State Health Secretariat of Ceará - SESA Cell Health Economics - CECONS Economic Evaluation of Dialysis in Patients with Acute

Renal Failure in Ceará Brasilia, December 9, 2005 Funder Project Health Economics Technical Cooperation Agreement between Brazil and the United Kingdom (DFID) Consultants Phase 1 - Juan Eduardo Tello Representative of European Union policies of Health in Jerusalem Phase 2-Jaume Puig-Junor (Professor, University Pompeu Fabra (Spai n), Coordinator of the MSc in Health Economics Team Search Coordinators Jose Alexandre Silva Mont'Alverne - Medical Sousa Maria Helena Lima - economist Statistics Rosa Maria Salani Mota Researchers Antonio Augusto Carvalho-Guimarães Ximenes doctor nefrologistga Ana Lucia Rodrig uez - nurse nephrologist Francidênia Barbosa Noble - Nurse Maria do Socorro neph rologist Menezes Rolim de Carvalho - nurse nephrologist Edilmar Carvalho de Lima - economist Cléber Domingos da Silva Cunha - Pharmacist Francisco Monteiro Alex andre Nogueira - statistical / sist information Interns Daniela M. Serpa Silva and Silvana Lima Machado (Nursing students) Why research? Demand Group for Technology Assessment in Health SESA In Ceará, in 2002, only wi th renal replacement therapy for chronic patients spent R $ 27.1 million. This r epresents 30% of the expense of high complexity and 13.7% of spending for health care and tertiary care with federal funds. Different connotations patient's acute In the NHS, the Renal Replacement Therapy (RRT), hemodialysis or peritoneal dial ysis patient in an acute hospital environment is held in the TRS are never the m ain reason for hospitalization, so do not appear as the main procedure in SIH. T he acute patient care does not have the same level of standardization that exist s in chronic dialysis patient is supposed to be the cost differential. Background (1) Lack of standardization of SUS The cost differential Shortage of supply - For the chronic patient is an adequate supply of services the list price of pr ocedures SUS - For the acute, it is increasingly difficult to find assistance. Difference between the market price and payment by SUS. Background (2) The existence of two technologies - Machine tank - machine ratio Hemodialysis - HD - Hemodialysis - HDL - Hemodialysis slow Context Study

The study was conducted in Fortaleza General Hospital Dialysis Center Sector of Nephrology of HGF is the only unit that meets the State Public Works under the a cute diuturnal daily also serves the chronically admitted through the Emergency Room and transplanted. Has 18 hemodialysis machines of proportion (Baxter system Altratouche 1000) and five equipment suitable for continuous hemodialysis (hemo lenta) marks Vital Systems From January 2004 to August/2005 hemodyalisis 6472 we re 41.5% (2685) are patients IRA General Purpose Contribute to increased efficiency of dialysis performed in acute patients at the General Hospital of Fo rtaleza (HGF), through economic analysis of treatment administered. Specific Objectives Know the main items of cost of dialysis treatment they were subjected to the pat ients with acute renal failure treated at the Hospital Geral de Fortaleza Calcul ate the cost of each form of dialysis treatment they are subjected to these pati ents. Analyze variations in costs calculated and the determinants of these varia tions. Verify and analyze the main consequences of treatments and relate them to the costs obtained Analyze the risk factors for hospital death Methodology Method - Cost-Consequence (reduced cost-effectiveness) Perspective Study - SUS-EC Inclusion criteria - Patients with urine output below 400 ml / day - Progressive azotemia (urea - c reatinine) - Presence of typical cylinders in urinary sediment (pyuria, hematuri a) - Renal Ultrassonogranfia to exclude the possibility of IRC. - Patients who u nderwent dialysis between August 2003 and June 2004 Methodology Exclusion Criteria - Patients transplant - Patients with ARF - prerenal (dehydration) - necrotizing - Patients with terminal cancer N = 96 Data Collection - Using a questionnaire for registration and patient identification by hospital records, stating the following: name, gender, date of birth, date of admission t o the hospital and place of residence Methodology To analyze the consequences were identified in the patient's health record: pati ent - The clinical status of patients to identify the disease responsible for hospit alization - The pre-existing medical conditions - The laboratory results obtaine d from the last survey before the first hemodialysis session - prior drug therap y - also gathered data on the dialysis sessions in regard to diuresis, duration, mode, taking place as a horizon of 14 sessions Methodology Outcomes - Partial recovery of renal function - Healing - Chronic Renal Failure - Death Identification of Costs Direct costs of dialysis - medical, hospital and Drug Administration (according to the standardization established to prevent the insertion of materials and med icines that were not associated with dialysis).

