Objective: To assess the costs associated with tuberculosis treatment to the public health services and to the patients.
Study design: Prospective data were collected from patients and followed-up until completion of their medication. Pharmacoeconomic methodology was applied to calculate direct and indirect costs.
Results: Three hundred and twenty tuberculosis patients were included in the study. Pulmonary and extra pulmonary regimens of treatment were used. The direct medical, direct non-medical and indirect costs for pulmonary TB were calculated and were found as follows: US$ 20.16 for anti-tuberculosis drugs, US$ 18 for x-ray examinations, US$ 5.4 for laboratory tests, US$ 5.33 for healthcare staff time, US$ 0.7 for overhead, US$ 33 for transportation and US$ 73.1 for time away from work, Cost to the patients constitutes approximately 67.2% of the total costs of treatment. While the cost for extra pulmonary TB were found US$ 30.24 for anti-tuberculosis drugs, US$ 2.5 for healthcare staff time, US$ 1.2 for overhead, US$ 93.8 for transportation and US$ 51.9 for time away from work, Cost to the patients constitutes approximately 87% of the total costs of treatment
Conclusions: The cost of illness of pulmonary TB per patients was US$ 161.2, while for extra pulmonary TB per patients was 322.8, cost of anti-tuberculosis drugs constitutes the highest proportion of the costs to the public health services (38.1%) and (78%) for pulmonary and extra pulmonary TB respectively, the cost to the patient constitutes the major proportion of the total cost of illness (67.2%) for pulmonary and (87%) for extra pulmonary.
Keywords tuberculosis, patients, costs, pharmacoeconomic, Sana'a, Yemen.
WHO and published reports considered the TB is the largest single infectious killer disease in the world although the availability of effective anti-tuberculosis drugs.
Statistically speaking, Mycobacterium tuberculosis infects one-third of the world's population and is the most common single death causing agent in young adults (1). Globally, it accounts for 2.5% of the other diseases. However, the consequences of tuberculosis (TB) on society are huge. Worldwide, one person out of three is infected with tuberculosis, i.e. two billion people in total. Currently, it holds the seventh place in the global ranking of the causes of death. (2, 3, 4).
Economically speaking, TB hinders socioeconomic development for the high percentage of the disease, 75%, afflict the productive age group that ranges between 15-54 years. Furthermore, ninety-five per cent of all cases and 99% of deaths occur in developing countries, with the greatest burden in sub- Saharan Africa and South East Asia (5, 6).
The estimated cost of TB treatment in patients with susceptible tuberculosis in developed countries ranges from US$ 276 to US$ 1546 and for multi-drug resistant tuberculosis (MDR-TB) ranges from USD 1000 to 10000. (7, 8). Determining the approximate costs for effective tuberculosis control is an important factor in specifying the actual expenditures required for treating tuberculosis. A matter that could be achieved by taking into consideration both the direct and indirect costs of tuberculosis.
Tuberculosis is still one of the major problems in Yemen and Yemen was considering one of the high burden countries in the region for long time based on latest evaluation of TB which had done by National-Wide Survey of the Tuberculin Testing among school children (9).
The annual expected incidence of NSS+ is =8480, and same number of other forms of Tuberculosis. The most recent estimated of tuberculosis in Yemen published by WHO (2007) shown that; the annual incidence of NSS+TB cases= (37/100,000 Population), which means = (7297 NSS+TB cases/Year), and for all forms of TB cases= (82/100,000 population), the capital city of Yemen, Sana'a city had the second one of highest cases for all forms of TB and the first one of cases of extra pulmonary diseases compared to other governorates.
