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Economic Considerations for Complex Mixture Drugs

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The Science and Regulations of Naturally Derived Complex Drugs

Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series ((AAPS,volume 32))

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Abstract

This chapter focuses on naturally derived complex drug products from an economic and regulatory point of view. Key stakeholders in the healthcare industry (e.g., physicians and payers) have been using pharmacoeconomic evaluations to make critical decisions, such as those pertaining to prescription and reimbursement coverage. The cost-effectiveness analytical tools used to conduct these evaluations are herein introduced. The pharmacoeconomic studies on commercially available naturally derived complex drug products are reviewed prior to discussion of the future prospect of these products.

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Notes

  1. 1.

    CMS National Health Expenditure Data in 2014.

  2. 2.

    CMS National Health Expenditure Projections 2015–2025: Forecast Summary.

  3. 3.

    Bootman et al. [6].

  4. 4.

    Parthasarthi et al. [61].

  5. 5.

    Ahmad et al. [1].

  6. 6.

    HTA 101: Introduction to Health Technology Assessment, National Information Center on Health Services Research and Health Care Technology (NICHSR) of the US National Library of Medicine (NLM)

  7. 7.

    Mark and Hlatky [48].

  8. 8.

    Thirugnanam et al. [80].

  9. 9.

    Menzin et al. [53].

  10. 10.

    Thirugnanam et al. [80].

  11. 11.

    CMS National Health Expenditure Data in 2014.

  12. 12.

    EMA official Web site regarding HTA bodies: http://www.ema.europa.eu/ema/index.jsp?curl=pages/partners_and_networks/general/general_content_000476.jsp&

  13. 13.

    Godman et al. [28].

  14. 14.

    http://www.npr.org/sections/health-shots/2016/03/09/469792479/medicare-looks-to-cut-drug-costs-by-changing-how-it-pays-doctors

  15. 15.

    http://www.sciencemag.org/careers/2000/08/pharmacoeconomics-overview-pharmacoeconomics-history-trends-and-recent-growth

  16. 16.

    Directive 2004/24/EC of the European Parliament, Official Journal of the European Union, L 136/85, 2004

  17. 17.

    “WHO Model List of Essential Medicines” (PDF). World Health Organization. October 2013. Retrieved 22 April 2014.

  18. 18.

    Charles and Scott [14].

  19. 19.

    Murray and Best [54].

  20. 20.

    Murray and Best [55].

  21. 21.

    http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/ScienceBoardtotheFoodandDrugAdministration/ucm399396.htm

  22. 22.

    Kapoor et al. [38].

  23. 23.

    Thirugnanam et al. [80].

  24. 24.

    Latour-Pérez and de-Miguel-Balsa [42].

  25. 25.

    Fanari et al. [26].

  26. 26.

    https://www.bloomberg.com/news/articles/2015-04-24/health-the-price-of-multiple-sclerosis-drugs-only-goes-up

  27. 27.

    Palace et al. [60].

  28. 28.

    Sumra et al. [76].

  29. 29.

    Owens et al. [59].

  30. 30.

    Boster et al. [7].

  31. 31.

    Sanz-Granda et al. [65].

  32. 32.

    http://www.mayoclinic.org/diseases-conditions/multiple-sclerosis/diagnosis-treatment/treatment/txc-20131903

  33. 33.

    Gold et al. [29].

  34. 34.

    FDA Guidance for Industry: Botanical Drug Products.

  35. 35.

    Official Web site of Drugs@FDA, regulatory profile of sinecatechins, NDA 021902.

  36. 36.

    Botanical and plant-derived drugs: global markets, Kim Lawson, 2015, BCC Research, ISBN: 1-62296-134-X.

  37. 37.

    Langley [41].

  38. 38.

    Langley [41].

  39. 39.

    Official Web site of Drugs@FDA, regulatory profile of crofelemer, NDA 202292

  40. 40.

    http://medicaleconomics.modernmedicine.com/tag/fulyzaq

  41. 41.

    See Footnote 36

  42. 42.

    Directive 2004/24/EC of the European Parliament, Official Journal of the European Union, L 136/85, 2004

  43. 43.

    Wah et al. [84].

  44. 44.

    De Smet et al. [17].

  45. 45.

    Ernst [24].

  46. 46.

    Regulations on Protection of Traditional Chinese Medicines, promulgated by Decree No. 106 of the State Council of the People’s Republic of China on October 14, 1992, and effective as of January 1, 1993.

