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ABSTRACT |
 TOP ABSTRACT INTRODUCTIONMETHODSRESULTSDISCUSSIONAppendix 1REFERENCES |
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INTRODUCTION |
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONAppendix 1REFERENCES |
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Cost measurement is one crucial step in presenting cost-effectiveness results, with costs being the numerator in the cost-effectiveness ratio, which gives crucial information on allocative efficiency in terms of the cost per health gain of a given health intervention.2,3 The cost-effectiveness ratio is essentially calculated by dividing the net costs of a health intervention by the net health effects.
In conducting a cost study, it is essential to follow appropriate methods to ensure scientific quality as well as comparability with studies of other health interventions. Economic evaluation guidelines have been available since the late 1960s in the days when cost-benefit analysis of development projects was routinely undertaken by Organization of Economic Cooperation and Development government donor agencies and the World Bank.4,5 In these early guidelines, detailed methods were presented for cost measurement that were consistent with theories of welfare economics.6,7 By the 1980s, economic evaluation guidelines were available for specific application in the health domain.8–12 These early economic evaluation guidelines for health interventions, as well as later ones,2,3,13–16 have been widely used in the health field, and are commonly referred to as the standard by which economic evaluation studies are judged.
Although in the past it has been recognized that the application of economic evaluation in the health field was not standardized and had a lack of guidance,17 the problem is of a different nature now that there exist an abundance of health economic evaluation guidelines, which propose a variety of approaches. While standardization of methods has been attempted by several groups in the United Kingdom, the United States, and the European Union, EU,14,15,18–20 complete standardization of economic evaluation methods remains elusive.
The implication of the different approaches recommended by these guidelines is that there remains quite some discretion to the analyst in conducting and presenting a cost study. Therefore, this present study endeavors to follow closely the highest current standards for cost measurement, taking into account the weaknesses inherent in what is essentially a desk study.
Previous studies on the costs of adding interventions to the EPI. The delivery of a malaria vaccine through the EPI is a new intervention that has not been implemented or modeled anywhere in the world. Therefore, in conducting a study that measures the hypothetical cost of adding a malaria vaccine to the EPI, in a first step it is important to identify previous cost studies that have measured costs of adding other interventions to the EPI. The main aims of this literature review were to identify important costs items to give an indication of what data are easily available for different costs of the EPI, and to identify variables, factors and assumptions that need to be taken into account in developing a generalizable cost model and menu for a malaria vaccine provided within EPI, including both supply (health system) and demand (population) side variables. In particular, useful information on the main features of immunization programs, their costs, funding, and performance was obtained from the World Health Organization (WHO) website on immunization financing.21
The review found that the costs of introducing a new vaccine are essentially a function of the cost structure of the EPI and of the particular operational conditions of the program. Among the most important determinants of the incremental costs of adding a new vaccine into the EPI are the characteristics of the vaccine itself, the delivery modalities, and the capacity use of the EPI.22–31 For instance, the studies on the introduction of hepatitis B vaccine into EPI schedule showed that at US$1 per dose, approximately 80% of the additional costs were due to the vaccine.32–34 The remaining costs were mainly those of supplies, distribution system (mainly cold chain), and social mobilization. However, vaccine delivery costs vary according to the level of capacity use and volume of immunizations given.
Thus, the evidence shows that although the vaccine accounts for a large part of the incremental cost of adding a new vaccine into the EPI schedule, the immunization program can incur considerable additional costs and these depend heavily on the operational conditions of the program itself. Based on these findings, it was justified to gather information on the current status of the EPI program in a malaria-endemic country for the purposes of the cost-effectiveness modeling. Therefore, a method was developed to estimate the incremental cost of delivering a potential malaria vaccine through the EPI program and it was applied to collect the data needed to calculate vaccine delivery costs in one such country.
Study setting: the EPI in Tanzania. In presenting a cost-effectiveness study based on modeled data, ideally the results should reflect a specific setting. A variety of settings have been defined in previous cost-effectiveness modeling studies. For example, the comprehensive study of Goodman and others35 stratified sub-Saharan African countries by three income levels and presented cost-effectiveness simulations for each of these.