This study was Assessment economic burden of pulmonary and extra pulmonary tuberculosis in Sana'a, the capital city of Yemen, for the patient and the health services and providing government with good data concerning the cost of tuberculosis diseases. So, the study will enable estimating the public health expenditures on tuberculosis treatments, investing its results by using an effective and accurate financial policy for the tuberculosis control, it also may help in the assessment of economic burden of tuberculosis in capital city Sana'a, allocation of resources and sets of priorities for tuberculosis control activities, give estimation for the total budget needed for National Tuberculosis Control Programme and encourage the health authorities to pay for prevention and early detection of tuberculosis infection before progression to disease in order to save large amount of money needed for treatment of tuberculosis diseases
Prospective prevalence-based pharmacoeconomic evaluations were used in this study. The study total cost stems from two sources: direct and indirect costs. Direct medical cost includes the cost of prescribing medication, diagnostic laboratory tests, x-ray films, reagents and supplies for X-ray departments and the cost of the time taken by health professional workers. Indirect medical cost includes the cost of transporting to and from center, telephone bills, electric and water bills. During this period, the rate of the estimated cost of building consumption, vehicles and other pieces of furniture is excluded while of the time away from work is counted for 48 patients. Indirect cost is calculated by multiplying the average cost of the time lost due to illness with the average of daily earning. Costs were obtained from TB center and health facilities in Sana'a city. All costs were calculated in Yemen currency (YR) and converted to the United State dollar at the 2009 exchange rate of US$ 1.00= YR 200.
The republic of Yemen is located on the south west of the Arabian Peninsula occupying 555.000 km and having a population of about (19,607,345) according to the last census on December 2004. Sana'a is the capital and one of twenty two cities in Yemen. It is situated in the north and has a population of (1,747,834). It is selected for this study for its high TB prevalence as compared to other cities (Annual report of NTCP 2007). Sana'a TB Center is selected to be the sample location of the study because it is characterized by being a large and rich medical TB centre with caseload, data availability, consultants, and with a good recording and reporting system which takes into consideration, The study populations consist of all tuberculosis patients, who started a new course of tuberculosis treatment at TB Sana'a center from March 1, 2008 until August 10, 2009. All Patients pulmonary and extra pulmonary was visited the center during working hours to take their medication. It was estimated that the pulmonary TB patients come eight months during the treatment period, so s/he comes 14 times to pharmacy (because in the first two months, checking should be weekly and after that it becomes once per month). While in case of extra pulmonary, the duration of treatment is 12 month, so s/he comes 12 times to pharmacy. Patients transferred from the Sana'a TB center to complete their treatment in other health center in other city, defaulted patients , Subjects with major co morbidity (HIV, malignancy, diabetes, underlying cardio respiratory disease, rheumatic disease, psychiatric disease), or if the patient die were excluded from the study.
The drug regimen prescribed according to the type of TB disease, if susceptible positive pulmonary tuberculosis, the initial (intensive) phase: 2HRZS (E); i.e., isoniazed, Rifampicin, pyrazinamide and either streptomycin or ethambutol, given one time daily for 2 months( 8 weeks), patients in this intensive phase should come to the health facility every week to collect their drugs. Continuation phase: 6HT, e.g. isoniazed and thioacetazone daily for six months, patients should come to the health facility every four week to collect their drugs for self administration at home in this phase. While the regimen of extra pulmonary and negative pulmonary was the initial intensive phase: 2HTS (E), i.e., isoniazid, thioacetazone and either streptomycin or ethambutol, patients should come to collect their drugs every month from TB center for self administration at home.
Continuation phase: 10 HT i.e., isoniazid and thioacetazone daily for 10 months. Patients should come to healthy facility every month to collect their drugs for self administration at home.
Statistical Package for the Social Sciences (SPSS) for windows version (12.0) and Microsoft Excel were used for data analysis. All descriptive statistics and appropriate Chi square test was used in the analysis. Statistical significance level used is 0.05 with confidence interval of 95%.
The study including 160 pulmonary TB patients and 160 extra pulmonary TB patients, in our study population include 74 (46%) in pulmonary TB while females were 86 (54%). In extra pulmonary TB, the percentage of females were approximately twice than males, i.e., 99 (62%) for females as compared to 61 (38%) for males. And the majority of pulmonary TB patients within an economically productive age group, ranging from 15-54, to register a percentage as high as 144 (89%) whereas 149 (93%) was for extra pulmonary TB.