  47. 47.

    Sun et al. [77].

  48. 48.

    Zhou et al. [86].

  49. 49.

    Chang and Xie [13].

  50. 50.

    The official Web site of NIH Office of Dietary Supplements

  51. 51.

    Kassirer and Angell [39].

  52. 52.

    Hillman et al. [36].

References

  1. Ahmad A, Patel I, Parimilakrishnan S, Mohanta GP, Chung H, Chang J. The role of pharmacoeconomics in current Indian healthcare system. J Res Pharm Practice. 2013;2(1):3.

    Article  Google Scholar 

  2. Annemans L, Minjoulat-Rey MC, De Knock M, Vranckx K, Czarka M, Gabriël S, Haentjens P. Cost consequence analysis of fondaparinux versus enoxaparin in the prevention of venous thromboembolism after major orthopaedic surgery in Belgium. Acta Clinica Belgica. 2014.

    Google Scholar 

  3. Bamber L, Muston D, McLeod E, Guillermin A, Lowin J, Patel R. Cost-effectiveness analysis of treatment of venous thromboembolism with rivaroxaban compared with combined low molecular weight heparin/vitamin K antagonist. Thrombosis J. 2015;13(1):1.

    Article  Google Scholar 

  4. Becker RV III, Dembek C. Effects of cohort selection on the results of cost-effectiveness analysis of disease-modifying drugs for relapsing-remitting multiple sclerosis. J Manag Care Pharm. 2011;17(5):377–81.

    PubMed  Google Scholar 

  5. Bjorvatn A, Kristiansen F. Fondaparinux sodium compared with enoxaparin sodium. Am J Cardiovasc Drugs. 2005;5(2):121–30.

    Article  CAS  PubMed  Google Scholar 

  6. Bootman JL, McGhan WF, Townsend RJ. Pharmacoeconomics: historical perspective. Ann Pharmacother. 2006;40(3):518–9.

    Article  PubMed  Google Scholar 

  7. Boster A, Bartoszek MP, O’Connell C, Pitt D, Racke M. Efficacy, safety, and cost-effectiveness of glatiramer acetate in the treatment of relapsing–remitting multiple sclerosis. Therap Adv Neurol Disorders. 2011;4(5):319–32.

    Article  CAS  Google Scholar 

  8. Botteman MF, Caprini J, Stephens JM, Nadipelli V, Bell CF, Pashos CL, Cohen AT. Results of an economic model to assess the cost-effectiveness of enoxaparin, a low-molecular-weight heparin, versus warfarin for the prophylaxis of deep vein thrombosis and associated long-term complications in total hip replacement surgery in the United States. Clin Ther. 2002;24(11):1960–86.

    Article  CAS  PubMed  Google Scholar 

  9. Bozkaya D, Livingston T, Migliaccio-Walle K, Odom T. The cost-effectiveness of disease-modifying therapies for the treatment of relapsing-remitting multiple sclerosis. J Med Econ. 2017;20(3):297–302.

    Article  PubMed  Google Scholar 

  10. Brandes DW, Raimundo K, Agashivala N, Kim E. Implications of real-world adherence on cost-effectiveness analysis in multiple sclerosis. J Med Econ. 2013;16(4):547–51.

    Article  PubMed  Google Scholar 

  11. Caprini JA, Arcelus JI, Kudraa JC, Sehgal LR, Oyslender M, Maksimovic D, MacDougall A. Cost-effectiveness of venous thromboembolism prophylaxis after total hip replacement. Phlebology. 2002;17(3–4):126–33.

    Article  Google Scholar 

  12. Chalayer E, Bourmaud A, Tinquaut F, Chauvin F, Tardy B. Cost-effectiveness analysis of low-molecular-weight heparin versus aspirin thromboprophylaxis in patients newly diagnosed with multiple myeloma. Research. 2016;145.

    Article  CAS  PubMed  Google Scholar 

  13. Chang YP, Xie YM. Overview of pharmacoeconomic studies on traditional Chinese medicines and western medicines in treatment of stroke]. Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China J Chin Materia Medica. 2012;37(23):3509–3512.