Given the diverse characteristics of the EPI throughout Africa, such country stratification was not considered possible in this present study. Therefore, a single country, Tanzania, was chosen. The EPI in Tanzania was established in 1974 as a vertical program and then, as part of the health sector reforms started in mid 1990s, it was integrated into the Reproductive and Child Health Unit in the directorate of Preventive Services of the Ministry of Health. Immunization services are provided by 3,544 fixed health facilities in Tanzania, both public and private for profit and non profit. A total of 10% of these provide outreach and mobile services.36 The private sector in Tanzania as a whole provides approximately 40% of health services. From 1996, as a consequence of the decentralization reforms, the management of day-to-day immunization activities at the service provisional point was left to the district and municipal councils.36,37
The recent reforms created a quasi-autonomous drug procurement agency, the Medical Store Department (MSD), which is responsible for procurement, storage, and distribution (until district level) of vaccines and related equipment. Other changes introduced in the last few years include government financing of procurement of oral polio vaccine, and use of kerosene in the cold chain, the integration of kerosene and vaccine distribution, supervision and monitoring in the district health system.37
The vaccines provided by the Tanzanian EPI in the year 2004 include bacille Calmette-Guérin (BCG) (1 dose), oral polio vaccine (OPV) (3 doses), diphtheria, pertussis, and tetanus–hepatitis B virus (DPT-HBV) (3 doses), tetanus toxoid (5 doses), Measles (1 dose), and vitamin A (3 doses). In 2002, the immunization coverage at national level was 88% for BCG, 91% for OPV, 89% for DPT-HBV, 89% for measles, and 86% for tetanus toxoid to pregnant women. The drop out rate for DPT1–DPT3 was 6%. However, it should be noted that the vaccine coverage rate varies widely between EPI providers.38
A considerable effort was made in recent years to improve the effectiveness of the program. In 2001, EPI introduced auto-destructing syringes in place of sterilizable needles and syringes, and incinerators were constructed in all district hospitals. Incinerators are not available at the health center and dispensary levels.36 The vaccine wastage rate has been decreasing in recent years, and in 2002 it was approximately 5% in most regions. However, there is a wide variability among districts in wastage rates, with some of them reporting wastage rates of up to 16%.38
Table 1
shows the cost structure of EPI in Tanzania for two financial years (2000/2001 and 2001/2002). In 2000/2001, the EPI budget in Tanzania was US$11.6 million for routine immunization services and US$3.3 million for supplementary immunization services. The program-specific spending on routine immunization service equated to approximately US$10.6 per DPT3 vaccinated child or US$0.33 per capita.36 In 2001/2002, the budget on routine immunization increased to US$13.6 million (an increase of 17% from 2000/2001) due to new vaccine introduction and an increase in other expenditures for the program. Total expenditures in 2001/2002 were close to US$18 million.
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also shows the cost profile of EPI program in Tanzania for the last two years available. Recurrent costs account for 67% of total cost and non-recurrent costs for 22% (mainly cold chain equipment). Vaccines and injection supplies account for most of recurrent costs. However, note that the EPI uses and shares certain resources of the national health system, and the costs of these resources are not included in these figures. Examples include general health service personnel and managers, health facility buildings, and utilities paid for by the health system (e.g., electricity). Therefore, the costs shown in Table 1 do not represent the full costs of providing the EPI. In terms of EPI financing, the Tanzanian government increased its allocation for the program from 2000/2001 to 2001/2002 when it funded approximately 44% of overall financing for immunization, as shown in Figure 1. The government pays mainly for injection supplies, salaries, transport and other recurrent costs, vehicles and cold chain equipment, and some vaccines. Donors pay for vaccines, injection supplies, training, monitoring and surveillance, vehicles, and cold chain and other capital equipment. Donors also fund supplementary immunization activities. However, according to the Financial Sustainability Plan, the Government of Tanzania is programmed to take over the funding of all vaccines in the next few years.
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Study aims. The aim of the present costing study is to measure the incremental costs of adding a hypothetical malaria vaccine to the EPI schedule to enable estimation of cost-effectiveness of such a vaccine.
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METHODS |
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONAppendix 1REFERENCES |
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Marginal cost. The marginal cost consists of the additional costs that would be incurred when introducing a malaria vaccine into the EPI schedule, based on new resources that would need to be used in the delivery of the intervention. This information is most relevant for a decision maker who has to make resource allocation decisions, based on the immediate resource impact of an intervention. Therefore, for example, when spare capacity in the health system exists, the use of that spare capacity is not included in the marginal cost analysis. However, when full capacity has been reached and new resources are needed, these are included in the marginal cost analysis.
Average cost. The average cost includes all those costs involved in delivering a health intervention, whether they are used specially for a new intervention, whether resources are shifted away from other activities, or whether spare capacity is used. Average costing involves sharing the costs of existing capacity among all the interventions benefiting from those resources. The usefulness of presenting full economic cost through this analysis is that it enables comparison of intervention efficiency in the long-term, where all resources can (hypothetically) be redeployed in alternative uses. Therefore, average costs are useful for cost-effectiveness analyses for long-term planning decisions.
In both marginal and average analyses, all types of cost are included where necessary. In this analysis, for policy making reasons a distinction is made between non-recurrent (capital) cost items (defined as resources that are not wholly used up within a one-year period) and recurrent cost items (defined as items that are used up during a year).
