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Can we still afford blood transfusion? Transfusion Economics

This talk explores the principles of pharmacoeconomic evaluations and the cost, efficacy, and benefits of blood transfusion. It also covers examples of cost-effectiveness analysis in transfusion medicine and strategies for affordability.

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Can we still afford blood transfusion? Transfusion Economics

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  1. Can we still afford blood transfusion? Transfusion Economics Prof. Dr. med. Thomas Frietsch, GÖ (EBS) Klinik für Anästhesie und Intensivtherapie Universitätsklinikum Giessen Marburg GmbH, Philipps Universität Marburg HAI Berlin 17.-19.09.09

  2. Agenda -of a potentially more boring talk you thought it would be Transfusion / Health economics is ---- NOT – minimizing expenditures BUT – maximizing effectiveness per unit of cost to GET THE MOST BANG FOR THE BUCK • Principles of pharmacoeconomic evaluations (Drummond 1997) • Kind of Blood Transfusion • Cost of Blood Transfusion • Effects of Blood Transfusion • Efficacy of Blood Transfusion • Efficiency of Blood Transfusion • Benefits of Blood Transfusion • Risks of Blood Transfusion • Economics of Blood Transfusion HAI Berlin 17.-19.09.09

  3. ICER € Profit QALY € / Program Economics in Health Care - definitions and methodsDealing with efficacy, cost effectiveness, cost benefit, cost utility Users' Guides to the Medical Literature: XIII. How to Use an Article on Economic Analysis of Clinical Practice: A. Are the Results of the Study Valid? Drummond, Michael; Richardson, W; OBrien, Bernie; Levine, Mitchell; Heyland, Daren JAMA. 277(19):1552-1557, May 21, 1997. • Types of pharmacoeconomic evaluations • cost-minimization analysis (CMA) • cost-effectiveness analysis (CEA) • cost-utility analysis (CUA) • cost-benefit analysis (CBA) HAI Berlin 17.-19.09.09

  4. and in detailed surview Economics in Health Care - HAI Berlin 17.-19.09.09

  5. Economics in Transfusion Medicine - Examples • CEA • Transmission of HIV, Hep B/C 289 000 to 9.75 mio US $/QALY ICER • HIV antibody screening in the US $ 3600/QALY • HIV nucleid acid testing NAT > $ 2 mio/QALY • HCV NAT $ 1.8 mio/QALY • HBsAG+anti HBc $ 1 mio/QALY • HBV NAT $ 66 mio/QALY • West Nile NAT (June-Nov/whole year) $ 0.3/0.5 mio/QALY • H1N1 ? • Donor selection ? • Mistransfusion (mechanical barrier) $ 189 000/QALY • TRALI $ 30 000 to 50 000/QALY • Sepsis $ 50 000 /QALY Custer B & Hoch JS. Cost-Effectiveness Analysis: What it really means for transfusion medicine decision making. Transfus Med Rev 2009; 23: 1-12 HAI Berlin 17.-19.09.09

  6. Surview of Affordability: General Approach • Allogeneic • Red • White • Platelets • Coags) • Autologous • Normovolemic Hemodilution • Predonation • Cell Salvage • Avoidance Strategies • Algorithms and Shresholds • Controlled Hypotension • Blood Substitutes • Point of Care Testing • Patient Blood Management HAI Berlin 17.-19.09.09

  7. Cost of blood transfusion HAI Berlin 17.-19.09.09

  8. Detailled Agenda-of a potentially more boring talk you thought it would be • Principles of pharmacoeconomic evaluations (Drummond 1997) • Effect of Blood Transfusion • Cost and efficacy of oxygenation therapy • Hospital economic perspectives of oxygenation therapy • Cost and Efficacy of Coagulation Therapy • Hospital economic perspectives of coagulation therapy • Solution : hospital fitted concepts HAI Berlin 17.-19.09.09

