-standardized incidence rates vary from 9 to 28.6 per 1,00,000 women, the lowest being from the rural area-based registry barshi. [7],[8] During last decade, survival rate for breast cancer patients have increased as a result of relatively earlier detection. Limited data exists on the sociodemographic profile and cost of the treatment. Baseline data was collected for all 172 study subjects. During the study period, 33.7% (69) were lost to follow-up. One-year follow-up of patients were 42% by Ganz (2004), [9] 86% by Wenzel LB (1999) [10] in United States. Arndt V (2005) [11] reported follow-up of 50% patients in Germany for similar period. Fallowfield LJ (2006) [12] could follow 85% patients for 2 years in UK, King MT (2006) [13] found response rate of 93% at 3 months and 88% at 1 year in Australia and 83% by Twillman R (2000) [14] in Swarowski. Ohira T [15] (2006) reported 91.9% follow-up for 6 months after intervention in Philadelphia. Parmar V (2006) [16] reported that out of the 299 women at first visit, 274 (91.6%) completed the second visit questionnaire and 239 (80%) completed the third visit questionnaire. Only those women who filled the questionnaires at all three visits were included as ′valid visits′ for analysis (193 of 299; 64.5%), Ramanakumar AV (2005) [17] reported that out of the total of 80 patients interviewed initially only 52 subjects could be followed up completely in Mumbai. Differences may be due to different country with different sociodemographic characteristics. In current study, the mean age of subjects was 46.99 years (SD=12.64, median 45, range 25-80 years). Pandey M [18] reported the mean age of the subjects to be 47.6 years (SD=11, median 47, range 20-80 years). Saxena S [19] reported 40.9 years (median 40, range 13-78 years). In a study, Vinod R [7] showed that the median age was 47 years (range 23-82 years) and Mousavi SM, [20] Matthews G, [21] reported the mean age of 51.5 years. Pinto BM, [22] reported the mean age of 57.4 years. Vinod R reported that the incidence rates in India began to rise in the early 30s with peak at age between 50 and 64 years. In the US, rates peaked at the age group of 75+ years. Age-specific incidence rates in India remain relatively stable compared with the US where rates rise dramatically after 65 years of age. [7] In present study, 2.9% subjects were below 30 years. For same age other studies reported the prevalances as Sim X (0.3%), [23] El Saghir NS (4.7%) [24] and Hisham AN (2 %). [25] In this study, 38.4% of the subjects were ≤ 40 years. For similar age group other studies also reported the highest by Hisham AN (16.8%), [25] Saxena S (22%) [19] and Smigal C (23 %), [26] while other studies by Sim X, [23] Palmer GR, [27] Eng SM, [28] El Saghir NS, [24] Do MH, [29] Murtaugh MA [30] and Hisham AN [25] the higher prevalent age group was 40-49 years. In studies, by Yip CH and El Saghir NS over 50% of the cases were from under 50 years age, as compared to 63 in industrialized nations. [25],[31] Saxena S showed that 31.8% belonged to age group of 45-54 years. [19] Earle C reported that 77% of breast cancer occurs in women > 50 years. [32] In the current study, the mean and median age of the study subjects was similar to the findings of other researchers Sim X, [23] Pandey M, [18] Saxena S, [19] Smigal C, [26] Nichols HB, [33] Suh YO [34] and Vinod R. [18] In most of the Indian studies the median age at presentation was 47 years, significantly lower than most of the Western figures. In current study, 70.3% subjects were living with their spouse. Fallowfield LJ (2006) [12] could follow 85% patients for 2 years in UK, King MT (2006) [13] found response rate of 93% at 3 months and 88% at 1 year in Australia and 83% by Twillman R (2000) [14] in Swarowski. Ohira T [15] (2006) reported 91.9% follow-up for 6 months after intervention in Philadelphia. Parmar V (2006) [16] reported that out of the 299 women at first visit, 274 (91.6%) completed the second visit questionnaire and 239 (80%) completed the third visit questionnaire. Only those women who filled the questionnaires at all three visits were included as ′valid visits′ for analysis (193 of 299; 64.5%), Ramanakumar AV (2005) [17] reported that out of the total of 80 patients interviewed initially only 52 subjects could be followed up completely in Mumbai. Differences may be due to different country with different sociodemographic characteristics. Remaining included widowed (27.3%), divorcee (1.2%) and unmarried (1.2%). Similar findings reported in other studies by Mahouri K [35] and Pandey M. [18] In this study, majority of the subjects (52.9%) originally belonged to urban areas. As per 