Algorithm for calculating vaccine delivery cost. The specific characteristics of a malaria vaccine are still unknown. This analysis is based on a hypothetical vaccine that must be stored between 2°C and 8°C, has a commercial package similar to that of DPT-HBV vaccine, and requires three doses to fully immunize a child delivered at the same time as the DPT-HBV.
The vaccine delivery cost per dose (Vd) is estimated according to the formula
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where, Pd is the purchase cost per dose, Dd is the distribution cost per dose, Sd is the storage cost per dose, Md is the management cost per dose, Ed is the delivery cost per dose, Td is the training cost per dose, and Zd is the social mobilization cost per dose.
The variables in equation 1 are covered in detail in this report. All variables are calculated, where relevant, under both marginal cost and average cost scenarios. The cost per fully immunized child (FIC) with the vaccine is computed by multiplying Vd by three. However, the average cost per FIC is marginally greater than three times the cost per dose because of the dropout of infants after the first dose. To estimate the total number of doses required per year in Tanzania, it is assumed that the coverage rate would be the same as that for three doses of DPT-HBV in 2003, which was 89%, with a dropout rate of 6% from the first to the third dose.
Net vaccine purchase cost. In the cost-effectiveness analysis, different price hypotheses are used that range from US$1.00 to US$10 per dose. No base case is presented because it may become misleading in presenting results. Instead, cost results are presented under a number of vaccine price assumptions: US$1, US$2, US$4, US$6, US$8, and US$10. Import duties are not included because these are not an economic cost but a transfer payment.
The contribution of freight costs to the price at which the country receives the vaccines (i.e., including carriage, insurance, and freight [CIF]) essentially depends on the original price of the vaccine, the packed volume of the vaccines, and the mode of transport. For DPT-HBV, the contribution of freight to the CIF price is reported in the Tanzanian Medical Stores Department (MSD) documents and in the Global Alliance for Vaccines and Immunization (GAVI) Financial Sustainability Plan. However, in this analysis the price assumptions include freight costs to the port of entry.
To estimate the total vaccine cost per dose delivered it is assumed that 5% of vaccine is wasted. The purchase costs per dose of the vaccine (Pd) is computed as
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where Vp is the vaccine price and Qv is the wastage rate.
Storage and distribution costs. The cold chain system of EPI in Tanzania includes five operational levels each equipped with cold chain equipment as follows:39 1 central vaccine store at the MSD in Dar es Salaam, 8 zonal vaccine stores at the MSD, 15 regional vaccine stores, 116 district vaccine stores, and 3,544 health facilities (dispensaries, health centers, hospitals). All health facilities conduct immunization activities and are equipped either with a small absorption refrigerator and freezer operating on either kerosene or electricity, or with liquid propane gas or a solar powered refrigerator.
However, the storage and distribution system is continuously undergoing changes and the MSD is restructuring the storage and distribution policy and is negotiating a new financial agreement with the Ministry of Health. Currently a new malaria vaccine would be distributed from the central MSD in Dar es Salaam to the eight zonal stores and from these directly to districts. The distribution from districts to the health facilities providing immunization services is under the direct responsibility of EPI.
The new agreement between MSD and EPI includes a tariff scheme for storage of products at central and zonal level and for distribution from central stores to zonal stores and then from zonal stores to districts. The tariffs are as follows. For storage of cold items at the national store, Tshs 300,000/m3 (US$286) is charged per month. For distribution of cold chain items to all MSD zones (other than Dar South), Tshs 625,000/ m3 (US$595) is charged. For distribution from any MSD zonal store to all districts, Tshs 145,000/m3 (US$138) is charged.
These new tariffs are the most reliable information currently available on the current and future cost of storage and distribution of vaccines. Therefore, to estimate the incremental cost of storing and distributing the vaccine the new tariff scheme is used, thus assuming that the MSD will distribute vaccine first to zonal stores and then to districts.
To estimate the incremental cost of storage and distribution of the vaccine, the package volume requirement for transportation and cold chain storage at national, zonal, and service delivery levels was estimated on the basis of the WHO guidelines for estimating costs of introducing new vaccines into the national immunization system.40 These guidelines provide a method to estimate the total volume package required for storage and distribution of a vaccine, taking into account wastage rates, cold chain, and transport grossing factors. The new tariffs defined by the MSD for storage and distribution were then applied to the volume package estimated for the vaccine. The estimated package volume per year was 901 m3 for storage and 684 m3 for the service delivery level. The estimated package volume for transport per year was 3,543 m3.
The MSD distributes vaccines from the central store to the eight zonal stores and from these to district stores every three months (four times a year). Every three months there is thus a need to store at national, zonal, and district levels one-fourth (i.e., 3 months’ worth) of the estimated package volume. It is assumed that the MSD is able to distribute the vaccines to zonal and district stores within one month from when it receives them, and thus every three months it has to store the estimated volume package for a maximum of one month at national and zonal levels.