  9. Blood transfusion : Effects • 1Transfusion volume in the US/D each year: • 29/4 mio units (14.2 mio PRBC, 5.5 mio FFP (2005-6)) • > 125 transfusion related fatalities • > 64 TRALI 1:100 000 • 9 AB0 incompatibility 1: 600 000 (FDA) • incompatibility general < 1:10 000 (estimate) • fatal septic transfusion reaction 1: 140 000 • 2ARDS  OR 1.06 (CI 1.03-1.1) • 2In ICU/ventilated pats.: •  length of stay by 6.3 days (CI 5.1-7.6) •  mortality by 21% (OR 1.21, CI 1.00 – 1.48) •  cost by 50 000 US $ (CI 46-52 000) 1Solheim BG. Indications for use and cost-effectiveness of pathogen reduced AB0-universal plasma. Curr Opin Hematol 2008; 15:612-7 2Chaiwat O, et al. Early Packed Red Blood Cell Transfusion and ARDS after Trauma. Anesthesiology 2009; 110: 351-60 3Zilberberg MD et al. Anemia, transfusions and hospital outcomes among critically ill. Critical Care 2008; 12: R60 (n=4400, retrospective, mv > 96h) HAI Berlin 17.-19.09.09

  10. Cost of blood transfusion • Fix and variable cost Basha et al. Transfusions And Their Costs: Managing Patients Needs And Hospitals Economics. Int J Emer Int Care Med 2009 HAI Berlin 17.-19.09.09

  11. Cost of blood transfusion • UNIT acquisition cost • PRBC, non leuko-depleted $154 >€ 300 / US$ 400 = hospital costs for the unit (€ 150), storage, cross match, labelling, processing etc.  administration €150-350 and production (donor testing €35, donor fee €5-80, transport, cooling, centrifugation, baging and storage until delivery of blood products), if possible detrimental outcomes are accounted US$1600 to $2400 • fresh frozen plasma (FFP) $ 51 € 80 / US$ 100 • platelets (pooled or apheresis) $ 461 € 450 / US$ 600 • Prothrombin complex / Cryoprecipitate € 800 / US $ 750 • 2,4 mg FVIIa (Eptacog alfa)€ 2600 / US$ 2500 • 600 IU/ kg rhEpo (30 000IU) € 570 / US$ 420 Custer B & Hoch JS. Cost-Effectiveness Analysis: What it really means for transfusion medicine decision making. Transfus Med Rev 2009; 23: 1-12 HAI Berlin 17.-19.09.09

  12. 68 RCTS: Carless P, Moxey A, O'Connell D, Henry D: Autologous transfusion techniques: a systematic review of their efficacy. Transfus Med 14:123-144, 2004. • 2) Davies et al.: Cost effectiveness of cell salvage and other methods of minimizing allogenic blood transfusion: a systematic review and ecomomic mode. HTA 44:1-229, 2006 • 7-10 g/dl, most 8-9 g/dl: Carson JL, Hill S, Carless P, Hébert P, Henry D: Transfusion triggers: a systematic review of the literature. Transfus Med Rev 16:187-99, 2002 Davies L et al. Cost Minimization Analysis of preoperative Erythropoietin vs. Autologous and Allogeneic Blood Donation in Total Joint Arthroplasty. J Arthroplasty 2008; in press Analysis of various methods-CMA HAI Berlin 17.-19.09.09

  13. Effect of alternatives to allogeneic transfusion n.s. n.s. effect Davies L et al. Cost-effectiveness of cell salvage and alternative methods. Health Technol Assess 2006; 10: 44 HAI Berlin 17.-19.09.09

  14. How precise a CEA has to be HAI Berlin 17.-19.09.09 Sonnenberg A et al. The cost-effectiveness of autologous transfusion revisited. Anesthesiology 1999; 39:811