2001 national census, 72.2% of Indian populations belong to rural area. [36] Sim X reported that 55%, and Jayalekshmi P 60%, of the women came from the rural areas. [23],[37] Dalton SO reported an urbanFallowfield LJ (2006) [12] could follow 85% patients for 2 years in UK, King MT (2006) [13] found response rate of 93% at 3 months and 88% at 1 year in Australia and 83% by Twillman R (2000) [14] in Swarowski. Ohira T [15] (2006) reported 91.9% follow-up for 6 months after intervention in Philadelphia. Parmar V (2006) [16] reported that out of the 299 women at first visit, 274 (91.6%) completed the second visit questionnaire and 239 (80%) completed the third visit questionnaire. Only those women who filled the questionnaires at all three visits were included as ′valid visits′ for analysis (193 of 299; 64.5%), Ramanakumar AV (2005) [17] reported that out of the total of 80 patients interviewed initially only 52 subjects could be followed up completely in Mumbai. Differences may be due to different country with different sociodemographic characteristics. -Rural gradient, with higher risk among rural women and lower risk among women in the capital suburbs and capital area. [ 38] Hebert JR showed notable differences was observed between rural and urban areas in India, while such differences appear to be much smaller in the US. [39] These differences might be due to location of hospital in urban area. Majority (68%) of the subjects in this study were Hindus while Muslims constituted the second largest group. Only one patient was a Sikh and one a Christian. At the national level, as per census (2001), [40] of 1028 million population, 828 million (80.5%) have written their religion as Hindus followed by 138 million (13.4%) as Muslims and 24 millions (2.3%) Christians. Nineteen million (1.9%) persons follow Sikh religion. In a study, Pandey M reported majority (64.3%) of the subjects as Hindu and 14.1% as Muslim. [18] These differences might be due to geographical variation. In this study, 62.2% subjects and 45.3% of spouses were illiterate. While, in similar study Pandey M reported only 4.6 % subjects and 2.4% spouses as illiterate. [18] Sim X reported, 14.4% of women had education of degree and above. [23] This difference may be due to different levels of education in different places. In this study, 95.3% subjects were housewives. A similar study, by Pandey M revealed 75.7% women as unemployed. [18] These could be due to their poor socioeconomic background and lack of education. According to modified Mahajan and Gupta socioeconomic status scale, most of the subjects (40.4%) belonged to lower middle class among per capita of per month income (Rs. 1400-2809) [Figure - 1]. In this study 79.1% subjects had parity of at least four children. 75.6% had breast fed < 4 children. In a study, Gadi VK revealed 32% of subjects had three or more children. [41] Studies by Smith AR, Gangadharan P showed pregnancy may have protective effects against cancer development because risk of breast cancer appears to decrease with each additional child. [42],[43] Claus EB, Paillocher N revealed that the additional babies after the first provide additional long-term protection of approximately 7.0% per birth. [44],[45] This study revealed that the median total direct expenditure was Rs. 4800 (before intervention Rs.100 and from diagnosis to 6 months of treatment Rs. 4500). The median total indirect expenditure was Rs. 6300 (before intervention Rs. 1000, and from diagnosis to 6 months of treatment Rs. 5400). The median total direct and indirect expenditure was Rs. 12,100 with the range of Rs. 1230-54000 (before intervention Rs. 1300; and from diagnosis to 6 months of treatment Rs. 10,000). Out of all the cost spent for breast cancer the direct expenditure was 37%. According to income parameter of modified Mahajan and Gupta scale, most of the subjects (40.4%) belonged to lower middle group (Rs. 1400-2809). It showed that per capita income of the patients as compared to their expenditure for treatment of breast cancer was less. Lidgren M reported that for subjects less than 65 year of age, indirect costs accounted for more than 50 percent of the total cost. [46] McKoy JM reported that the overall cost of cancer in 2005 was $209.9 billion--$74 billion for direct medical costs and $118.4 billion for indirect mortality costs, the mean total direct medical cost for breast cancer was $35,164 annually per patient.