Districts receive the vaccines every three months and distribute them to health facilities monthly. It is assumed that every three months districts have to store the estimated package volume of vaccine for a maximum of one month.
The cost of storage per vaccine dose at national level is computed according to the formula
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where Sd is the cost of storage per vaccine dose at national level, Sm is the storage cost/tariff per m3 per month, Nm is the number of months of storage (over one year), Fy is the volume package per year for storage at all levels (per m3), and Nvy is the number of doses of the vaccine per year.
The storage cost at zonal and district level is assumed to be the same as that at central level. The cost of storage at facility level is computed with the same formula but the volume package required, which is estimated according to WHO guidelines, is different. This is due to the different grossing factors that adjust for the different presumed percentage use of cold chain capacity at different MSD levels. For the national and provincial level, the grossing factor is 2.9, whereas for district level the grossing factor is 2.2.
The cost of distribution per dose of vaccine from central to zonal stores is computed according to the formula
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where 
and Dzd is the distribution cost from central to zonal stores per dose of vaccine, Dzm is the distribution cost/tariff from central to zonal stores per m3, Ft is the estimated volume package for transport of the vaccine, NvT is the total number of vaccine doses delivered in Tanzania, and NvD is the total number of vaccine doses delivered in Dar es Salaam.
The adjustment factor 
is included to account for the fact that the distribution from central to zonal store for the region of Dar es Salaam should not be included. This is because the MSD does not charge the EPI for vaccine supplies sent to Dar South because of its proximity to the MSD.
The cost of distribution from zonal to district stores per dose (Ddd) is computed according to the formula
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where Ddm is the distribution cost/tariff from zonal to district stores per m3. The cost of distribution of the vaccine from district to the health facilities, which is under the direct responsibility of the EPI, is assumed to be the same as that from zonal to district stores. This might overestimate distribution costs because the distance between district vaccine stores and health facilities is normally shorter than that between zonal stores and district vaccine stores. Conversely, it might not overestimate these costs because of (dis)economies of scale of distributing less quantity of vaccine to different facilities. However, in the absence of more detailed data to confirm which cost determinant predominates, the same cost per cubic meter is assumed.
The costs of cold chain storage are mainly capital costs because cold storage mainly consists of cold rooms and refrigerators that last longer than one year. Only personnel and electricity or fuel for refrigerators are recurrent costs and these account for a marginal part of storage costs. In the absence of detailed breakdown from the MSD, it is assumed that capital costs account for 80% of cold chain costs and recurrent costs the remaining 20%.
Distribution costs are both recurrent (e.g. fuel for vehicles, fares for air transport, personnel) and capital (e.g. cold boxes, costs of vehicles). Compared with the capital-recurrent breakdown of cold chain storage, fuel costs in distributing vaccines account for a considerable proportion of total distribution costs. Therefore, it is assumed that 50% of distribution costs are capital and 50% are recurrent costs.
Management costs. A wide range of personnel are involved in delivering a new vaccine, including managers, surveillance staff, community health workers, nurses, and doctors. The personnel involved in the EPI are distributed throughout all the levels of the health care system, i.e., national, regional, district, and health facilities.
The introduction of a new vaccine in the EPI will require additional management costs at all levels of the EPI system. It is thus assumed that all personnel of the EPI at national (excluding the EPI manager) and regional levels, the District Medical Officer, the District Reproductive and Child Health Coordinators, the Medical Officers, and the Medical Records Officers would have to allocate 10% of their working time devoted to the EPI. These management costs are included only in the average analysis because it is uncertain whether new personnel will be used by the EPI to manage the malaria vaccine.
Vaccine delivery costs. The costs at the point of delivery include the recurrent costs of personnel involved in the EPI at facility level, syringes, and of safety boxes, and the capital cost of waste management (other than safety boxes).
Personnel. According to interviews held with the EPI at the national level, the employees believe that introducing a new vaccine into EPI would not require additional personnel at facility level. The main justification given for this opinion is that EPI personnel at facility level are now integrated into the Reproductive and Child Health Unit and normally they do not dedicate 100% of their time to EPI.
Based on observations of selected health facilities in Tanzania, it became apparent that there are several ways of organizing an EPI session. In Dar es Salaam infants can get vaccinated on any working day (five) of the week, while in Mtwara Region in southern Tanzania vaccination availability varies from selected days every three months for outreach to remote villages to two days per week for health centers.
In terms of the spare capacity of the staff to administer a new vaccine, vaccinators interviewed generally concurred that a new vaccine requiring five extra minutes per child could be accommodated without needing additional staff. However, during the health facility visits the issue of lack of skilled personnel was often raised, thus suggesting that staff are often under pressure from the volume of clients. Therefore, the impression is that the EPI staff could probably accommodate a new vaccine using the current capacity but this may lower the quality of services as a whole. Thus, to maintain the minimum quality of services, vaccination staff will need to be strengthened in numbers, targeting those facilities that are already close to their limit in terms of proportion of working time already used.