  15. Alternatives : Autologous Predonation / Cell Salvage - • Background: • Autologous techniques too expensive - avoidance of postoperative infections not considered • Methods: • CUA: Markov cohort analysis, hip replacement, cost per QALY • Assumption: serious infection – in 3.7% of cases  12 980 US $ addit. costs • Results: • RR > 2.4  autologous is dominant – lower costs • at RR 3.7, cost effectiveness 2 470 $/QALY • 2,4 > RR > 1.1  cost effectiveness < 50 000 $/QALY • 1,1 > RR > 0  cost effectiveness up to 3,400,000 $/QALY • Conclusion: • Cost effectiveness dependent on risk of bacterial infection HAI Berlin 17.-19.09.09

  16. PAD vs. EPO vs. Combination HAI Berlin 17.-19.09.09

  17. Another not calculated aspect • Immunosuppression and cancer recurrence HAI Berlin 17.-19.09.09

  18. CMA CEA/CUA € /pat ICER/QALY Red blood cell transfusion/alternatives below the Hb content of 8g/L € 1500** $ 7.7 mio Elective surgery • Allogeneic • Red PRBC Avoidance of Allogeneic T. • Autologous • Hemodilution (ANH) • Predonation (PAD) • Cell Salvage (CS) • Avoidance Strategies • Restrictive Shreshold • Controlled Hypotension • Blood Substitutes/ EPO • Point of Care Testing • Patient Blood Management n.s. RR 0.69 200-700*,** RR 0.36 (.25 –.51) $ 500 - $ 2580 RR 0.59 (CI 0.27 – 0.52) € 300* $ 5.7 mio n.d. RR 0,58 (.47-.71) 30-1800*,**** n.s. € 300* € 200-600** RR 0.49 (.38 –.64) $ 5000-8 Mio n.d. n.d. n.d. € 32*** n.d. n.d. Davies L et al. Cost-effectiveness of cell salvage and alternative methods. Health Technol Assess 2006; 10: 44 *Mirzy et al. Efficacy and economics of postop. CS for elective total hip replacement. Ann R Coll Surg Engl 2007; 89: 777 ** Green et al. Cost Minimization Analysis of Preoperative Erythropoietin .. J Arthroplasty 2009, epub ***Martinez et al. Transfusion strategy for primary knee and hip arthroplasty. BJA; 2007; 99: 794-800 ****O´Keeffe et al. A massive transfusion protocol to decrease blood component use and costs. Arch Surg 2008; 143: 686-91 HAI Berlin 17.-19.09.09

  19. How to perform PAD- Impact on efficacy Goodnough et al. Preoperative red cell production in patients undergoing aggressive autologous blood phlebotomy with and without erythropoietin therapy. Transfusion. 1992 Jun;32(5):441-5. Goodnough et al. The effect of patient size and dose of recombinant human erythropoietin therapy on red blood cell volume expansion in autologous blood donors for elective orthopedic operation. J Am Coll Surg. 1994 Aug;179(2):171-6 Wittig et al. Short donation intervals in preoperative autologous blood donation in the concept of autologous transfusion. Anaesthesist. 1994 Jan;43(1):9-15. Singbartl et al. Preoperative autologous blood donation - part II. Adapting the predeposit concept to the physiological basics of erythropoiesis improves its efficacy. Minerva Anestesiol. 2007 Mar;73(3):153-60. HAI Berlin 17.-19.09.09

  20. Avoidance Strategies: Cell Salvage • 1CEA in lumbar fusion: €225 per patient: • Unit PRBC €450 vs unit CS €370 • Costs with CS €995 ± 447 / pat. vs w/o CS €1220 ± 269 (P < 0.05). • 2CBA in lumbar fusion: • PAD no allogeneic blood, 20% w/o PAD + w/o CS vs 24% w/o PAD with CS • 1 Savvidou C. et al. Efficacy and cost-effectiveness of cell saving blood autotransfusion in adult lumbar fusion. Transfus Med 2009; 19: 202-6 • 2 Reitmann CA et al. The Cell Saver in Adult Lumbar Fusion Surgery. Spine 2004;29:1580-4 HAI Berlin 17.-19.09.09