Methodology Medical Equipment-Hospital 1 2 3 4 5 6 7 8 9 10 11 12 Lumen Catheter Kit Capillary dialyzer type (F5) type capillary dialyzers (F6) capillary dialyzer type (F7) type capillary dialyzer (F 8) Soplução Peritoneal Dialysis 1.5% Heparin (used the patient) - Sodium Heparin (used for patient) - Subcutaneous Protamine Sulfate Concentrated erythrocytes E quipo Equipo Peritoneal Dialysis hemodialysis Potassium Chloride 10% Unit Price. R $ 109.00 119.80 124.80 75.02 70.00 1.77 2.74 1.06 1.99 19.13 2.78? 0.16 Material Médicohospitalar Methodology Medicines 1 2 3 4 5 6 7 8 9 10 11 11.1 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 Digoxi n 0.25 mg Insulin-Comp 100 U regular insulin NHP 100U ² ² Methyldopa Methyldopa 250 mg-comp-comp 500 comp-mg Enalapril 20 mg captopril (cap) - comp 25 mg Adalat (nifedipine)-caps 20 mg Atensina (AT) - 0.100 mg Saline (SF) - fr 500 ml serum glucose (SG) - fr 500 ml 5% 500 ml serum glucose (SG) - fr 500 ml 10% 500 ml Dip yrone (DIP) --drops 500 mg / ml Dipyrone (DIP) - comp .- 500 mg dipyrone (DIP) amp-500 mg / ml Plasil ( Plas) - amp. 500 mg / ml amikacin (Am) - amp.250 mg / ml hypertonic glucose (HG) - 50% amp 500 ml Gentamicin (Gen) - amp-80 mg / ml va ncomycin (Van) - 50 mg / ml cephalothin (kef) - 1g/ml Acid solution for hemodial ysis - Gallon w / 5 liters Basic solution for hemodialysis - Gallon w / 5 liters of intravenous access line solution Proxitano-Gallon 20 liters arterial access line 06 mm 08 mm arterial line access Price $ Unit.R 0.02 19.20 17.44 0.15 0.33 0.04 0.02 0.14 0.10 0.71 0.79 0.93 0.38 0.05 0.20 0.1 8 0, 74 0.83 0.25 8.95 2.08 3.90 3.90 9.48 5.28 5.28 343.00 Selected drug Methodology Cost sector Staff - nephrologists, vascular surgeons, nurses (a) s, nursing, cleaning profes sionals, nutritionists and social workers (per hour worked, gross wages more soc ial security contributions, overtime, productivity and gratuities) - Other mater ials used in the consumption industry - Maintenance of equipment - for control a nd water treatment, maintenance of machines corrective and preventive maintenanc e of central air conditioning. - Consumption of water, power, telephone and othe r direct costs Methodology Statistical treatment - Descriptive Analysis Technique - to know the profile of the population, throug h tables, measures of central tendency and measures of variability. - Total Cost s of hemodialysis treatment and the total - were reported per patient per sessio n and per hour of hemodialysis. - Outsourced - costs that are borne by the Compa ny outsourced. Methodology Multiple Linear Regression Analysis for Cost per hour of Hemodialysis - Utilizing the technique of Linear Correlation Pearson, and technical charts Di spersion Equation for Multiple Linear Regression stepwise backward and Wald stat istics. Analysis of risk factors for death from patient - Utilizing the technique of stepwise logistic regression and Wald statistics Be