In the marginal analysis only the incremental cost of vaccinators is included, while in the average analysis both the costs of vaccinators and that of other personnel at district and other facility level staff are included.
In the average analysis it is assumed that personnel of the districts other than vaccinators, i.e., medical assistants, health officers, and nurses, would have to increase by 10% their working time spent on vaccination with the malaria vaccine.
The incremental cost per dose for these personnel (Ild) is computed as follows:
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where Wy is the annual gross wage, Pit is the % of staff working time for immunization, Pmv is the percentage increase in the EPI working time spent on malaria vaccine, and Np is the number of personnel.
Data for the annual gross wage, the percentage of working time for immunization, and the number of personnel come from the Ministry of Health.36 In the marginal analysis it is assumed that these personnel have enough spare capacity to accommodate the increase in working time required by the new vaccine and thus the incremental cost is zero.
A cost per dose of vaccine for vaccinators is estimated assuming an administration time of 7 minutes, and the cost per working minute of vaccinators is computed assuming 230 working days per year and 6 productive hours per day.
The cost per dose is computed as
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where Ld is the cost of vaccinators per dose, Wy is the annual gross wage, My is the total number of working minutes per year, and At is the vaccine administration time. The personnel vaccine delivery cost is thus computed as average analysis = Ld + Ild and marginal analysis = Ld.
Syringes. For both marginal and average analyses, the syringe incremental cost per dose (Gd) is calculated as
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where Ngd is the number of injection syringes per dose, Gi is the unit cost of injection syringes (freight included), Nrd is the number of reconstitution syringes per dose, Gy is the unit cost of reconstitution syringes (distribution included), and is Qs the syringe wastage rate.
The syringe wastage rate is 10% as suggested by the WHO guidelines and confirmed by GAVI documents. The cost of syringes used is that of the MSD catalogue for 2004,41 while the distribution costs are assumed to be 3% of the cost of syringes.
Safety boxes. Safety boxes are present at the place of vaccination, and after vaccination the used syringes are disposed immediately into these. The safety boxes incremental cost per dose (Bd) is computed as
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where Ns is the total number of syringes, Yb is the capacity of safety boxes, Qb is the wastage factor for safety boxes, and Bi is the unit cost of safety boxes (distribution included).
The capacity of safety boxes is 100 syringes, and the wastage rate for safety boxes used is assumed to be 11% (giving a factor of 1.11) as reported in the GAVI annual progress report.41 The unit cost of safety boxes comes from MSD 2004 catalogue (http://www.msd.or.tz/) and includes 3% of the distribution cost.
Waste management incremental cost per dose. The capital resources required for effective waste management should include the capital cost of incinerators and any buildings required to house them. Recurrent costs include those associated with incinerator fuel and maintenance, training, and salaries of staff. However, in Tanzania only hospitals have incinerators while in health centers and dispensaries the waste management practice is to throw the safety boxes into a deep hole and fire them with kerosene. This was confirmed in all the facilities visited by the study team.
The waste management of the malaria vaccine should be the same as that for other vaccines currently delivered through the EPI, and it is unlikely that the EPI would introduce different waste management practices because of a new vaccine. The cost of waste management was thus considered to be zero (except for the safety box cost, as considered above).
Training. The EPI personnel must be trained for the administration of the new vaccine. The training on the new vaccine can either be limited to the period just before or during its introduction or can continue in successive years. In this analysis it is assumed that the training is limited to the introduction period and has duration of effect of five years, which enables an annual value for training cost to be computed.
Training of health workers in Tanzania can be organized at zonal, district, and facility levels. When it is organized at the zonal and district levels the health workers get a per diem to cover the cost of being outside the health facility. It is assumed that in the first year of vaccine introduction five days of training are provided at the zonal and district levels, and four days are provided at the health facilities. An ingredient approach is used to estimate the cost of training at each level.
The training at the zonal level is assumed to be organized as a five-day workshop in each of the eight zonal training centers, with two trainers per workshop, and attended by personnel at the regional and district levels (i.e., not staff from health facilities), comprising one regional cold chain officer, one district cold chain officer, one medical records officer, one district reproductive and child health coordinator, and one regional reproductive and child health coordinator.