All costs of anti-TB drug were calculated according to the standard government drug price, US$ 3225.6 for pulmonary TB for 160 patients (US$ 20.2 for each patient), while US$ 4838.4 for pulmonary TB for 160 patients (US$ 30.2 for each patient).
Diagnosing TB by using x-ray is unreliable because other chest diseases can look like TB on x-ray. The study used 320 films and by multiplying this number with the cost of each film, US$ 8.5, the total x-ray films including supplies and reagents was US$ 2880 with US$ 9, an average cost of each patient cured. Out of these costs, patients pay only one US$ in the first time and later any other x-rays will be free.
Bacteriologic examination of sputum is the only way by which the diagnosis of pulmonary TB can be confirmed in most developing countries & the patients are cured. Sana'a TB Centre does only acid fast bacilli (AFB) for positive pulmonary and sputum culture and AFB for the negative pulmonary patients. Patients are required to pay only one US$ in the first time and nothing in any others tests. Calculating acid fast bacilli test for TB patients can be done by multiplying the amount of items used in milliliters in the cost of milliliters. Moreover, calculating the total cost of this test for all patients is achieved by multiplying 0.9 (the total cost per patient) by the number of pulmonary patients, 160, and then by 6 times; it was found US$864 for 160 patients and US$ 5.4 for each patient.
Health Staff Time
In this study, the health staff consists of all staff types that deal with different TB diagnosis and treatment sections. Calculating such a cost can be done by adding all the cost of time of health workers in x-ray, laboratory, pharmacy, and chest clinical sections per minute, and according to Yemen government salary. It was found the total cost the public health staffs was US$ 836.04 in case of pulmonary TB and US$ 395.8 in case of extra pulmonary TB.
Indirect Medical Cost
Cost of overhead can be done by calculating electricity expenditures in TB Center, water bill and telephone bill throughout the period of the study. This study excluded the cost of equipment machines and building. The cost was obtained from the staff in the management office who estimated the cost according to the actual bills of the TB center. The total cost was US$ 107.4 in case of pulmonary TB and 161 in case of extrapulmonary TB.
Cost of Transportation
TB patients were living in different inhabited areas in Sana'a capital city and some of them came from other governorate, some of them came back to his/her governorate and others gave a local address in Sana'a. The cost of transportation was calculated by multiplying by the times s/he comes to the center with the number of patients and take the average for each area, The transportation cost per patient was US$ 33 which constitutes 30.4% from the total cost to the pulmonary TB patient, while US$ 93 which constitutes 29% from the total cost to the extra pulmonary TB patient.
Cost of time away from work
Cost of time lost due to the illness was calculated for 48 patients. Such a cost was counted by multiplying the time period during which s/he was incapable of doing his/her work due to illness and with his/her monthly income when being healthy and when working. For the 48 patients who were working, their time lost when being away from work was 622 days and the average time spent away from work was 12.9 days
Table (1) calculates the time lost in terms of money depending on the patients' monthly income (170.2 in case of pulmonary and USD 120.7 in case of extra pulmonary) and the average time lost by the patient. The average of money lost was US$ 73.2 and US$ 51.9 in case of pulmonary and extra pulmonary patients, respectively.
Total Cost of Health Services
The expenditures related to the treatment of TB help policymakers to issue better decisions and plans in the future. Table (2) illustrates the total cost of different health sites that deal with pulmonary TB patients. Government expenditures on drugs treatment were close to half the total costs of health services (38.2%) and to that of X-ray examination (34.1%).
The total number of patients was 160 in this regimen, and the cost of pharmacy and chest clinic staff time spent on extra pulmonary patients was US$ 395.8. While table (3) illustrates the total cost of different health sites, dealing with extra pulmonary TB patients. Government expenditures on drugs and treatments were more than three- quarter of the total costs of health services, (77%), followed by stationary costs which equal (13%).
