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. 2003 Nov 7;25(9):2464–2486. doi: 10.1016/S0149-2918(03)80288-6

Cost-effectiveness of transfusion of platelet components prepared with pathogen inactivation treatment in the United States

Christopher E Bell 1, Marc F Botteman 1, Xin Gao 1, Joel L Weissfeld 2, Maarten J Postma 3, Chris L Pashos 4, Darrell Triulzi 2, Ulf Staginnus 5,∗
PMCID: PMC7133650  PMID: 14604745

Abstract

Background: The Intercept Blood System (IBS) for platelets has been developed to reduce pathogen transmission risks during transfusions.

Objective: This study was a comprehensive economic analysis of the cost-effectiveness of using the IBS for single-donor apheresis platelets (AP) and random-donor pooled platelet concentrates (PC) versus AP and PC without the IBS in the United States in patient populations in which platelets are commonly transfused.

Methods: All data used in this analysis were summarized from existing published sources (primarily indexed in MEDLINE) and data on file at Baxter Healthcare Corporation (Chicago, Illinois) and Cerus Corporation (Concord, California). A literature-based decision-analytic model was developed to assess the economic costs and clinical outcomes associated with the use of AP and PC treated with the IBS for several conditions and procedures that account for a considerable proportion of the platelet usage in the United States: acute lymphocytic leukemia, non-Hodgkin's lymphoma, coronary artery bypass graft, and hip arthroplasty Risks of infection with HIV, hepatitis C virus (HCV), hepatitis B virus, human T-cell lymphotropic virus type 1, or bacterial agents were incorporated into the model. Possible benefits of reduction of the risk of emerging HCV like pathogens and elimination of the need for gamma irradiation were explored in sensitivity analyses.

Results: The incremental cost per quality-adjusted life-year gained by using AP + IBS versus untreated AP ranged from $1,308,833 to $4,451,650 (without bacterial testing) and $4,759,401 to $22,968,066 (with bacterial testing). Corresponding figures for PC + IBS versus untreated PC ranged from $457,586 to $1,816,060. Inclusion of emerging HCV like virus and the elimination of the need for gamma irradiation improved the cost-effectiveness to a range of $177,695 to $1,058,127 for AP without bacterial testing, $176,572 to $1,330,703 for AP with bacterial testing, and $22,888 to $153,564 for PC. The model was most likely to be affected by mortality from bacterial contamination, IBS effect on platelet utilization, and the inclusion of potential benefits (ie, gamma irradiation and/or emergent HCVlike virus). The model was relatively insensitive to changes in the IBS price and viral transmission risks.

Conclusions: The cost-effectiveness of pathogen inactivation via the IBS for platelets is comparable to that of other accepted blood safety interventions (eg, nucleic acid amplification technology). The IBS for platelets may be considered a desirable strategy to increase the safety of platelet transfusions and a potential insurance against the threat of emerging pathogens.