- [47] Radice D reported that, for all cancers the total economic burden of this disease worldwide was projected by the authors to be in the range of $ 300-400 billion in 2001 [about $ 100-140 billion as direct costs and the remainder as indirect costs (morbidity and mortality)]. [48] Arozullah AMFallowfield LJ (2006) [12] could follow 85% patients for 2 years in UK, King MT (2006) [13] found response rate of 93% at 3 months and 88% at 1 year in Australia and 83% by Twillman R (2000) [14] in Swarowski. Ohira T [15] (2006) reported 91.9% follow-up for 6 months after intervention in Philadelphia. Parmar V (2006) [16] reported that out of the 299 women at first visit, 274 (91.6%) completed the second visit questionnaire and 239 (80%) completed the third visit questionnaire. Only those women who filled the questionnaires at all three visits were included as ′valid visits′ for analysis (193 of 299; 64.5%), Ramanakumar AV (2005) [17] reported that out of the total of 80 patients interviewed initially only 52 subjects could be followed up completely in Mumbai. Differences may be due to different country with different sociodemographic characteristics. Reported that the out-of-pocket expenditures and lost income costs averaged $ 1,455 per month and varied widely. The majority of out-of-pocket costs were for copayments for hospitalizations and physician visits. [49] Similar finding by Chang S reported that the cancer accounts for $ 60.9 billion in direct medical costs and $ 15.5 billion for indirect morbidity costs. [50] Barron JJ showed that the annual costs for a breast cancer patient would be at least $ 12,828 higher than that for women without breast cancer based upon unadjusted cost differences. [51] According to the National Institute of Health (NIH), Radice D showed the total cost of cancer was estimated at $ 156.7 billion ($ 56.4 billion as direct costs, $ 15.6 as indirect morbidity costs and $ 84.7 billion as indirect mortality costs). Based on limited information, in the US, breast cancer can be projected to account for about one-fifth/one-fourth of the total cost of cancer. [48] Earle C estimated the average 20-year cost of a case of breast cancer in Canada is $ 26,288. [52] Lidgren M reported that the total cost of breast cancer in Sweden in 2002 was estimated at 3.0 billion SEK (1 < euro > = 9.4 SEK). The direct costs were estimated at 895 million SEK (30%) and indirect costs were estimated at 2.1 billion SEK (70%). The main cost driver was production losses caused by premature mortality, amounting to 52% of the indirect costs. [53] The total cost of breast cancer, direct as well as indirect varied in different studies, the reason being different methods of estimation and different inclusion criteria in direct as well as indirect cost. This study showed that the median total cost of medicine per patient was Rs. 2900 (range Rs. 0-30,000). The cost of medicine was 54% of the direct cost and 20% of the total expenditure that was spent. In a study by Hisham A.N reported that the costs for administration of antineoplastic drugs contributed the least. Of that receiving antineoplastic drug therapy, nearly all (99%) received it in an outpatient setting. [25] McKoy JM considered emerging targeted cancer drug costs range from $ 20,000 to $ 50,000 annually per patient. [47] The observed wide range in the cost of treatment was because of kind of regime of the drugs and availability of the drugs on cost or free-of-cost in the hospital. This study showed that the median total transportation cost per patient was Rs. 3400. The transportation cost was 70% of the indirect cost and 33% of the total expenditure that was spent. Longo CJ reported that the mean monthly out-of-pocket cost was $ 213, with an additional $ 372 related to travel costs. [54] In the present study the cost varied according to stages of breast cancer. As the stage advances the median direct cost increases from stage II to stage IV. The direct cost in stage I was more but it was not significant as the number of subjects in this stage was small. The indirect cost and total of direct and indirect cost also shows increasing trends with stages. Taplin SH presented the total continuing medical care costs increased with stage at diagnosis for breast cancer. [55] The results of other study, Lidgren M showed that the total cost vary by stage at diagnosis. [46] Earle C estimated that the more advanced the stage of cancer the greater the cost; for a woman aged over 50 the cost is $ 13,888 for stage I compared to $ 64,340 for stage IV. [52] Radice D reported breast cancer treatment costs are higher in the US than in other developed countries. Both direct and indirect costs are dependent on disease stage. [48] The present study showed that the total direct (median Rs. 5900), total indirect costs (median Rs. 7600) and the total expenditures (median Rs. 13,100) were the