    Google Scholar 

  14. Charles AF, Scott DA. Studies on heparin: observations on the chemistry of heparin. Biochem J. 1936;30(10):1927.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  15. Chevalier J, Chamoux C, Hammès F, Chicoye A. Cost-effectiveness of treatments for relapsing remitting multiple sclerosis: a French societal perspective. PLoS ONE. 2016;11(3):e0150703.

    Article  PubMed  PubMed Central  CAS  Google Scholar 

  16. Darbà J, Kaskens L, Sánchez-de la Rosa R. Cost-effectiveness of glatiramer acetate and interferon beta-1a for relapsing-remitting multiple sclerosis, based on the CombiRx study. J Med Econ. 2014;17(3):215–22.

    Article  PubMed  Google Scholar 

  17. De Smet PA, Bonsel G, Van der Kuy A, Hekster YA, Pronk MH, Brorens MJ, Lockefeer JH, Nuijten MJ. Introduction to the pharmacoeconomics of herbal medicines. Pharmacoeconomics. 2000;18(1):1–7.

    Article  PubMed  Google Scholar 

  18. Deitelzweig SB, Becker R, Lin J, Benner J. Comparison of the two-year outcomes and costs of prophylaxis in medical patients at risk of venous thromboembolism. Thromb Haemost. 2008;100(5):810–20.

    Article  CAS  PubMed  Google Scholar 

  19. Dembek C, White LA, Quach J, Szkurhan A, Rashid N, Blasco MR. Cost-effectiveness of injectable disease-modifying therapies for the treatment of relapsing forms of multiple sclerosis in Spain. Eur J Health Econ. 2014;15(4):353–62.

    Article  PubMed  Google Scholar 

  20. Diamantopoulos A, Lees M, Wells PS, Forster F, Ananthapavan J, McDonald H. Cost-effectiveness of rivaroxaban versus enoxaparin for the prevention of postsurgical venous thromboembolism in Canada. Thromb Haemost. 2010;104(4):760–70.

    Article  CAS  PubMed  Google Scholar 

  21. Dranitsaris G, Kahn SR, Stumpo C, Paton TW, Martineau J, Smith R, Ginsberg JS. Pharmacoeconomic analysis of fondaparinux versus enoxaparin for the prevention of thromboembolic events in orthopedic surgery patients. Am J Cardiovasc Drugs. 2004;4(5):325–33.

    Article  PubMed  Google Scholar 

  22. Drummond M, Aristides M, Davies L, Forbes C. Economic evaluation of standard heparin and enoxaparin for prophylaxis against deep vein thrombosis in elective hip surgery. Br J Surg. 1994;81(12):1742–6.

    Article  CAS  PubMed  Google Scholar 

  23. Duran A, Sengupta N, Diamantopoulos A, Forster F, Kwong L, Lees M. Cost effectiveness of rivaroxaban versus enoxaparin for prevention of post-surgical venous thromboembolism from a US payer’s perspective. Pharmacoeconomics. 2012;30(2):87–101.

    Article  PubMed  Google Scholar 

  24. Ernst E. Editorial: Cost Evaluation of Herbal Medicine. J Herbal Pharmacotherapy. 2003;3(4):55–6.

    Google Scholar 

  25. Etchells E, McLeod RS, Geerts W, Barton P, Detsky AS. Economic analysis of low-dose heparin vs. the low-molecular-weight heparin enoxaparin for prevention of venous thromboembolism after colorectal surgery. Arch Intern Med. 1999;159(11):1221–8.

    Article  CAS  PubMed  Google Scholar 

  26. Fanari Z, Weiss S, Weintraub WS. Cost effectiveness of antiplatelet and antithrombotic therapy in the setting of acute coronary syndrome: current perspective and literature review. Am J Cardiovasc Drugs. 2015;15(6):415–27.

    Article  PubMed  PubMed Central  Google Scholar 

  27. Francis CW, Reinhart SP, Pleil AM, Cohen B. A pharmacoeconomic evaluation of low-molecular-weight heparin in total hip-replacement surgery. P AND T. 1999;24:136–43.

    Google Scholar 

  28. Godman B, Abuelkhair M, Vitry A, Abdu S, Bennie M, Bishop I. Payers endorse generics to enhance prescribing efficiency: impact and future implications, a case history approach. Doctoral dissertation, No Code. 2012.

    Article  Google Scholar 

  29. Gold LS, Suh K, Schepman PB, Damal K, Hansen RN. Healthcare costs and resource utilization in patients with multiple sclerosis relapses Treated with HP Acthar Gel®. Adv. Therapy. 2016;33(8):1279–92.