ckward Methodology For the analysis of risk factors for patient death were considered the following blocks of variables - State of the Clinical Entry HD - IRC / IRA - Socio Demographic Factors - CID Primary - CID - Secondary - CID trigger - Other CID triggering factor - pre-exi sting diseases Methodology For the analysis of risk factors for patient death were considered the following blocks of variables (cont) - Laboratory results taken from the last examination before hemodialysis - Thera peutic Drug previous - Prior clinical conditions - Clinical conditions during he modialysis sessions - Laboratory extracted from the last examination before hemo dialysis - Over the course of the hemodialysis (diuresis average final value of diuresis , maximum diuresis, no. hemodialysis sessions etc) Results Table 1: Average cost of hospital treatment with hemodialysis in relation to out come Variables Total Recovery% Recovery% Partial Chronic Renal Failure Death%% 54 96 56 100 20 21 July 7 No.% Drugs (U.S. $) Investigations Complement ares (U.S. $) Dialysis (U.S. $) To tal (U.S. $) 15 16 50.17 1.1 57.05 1.1 100.35 2.3 114.46 2.3 280.94 6.3 183.09 3.7 233.27 5.4 397.87 7.8 92.6 95.2 4129.20 4758.43 3985.88 4557.59 92.3 89.9 100.0 100.0 4460.31 4998.58 4319.40 5069.92 100.0 100.0 Results Table 2: Average cost of hospital treatment in relation to sex, age, loc ation and professional activity VAR IAV is exo S IS F in in in the%% M ember lin the Id and d (n the) ad m issio n in <40% 40 --- 60%> 60% P ro ced ence C ap ital% In teri r% A p ro ad tivid fissio A n al po sen a tad (a)% A g ricu lto r (a) ren% P d L of the air u% O tr o s 60 96 62.5 100.0 36 37.5 174.91 3.8 50.68 1.0 21.52 0.5 126.22 2.8 106.23 2. 0 91.83 1.9 101.15 2.1 147.46 2 5 44.66 3.1 42.99 1.3 161.00 362.71 8.0 309.81 6 .2 303.87 7.5 265.14 6.1 375.83 346.76 7.0 7.1 6.6 317.42 401.22 6.2 278.00 8.2 399.16 244.72 7.7 3984.82 88.1 4627.02 3719.40 92.8 92.0 3988, 39 91.1 91.0 4843 .63 4412.64 91.0 4367.30 5412.26 91.3 90.8 3074.35 4597.57 90.5 89.2 3913.41 452 2.44 100.0 4987 50 100.0 4044.80 100.0 4379.75 100.0 5325.68 100.0 4851.23 100.0 4785.87 100.0 5960.94 100.0 3397.01 100.0 5157.74 No. 4201.12 100.0% icam en M ed to s (R $) E Xam es C omp lem en tary (R $) D $ ER IS ITB) TOTAL (U.S. $) +10% italia ho sp 17 29 50 96 40 17.7 30.2 52.1 100.0 41.7 +30% 56 96 36 20 12 28

58.3 100.0 37.5 20.8 12.5 29.2 % 96 100.0 1.0 5.8 93.2 100.0 Results Results Table 3: MAIN primary diseases Infectious and parasitic diseases Neoplasms D. Metabolic a nd nutritional D. circulatory D. digestive D. No Other genitourinary system dise ases Infectious and parasitic Secondary D. circulatory D. respiratory D. digesti ve D. Other genitourinary No triggering factor Sepsis complications, infectious complications, cardiovascular Alcoholism Dehydration Other Diseases preexisting chronic hypertension Diabetes Chronic Alcoholism Smoking Liver Neoplasms Other A utoimmune diseases Lupus Erythematosus obstructive uropathy 43 21 09 16 06 09 02 13 January 109.42 187.52 21.97 53.57 10.00 42.79 0.00 0.93 93.11 383.20 500.46 257.62 351.69 306.56 391.52 251.64 400.34 365.72 4,850, 40 6380.36 3489.69 4631. 29 2717.84 4642.69 1180.45 7888.80 5519.29 5343.01 7068.34 3769.28 5036.55 3034. 40 5077.00 1432.09 8290.07 5978 12, No. Average cost of hospital treatment for diseases with primary, secondary, and to trigger pre-existing donc Drug tests complementarity (R $) s (R $) 148.61 68.77 157.20 92.04 167.69 100.81 4.29 0.00 31.19 104.02 173.06 53.18 101 76 217.65 25.05 10.95 61.93 32.08 211.8 0 46.05 204.25 247.52 401.23 456.78 370.52 315.93 289.67 245.53 111.44 184 , 05 389.47 381.12 360.14 347.63 370.97 236.03 398.55 275.55 266.31 371.13 332.28 355 .53 Dialysis (U.S. $) 3655.53 5861.67 5763.72 4270.86 4073.30 4991.06 3179.60 2680.7 5 2310.59 5379.35 4032.35 4718.85 4497.17 6336.49 4059.21 4260.75 3731.04 2216.1 1 5339.01 4002.74 5359.89 Total (U.S. $) 4051.66 6331.66 6377.70 4733.42 4556.92 5381.54 3429.42 2792.19 2 525.82 5872.83 4586.53 5132.17 4946.56 6925.11 4320.29 4670.26 4068.52 2514.50 5 921.94 4381.07 5919.67 04 11 18 38 16 15 14 02 05 16 15 10 28 09 18 18 25 4 17 10 14 Conclusions Results Diseases of the circulatory system - present lack of full recovery - Prevalence of chronic infection (50%) -Death (44%) - In multivariate analysis, appear associated with death, both the diseases of b oth primary and joint analysis (Primary and Secondary) - No association between this group of diseases with costs. Diseases of the genitourinary system