highest in younger age group (< 40). The total expenditures (median Rs. 12,100) were the second highest in the older age group (> 60 years). Also the cost before intervention (median Rs. 1600) and the cost from diagnosis to 6 months of treatment (median Rs. 11,000) was the highest in younger age group (< 40). Cancer subjects who were elder than > 60 years with medicare coverage had lower expenditures than younger age groups. Similar studies by Feuer EJ, Gordon L, Longo CJ, Rains SA, Lidgren M reported that the breast cancer costs vary by age. [56],[57],[54],[58],[46] Barlow WE reported that the cost also varied by age, with women under 65 years having higher treatment costs than older women. [59] Taplin SH reported that the total initial costs decreased with age for breast cancer. [60] Lidgren M reported that for subjects younger than 65 years of age, the first year after a primary diagnosis total cost amounted to 280,000 SEK ($ 39,000) and the first year after a local or contralateral recurrence total cost was 351,000 SEK ($ 48,900), and for subjects older than 65 years of age, the total cost for the first year after a primary diagnosis amounted to 80,000 SEK ($ 11,200) and the total cost for the first year after a local or contra lateral recurrence was 92,000 SEK ($ 12,900). [46] Gordon L reported that the younger women (≤ 50 years) with positive lymph nodes experienced costs 80% greater than older women ($ 8880 versus $ 4937, P<0.001). [57] Earle C estimated that the cost of breast cancer for women under the age of 50 was $ 28,880, while for the woman over 50 it was $ 25,514. [52] The cost of the breast cancer was the highest in the younger age group (< 40 years) followed by the older age group (>60years). These findings are consistent with the findings of most of the researchers. This difference may be because of different stage of cancer by age, and different payments negotiated by Medicare, or it might be because of younger subjects receiving more aggressive treatments or they are more sensitive to Medicare treatment. The present study showed that the median cancer-related direct, indirect costs and total medical expenditures was less among the subjects living in the state of Delhi as compared to others (Uttar Pradesh, Haryana, etc). The difference in indirect cost was statistically significant (P < 0.05). The total direct costs and total medical expenditures were significantly higher (P<0.05) in rural area compared to urban area by independent samples test. It may be related to location of living, travel costs, foods and lodging, etc. The present study showed that the median direct expenditure (before intervention) as well as (from diagnosis to 6 months of treatment) were higher in the subjects who visited private setup before coming to Hospital than those who came directly (Rs. 2600 versus Rs. 100) and (Rs. 8250 versus Rs. 4500), respectively. Most of the services (like availability of the drugs) at this hospital were free. Although the objective of this study was not to compare the cost of breast cancer treatment between government and private or medicare-insured cancer subjects, we observed that there was significant difference between government and private services. In conclusion, our study estimates the direct and indirect medical costs for a range of cancer subjects on the basis of sociodemographic characteristics, place of residence and cancer stages. Cost of treatment for breast cancer depends on many factors, including the size and stages of the cancer, the woman′s age, perhaps the costs of treatment (different regimens), private hospital and insurance. In fact, most of subjects in this study were illiterate, living in rural area, unemployed and of lower-income group (low sociodemographic), so there were certain limitations to answer some items of cost and moreover, with the small sample size; it could not be possible to analyze all items separately. The limitations of this study are: 1-General tendency of the subjects is not to reveal the cost correctly, and some of them did not report clearly, thus, cost estimation may not be accurate. 2-This study was not able to determine precisely the cost of lost wages due to disease (worklessness), lodging, food, physician fee, indoor admission charges, etc., thus, study of cost estimates do not cover costs of many individuals correctly. The economic burden attributed to the breast cancers is considerable and indicates a need for increased prevention, earlier diagnosis, kind of investigation and different therapies that may assist in reducing direct, indirect and total costs. References
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