    Article  CAS  Google Scholar 

  30. Gordois A, Posnett J, Borris L, Bossuyt P, Jönsson B, Levy E, De Pouvourville G. The cost-effectiveness of fondaparinux compared with enoxaparin as prophylaxis against thromboembolism following major orthopedic surgery. J Thromb Haemost. 2003;1(10):2167–74.

    Article  CAS  PubMed  Google Scholar 

  31. Hawkins DW, Langley PC, Krueger KP. A pharmacoeconomic assessment of enoxaparin and warfarin as prophylaxis for deep vein thrombosis in patients undergoing knee replacement surgery. Clin Therap. 1998;20(1), 182–195.

    Article  CAS  PubMed  Google Scholar 

  32. Hawkins DW, Langley PC, Krueger KP. Pharmacoeconomic model of enoxaparin versus heparin for prevention of deep vein thrombosis after total hip replacement. Am J Health Syst Pharm, 1997;54(10):1185–90.

    Article  CAS  PubMed  Google Scholar 

  33. Heerey A, Suri S. Cost effectiveness of dalteparin for preventing venous thromboembolism in abdominal surgery. Pharmacoeconomics. 2005;23(9):927–44.

    Article  PubMed  Google Scholar 

  34. Hernandez L, Guo S, Kinter E, Fay M. Cost-effectiveness analysis of peginterferon beta-1a compared with interferon beta-1a and glatiramer acetate in the treatment of relapsing-remitting multiple sclerosis in the United States. J Med Econ. 2016;19(7):684–95.

    Article  PubMed  Google Scholar 

  35. Hernandez L, Guo S, Toro-Diaz H, Carroll S, Syed Farooq SF. Peginterferon beta-1a versus other self-injectable disease-modifying therapies in the treatment of relapsing-remitting multiple sclerosis in Scotland: a cost-effectiveness analysis. J Med Econ. 2017;20(3):228–38.

    Article  PubMed  Google Scholar 

  36. Hillman AL, Schwartz JS, Eilers RD, Pauly MV, Bloom BS, Eisenberg JM, Willian MK, Donaldson M, Lazar A, Leatherman S, Luce BR. Economic analysis of health care technology. Ann Intern Med. 1995;123(1):61–70.

    Article  Google Scholar 

  37. Hull RD, Raskob GE, Pineo GF, Feldstein W, Rosenbloom D, Gafni A, Green D, Feinglass J, Trowbridge AA, Elliott CG, Lerner RG. Subcutaneous low-molecular-weight heparin vs. warfarin for prophylaxis of deep vein thrombosis after hip or knee implantation: an economic perspective. Arch Intern Med. 1997;157(3):298–303.

    Article  CAS  PubMed  Google Scholar 

  38. Kapoor A, Chuang W, Radhakrishnan N, Smith KJ, Berlowitz D, Segal JB, Katz JN, Losina E. Cost effectiveness of venous thromboembolism pharmacological prophylaxis in total hip and knee replacement. Pharmacoeconomics. 2010;28(7):521–38.

    Article  PubMed  PubMed Central  Google Scholar 

  39. Kassirer JP, Angell M. The journal’s policy on cost-effectiveness analyses. N Engl J Med. 1994;331(10):669–70.

    Article  CAS  PubMed  Google Scholar 

  40. Lamy A, Wang X, Kent R, Smith KM, Gafni A. Economic evaluation of the MEDENOX trial: a Canadian perspective. Can Respir J. 2002;9(3):169–77.

    Article  PubMed  Google Scholar 

  41. Langley PC. A cost-effectiveness analysis of sinecatechins in the treatment of external genital warts. J Med Econ. 2010;13(1):1–7.

    Article  PubMed  Google Scholar 

  42. Latour-Pérez J, de-Miguel-Balsa E. Cost effectiveness of anticoagulation in acute coronary syndromes. Pharmacoeconomics 2012. 30(4):303–21.

    Article  PubMed  Google Scholar 

  43. Lloyd A, Aitken JA, Hoffmeyer UK, Kelso EJ, Wakerly EC, Barbe ND. Economic evaluation of the use of nadroparin calcium in the prophylaxis of deep vein thrombosis and pulmonary embolism in surgical patients in Italy. Pharmacoeconomics. 1997;12(4):475–85.