- They have a higher proportion of recovery - appear at all stages of the analys is as being associated with a lower risk of death (both in the analysis univ. As mult) Results Results Respiratory Diseases events (death or chronic infection) - How have 100% secondary disease outcomes - In univariate analysis presents a high risk of death (p <0.01), however in the multivariate analysis did not show an association with even 15% significance. Diseases of the Digestive System - Are related to death as both primary and secondary disease or chronic pre-exis ting, though not confirmed the association for 5% significance. Endocrinopathies (including diabetes) to death (this differs from the literature). - Failure to appear at any time as a risk factor Results Results Table 4: Average cost of hospital treatment in relation to previ ous drug therapies, the number and type of hemodialysis Variables No. MedicamenExames tos Complementary £ 1.56 1.70 45.92 24.18 293.94 3 0.41 27.76 184.54 23.51 982.02 299.12 308.80 359.41 404.96 345 06 185.69 328.89 443.14 141.53 284.00 Total Dialysis Drug therapy prior Aminoglycosides Analgesics Anti-inflammatory immunosuppressive radiocontrast 1 --- --- March 2 5> 5 5 5 17 5 1 33 21 42 41 91 1.769,02 1 .902,90 3.285,63 4 .758,21 5.690,33 1.427,28 2.558,04 7.625,13 2.622, 59 3.445,59 2.069,70 2.213,40 3.690,96 5.187,35 6.329,33 .643,38 .914,70 8.252,81 2.787,63 3 .821,60 N ª sessions Hemnodiálise Mode Homodiálise Conventional Slow Flow Results Results Table 5: Average cost of components and associated with dialysis Clinical Condition Initial IRA IRC Cost% Cost 918.6 2908.9 365.2 148.7 4341.4 67 .0 21.2 8.4 3.4 100.0 3136.8 1080.3 393.8 160.4 Components TOTAL% 8.3 65.7 22.6 3.4 % Human Resource Medical Equipment, Hospital Equipment Maintenance Other Consumabl es Total Tratamentno

2.932,7 66.9 935.4 21.3 368.2 8.4 149.9 3.4 4.386,2100,0 4771.3 100.0 Results Results Table 6: Analysis of Average Cost per patient according to the f inal position of patients and type of hemodialysis The Chronic Renal Insufficiency 14 13 4467.38 4858.75 2295.22 2448.78 All arrangements Hemodialysis No. of patients Total Cost of dialysis treatment N o. of HD patients on dialysis Cost Cost of Treatment HDL No. of patients Total C ost of Dialysis Treatment Total recovery RECOVERY the Partial 15 12 4129.20 4460.31 2370.52 2546.96 July 4 758.43 4998.58 6020.87 6298.15 7 Death 6 50 4311.43 4818.37 2241.17 2534.85 12 2790.98 3028.44 7 1317.93 1399.63 13 2515.81 2783.72 50 4042.49 4514.19 Results Results Table 7: Analysis of Average Cost per session per patient accord ing to the final situation of patients and type of hemodialysis Modalities Total Partial Recovery Recovery Chronic Renal Failure Death All hemodialysis patients No. of Cost No. of dialysis HD patients on dialysis HD L Cost No. of Cost of Dialysis Patients 15 554.86 12 383.86 12 866.26 7 696.69 7 410.05 7 888.02 14 580.32 13 418.67 13 858.57 50 873.85 6 398.34 50 900.62 Results Results Table 8: Analysis of Average Cost per hour, according to the final situation of patients and type of hemodialysis Total Partial Recovery Recovery Chronic Renal Failure Modalities Death