Keywords: pathogen inactivation, transfusion risks, cost-effectiveness, platelet

References

  • 1.Dodd RY. The safety of the blood supply: Current concepts. In: Hillyer CD, ed. The Safety of the Blood Supply: The Fenwal Monograph Series. Deerfield, Ill: Baxter Healthcare Corporation; 199; 1–17.
  • 2.Dow B.C., Peterkin M.A., Green R.H., Cameron S.O. Hepatitis B virus transmission by blood donation negative for hepatitis B surface antigen, antibody to HBsAg, antibody to hepatitis B core antigen and HBV DNA. Vox Sang. 2001;81:40. doi: 10.1046/j.1423-0410.2001.00089.x. Letter. [DOI] [PubMed] [Google Scholar]
  • 3.Dodd R.Y., Notari E.P., Stramer S.L. Current prevalence and incidence of infectious disease markers and estimated window-period risk in the American Red Cross blood donor population. Transfusion. 2002;42:975–979. doi: 10.1046/j.1537-2995.2002.00174.x. [DOI] [PubMed] [Google Scholar]
  • 4.Schuttler C.G., Caspari G., Jursch C.A. Hepatitis C virus transmission by a blood donation negative in nucleic acid amplification tests for viral RNA. Lancet. 2000;355:41–42. doi: 10.1016/S0140-6736(99)04719-4. Letter. [DOI] [PubMed] [Google Scholar]
  • 5.Blajchman M.A., Goldman M. Bacterial contamination of platelet concentrates: Incidence, significance, and prevention. Semin Hematol. 2001;38(Suppl 11):202. doi: 10.1016/s0037-1963(01)90120-9. [DOI] [PubMed] [Google Scholar]
  • 6.Kuehnert M.J., Roth V.R., Haley N.R. Transfusion-transmitted bacterial infection in the United States, 1998 through 2000. Transfusion. 2001;41:1493–1499. doi: 10.1046/j.1537-2995.2001.41121493.x. [DOI] [PubMed] [Google Scholar]
  • 7.Ness P., Braine H., King K. Single-donor platelets reduce the risk of septic platelet transfusion reactions. Transfusion. 2001;41:857–861. doi: 10.1046/j.1537-2995.2001.41070857.x. [DOI] [PubMed] [Google Scholar]
  • 8.Perez P., Salmi L.R., Follea G. Determinants of transfusion-associated bacterial contamination: Results of the French BACTHEM Case-Control Study. Transfusion. 2001;41:862–872. doi: 10.1046/j.1537-2995.2001.41070862.x. [DOI] [PubMed] [Google Scholar]
  • 9.Barbara J. 2nd ed. Vol. 38. 2001. The rationale for pathogen inactivation treatment of platelet components—introduction; pp. 1–3. (Semin Hematol.). Suppl 11. [DOI] [PubMed] [Google Scholar]
  • 10.Grass J.A., Wafa T., Reames A. Prevention of transfusion-associated graft-versushost disease by photochemical treatment. Blood. 1999;93:3140–3147. [PubMed] [Google Scholar]
  • 11.Knutson F., Alfonso R., Dupuis K. Photochemical inactivation of bacteria and HIV in buffy-coat-derived platelet concentrates under conditions that preserve in vitro platelet function. Vox Sang. 2000;78:209–216. doi: 10.1159/000031183. [DOI] [PubMed] [Google Scholar]
  • 12.Rios J., Hambleton J., Viele M. Presented at: 54th Annual Meeting of the American Association of Blood Banks. October 13–17, 2001. Helinx treated RBC transfusions are well tolerated and show comparable recovery and survival to control RBCs. San Antonio, Tex. [Google Scholar]
  • 13.deAlarcon P., Benjamin R., Shopnick R. Presented at: 54th Annual Meeting of the American Association of Blood Banks. October 13–17, 2001. Hemostatic response in congenital coagulation factor-deficient patients transfused with fresh frozen plasma (FFP) prepared by Helinx pathogen inactivation technology—The Step CC Trials. San Antonio, Tex. [Google Scholar]
  • 14.Drummond M.E., O'Brien B., Stoddart G.L. 2nd ed. Oxford University Press; New York: 1997. Methods for the Economic Evaluation of Health Care Programmes. [Google Scholar]