  21. Business economics: Recalculate your ressources *) Cost analysis: Klinikum Mannheim 2004 **) Leukocyte depletion does not improve outcome: Frietsch T, Karger R, Schöler M, Huber D, Bruckner T, Kretschmer V, Schmidt S, Leidinger W, Weiler-Lorentz A: Leukodepletion of autologous whole blood has no impact on perioperative infection rate and length of hospital stay. Transfusion 2008 Oct;48(10):2133-42 HAI Berlin 17.-19.09.09

  22. Identify the dominant strategy Alternative decisions: Example- PAD vs CS Total PAD Costs Personnel *) Cost analysis: Klinikum Mannheim 2002 HAI Berlin 17.-19.09.09

  23. Avoidance Strategies: Algorithms • 1Retrospective CMA: • Reduction of „turnaround time“ from 40 ´ to 10 (20) min • 2 270 US$ per patient, 200 000 US$ per y 1O´Keeffe et al. A massive transfusion protocol to decrease blood component use and costs. Arch Surg 2008; 143:686-91 2Martinez V et al. Transfusion strategy for primary knee and hip arthroplasty. BJA 2007; 99:794-800 3 Hebert et al. A multicenter, randomized, controlled clinical trial of transfusion requirements in critical care. N Engl J Med 1999;340:409-417 HAI Berlin 17.-19.09.09

  24. Conclusion for the Cost-efficiency of Oxygenation therapy: • It depends: • on risk profile of the patient • on the surgical procedure • your country (pay scale, ethical opinions, etc.) • your institution • available strategies • budget range • personnel • ... • .. • .

  25. Coagulation Therapy: plasma or factor substitution, haemostatic agents • POCT: see avoidance strategies • Algorithms: see avoidance strategies • Plasma (FFP): efficacy low , high volume needed, all factors included, not standardized • Lyophilized Plasma: same, only volume to substitution ratio improved • ABO-universal plasma: not approved yet (Solheim et al Current Opin Hematol 2008) • Platelets: • Vitamin K: • PPSB/prothrombin complex: • Cryoprecipitate: • Fibrinogen: • Recombinant F VIIa: • F XIII: • Antifibrinolytics: Aprotinin, Tranexamic acid, e-Aminocapron acid • DDAVP/Desmopressin: HAI Berlin 17.-19.09.09

  26. Coagulation Therapy: Plasma • Indication: • Treatment and prophylaxis of complex coagulopathy due to acquired (perioperative) loss, • Isolated factor deficiency w/o the availability of special concentrate preperations (FV, FXI oder VWF:CP(ADAMTS13)). • Dose: • quick 30-50 mL/min admin. of 15-20mL/kg if no lab, • 1mL/kg for 1% increase in QuickAim at stop of oozing or Quick > 50, Fibrinogen > 1, APTT < 45 s • Efficacy: Bundesärztekammer. German Cross sectional Guidelines for Therapy with Blood Components and Plasma Derivatives. 4th ed. Dtsch Arztebl 2008; 105: A 2121 http://www.bundesaerztekammer.de/page.asp?his=0.6.3288.6716 HAI Berlin 17.-19.09.09

  27. Coagulation Therapy: Platelets • Indication: • prophylaxis of DIC (WHO IV° 2c) below 10 000/µL • treatment of bleeding episodes below 10 000/µL(WHO III° 2c) • Efficacy: Bundesärztekammer. German Cross sectional Guidelines for Therapy with Blood Components and Plasma Derivatives. 4th ed. Dtsch Arztebl 2008; 105: A 2121 http://www.bundesaerztekammer.de/page.asp?his=0.6.3288.6716 HAI Berlin 17.-19.09.09

