PUK12 A REVIEW OF COST OF ILLNESS STUDIES IN PATIENTS WITH END STAGE RENAL DISEASE Rosirene Paczkowski1, Kirsi Norrbacka1, Kate Van Brunt1, and Tessa Kennedy-Martin2 1Eli 2Kennedy BACKGROUND • End-stage renal disease (ESRD) is a debilitating medical condition of chronic kidney failure, also known as stage 5 chronic kidney disease. In ESRD the kidneys are permanently impaired, and patients may require dialysis or renal replacement therapy (RRT). • Over the past 30 years, the prevalence of ESRD has increased worldwide.1 By the end of 2008, around 2.3 million patients had received RRT.2 Some 530,000 patients were living with a transplanted kidney, with the remainder receiving dialysis – either haemodialysis (HD; n=1,580,000) or peritoneal dialysis (PD; n=190,000).2 • RRT is intensive and costly: according to the US Renal Data System 20123, 1.3% of US Medicare patients had ESRD in 2010, yet they accounted for 7.5% of Medicare spending. OBJECTIVE The objective of this scoping literature review was to identify and document published cost of illness (COI) journal articles that describe the economic impact of ESRD in selected countries. METHODS Lilly and Company, Indianapolis, IN, USA Martin Health Outcomes Limited, Brighton, UK Study Overview Patient-level data • National-level total (direct + indirect), direct, and indirect costs are provided for ESRD, dialysis and transplant. • Ten studies4,7,11–16 reported annual patient-level healthcare costs for ESRD (Table 5). • Caution should be exercised in drawing comparisons across studies, given that • A 2013 study16 presented regression coefficients and cost multipliers associated with tobacco use status and each patient’s demographic characteristics, diabetes treatment, complications, and comorbidities. ESRD treated with dialysis or kidney transplantation was associated with ~300% and ~500% higher costs, respectively. • A comparison of costs between patients with/without DM reported that adjusted annual per-patient costs post-ESRD onset were significantly higher for patients with diabetes mellitus (DM) versus those without DM (p<0.0001).17 • A 2006 study18 noted substantial ESRD-related nonmedical costs that fell on employers. • − Each study took a different approach to costing − The resource use items on which analyses were based were not consistent − Methodologies and costing years varied. Table 5 includes ESRD costs per patient level. Annual healthcare costs of dialysis and transplant was reviewed on a per patient level. National-level data • Two studies4,6 reported total costs of ESRD (direct + indirect costs), whereas two5,7 reported direct healthcare costs of ESRD only (Table 2). • The key cost driver of healthcare costs in the Canadian study4 was HD undertaken in a medical centre; this was followed by the cost of ongoing transplant for a functioning kidney and then the cost of PD. • In the Spanish the main cost driver was that of dialysis treatment sessions. study,6 Table 2. Total annual national direct costs for ESRD patients (in millions) • This project was a scoping review – an approach that examines the extent, range and nature of research activity in a given field; though similar to a systematic review, it does not define outcome parameters a priori. • The search protocol defined the focus of review (patient population, relevant study designs and characteristics, outcomes of interest, perspectives and limitations); the search strategy; study selection criteria; data extraction methods; and data synthesis methods. • The search strategy identified studies quantifying the economic burden of ESRD in adults in nine countries (Australia, Canada, France, Germany, Italy, Japan, Spain, UK and USA). Country Total cost Direct cost Indirect cost Canada4 $Can 1857 $Can 1273 $Can 583 England5 Spain6 £780 €1829 €1407 UK7 £184.5* USA7 $3611* Cost year 2000 €423 2010 2001 • Results were de-duplicated and downloaded into a reference database. • Costs were not always limited solely to direct healthcare and indirect costs. 4,6 For example, the 2012 English study5 estimated that annual transport costs for a patient to attend dialysis was £50 million. These transport costs are often not captured in studies; also typically overlooked are social/community care costs, or personal costs associated with renovations to accommodate home dialysis. • • We identified 2094 de-duplicated references from the combined search in which 57 manuscripts remained after review of titles/abstracts and 40 after full-text review (Figure 1). • Three studies4,6,7 reported total annual direct healthcare costs of dialysis (Table 3); they all found the economic burden of HD to be considerably higher than PD. Country Reports not published as peer-reviewed journal articles were not included in the review. Figure 1. Flow chart of search strategy results Total number of records identified (n=3629) Direct healthcare HD: HHD: PD: $Can 646 $Can 80 $Can 147 England7 HD: PD: £437 £67 Spain6 HD: PD: €1077 €85 Canada4 Lost productivity HD: $Can 113 $Can 63,045 2000 Canada4 Mean total healthcare cost for ESRD care per patient $Can 51,099 2000 France11 Mean weighted total annual healthcare cost of ESRD per patient Italy12 Mean total annual cost for ESRD care per patient Japan13 Mean total annual healthcare cost of ESRD per patient $41,681 2003 UK7 Mean weekly healthcare costs for ESRD with diabetes Patients with DM: £537 (weekly) 2001 USA14 Healthcare cost of ESRD health state in $37,022 someone with T2DM 2000 USA7 Mean weekly healthcare costs for ESRD patients with diabetes Patient with DM: $605 (weekly) 2001 USA15 Annual per-patient healthcare costs of ESRD with and without DM Patients with DM: $96,014 Patients without DM: $53,653 2002 €40,975 (US $45,327 PPP) €31,472 ($38,427 