  • 15.Lopez-Plaza I., Weissfeld J., Triulzi D.J. The cost-effectiveness of reducing donor exposures with single-donor versus pooled random-donor platelets. Transfusion. 1999;39:925–932. doi: 10.1046/j.1537-2995.1999.39090925.x. [DOI] [PubMed] [Google Scholar]
  • 16.HCUPnet Healthcare Cost and Utilization Project Web site. http://hcup.ahrq.gov/HCUPnet.asp. Available at: Acessed.
  • 17.Blood Products Usage Summary 2002. InforMedix Marketing Research, Inc; Rockville, Md: 2002. [Google Scholar]
  • 18.Meehan K.R., Matias C.O., Rathore S.S. Platelet transfusions: Utilization and associated costs in a tertiary care hospital. Am J Hematol. 2000;64:251–256. doi: 10.1002/1096-8652(200008)64:4<251::aid-ajh3>3.0.co;2-n. [DOI] [PubMed] [Google Scholar]
  • 19.Garellick G., Malchau H., Herberts P. Life expectancy and cost utility after total hip replacement. Clin Orthop. 1998;346:141–151. [PubMed] [Google Scholar]
  • 20.Dearborn J.T., Harris W.H. Postoperative mortality after total hip arthroplasty An analysis of deaths after two thousand seven hundred and thirty-six procedures. J Bone Joint Surg Am. 1998;80:1291–1294. doi: 10.2106/00004623-199809000-00007. [DOI] [PubMed] [Google Scholar]
  • 21.Berg S., Steuber P., Poplack D. Clinical manifestations of acute lymphoblastic leukemia. In: Hoffman R., Benz E. Jr, Shattil S.J., editors. Hematology, Basic Principles and Practice. Churchill Livingstone; New York: 2000. pp. 1070–1078. [Google Scholar]
  • 22.Bhatia S., Sather H.N., Pabustan O.B. Low incidence of second neoplasms among children diagnosed with acute lymphoblastic leukemia after 1983. Blood. 2002;99:4257–4264. doi: 10.1182/blood.v99.12.4257. [DOI] [PubMed] [Google Scholar]
  • 23.Tengs T.O., Wallace A. One thousand health-related quality-of-life estimates. Med Care. 2000;38:583–637. doi: 10.1097/00005650-200006000-00004. [DOI] [PubMed] [Google Scholar]
  • 24.Beck J.R., Kassirer J.P., Pauker S.G. A convenient approximation of life expectancy (the “DEALS”). I. Validation of the method. Am J Med. 1982;73:883–888. doi: 10.1016/0002-9343(82)90786-0. [DOI] [PubMed] [Google Scholar]
  • 25.Beck J.R., Pauker S.G., Gottlieb J.E. A convenient approximation of life expectancy (the “DEALS”). 11. Use in medical decision-making. Am J Med. 1982;73:889–897. doi: 10.1016/0002-9343(82)90787-2. [DOI] [PubMed] [Google Scholar]
  • 26.Brecher M.E., Means N., Jere C.S. Evaluation of an automated culture system for detecting bacterial contamination of platelets: An analysis with 15 contaminating organisms. Transfusion. 2001;41:477–482. doi: 10.1046/j.1537-2995.2001.41040477.x. [DOI] [PubMed] [Google Scholar]
  • 27.Blood Products Advisory Committee 76th Meeting Minutes. US Dept of Health and Human Services, Food and Drug Administration Center for Biologics Evaluation and Research; Rockville, Md: 2003. [Google Scholar]
  • 28.Trivedi M. Newly diagnosed hepatitis C. Lack of symptoms doesn't mean lack of progression. Postgrad Med. 1997;102:95–98. doi: 10.3810/pgm.1997.12.379. [DOI] [PubMed] [Google Scholar]; Trivedi M. Newly diagnosed hepatitis C. Lack of symptoms doesn't mean lack of progression. Postgrad Med. 1997;102:101. doi: 10.3810/pgm.1997.12.379. [DOI] [PubMed] [Google Scholar]
  • 29.Muir A.J. The natural history of hepatitis C viral infection. Semin Gastrointest Dis. 2000;11:54–61. [PubMed] [Google Scholar]
  • 30.Birkmeyer J.D., AuBuchon J.P., Littenberg B. Cost-effectiveness of preoperative autologous donation in coronary artery bypass grafting. Ann Thorac Surg. 1994;57:161–168. doi: 10.1016/0003-4975(94)90386-7. [DOI] [PubMed] [Google Scholar]
  • 31.National Center for Infectious Diseases Viral hepatitis B. http://wwwcdc.gov/ ncidod/diseases/hepatitis/b/index.htm. Available at: Accessed.