  28. Coagulation Therapy: Factor VIIa • Indication: • Inherited (hemophilia), acquired (perioperative) deficiency, Glanzman thrombasthenia (refract. Platelets (EU)) • Prophylaxis & treatment of bleeding episodes • Efficacy: OR 0.29 (CI 0.1-0.8), > 50µg/kg OR 0.49 (0.23- 0.78) for reduction of allogeneic units • CBA: • preconsiderations: • dose 90µg/kg cost 5000 € /8000 US $ (2008) • Cost of a PRBC 250€ / 350 US$ • No benefit in ICU stay, LOS, mortality • No thromboembolic complications • Cost-benefit ratio beneficial (RR> 0.5) only if a patient > 40 PRBCs Rannucci, M et al. Efficacy and Safety of Recombinant Avctivated Factor VII in Major Surgical Procedures. Arch Surg 2008; 143:296-304 HAI Berlin 17.-19.09.09

  29. Coagulation Therapy: Desmopressin, DDAVP • Indication: • Mild hemophilia, von Willebrands disease, • acquired (perioperative) platelet dysfunction or deficiency, • Efficacy: • 1single dose 0.3µg/kg reduces transfusion requirements by 0.29 (0.06-0.52) units per pat (80 mL), more in non-cardiac surgery. • Safety: • 5 mild hypotension (8.4% vs 2.1%, p<0.001) • 1+4increase of thromboemboli 5.7% vs. placebo 4.6% (n.s.) • 3 2.4-fold risk of periop. MI (Levy et al) • 4 4-fold risk of stroke (Mannucci et al) • CMA: • Cost 5 – 10 US$ 0.3 unit  100€ (150 US $) 1Crescenzi, G et al. Desmopressin Reduces Transfusion Needs after Surgery. A Meta-analysis of RCTs. Anesthesiology 2008; 109:1063-76 (38 trials, 2 500 pats. included) 2 Carless et al. Desmopressin Reduces Transfusion Needs after Surgery. A Meta-analysis of RCTs. Anesthesiology 2008; 109:1063-76 (25 trials included) 3Levy M. Pharmacological strategies to decrease excessive blood loss in cardiac surgery. Lancet 1999; 354:1940–7 4Mannucci PM et al. Desmopressin, surgery and thrombosis. Thromb Haemost 1994; 71: 154-5 HAI Berlin 17.-19.09.09

  30. Coagulation Therapy: Antifibrinolytics • Indication: • Efficacy: • 3 reduction massive bleeding by aprotinin vs. TXA vs ACA RR 0.79 (CI 0.59 – 1.5) • Safety: • 3 death from any cause RR 1.53 (CI 1.06-2.22) 1Henry et al. The safety of aprotinin and lysine-derived antifibrinolytic drugs in cardiac surgery: a meta-analysis. CMAJ 2009;180(2)183-93 2 Henry et al. Anti-fibrinolytic use for minimising perioperative allogeneic blood transfusion. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD001886 3Fergusson et al. A Comparison of Aprotinin and Lysine Analogues in High-Risk Cardiac Surgery. NEJM 358: 2319-31 HAI Berlin 17.-19.09.09

  31. ? Reduced cost for blood products per month € 50 000, ROTEM € 1580 Avoidance Strategies: POCT 1 Spalding et al. Cost reduction of perioperative coagulation management in cardiac surgery: value of ‘bedside’ thrombelastography (ROTEM). Eur J Cardiothorac Surg. 2007 Jun;31(6):1052-7 HAI Berlin 17.-19.09.09

  32. CMA CEA/CUA € /pat ICER/QALY Coagulation & transfusion/alternatives n.d. yes • Allogeneic • Plasma/FFP • Platelets • Cryo/PPSB • Aprotinin • TXA • EACA • F VIIa • Desmopressin • Fibrinogen • F XIII • Algorithms and Shresholds • Substitutes/universal P • Point of Care Testing • Patient Blood Management n.d. RR 0.7 RR 0.3-0.42 € 115* RR 0.17-0.3 n.s. RR 0.52 RR 0.43(.23-78) € 100*** n.d. n.d. € 700** n.d. *Lozano et al. Effectiveness and safety of tranexamic acid administration during total knee arthroplasty Vox Sang 2008 Jul;95(1):39-44 **Spalding et al. Cost reduction of perioperative coagulation management in cardiac surgery: value of ‘bedside’ thrombelastography (ROTEM). Eur J Cardiothorac Surg. 2007 Jun;31(6):1052-7 ***Crescenzi, G et al. Desmopressin Reduces Transfusion Needs after Surgery. A Meta-analysis of RCTs. Anesthesiology 2008; 109:1063-76 HAI Berlin 17.-19.09.09