All hemodialysis patients No. of Cost No. of dialysis HD patients on dialysis HD L Cost No. of Cost of Dialysis Patients 15 122.10 12 128.58 12 115.05 7 131.25 7 122.31 7 126.82 14 118.30 13 127.77 13 112.14 50 124.47 6 132.67 50 124 Results Table 9: Comparison between the cost of hemodialysis for the HGF and outsourcing SERVICE COMPONENT HUMAN RESOURCES Nurse Vascular Surgeon Nephrologist (a) s Nursing Assi stant Technical AOSD Clean MATERIAL MÉDICOHOSPITALAR Double Lumen Catheter Kit H air (Type: F5) Hair (Type: F6) Peritoneal Dialysis Solution 1.5% Heparin Protami ne Sulfate erythrocyte concentrate Equipo Equipo Hemodialysis Peritoneal Dialysi s Potassium Chloride 10% Saline Line Arterial Venous Line Acid Sodium Hypochlori te Solution Basic Solution Hydrogen + Acid Parasitic Equipment Maintenance Maint enance of machinery maintenance of air conditioning Control of Water Treatment W ater Energy Telephone OTHER MATERIALS CONSUMPTION TOTAL COST (h) OF HEMODIALYSIS BLOOD DRUG _PRONTUÁRIO TOTAL COST (h) TREATMENT Average 77.07 35.32 4.00 11.35 21.22 1.85 1.64 32.84 1.68 0.00 1 , 60 9.74 6.16 0.14 0.01 2.77 0.26 0.70 0.00 0 .29 1.19 0.67 0.70 0.39 0.43 0.75 9.68 1.98 0.41 5.06 0.90 1.17 0.16 3.94 2.16 1 2.95 123.53 138.65 STATE SD 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 14.63 0.00 3.22 7.29 3.24 0.21 0.05 4 .53 0 , 37 0.64 0.00 0.41 0.78 0.44 1.30 0.57 0.62 0.27 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 14.63 4.87 11.63 23.53 Low 77.07 35.32 4.00 11.35 21.22 1.85 1.6 4 1.68 10.32 0.00 0.00 0 , 00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.51 9.68 1.98 0.41 5.06 0.90 1.17 0.16 3.94 101.01 104.76 0.00 0 .00 Maximum 77.07 35.32 11.35 21.22 4.00 1.85 1 , 64 1.68 80.39 0.00 14.98 31.20 20.34 1.64 0.42 26.30 2.09 2.99 0.02 1.42 3.65 2.03 11.03 2.84 2.84 1.63 9.68 1 .98 0.41 5.06 0.90 1.17 0.16 3.94 171.08 29.19 65.74 214.46 101.03 101, 2003 Ave rage 69.53 35.32 11.35 21.22 1.64 29.51 0.00 1.60 9.74 6.16 0.14 Outsourced Dp Results The Minimum Maximum 0.00 69.53 69.53 0.00 35.32 35.32 does not offer 11.35 0.00 11.35 0.00 21.22 21.22 0.00 does not offer 1.64 1.64 does not offer 12.20 0.00 3 .22 7.29 3.24 9.37 0.00 0.00 0.00 0.00 69.72 0.00 14.98 31 20 20.34 1.64 0.70 1.19 0.67 0.70 0.39 0.43 0.75 1.98 1.98 0.21 0.00 does not offer the service does not offer the service does not offer 0 .64 0,00 does not offer the service does not offer 0.78 0.00 0.44 0.00 1.30 0.00 0.57 0.00 0.62 0.00 0.27 0.51 0.00 1, 98 2.99 3.65 2.03 11.03 2.84 2.84 1.63 1.98 1.98

0.00 1.98 does not offer the service does not offer the service does not offer t he service does not offer the service does not offer the service does not offer 12.20 80.88 141.23 not providing the service does not offer 12.20 80.88 141.23 Concluding Remarks • They are associated with: • • a higher death risk: age, low urine output of 24 and high frequency pulse prior to dialysis and a higher proportion of slow dialysis. • a lower risk for death: the presence of Bito genitourinary tract diseases and elevated creatinine. • a higher cost per hour: a low creatinine, time acidosis, sodium (when adjusted for age), low temperature (for I did not die), the low fre quency pulse, low urine output during dialysis . • The slow hemodialysis has hig her cost than hemodialysis Concluding Remarks • Diseases of the digestive tract, especially the liver as a trigger and acidosi s, appreciate strongly associated with death in multivariate analysis, however h ad to be excluded from the multivariate analysis the small number of people in t he group. • The situation of patients with ARF has been little studied, both fro m the clinical point of view about the costs, which led the team to study a larg e number of factors. • It is recommended to be studied a larger number of patien ts to seek more associations. Concluding Remarks • The cost of outsourcing the service, on average, is higher than the cost of se rvice by the hospital. • The price of outsourcing between public hospitals range s from R $ 380.00 / session ($ 90.00 / h) and R $ 460.00 / session (U.S. $ 115.0 0 / h) • The conclusion is that outsourcing may or may not be economically advan tageous, depending on the efficiency of contracting the service. • Observing the cost for the consequences it is observed that the most expensive is the patient who goes to death. Thank you and ... Merry Christmas!!