PPP) 2004 2003 2001 (CI: $3556-25,870) Mean total annual cost for ESRD patients with T2DM USA16 ESRD with dialysis: $41,117 2010 (CI: $28,948-53,286) ESRD with transplant: $30,361 (CI: $2848-57,618) 2001 HD: PD: €250 €24 2010 • Only one study6 reported total costs associated with transplant: for Spain, estimated to be €393 million. • Five studies4–8 reported total annual direct healthcare costs of transplant (Table 4). Manuscript reviewed for relevance (n=57) CI, 95% confidence interval; DM, diabetes mellitus; ESRD, end-stage renal disease; PPP, purchasing power parity; T2DM, type 2 diabetes mellitus. CONCLUSIONS • This review identified a number of informative studies on the economic burden of ESRD, including costs split by transplant and dialysis care. • However, significant gaps in the evidence base were identified that warrant further research: • One study7 provided data for both the UK and the USA. Manuscripts excluded (n=17) Not a cost study (e.g. review) (n=11) Non-English language (n=3) Not ESRD (n=2) Not journal paper (n=1) Manuscripts for inclusion (n=40) • A breakdown of costs5 shows that ongoing care after the first year is the biggest cost driver. Table 4. Total national healthcare costs of transplant (in millions) Country STUDY RESULTS The 40 included studies used a range of study designs: − 35 used existing data (e.g. published studies, hospital records, registries and databases) − Five were prospective studies. • The focus of the studies varied: − ESRD in general (n=16) − Dialysis (n=16) − Transplant (n=8) − Diabetes (n=7). Canada4 $Can 2 $Can 3 $Can 106 $Can 289 England5 Annual healthcare costs: £225.4 Spain6 Annual healthcare costs: €244 UK7 In patients with prior kidney transplants: T1DM patients: £2.2 T2DM patients: £0.4 All diabetes patients: £2.6 In patients with new kidney transplants: T1DM patients: £2.5 T2DM patients: £0.3 All diabetes patients: £2.8 USA7 In patients with prior kidney transplants: T1DM patients: $17 T2DM patients: $205 All diabetes patients: $222 In patients with new kidney transplants: T1DM patients: $68 T2DM patients: $281 All diabetes patients: $350 USA8 Aggregate hospital cost for kidney transplant: $31,000 Table 1. Number of studies reported by country Number of studies 1 7 2 2 5 1 1 2 3 16 Total annual healthcare cost of kidney transplant Living kidney donor costs: Cadaveric kidney retrieval: Transplant care: Functioning transplant care: • There was a wide range of geographic settings (Table 1). Country Australia Canada France Germany Multi-country Italy Japan Spain UK USA ($36,917 PPP) National-level data: Transplant Records excluded at abstract review (n=2037) • $Aus 50,576 ESRD not on dialysis: $14,713 $Can 33 HD, haemodialysis; HHD, home haemodialysis; PD, peritoneal dialysis; Number of records after duplicates removed (n=2094) Healthcare cost of ESRD health state in someone with T2DM 2000 PD: Cost year Canada10 Table 3. Annual national cost of dialysis (in millions) Cost year Direct healthcare cost Australia9 *Diabetic patient with ESRD • The 2011 Spanish study6 reported total (direct and indirect) annual dialysis costs for Spain. Costs in 2010 were €1327 million (HD), €109 million (PD). Cost item Mean total healthcare cost of ESRD per patient 2001 • Searches were conducted in MEDLINE and MEDLINE in process, EMBASE, Science Citation Index, National Health Service Economic Evaluation Database (NHS EED), Health Economic Evaluations Database (HEED), Cost-Effectiveness Analysis (CEA) Registry, RePEc (Research Papers in Economics) and Health Technology Assessment (HTA) database; these were supplemented with reference checking. SEARCH RESULTS Country 2009–10 National-level data: Dialysis • Two reviewers independently assessed the abstracts and included manuscripts for relevance. Table 5. Total annual healthcare costs of ESRD per patient Cost year 2000 2009–10 T1DM, type 1 diabetes mellitus; T2DM, type 2 diabetes mellitus. ISPOR 17th Annual European Congress; Amsterdam, The Netherlands; November 8-12, 2014 2010 • 2001 2008 There were few national-level studies − Most studies were retrospective − Even robust and informative studies have so far taken a relatively narrow focus − Costs to non-healthcare budgets (e.g. social services) and to patients (lost productivity, out-ofpocket costs) should also be quantified. A prospective Europe-wide costing study of ESRD using a consistent methodology across all countries and taking a societal perspective would add significantly to the evidence base. Acknowledgements: The authors thank Mick Arber for his expert insight in devising and running the searches. References: 1. 2. 3. 2001 − 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. Grassmann A, et al. Nephrol Dial Transplant 2005;20:2587–93. Covic A, et al. Clin Nephrol 2010;74(suppl 1):S23–7. US Renal Data System. 2012. Available at: http://www.usrds.org/atlas.aspx Zelmer JL. Kidney Int 2007;72:1122–9. Kerr M, et al. Nephrol Dial Transplant 2012;27(suppl 3):iii73–80. Villa G, et al. Nephrol Dial Transplant 2011;26:3709–14. Gordois A, et al. J Diabetes Complications 2004;18:18–26. Janjua HS, et al. Prog Transplant 2013;23:78–83. Harris A, et al. Int J Health Care Finance Econ 2007;7:113–32. O’Brien JA, et al. BMC Health Serv Res 2003;3:7. Durand-Zaleski I, et al. Int J Health Care Finance Econ 2007;7:171– 83. Pontoriero G, et al. Int J Health Care Finance Econ 2007;7:201–15. Fukuhara S, et al. Int J Health Care Finance Econ 2007;7:217–31. O’Brien JA, et al.. Clin Ther 2003;25:1017–38. Mau LW, et al. Am J Kidney Dis 2010;55:549–57. Li R, et al. Am J Manag Care 2013;19:421–30. Joyce AT, et al. Diabetes Care 2004;27:2829–35. Kamal-Bahl SJ, et al. Prev Chronic Dis 2006;3:1–10. 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