  33. Conclusion for the Cost-efficiency of Coagulation therapy: • It depends: • on risk profile of the patient • on the surgical procedure • your country (pay scale, ethical opinions, etc.) • your institution • available strategies • budget range • personnel • ... • .. • .

  34. - Conclusions for the general approach* - • Whenever you can afford it – do not use the general approach! • When there is a choice and efficious method to avoid allogeneic transfusion- afford it • Use PAD (w.or w/o EPO) before CS before ANH • In the elderly (where infections and cancer by transfusions might not be life determinating)- PAD and ANH more cost-effective than CS • dependent on procedure: intraop CS > postop CS • Recalculate the use of EPO (on the base of new cost analyses) Modified from Davies L et al. Cost-effectiveness of cell salvage and alternative methods. Health Technol Assess 2006; 10: 44 HAI Berlin 17.-19.09.09

  35. The better and better affordable solution : „Patient Blood Management“ 3 main elements: • (1) correction of a low preoperative erythrocyte mass or preoperative anemia, • (2) minimizing peri- operative erythrocyte loss • (3) using minimal (i.e., low) hemoglobin- based transfusion triggers. HAI Berlin 17.-19.09.09 Goodnough & Shander. Blood Management. Archives of Pathology and Laboratory Medicine: Vol. 131, No. 5, pp. 695–701. Spahn D et al. Patient Blood Management: The Pragmatic Solution for the Problems with Blood Transfusions Anesthesiology 2008; 109: 951-3

  36. The Toolbox: „Patient Blood Management“ • further elements (EVIDENCE BASED): • Implement a transfusion protocol- PATIENT BLOOD MANAGEMENT SOP for most of procedures • Involve surgeons, hemastesiologist, transfusion medicine • Determination of the exposure risk to allogeneic transfusion • Low preoperative red cell mass • High blood loss (Procedure/Surgeon specific) • Identify and correct coagulation disorder • Increase low red cell mass • Iron and EPO • PAD • ANH • Decrease perioperative blood loss • Blood sparing surgical techniques • Low/restrictive transfusion triggers • POCT-based algorithm • Avoid hypothermia • CS • Antifibrinolytics, Fibrinogen and F XIII • Renew your circuit techniques (i.e. match oxygenator size, vacuum assisted venous return, reduce prime volume, full biocompatibility....) • Controlled hypotension • Incorporate blood unit quality analysis (age and cross match) Evidence Based Individualized Specific HAI Berlin 17.-19.09.09

  37. 2010 IAG Klinische Hämotherapie der DIVI Fehlerregister der IAKH – national CIRS for Transfusion Incidents Arbeitskreis der DIVI Hämotherapie in Zusammenarbeit mit der Interdisziplinären Arbeitsgemeinschaft für Klinische Hämotherapie (IAKH) www.IAKH.de Mannheimer Transfusionsgespräche der IAKH e.V. 27/28.Feb. 2010 • Among Topics: • Submeeting of Quality Control Managers • Patient Blood Management • www.IAKH.de/Veranstaltungen