Costs of Public Health Services per Pulmonary & Extra Pulmonary Patient
To assign TB treatment and prevention resources, planners should identify the cost of the public health services per patients. The total cost of TB treatment to the health service was US$ 7733.44 for pulmonary TB and US$ 6214.2 for extra pulmonary TB and the average costs were 48.33 US$ and 38.8 US$ per pulmonary and extra pulmonary patient, respectively.
Costs to Pulmonary Patient
To be cured of TB disease, the patient needs to spend a lot of time and money in terms of transportation cost and time away from work.
Total Cost of TB for Pulmonary Patients Studies
Table (5) illustrates that the money paid by the patients represents the majority of the total cost of TB (USD 17336), compared to the government expenditures on public health services (USD7733.44).
Average Cost of Pulmonary TB Treatment per Patient
Table (6) illustrates the average cost of TB disease per patients which includes the cost to the public health services, US$ 52.8 and the cost to the patient US$, 108.4.
Total Costs to Extra Pulmonary Patients
Table (7) illustrates the total costs to the patients which include fees of medication, cost of laboratory tests and operations (outside the TB center), transportation and the cost of being away from work. The total cost was approximately USD 45257.9
Total Cost of TB for Extra Pulmonary Patients
Table (8) shows that the total cost for the extra pulmonary patients were US$ 51672.9, which consist of the total costs to the patients, US$ 45457.9, and the total costs the public health services, US$ 6214.2.
TB Cost per Extra Pulmonary Patient
Table (8) shows that the cost of public health service per patient was US$ 38.8, the cost of the services paid by the patient was US$ 284.1 and the total cost per extra pulmonary patient was approximately US$ 323.
In the present study, the majority of the facts are based on actual expenditures paid for tuberculosis treatment. The average cost was taken into consideration in all the calculation of tuberculosis treatment regimens because they best reflect the real expenditure and therefore, it is of grave importance for both policymakers and health planners. Then, the total cost of tuberculosis was grouped into two main categories: first was the cost to the health services, which included the cost of anti-tuberculosis drugs, x-ray staff time, pharmacy staff time, TB center staff time, electric, water and telephone bills; while the annual consumption rate of the building, x-ray machine, microscope, in addition to other equipments that were excluded from the study. Second was the cost to the patients that included transporting to and from TB centers to their homes in addition to the cost of the time being away from work either because they were seeking treatment or were disable to work.
Launching from the fact that people in Yemen are very poor, NTCP carried out a strategy to reduce the incurred such types of costs, by which drugs were being weekly distributed to patients from the nearest health unites, when they are in the initial phase and monthly in a continuous phase in case of pulmonary tuberculosis while in case of extra pulmonary tuberculosis the patients take their drug only monthly from the TB center. All costs were calculated in Yemen currency (YR) and was, then, converted to the united state dollar at the 2009 exchange rate where US$1.00= YR 200.
Direct Medical Costs
The current study noticed that the large proportion of anti-TB drugs direct cost was (12.5%) & (38.2%) out of the total costs and costs of health services, respectively. and that the cost pulmonary tuberculosis patients was equivalent to US$ 20.2. Whereas in the case of extra pulmonary tuberculosis, the anti-tuberculosis drugs constituted (9.3%) & (78%) from the total costs and costs of health services, respectively, and the cost per patient was equivalent to US$ 30.2. The percentage of health service cost was higher in extra pulmonary tuberculosis than in pulmonary tuberculosis in terms of drug cost; because the extra pulmonary tuberculosis did not do the laboratory test and x-ray examination in the TB center, for they came to such center after they have already done their diagnosis, furthermore the cost of drug for extra pulmonary tuberculosis was more than of pulmonary tuberculosis.
A Similar finding was arrived at by Islam (2002), when he compared the drug cost to the total expenditures (37.8%). Slightly a higher cost was found by Wyss (2001) when he compared drug cost compared with the health services (44.4%). On the other hand the present study was consistent with Wyss (2001) and Sanderson (1995) in terms of the proportion of the drug cost compared with the total cost of treatment, which constitutes 7% and 10.7%, respectively.
