Romanian data are limited in this area. One paper with mid 1990s data did not report empirical cost measurements, but gave an overall budget estimate for 1993 quoted from a secondary source
176
, 177.
Approaches to costing end-stage renal failure in the literature are complex and very varied, and the results probably less generalisable to Romania than some epidemiological parameters 25; 90; 95,
102;159; 178, 179,180
. However decisions on investment of scarce capital and labour are required, and these require data on costs.
There is no single costing framework recommended by health economists. However, some rules have been universally agreed, e.g.:
distinguish between direct and indirect costs, and between fixed and variable costs 1. include as many types of cost as possible and acknowledge those that are left out; consider opportunity costs where available;
state what the components of each type of cost are; and
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Economic theory provides a basis for constructing cost functions for any quantity of products or services for which a price is given. From these we can derive marginal economic costs 1. 2.13.2 Economic measurements of benefits
If costs are seen as ‘investments’ (which could otherwise earn interest, or be spent on housing, education, etc.) then, what is expected in return? What types of benefits are there, and what units are they measured in?
The units of benefit used are:
natural units (e.g. life years gained) which measure the (opportunity) costs of buying a unit of effect (e.g. one year of life gained); or the extra cost of an extra unit of effect;
utilities (e.g. QALY’s - years of life gained weighted for their quality or quality adjusted life years); and
monetary units (assuming that one life year saved is worth e.g. $3,500). Many different types of benefit (e.g. avoided use of hospital services) can be added together or compared. This type of cost analysis is normally applied at national level (e.g. when choosing between defence vs. education vs. housing, etc).
The type of units chosen defines the approach to economic analysis: natural units for cost-
effectiveness (CEA), utilities for cost-utility analysis (CUA), and monetary values for cost-benefit analysis (CBA) 1.
2.13.3 Economic evaluation of renal replacement therapy and related disease management
There have been a number of economic evaluations of renal replacement therapy, some going back to the late 1960s. For the purposes of this study they have been evaluated using ‘guidelines for authors and peer reviewers of economic submissions to the BMJ’181
. Each relevant study should be scored under each of the evaluation criteria182, 183. On this basis only one study was been identified as a marginal cost-effectiveness analysis184. There are few cost-utility studies; and they have been concerned with secondary prevention of CKD, e.g. due to diabetes mellitus 185. In theory, economic evaluations should consider opportunity costs but there is only one study which achieved this 186.
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Fig. 2.2 presents a general framework of costs adapted from Ehreth 187.
The major weakness which most of these studies suffer from is the lack of good evidence on the relative effectiveness of the different modalities. Also cost estimates change on a continuous basis and vary among countries, depending also on what is measured. However, the literature suggests consistently that the most cost-effective therapy is transplantation (living related followed by cadaver), followed by CAPD, and then hospital haemodialysis 130. Transplantation provides not only ‘best value for money’, but also best quality of life for the renal replacement therapy patient. Also, renal anaemia becomes significantly less of an issue under transplantation because the transplanted kidney secretes erythropoietin.
Other forms of therapy, such as the newly introduced continuous-cyclic peritoneal dialysis (CCPD) and automated peritoneal dialysis (APD), or the combination of High Flux- and
haemodialysis (HFHD), or haemodiafiltration and classical haemodialysis (HDF vs. HD) although appear effective treatment modality have yet to prove their cost-effectiveness. As with any “new” technology, there is not enough evidence and this will only become available once these therapies have been more widely established.
Cameron refers to estimates of cost/QALY, but these appear to be based on costs from some studies and utilities from others. The UK values for cost/ QALY in the 1980s were: £4,710 for kidney transplant, £19,870 for CAPD and £21,970 for hospital HD 6. These values would be undoubtedly higher by 2010: a Greek study estimated values of: €60,353, €54,504 and €45,523 per QALY for haemodialysis, peritoneal dialysis and 1st year transplant 188. A more recent, 2010, Canadian cost-utility analysis showed that the introduction of erythropoiesis-stimulating agents (ESA) or hu-Recombinant erythropoietin or genetically recombined erythropoietin (hu-EPO) for the treatment of targeted renal anaemia levels has costs to the level of (Canadian) $ 96,270 per QALY for low target haemoglobin in CKD patients with or without dialysis. If they were not treated with ESA such costs escalate to $147,980 per QALY 189. The literature has not updated this indicator, RRT cost/QALY by modality for some time.
When referring to the types of costs measured, the averted cost was mentioned only in those studies of secondary prevention of end-stage renal failure. Studies on tertiary care (i.e. HD, CAPD, etc) do not include such [averted] costs.
76 Figure 2.2 A programme cost input
A more recent review by Ray surveyed the costs of major complications of diabetes (including end-stage renal disease) in 6 countries. Compared with the costs of treating other complications, end-stage renal disease was most expensive, but varied between the six countries according to mode of renal replacement therapy and year of treatment (year 1 and year 2) as shown in Table 2.21. These are not adjusted for quality of life 190:
staff HD stations Dialysers Catheters Fluids Drugs etc. supplies direct maintenance administration building lease phone line interest on debt building depreciation indirect (overhead) direct indirect (overhead) variable fixed Total programme operating cost
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Table 2.21: Costs of renal replacement therapy treatment in Europe (Italy and Spain), Canada and Australia (in €, inflated to 2003 – data on costs from 1998 to 2002)
Australia Canada France Germany Italy Spain
HD year 1 17,188 58,159 56,487 58,116 43,075 31,233
HD year 2 n/a 93,840 n/a n/a n/a n/a
PD year 1 27,552 33,811 n/a 46,296 n/a 32,706
PD year 2 n/a 47,447 n/a n/a n/a n/a
Tx year 1* 16,246 60,903 24,608 68,175 56,717 28,370
Tx year 2 791 19,986 6,866 10,904 11,582 8,336
* does not specify type of transplant (living donor or cadaveric kidney); n/a= not available
Table 2.21 suggests that:
1) the methodology applied must have differed between countries (Australia has by far the lowest costs); and that
2) both dialysis modalities are difficult to cost during the second year of treatment and beyond; these costs were not available in 5 of the 6 countries. This may reflect the need to target methods of measuring such costs if they are to inform decision makers for policy purposes. From the Canadian figures, the costs of the second year of treatment are very different from the first, HD with a 61% increase, PD with a 40% increase and transplantation with more than a 300% decrease
187;190
.
Increasingly, measuring costs of CKD5 and complications is becoming difficult because of the complexity of both leading conditions and the care provided. Conditions leading to end-stage renal failure, such as diabetes mellitus and hypertension, incur costs from the moment of initial
diagnosis. Costing a pre-end-stage renal failure stage is very difficult.
Given the heterogeneity in approaches for cost estimation, the question asked was not whether costs were important for this study, but if they were, could they be reasonably measured in order to link this aspect to the treatment model? That is, after having established that, like other
parameters for the epidemiological model, costs were also difficult to measure for this model, but worth attempting for the treatment model.
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This research has considered accounting costs rather than opportunity costs. However, the dual elements of costing (data from sampled centres) and funding (national programme; reported average costs) were considered separately. There was some limited benchmarking in relation to average costs (reported and estimated by this research).
2.14 Decision support: modelling for health planning and policy in renal replacement