    Article  CAS  PubMed  Google Scholar 

  44. Lloyd AC, Anderson PM, Quinlan DJ, Bearne A. Economic evaluation of the use of enoxaparin for thromboprophylaxis in acutely ill medical patients. J Med Econ. 2001;4(1–4):99–113.

    Article  Google Scholar 

  45. Lundkvist J, Bergqvist D, Jönsson B. Cost-effectiveness of fondaparinux vs. enoxaparin as venous thromboembolism prophylaxis in Sweden. Eur J Health Econ HEPAC. 2003;4(4):254–62.

    Google Scholar 

  46. Marchetti M, Liberato NL, Ruperto N, Barosi G. Long-term cost-effectiveness of low molecular weight heparin versus unfractionated heparin for the prophylaxis of venous thromboembolism in elective hip replacement. Haematologica 1999;0(8):730–37

    Google Scholar 

  47. Marcoff L, Zhang Z, Zhang W, Ewen E, Jurkovitz C, Leguet P, Kolm P, Weintraub WS. Cost effectiveness of enoxaparin in acute ST-segment elevation myocardial infarction: The ExTRACT–TIMI 25 (enoxaparin and thrombolysis reperfusion for acute myocardial infarction treatment-thrombolysis in myocardial infarction 25) study. J Am Coll Cardiol. 2009;54(14):1271–9.

    Article  PubMed  Google Scholar 

  48. Mark DB, Hlatky MA. Medical economics and the assessment of value in cardiovascular medicine: part I. Circulation. 2002;106(4):516–20.

    Article  PubMed  Google Scholar 

  49. Mark DB, Cowper PA, Berkowitz SD, Davidson-Ray L, DeLong ER, Turpie AG, Califf RM, Weatherley B, Cohen M. Economic assessment of low-molecular-weight heparin (enoxaparin) versus unfractionated heparin in acute coronary syndrome patients Results from the ESSENCE randomized trial. Circulation. 1998;97(17):1702–7.

    Article  CAS  PubMed  Google Scholar 

  50. Mauskopf J, Fay M, Iyer R, Sarda S, Livingston T. Cost-effectiveness of delayed-release dimethyl fumarate for the treatment of relapsing forms of multiple sclerosis in the United States. J Med Econ. 2016;19(4):432–42.

    Article  PubMed  Google Scholar 

  51. McCullagh L, Tilson L, Walsh C, Barry M. A cost-effectiveness model comparing rivaroxaban and dabigatran etexilate with enoxaparin sodium as thromboprophylaxis after total hip and total knee replacement in the Irish healthcare setting. Pharmacoeconomics. 2009;27(10):829–46.

    Article  PubMed  Google Scholar 

  52. McGarry LJ, Thompson D, Weinstein MC, Goldhaber SZ. Cost effectiveness of thromboprophylaxis with a low-molecular-weight heparin versus unfractionated heparin in acutely ill medical inpatients. Am J Manag Care. 2004;10(9):632–42.

    PubMed  Google Scholar 

  53. Menzin J, Colditz GA, Regan MM, Richner RE, Oster G. Cost-effectiveness of enoxaparin vs. low-dose warfarin in the prevention of deep-vein thrombosis after total hip replacement surgery. Arch Intern Med. 1995;155(7):757–64.

    Article  CAS  PubMed  Google Scholar 

  54. Murray GD, Best CH. The use of heparin in thrombosis. Ann Surg 1938;108(2), p. 163.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  55. Murray J, Best P. Heparin and the thrombosis of veins following injury. Surgery. 1937;2(2):163.

    Google Scholar 

  56. Nerurkar M, Wade WE, Martin BC. 2002. Cost/death averted with venous thromboembolism prophylaxis in patients undergoing total knee replacement or knee arthroplasty. Pharmacother J Human Pharmacol Drug Therapy. 22(8):990–1000.

    Article  PubMed  Google Scholar 

  57. O’Brien BJ, Anderson DR, Goeree R. Cost-effectiveness of enoxaparin versus warfarin prophylaxis against deep-vein thrombosis after total hip replacement. CMAJ Can Med Assoc J. 1994;150(7):1083.

    Google Scholar 

  58. Offord R, Lloyd AC, Anderson P, Bearne A. Economic evaluation of enoxaparin for the prevention of venous thromboembolism in acutely ill medical patients. Pharm World Sci. 2004;26(4):214–20.