  38. Allogeneic Blood Transfusion in the view of a viral pandemia Decision tree analysis HAI Berlin 17.-19.09.09

  39. Allogeneic Transfusion during Hip Surgery 0,04 Healthy Hep. C 0,6 0,11 Death 0,5 0,9 0,001 0,00001 Cirrhosis Carcinoma 0,7 0,0001 The Markov Model • Favourable over decision tree when • Probabilities of alternatives are not enough, • time points or periods of medical states or events after the decision are important • Markov Model characteristics: • Finite number of health states in which identical patients can be • Time cycles of same sizes • Transition from on to another cycle at a distinct probability • Transition probabilities solely dependent from actual health condition • Accounting for acute medical events during and subsequent hospital stay • Here basic choice: probability of autologous donation and transfusion, allogeneic transfusion • Acute events: transfusion and related complications, infections, mortality • Subsequent: hepatitis, HIV, cancer, a.s.o. • Markov Chain: same transition probabilities • Markov process: transition probabilities vary with time • Cohort Simulation: cohort runs various cycles creating a table column (which part of cohort is in which cycle) production of cumulating incidence of medical events, life span, costs etc. Adapted from Siebert, U. Transparente Entscheidungen in Public Health mittels Systemat. Entscheidungs- analyse. In: Schwartz, F.W. 2.ed. Das Public Health Buch. Elsevier, München, 2002, 932 S HAI Berlin 17.-19.09.09

  40. 10 – Point – Checklist according to Drummond • Q: Was a well-defined question posed in answerable form? A:Yes; allogeneic safety increase – why then costs for autologous? Increased risk for infections associated to allogeneic transfusion have impact on cost effectiveness? alternatives clear, both costs and effects considered-defined as dominance, viewpoint relevant for decision making 2. Q: Was a comprehensive description of the competing alternatives given? A: Autologous versus Allogeneic description not necessary (practice Mayo Clinic n = 332), do-nothing alternative is not considered (tolerance of low hemoglobin levelsrisk of transfusion in elective hip surgery , infection induction effect , statistical power?) • Q: Was the effectiveness of the programs or services established? A: not always RCTs, simulation CU Model/Decision Maker, Data: empirical, given sources (studies, NIH, Heiss, Record review New Jersey Hospitals), assumptions used, a range of risks with various effectiveness given 4. Q: Were all the important and relevant costs and consequences for each alternative identified? • A: Previous assumptions of calculated models adopted, only one view point - third party payer (insurance), operating and capital costs from a single publication (table 2) HAI Berlin 17.-19.09.09

  41. - • Background: • Autologous techniques too expensive - avoidance of postoperative infections not considered • Methods: • CUA: Markov cohort analysis, hip replacement, cost per QALY • Assumption: serious infection – in 3.7% of cases  12 980 US $ addit. costs • Results: • RR > 2.4  autologous is dominant – lower costs • at RR 3.7, cost effectiveness 2 470 $/QALY • 2,4 > RR > 1.1  cost effectiveness < 50 000 $/QALY • 1,1 > RR > 0  cost effectiveness up to 3,400,000 $/QALY • Conclusion: • Cost effectiveness dependent on risk of bacterial infection HAI Berlin 17.-19.09.09

  42. Allogeneic Transfusion during Hip Surgery 0,04 Healthy Hep. C 0,6 0,11 Death 0,5 0,9 0,001 0,00001 Cirrhosis Carcinoma 0,7 0,0001 Explanation of used analysis: The Markov Model • Favourable over decision tree when • Probabilities of alternatives are not enough, • time points or periods of medical states or events after the decision are important • Markov Model characteristics: • Finite number of health states in which identical patients can be • Time cycles of same sizes • Transition from on to another cycle at a distinct probability • Transition probabilities solely dependent from actual health condition • Accounting for acute medical events during and subsequent hospital stay • Here basic choice: probability of autologous donation and transfusion, allogeneic transfusion • Acute events: transfusion and related complications, infections, mortality • Subsequent: hepatitis, HIV, cancer, a.s.o. • Markov Chain: same transition probabilities • Markov process: transition probabilities vary with time • Cohort Simulation: cohort runs various cycles creating a table column (which part of cohort is in which cycle) production of cumulating incidence of medical events, life span, costs etc. Adapted from Siebert, U. Transparente Entscheidungen in Public Health mittels Systemat. Entscheidungs- analyse. In: Schwartz, F.W. 2.ed. Das Public Health Buch. Elsevier, München, 2002, 932 S HAI Berlin 17.-19.09.09