The daily cost per trainers is assumed to be US$30, the overheads cost of each premises used for the training (one per zone) US$40, the per diem of personnel US$30, the transport cost per workshop per person US$4, stationary cost per person per day US$1, and tea and coffee per day US$ 2 per person.41 The training at district level is assumed to be attended by one person per health facility providing immunization services, and led by one trainer per district. The daily cost per trainer is assumed to be US$30, the overhead cost each premise (one per district) used for the training US$10, the per diem of personnel US$5, the transport per meeting US$2 per person, and stationary and tea and coffee costs the same as at the zonal level.36
The training cost per dose of vaccine at the zonal (Tz) andat district levels (Td) is computed according to the following formula, assuming the training has duration of effect of five years:
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where Ntr is the number of days of training, NtrL is the number of trainers, CL is the cost per trainer per day, Na is the number of person attending training, Ca is the per diem of training attendants, Cst is the cost of stationary per person per day, Ctea is the cost of tea and coffee per person per day, Nloc is the number of premises used for training, Cloc is the overheads cost of premises used for training per day, and Ctra is the cost of transport per person per workshop. To estimate the annual equivalent cost, equation 10 can be divided by 5.
The training at the facility level is supposed to be attended by all personnel at the facility level, except those that were already involved in training at the district level. A trainer per health facility providing immunization services is assumed to be used, and the daily cost per day of training is US$ 20 plus US$ 20 of transport cost per trainer (assuming that trainers travel only once to each facility during the four days of training).
The total training cost at facility level (Tf) is computed according to the formula
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where Nf is the number of facilities providing immunization services. The total cost of training is computed as the sum of training cost at the zonal, district, and facility levels:
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Social mobilization.
Advocacy and social mobilization efforts are crucial for ensuring the successful introduction of a new vaccine. The introduction of the new vaccine should be followed by an increase in the social mobilization efforts. It is assumed that in the first years after the introduction of the vaccine into the EPI a substantial number of social mobilization activities will be organized. In the marginal analysis it is assumed that the budget for these social mobilization activities would be approximately equal to the current expenditure on social mobilization (Table 1) and it is thus estimated as approximately US$ 300,000 per year. This scale of social mobilization is warranted by the fact that messages will need to inform the population about the characteristics of the vaccine, and the importance of continuing other preventive and curative strategies.
In the average analysis social mobilization costs are assumed to be US$ 450,000 per year. Thus, the addition of US$150,000 is assumed to account for the time dedicated to social mobilization efforts by the personnel already used by the health care system. Although this amount may seem relatively small, the relatively low unit labor cost in Tanzania explains why there is not a sharp increase in costs.
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RESULTS |
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONAppendix 1REFERENCES |
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).
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shows the average cost per FIC at each vaccine price per dose assessed. The average cost per FIC increases almost linearly from US$4.2 per FIC at a vaccine price of US$1 per dose to US$31.2 at vaccine price of US$10 per dose.
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shows more detailed cost data indicating that marginal costs are not considerably less than average costs. The marginal cost per dose is 6–7 US cents less than the average cost, thus making it less than US$0.2 per FIC. This difference is less than the 5% difference between average and marginal costs.
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also shows the contribution of recurrent and non-recurrent costs to total cost. As the vaccine price increases, the non-recurrent contribution does not change, thus giving a considerably greater weight to recurrent costs at higher prices.
Total cost to the EPI.
Figure 3 shows the marginal costs to the EPI at each vaccine price per dose assessed. The marginal costs increase almost linearly from US$5.7 million at a vaccine price of US$1 per dose to US$45.3 million at a vaccine price of US$10 per dose. In this case, the marginal cost is more relevant because this is the additional cost that the EPI is likely to finance, in addition to the current resources available and the annual budget. However, the average cost is not considerably greater, but is somewhere in the order of US$250,000 more for all vaccine price scenarios less than 5% more than the marginal cost.
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In comparison to the current budget and expenditure patterns of the EPI, these total costs represent a considerable impact on the budget if the malaria vaccine were included in the vaccination schedule (Table 1 and Appendix 1). The budget for 2001/2002 of US$17 million is more than three times the cost scenario modeled at a vaccine price of US$1 per dose. At higher vaccine prices, the costs of the malaria vaccine become greater than the current EPI budget, increasing to three times the current budget at a vaccine price of US$10 per dose.
Components of cost.
Figure 4 shows the percentage contribution of different cost components to total cost at each vaccine price per dose (US$1, US$2, US$4, US$6, US$8, and US$10). It demonstrates the change in the contribution of different cost components (described in the Methods) at different vaccine prices. The conclusion is that most cost components become more insignificant as vaccine price increases. For example, all cost components except vaccine price and storage and distribution contribute less than 10% to the total cost at vaccine prices greater than US$6 per dose.
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Management costs are included only in the average analysis and are the same for both options. The management costs were insignificant at US$ 0.0023 per dose. All of these are recurrent costs.
Vaccine delivery costs are shown in Appendix 1 and contribute US$0.22 to the average cost and US$0.20 to the marginal cost. All these costs are recurrent costs. Figure 5 shows the contribution of personnel, syringes, and safety boxes diagrammatically. The training cost per dose is US$0.03 in both types of analysis, most of which are recurrent costs. The Appendix shows the breakdown by resource input, with the main contributor (50%) being the cost of trainers. The social mobilization cost is US$0.11 per dose in the average cost analysis and US$0.08 in the marginal cost analysis. The entire social mobilization cost is recurrent.