  • 32.Wong J.B., Poynard T., Ling M.H. 15th ed. Vol. 95. International Hepatitis Interventional Therapy Group; 2000. Cost-effectiveness of 24 or 48 weeks of interferon alpha-2b alone or with ribavirin as initial treatment of chronic hepatitis C; pp. 1524–1530. (Am J Gastroenterol). [DOI] [PubMed] [Google Scholar]
  • 33.Theodore D., Fried M.W. Natural history and disease manifestations of hepatitis C infection. Curr Top Microbiol Immunol. 2000;242:43–54. doi: 10.1007/978-3-642-59605-6_3. [DOI] [PubMed] [Google Scholar]
  • 34.Singer M.E., Younossi Z.M. Cost effectiveness of screening for hepatitis C virus in asymptomatic, average-risk adults. Am J Med. 2001;111:614–621. doi: 10.1016/s0002-9343(01)00951-2. [DOI] [PubMed] [Google Scholar]
  • 35.Lam N.P. Hepatitis C: Natural history, diagnosis, and management. Am J Health Syst Pharm. 1999;56:961–973. doi: 10.1093/ajhp/56.10.961. [DOI] [PubMed] [Google Scholar]
  • 36.Satoor S., Raufman J.P. Treatment of hepatitis C. C. Clin Cornerstone. 2001;3:37–46. doi: 10.1016/s1098-3597(01)90077-8. [DOI] [PubMed] [Google Scholar]
  • 37.Dienstag J.L., Isselbacher K.J. Acute viral hepatitis. In: Braunwald E., Fauci A.S., Kasper D.L., editors. Harrison's Principles of Internal Medicine. 15th ed. McGraw-Hill; New York: 2001. pp. 1721–1742. [Google Scholar]
  • 38.Owens D.K., Nease R.F., Jr Occupational exposure to human immunodeficiency virus and hepatitis B virus: A comparative analysis of risk. Am J Med. 1992;92:503–512. doi: 10.1016/0002-9343(92)90747-y. [DOI] [PubMed] [Google Scholar]
  • 39.Etchason J., Petz L., Keeler E. The cost effectiveness of preoperative autologous blood donations. N Engl J Med. 1995;332:719–724. doi: 10.1056/NEJM199503163321106. [DOI] [PubMed] [Google Scholar]
  • 40.Roback J.D., Hillyer C.D. The role of leukocyte reduction in minimizing the risk of transfusion-transmission of cell-associated infectious agents and immunomodulation. In: Hillyer C.D., editor. The Safety of the Blood Supply: The Fenwal Monograph Series. Baxter Healthcare Corporation; Deerfield, Ill: 1999. pp. 28–45. [Google Scholar]
  • 41.Ohlen J., Liegl J.M., Selmair H. Long-term prognosis of chronic B and C viral hepatitis. Leber Magen Darm. 1995;25:205–210. [in German] [PubMed] [Google Scholar]
  • 42.Kim W.R., Poterucha J.J., Hermans J.E. Cost-effectiveness of 6 and 12 months of interferon-alpha therapy for chronic hepatitis C. Ann Intern Med. 1997;127:866–874. doi: 10.7326/0003-4819-127-10-199711150-00002. [DOI] [PubMed] [Google Scholar]
  • 43.Younossi Z.M., Singer M.E., McHutchison J.G., Shermock K.M. Cost effectiveness of interferon alpha2b combined with ribavirin for the treatment of chronic hepatitis C. Hepatology. 1999;30:1318–1324. doi: 10.1002/hep.510300518. [DOI] [PubMed] [Google Scholar]
  • 44.Bennett W.G., Inoue Y., Beck J.R. Estimates of the cost-effectiveness of a single course of interferon-alpha 2b in patients with histologically mild chronic hepatitis C. Ann Intern Med. 1997;127:855–865. doi: 10.7326/0003-4819-127-10-199711150-00001. [DOI] [PubMed] [Google Scholar]
  • 45.Bayoumi A.M., Redelmeier D.A. Economic methods for measuring the quality of life associated with HIV infection. Qual Life Res. 1999;8:471–480. doi: 10.1023/a:1008969512182. [DOI] [PubMed] [Google Scholar]
  • 46.Patil R., Cotler S.J., Banaad-Omiotek G. Physicians' preference values for hepatitis C health states and antiviral therapy: A survey. BMC Gastroenterol. 2001;1:6. doi: 10.1186/1471-230X-1-6. [DOI] [PMC free article] [PubMed] [Google Scholar]
  • 47.Stigum H., Magnus P., Samdal H.H., Nord E. Human T -cell lymphotropic virus testing of blood donors in Norway: A cost-effect model. Int J Epidemiol. 2000;29:1076–1084. doi: 10.1093/ije/29.6.1076. [DOI] [PubMed] [Google Scholar]