  43. Avoidance Strategies: Rules based on evidence • Prospective Trial: Hebert PC et al. A multicenter, randomized, controlled clinical trial of transfusion requirements in critical care. N Engl J Med 1999; 340:409-17 • Efficacy of a restrictive strategy 8g/l vs liberate 10g/l hemoglobin HAI Berlin 17.-19.09.09

  44. 2.5 - Clinical Study 2 – 10 – Point - Checklist • Q: Was a well-defined question posed in answerable form? • A:Yes; allogeneic safety increase – why then costs for autologous? Increased risk for infections associated to allogeneic transfusion have impact on cost effectiveness? • alternatives clear, both costs and effects considered-defined as dominance, viewpoint relevant for decision making • 2. Q: Was a comprehensive description of the competing alternatives given? • A: Autologous versus Allogeneic • description not necessary (practice Mayo Clinic n = 332), do-nothing alternative is not considered (tolerance of low hemoglobin levelsrisk of transfusion in elective hip surgery , infection induction effect , statistical power?) • Q: Was the effectiveness of the programs or services established? • A: not always RCTs, simulation CU Model/Decision Maker, Data: empirical, given sources (studies, NIH, Heiss, Record review New Jersey Hospitals), assumptions used, a range of risks with various effectiveness given • 4. Q: Were all the important and relevant costs and consequences for each • alternative identified? • A: Previous assumptions of calculated models adopted, only one view point - third party payer (insurance), operating and capital costs from a single publication (table 2) HAI Berlin 17.-19.09.09

  45. 2.5 - Clinical Study 2 – 10 – Point - Checklist HAI Berlin 17.-19.09.09

  46. 2.5 - Clinical Study 2 – 10 – Point - Checklist • Q: Were costs/consequences measured accurately in appropriate physical units? • A: 1997 $, QALYs, some estimates, omitted were severe transfusion reactions • (too rare), administration of wrong blood (equal for both), discarded blood • Q: Were costs and consequences valued credibly? • A: yes, sources and methods of valuation mentioned • Q: Were costs and consequences adjusted for differential timing? • A: equal for both alternatives, 1997 $, adjusted to medical care component of the Consumers Price Index, future costs and life expectancies with annual discount rate 3%, plus excess mortality from HIV, Cancer a.s.o., no discount factor applied, QAL weights-utilities from most recent literature • Q: Was an incremental analysis of costs/consequences of alternatives performed? • A: yes, two way sensitivity analysis identifies the costeffectiveness threshold above autologous transfusion is dominant dependent on risk versus cost of infection • Bnm, HAI Berlin 17.-19.09.09

  47. 1,6% TR = 56% AAT < 5% mortality 0% 2.5 - Clinical Study 2 – 10 – Point - Checklist • Q: Was allowance made for uncertainty in the estimates of costs/consequences? • A: Yes, the Markov model is a cohort simulation with a finite n of health states, transition rate • Q: Did the presentation of study results include all issues of concern to users? • A: Almost, but - • Postop. Bacterial infection rate 0.37% • age of base case model ok for 1999, but too young, now rising> 65y • no sex difference (Blood loss and transfusion rates difference) • exclusion of transfusion reactions and blood erroneous administration • rate of transfusion from only 332 pat in US , 89% transfusion rate TR too high –2.4 units AT, 1.1 U addit. AAT in 36% • American vs German morbidity & mortality from elective hip surgery i.e. 1.1% mortality, HAI Berlin 17.-19.09.09

  48. 2.5 Results of the assessment study 2 - Conclusion - HAI Berlin 17.-19.09.09

  49. Comparison Allogeneic vs. autologous transfusion HAI Berlin 17.-19.09.09

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