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DISCUSSION |
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONAppendix 1REFERENCES |
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The costs included in the analysis are those related to purchase of the vaccine, taking into account the wastage rate; costs of distributing and storing the vaccine at the central, zonal, district, and facility levels; costs of managing the vaccination program; costs of delivery at the facility level (including personnel, syringes, safety boxes, and waste management); and costs of additional training of EPI personnel and of social mobilization activities.
Although the vaccine price still determines most of the total delivery costs, the analysis shows that other costs are relevant and should be taken into account before marketing the vaccine and planning its inclusion into the EPI. This is particularly important because new vaccines are likely to have bigger volume packages than that used in this analysis.
The vaccine delivery cost, even when the vaccine price is excluded, is relatively high and would require additional resources to be allocated to the EPI. At a vaccine price of US$1 per dose, the total annual cost to the EPI would be more than 35% of the current budget.36 When the vaccine price increases to US$4 per dose, the total annual cost would increase to more than US$ 19 million, which is slightly more the annual EPI budget in 2002.
It is thus important to bear in mind that for the vaccine to be delivered through the EPI some investments are required in strengthening the program. In particular, the storage capacity at the central, zonal, district and facility levels would need to be reinforced.
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Appendix 1 |
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TOPABSTRACTINTRODUCTIONMETHODSRESULTSDISCUSSIONAppendix 1REFERENCES |
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| Incremental cost per dose administered |
Total cost for EPI per year |
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| Average | Marginal | Average | Marginal | |
| Purchase cost | 1.10 | 1.10 | 4,365,768 | 4,365,768 |
| Distribution | 0.08 | 0.08 | 322,981 | 322,981 |
| Cold chain storage | 0.03 | 0.03 | 106,688 | 106,688 |
| Management cost | 0.002 | 0.000 | 9,268 | – |
| Vaccine delivery | 0.22 | 0.20 | 882,535 | 795,778 |
| Training (over one year) | 0.03 | 0.03 | 117,165 | 117,165 |
| Social mobilization | 0.11 | 0.08 | 450,000 | 300,000 |
| Total cost | 1.58 | 1.51 | 6,254,405 | 6,008,379 |
| Recurrent costs | 1.51 | 1.45 | 5,990,191 | 5,744,165 |
| Non-recurrent costs | 0.07 | 0.07 | 264,214 | 264,214 |
| Total cost per FIC | 4.73 | 4.54 | – | – |
| * FIC = fully immunized child. | ||||
| Incremental cost per dose administered |
Total cost for EPI per year |
|||
| Average | Marginal | Average | Marginal | |
| Purchase cost | 2.20 | 2.20 | 8,731,536 | 8,731,536 |
| Distribution | 0.08 | 0.08 | 322,981 | 322,981 |
| Cold chain storage | 0.03 | 0.03 | 106,688 | 106,688 |
| Management cost | 0.002 | 0.000 | 9,268 | – |
| Vaccine delivery | 0.22 | 0.20 | 882,535 | 795,778 |
| Training (over one year) | 0.03 | 0.03 | 117,165 | 117,165 |
| Social mobilization | 0.11 | 0.08 | 450,000 | 300,000 |
| Total cost | 2.68 | 2.61 | 10,620,173 | 10,374,147 |
| Recurrent costs | 2.61 | 2.55 | 10,355,959 | 10,109,933 |
| Non-recurrent Costs | 0.07 | 0.07 | 264,214 | 264,214 |
| Total cost per FIC | 8.03 | 7.84 | – | – |
| * FIC = fully immunized child. | ||||
| Incremental cost per dose administered |
Total cost for EPI per year |
|||
| Average | Marginal | Average | Marginal | |
| Purchase cost | 4.40 | 4.40 | 17,463,072 | 17,463,072 |
| Distribution | 0.08 | 0.08 | 322,981 | 322,981 |
| Cold chain storage | 0.03 | 0.03 | 106,688 | 106,688 |
| Management cost | 0.002 | 0.000 | 9,268 | – |
| Vaccine delivery | 0.22 | 0.20 | 882,535 | 795,778 |
| Training (over one year) | 0.03 | 0.03 | 117,165 | 117,165 |
| Social mobilization | 0.11 | 0.08 | 450,000 | 300,000 |