  • 48.American Red Cross Hospital Information: Reimbursement. http://www.redcrosslife.org/hospital/hos_reimbursement.asp Available at: Accessed.
  • 49.Testimony by America's Blood Centers before Medicare Payment Advisory Commission. February 6, 2003. Financial impact of technologies to improve blood safety.http://www.americasblood.org/index.cfm?fuseaction=Display.showPage&pageid=61 Available at: Accessed. [Google Scholar]
  • 50.Bozzette S.A., Berry S.H., Duan N. The care of HIV infected adults in the United States. HIV Cost and Services Utilization Study Consortium. N Engl J Med. 1998;339:1897–1904. doi: 10.1056/NEJM199812243392606. [DOI] [PubMed] [Google Scholar]
  • 51.AuBuchon J.P., Birkmeyer J.D., Busch M.P. Cost-effectiveness of expanded human immunodeficiency virus-testing protocols for donated blood. Transfusion. 1997;37:45–51. doi: 10.1046/j.1537-2995.1997.37197176950.x. [DOI] [PubMed] [Google Scholar]
  • 52.Hart A.C., Richards B., editors. 17th ed. St. Anthony Publishing; Reston, Va: 2000. (DRG Guidebook). [Google Scholar]
  • 53.Solheim B.G., Wesenberg F. Rational use of blood products. Eur J Cancer. 2001;37:2421–2425. doi: 10.1016/s0959-8049(01)00324-0. [DOI] [PubMed] [Google Scholar]
  • 54.Zeger G., Williams C.T., Shulman I.A. Single donor platelets: Can we afford to use them? Can we afford not to use them? Transfus Sci. 1997;18:585–588. doi: 10.1016/s0955-3886(97)00057-x. [DOI] [PubMed] [Google Scholar]
  • 55.Guidance for Industry: Gamma Irradiation of Blood and Blood Components: A Pilot Program for Licensing. US Dept of Health and Human Services, Food and Drug Administration Center for Biologics Evaluation and Research; Rockville, Md: 2000. [Google Scholar]
  • 56.Vol. 85. 2003. The future use of pathogen-inactivated platelet concentrates; pp. 54–66. (Vox Sang). [DOI] [PubMed] [Google Scholar]
  • 57.List of ambulatory payment classifications (APCs) with status indicators, relative weights, payment rates, and copayment amounts calendar year 2002. 2001. (66 Federal Register 44726). [Google Scholar]
  • 58.Solberg C.O. Microorganisms strike back—Infectious diseases during the last 50 years. Tidsskr Nor Laegeforen. 2001;121:3538–3543. [in Norwegian] [PubMed] [Google Scholar]
  • 59.Hepatitis C. US Department of Health and Human Services Web site; February 14, 2003. An emerging threat to public health.www.hhs.gov/news/press/2001pres/OlfshepatitisC.html Available at: Accessed. [Google Scholar]
  • 60.Donahue J.G., Munoz A., Ness P.M. The declining risk of post-transfusion hepatitis C virus infection. N Engl J Med. 1992;327:369–373. doi: 10.1056/NEJM199208063270601. [DOI] [PubMed] [Google Scholar]
  • 61.McCullough J., Vesole D., Benjamin R.J. Pathogen inactivated platelets (plt) using Helinx technology (INTERCEPT plt) are hemostatically effective in thrombocytopenic patients (tcp plts): The SPRINT trial. Blood. 2001;95:450a. Abstract. [Google Scholar]
  • 62.van Rhenen D., Gulliksson H., Pamphilon D. S-59 (Helinx) photochemically treated platelets (pit) are safe and effective for support of thrombocytopenia: Results of the EuroSPRITE phase 3 trial. Blood. 2000;96:823a. Abstract. [Google Scholar]
  • 63.van Hout B.A., Al M.J., Gordon G.S., Rutten F.E. Costs, effects and C/E-ratios alongside a clinical trial. Health Econ. 1994;3:309–319. doi: 10.1002/hec.4730030505. [DOI] [PubMed] [Google Scholar]
  • 64.Hirth R.A., Chernew M.E., Miller E. Willingness to pay for a quality-adjusted life year: In search of a standard. Med Decis Making. 2000;20:332–342. doi: 10.1177/0272989X0002000310. [DOI] [PubMed] [Google Scholar]