Slightly a lower cost was found in other studies which had greatly concentrated on the aspect of costs; such a study was carried out by Elamin et al. (2008). The latter found that a large proportion of direct medical costs out of the total costs of illness were associated with anti-tuberculosis drugs figuring out (32.4%) from the total cost of illness, besides, the cost per patient was equivalent to US$ 61.44. and Muniyandi et al. (2005), which found the drug costs with total expenditure was (25%). A similar finding was reached by Sanderson (1995) entailing that there were additional costs associated with streptomycin drug (water for injection and syringe) and therefore, additional costs were incurred.
A higher cost, which was associated with x-ray services per patient in the TB center, was US$ 18, i.e., it constituted 11.2% and 34.1% from the total costs and costs of health services, respectively. In a comparison with the previous study conducted by Elamin et al. (2008), they found that the highest cost, US$ 28.6, constituted 3.1% and 15.1% from the total costs and costs of health services, respectively. The study by Wyss (2001) found that only US$ 3.60 was paid for this service per patient and that the high percentage of x-ray cost was in the present study; although the cost of a film and its reagent was lower than any other studies. This attributed to the fact that TB center did only the AFB test, while other studies included many other tests in addition to the AFB.
The study found that cost of laboratory tests per treated patient was US$ 5.4 and constituted 3.3% and 10.2% from the total costs and costs of health services, respectively. Elamin et al. (2008) stated that a higher cost was that of the laboratory tests per treated patient, which was $ 28.50, and which constituted 3.1% and 15.2% of the total costs and costs of government health services, respectively. Islam et al. (2002) showed a lower cost laboratory examination, US$ 2.19 that constituted 2.8% and 3.7% from the total costs and costs to the health services, respectively.
The present study showed the total direct expenditures for pulmonary tuberculosis was US$ 52.8 per pulmonary tuberculosis patient and for extra pulmonary tuberculosis was US$ 38.7 per extra pulmonary tuberculosis patient. The study was consistent with finding by Muniyandi et al. (2005) which found the total direct expenditures was US$30 to US$43 according to the category of treatment. On other hand very high expenditure was found in the study conducted in Haiti by Jacquet et al. (2006), which found the total direct expenditures for pulmonary tuberculosis was US$ 432 per tuberculosis patient, while in other study by Elamin et al. (2006), they found that the total direct expenditures for pulmonary tuberculosis was US$ 189.50.
Indirect Medical Costs
Implementing TB patients' treatment using the direct observation strategy helps decongesting TB center and increases the capacity to manage with the widespread increasing demand of having tuberculosis care centers. For that reason, pulmonary tuberculosis patients should visit the center either weekly (in the initial phase) or monthly (in the continuous phase) while extra pulmonary tuberculosis patients should visit it monthly to take their medicines. Accordingly, the cost associated with transporting to and from TB centers constituted 30.4% & 21.1% for pulmonary tuberculosis and 33. %2& 29.1% for extra pulmonary tuberculosis in terms of the cost to the patient and the total cost of treatment, respectively.
The high expenditure on transportation was found in a study conducted by Elamin et al. (2008). The study found that transportation constituted 71.0 % and 56.5%, to the patient and the total cost of treatment, respectively. A very low cost on transportation was found in a study carried out by Wyss (2001), where the cost of transportation constituted only 3.5% and 3% for the cost to the patient and the total cost of treatment, respectively. Floyd (1997) added that visits for directly observed treatment constituted 14% of the total cost.
The indirect cost consisted of the loss of time off work due to illness. Such a cost was estimated using a special designed data-collection form, whereby patients were asked to give information about their employment status; the amount of time lost if he was ill, and of his monthly salary when being healthy. The study found that the cost associated with the loss of productivity in pulmonary tuberculosis patients was (US$ 73.2), which constitutes 67.5% to the patient cost and 46.7% the total cost. While in case of extra pulmonary tuberculosis patients, it was equivalent to (US$ 51.9), p>The low percentage cost was associated with the loss of productivity in extra pulmonary tuberculosis patients, due to high cost of tests done for extra pulmonary tuberculosis patients outside TB center, to figure out (55.6%). Furthermore, the cost of transportation for extra pulmonary tuberculosis patients was (28.6%). This was due to the fact that extra pulmonary tuberculosis patients should come to the TB center to take his/her medication monthly while pulmonary tuberculosis patients could take his medication from the center near his home.