| Total cost | 4.88 | 4.81 | 19,351,709 | 19,105,683 |
| Recurrent costs | 4.81 | 4.75 | 19,087,495 | 18,841,469 |
| Non-recurrent costs | 0.07 | 0.07 | 264,214 | 264,214 |
| Total cost per FIC | 14.63 | 14.44 | – | – |
| * FIC = fully immunized child. | ||||
| Incremental cost per dose administered |
Total cost for EPI per year |
|||
| Average | Marginal | Average | Marginal | |
| Purchase cost | 6.60 | 6.60 | 26,194,608 | 26,194,608 |
| Distribution | 0.08 | 0.08 | 322,981 | 322,981 |
| Cold chain storage | 0.03 | 0.03 | 106,688 | 106,688 |
| Management cost | 0.002 | 0.000 | 9,268 | – |
| Vaccine delivery | 0.22 | 0.20 | 882,535 | 795,778 |
| Training (over one year) | 0.03 | 0.03 | 117,165 | 117,165 |
| Social mobilization | 0.11 | 0.08 | 450,000 | 300,000 |
| Total cost | 7.08 | 7.01 | 28,083,245 | 27,837,219 |
| Recurrent costs | 7.01 | 6.95 | 27,819,031 | 27,573,005 |
| Non-recurrent costs | 0.07 | 0.07 | 264,214 | 264,214 |
| Total cost per FIC | 21.23 | 21.04 | – | – |
| * FIC = fully immunized child. | ||||
| Incremental cost per dose administered |
Total cost for EPI per year |
|||
| Average | Marginal | Average | Marginal | |
| Purchase cost | 8.80 | 8.80 | 34,926,144 | 34,926,144 |
| Distribution | 0.08 | 0.08 | 322,981 | 322,981 |
| Cold chain storage | 0.03 | 0.03 | 106,688 | 106,688 |
| Management cost | 0.002 | 0.000 | 9,268 | – |
| Vaccine delivery | 0.22 | 0.20 | 882,535 | 795,778 |
| Training (over one year) | 0.03 | 0.03 | 117,165 | 117,165 |
| Social mobilization | 0.11 | 0.08 | 450,000 | 300,000 |
| Total cost | 9.28 | 9.21 | 36,814,781 | 36,568,755 |
| Recurrent costs | 9.21 | 9.15 | 36,550,567 | 36,304,541 |
| Non-recurrent costs | 0.07 | 0.07 | 264,214 | 264,214 |
| Total cost per FIC | 27.83 | 27.64 | – | – |
| * FIC = fully immunized child. | ||||
| Incremental cost per dose administered |
Total cost for EPI per year |
|||
| Average | Marginal | Average | Marginal | |
| Purchase cost | 11.00 | 11.00 | 43,657,680 | 43,657,680 |
| Distribution | 0.08 | 0.08 | 322,981 | 322,981 |
| Cold chain storage | 0.03 | 0.03 | 106,688 | 106,688 |
| Management cost | 0.002 | 0.000 | 9,268 | – |
| Vaccine delivery | 0.22 | 0.20 | 882,535 | 795,778 |
| Training (over one year) | 0.03 | 0.03 | 117,165 | 117,165 |
| Social mobilization | 0.11 | 0.08 | 450,000 | 300,000 |
| Total cost | 11.48 | 11.411 | 45,546,317 | 45,300,291 |
| Recurrent costs | 11.41 | 11.35 | 45,282,103 | 45,036,077 |
| Non-recurrent costs | 0.07 | 0.07 | 264,214 | 264,214 |
| Total cost per FIC | 34.43 | 34.24 | – | – |
| * FIC = fully immunized child. | ||||
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Received September 18, 2005. Accepted for publication November 25, 2005.
Acknowledgments: We thank Dan Anderegg for editorial assistance, and the members of the Technical Advisory Group (Michael Alpers, Paul Coleman, David Evans, Brian Greenwood, Carol Levin, Kevin Marsh, F. Ellis McKenzie, Mark Miller, and Brian Sharp), the Project Management Team of the Program for Appropriate Technology in Health (PATH) Malaria Vaccine Initiative, and GlaxoSmithKline Biologicals S.A for their assistance.
Financial support: The mathematical modeling study was supported by the PATH Malaria Vaccine Initiative and GlaxoSmithKline Biologicals S.A.
Disclaimer: Publication of this report and the contents hereof do not necessarily reflect the endorsement, opinion, or viewpoints of the PATH Malaria Vaccine Initiative or GlaxoSmithKline Biologicals S.A.
* Address correspondence to Guy Hutton, Swiss Tropical Institute, Socinstrasse 57, PO Box, CH-4002, Basel, Switzerland. E-mail: guy.hutton{at}unibas.ch 
Authors’ address: Guy Hutton and Fabrizio Tediosi, Swiss Tropical Institute, Socinstrasse 57, PO Box, CH-4002, Basel, Switzerland, Telephone: 41-61-284-8127, Fax: 41-61-284-8103, E-mails: guy.hutton{at}unibas.ch and fabrizio.tediosi{at}unibas.ch.
Reprint requests: Guy Hutton, Swiss Tropical Institute, Socinstrasse 57, PO Box, CH-4002, Basel, Switzerland.
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