  • 65.Jackson B.R., Busch M.P., Stramer S.L., AuBuchon J.P. The cost-effectiveness of NAT for HIV, HCV, and HBV in whole-blood donations. Transfusion. 2003;43:721–729. doi: 10.1046/j.1537-2995.2003.00392.x. [DOI] [PubMed] [Google Scholar]
  • 66.Stone P.W., Teutsch S., Chapman R.H. Cost-utility analyses of clinical preventive services: Published ratios, 1976–1997. Am J Prev Med. 2000;19:15–23. doi: 10.1016/s0749-3797(00)00151-3. [DOI] [PubMed] [Google Scholar]
  • 67.AuBuchon J.P., Birkmeyer J.D. Safety and cost-effectiveness of solvent-detergent-treated plasma. In search of a zero-risk blood supply. JAMA. 1994;27:1210–1214. [PubMed] [Google Scholar]
  • 68.Pereira A., Sanz C. A model of the health and economic impact of posttransfusion hepatitis C: Application to cost-effectiveness analysis of further expansion of HCV screening protocols. Transfusion. 2000;40:1182–1191. doi: 10.1046/j.1537-2995.2000.40101182.x. [DOI] [PubMed] [Google Scholar]
  • 69.Pereira A. Cost-effectiveness of transfusing virus-inactivated plasma instead of standard plasma. Transfusion. 1999;39:479–487. doi: 10.1046/j.1537-2995.1999.39050479.x. [DOI] [PubMed] [Google Scholar]
  • 70.Yeh J.M., Botteman M., Pashos C.L. Economics of transfusion. Infusionsther Transfusionsmed. 2002;29:218–225. [Google Scholar]
  • 71.Loubiere S., Rotily M., Durand-Zaleski I. Adjunction of polymerase chain reaction in screening for hepatitis C virus RNA in blood donations: Misuse of the principle of caution. Hypotheses Debats. 2001;17:344–349. doi: 10.1046/j.1423-0410.2001.00036.x. [DOI] [PubMed] [Google Scholar]
  • 72.Simmonds P., Kurtz J., Tedder R.S. The UK blood transfusion service: Over a (patent) barrel? Lancet. 2002;359:1713–1714. doi: 10.1016/s0140-6736(02)08663-4. [DOI] [PubMed] [Google Scholar]
  • 73.Grima D.T., Marshall D., Weinstein M. Cost-effectiveness of screening donated blood with minipool nucleic acid testing for hepB virus, hepatitisC virus, and HIV. Value Health. 2002;5:446. Abstract. [Google Scholar]
  • 74.van Hulst M., de Wolf J.T., Staginnus U. Pharmaco-economics of blood transfusion safety: Review of the available evidence. Vox Sang. 2002;83:146–155. doi: 10.1046/j.1423-0410.2002.00198.x. [DOI] [PubMed] [Google Scholar]
  • 75.Sibrowski W., Penner M., Kuhnl P. Transfusion-induced virus infections: How great is the risk? [in German] Infusionsther Transfusionsmed. 1993;20(Suppl 2):4–9. [PubMed] [Google Scholar]
  • 76.Roth V.R., Kuehnert M.J., Haley N.R. Evaluation of a reporting system for bacterial contamination of blood components in the United States. Transfusion. 2001;41:1486–1492. doi: 10.1046/j.1537-2995.2001.41121486.x. [DOI] [PubMed] [Google Scholar]
  • 77.http://www.fda.gov/cber/minutes/workshopmin.htm Workshop on bacterial contamination of platelets—9/24/1999. US Food and Drug Administration Web site. Available at: Accessed November 21, 2002.
  • 78.Seeff L.B. Why is there such difficulty in defining the natural history of hepatitis C? Transfusion. 2000;40:1161–1164. doi: 10.1046/j.1537-2995.2000.40101161.x. [DOI] [PubMed] [Google Scholar]
  • 79.New data show that INTERCEPT Blood System inactivates virus in same viral family as SARS. Baxter Healthcare Corporation; Madrid, Spain: June 17, 2003. [press release] [Google Scholar]
  • 80.Dupuis K., Alfonso R., Savoor A. Abstract presented at: VIII International Society of Blood Transfusion Regional European Congress. July 5–9, 2003. Helinx Technology, used in the Intercept Blood System, inactivates high titers of emerging insect-borne pathogens in platelets and red blood cells. Istanbul, Turkey. [Google Scholar]

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