The cost of this study was very low if compared to the finding of Muniyandi et al (2007), Sanderson (1995) and Wyss (2001), which found that the highest cost for the loss of the ability to work was US$112, US$ 162; and between US$ 154 and USD 1384 respectively, and different explanations are possible for this low cost in this study. African countries, for instance, found that the cost associated with the loss of productivity was high due to the fact that patients may take longer time treating themselves by using religious practitioners, herbal medicines and divining, instead of coming cross hospitals and using the medicine offered by them (Wyss et al., 2001).
Slightly higher to the findings of the present study was that done by Guwatudde et al. (2003), where the costs to the patients constituted approximately 80% of the total costs of the treatment. The cost of this study was very low if compared to the finding by kik et al. (2009), where the indirect cost associated with the loss productivity was 2608 per patient.
The study carried out by Elamin et al. (2008) was consistent to the present study, particularly, in the case of extra pulmonary tuberculosis; the study found that the cost associated with the loss of productivity was constituted 16.3% of the patient cost and 12.9% of the total cost
Total Costs of Tuberculosis
Among the findings of the current study was that the total cost of tuberculosis treatment was US$ 161.2 and USD 322.8 for pulmonary tuberculosis and extra pulmonary tuberculosis patients, respectively. Such a cost was very much lower than that found by WHO (2000) in developed countries (US$ 2,000-US$ 21,000). Elamin et al. (2008) found that in Malaysia the total cost was US$ 916.4, and a study in South Africa showed that the total cost was US$ 890.50.
Other studies in India by Rajeswari et al. (1999) which found the total cost wasUS$171, Sanderson (1995), in Uganda showed the total cost of tuberculosis treatment was (US$ 403.20) and Khan et al. (2002) stated that the cost in Pakistan was (US$ 310.0), which was close to the findings of the Present study.
The costs to the patients of the present study were 67.2% & 87% for pulmonary tuberculosis & extra pulmonary tuberculosis, respectively. A matter that was similar to the previous studies conducted by Sanderson (1995), Elamin (2008) and Wyss et al. (2001). The latter found that the cost to the patients were approximately 70%, 79.5% and 84.2%. Such a cost, to the patients, looks very high although an alternative treatment design was applied to reduce the cost of transportation incurred by patients during the treatment period. However, there are still other options to reduce the cost through the early tuberculosis diagnosis and detection, which helps avoid the loss of time away from work due to illness. Continuous health education and counseling were freely done by the staff members of TB center; a matter that played a very important and effective role in improving patient's compliance to the treatment.
According to NTCP report in 2007, there were 3537 cases of positive pulmonary tuberculosis and 2369 cases of extra pulmonary tuberculosis by multiplying these number by the average cost of tuberculosis per patients (US$ 156.7 and US$ 327.95), respectively. That is to say the estimated cost of positive pulmonary tuberculosis and extra pulmonary tuberculosis in Yemen will be (US$ 554248 and US$ 776914), respectively.
The study highlights the direct cost and indirect cost for the patients as well as for the health services in case of pulmonary and extra pulmonary TB. The indirect cost was more than direct cost for pulmonary TB (69%) or extraplumonary TB (87%). The cost of illness of pulmonary TB per patients was US$ 156.7, while for extra pulmonary TB per patients was 322.8, cost of anti-tuberculosis drugs constitutes the highest proportion of the costs to the public health services (42%) and (78%) for extra pulmonary TB, the cost to the patient constitutes the major proportion of the total cost of illness(87%) for pulmonary and (69%) for extra pulmonary. The results of this study may be used to develop new approaches for policy makers, potential donors and health service worker towards more effective promotion of tuberculosis control.
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