    Article  PubMed  Google Scholar 

  59. Owens GM, Olvey EL, Skrepnek GH, Pill MW. Perspectives for managed care organizations on the burden of multiple sclerosis and the cost-benefits of disease-modifying therapies. J Manage Care Pharm. 2013;19(1 Supp A):S41–53.

    Article  PubMed  Google Scholar 

  60. Palace J, Duddy M, Bregenzer T, Lawton M, Zhu F, Boggild M, Piske B, Robertson NP, Oger J, Tremlett H, Tilling K. Effectiveness and cost-effectiveness of interferon beta and glatiramer acetate in the UK Multiple Sclerosis Risk Sharing Scheme at 6 years: a clinical cohort study with natural history comparator. Lancet Neurol. 2015;14(5):497–505.

    Article  PubMed  Google Scholar 

  61. Parthasarthi G, Nyfort-Hansen K, Nahata MC. A text book of clinical pharmacy practice–essential concepts and skills. Orient Longman; 2007. p. 378.

    Google Scholar 

  62. Pechevis M, Detournay B, Pribil C, Fagnani F, Chalanson G. Economic evaluation of enoxaparin vs. placebo for the prevention of venous thromboembolism in acutely ill medical patients. Value Health. 2000;3(6):389–96.

    Article  CAS  PubMed  Google Scholar 

  63. Pinto DS, Stone GW, Shi C, Dunn ES, Reynolds MR, York M, Walczak J, Berezin RH, Mehran R, McLaurin BT, Cox DA. Economic evaluation of bivalirudin with or without glycoprotein IIb/IIIa inhibition versus heparin with routine glycoprotein IIb/IIIa inhibition for early invasive management of acute coronary syndromes. J Am Coll Cardiol. 2008;52(22):1758–68.

    Article  CAS  PubMed  Google Scholar 

  64. Sabanov AV, Luneva AV, Matveev NV. Pharmacoeconomic analysis of the efficacy of natalizumab in relapsing-remitting multiple sclerosis. 2013.

    Google Scholar 

  65. Sanz-Granda A, Garcia-Jurado L, Polanco-Sanchez C. Budget impact analysis of the first-line treatment of relapsing remitting multiple sclerosis in Spain. Revista de neurologia. 2012;54(7):446–7.

    Article  CAS  PubMed  Google Scholar 

  66. Schädlich PK, Kentsch M, Weber M, Kämmerer W, Brecht JG, Nadipelli V, Huppertz E. Cost effectiveness of enoxaparin as prophylaxis against venous thromboembolic complications in acutely Ill medical inpatients. Pharmacoeconomics. 2006;24(6):571–91.

    Article  PubMed  Google Scholar 

  67. Schousboe JT, Brown GA. Cost-effectiveness of low-molecular-weight heparin compared with aspirin for prophylaxis against venous thromboembolism after total joint arthroplasty. J Bone Joint Surg Am. 2013;95(14):1256–64.

    Article  PubMed  Google Scholar 

  68. Schwenkglenks M, Toward TJ, Plent S, Szucs TD, Blackman DJ, Baumbach A. Cost-effectiveness of bivalirudin versus heparin plus glycoprotein IIb/IIIa inhibitor in the treatment of acute ST-segment elevation myocardial infarction. Heart. 2012.

    Google Scholar 

  69. Sculpher MJ, Lozano-Ortega G, Sambrook J, Palmer S, Ormanidhi O, Bakhai A, Flather M, Steg PG, Mehta SR, Weintraub W. Fondaparinux versus eEnoxaparin in non–ST-elevation acute coronary syndromes: short-term cost and long-term cost-effectiveness using data from the Fifth Organization to Assess Strategies in Acute Ischemic Syndromes Investigators (OASIS-5) trial. Am Heart J. 2009;157(5):845–52.

    Article  CAS  PubMed  Google Scholar 

  70. Soini E, Joutseno J, Sumelahti ML. Cost-utility of first-line disease-modifying treatments for relapsing–remitting multiple sclerosis. Clin Therap. 2017.

    Google Scholar 

  71. Spruill WJ, Wade WE, Leslie RB. A cost analysis of fondaparinux versus enoxaparin in total knee arthroplasty. Am J Ther. 2004;11(1):3–8.

    Article  PubMed  Google Scholar 

  72. Spruill WJ, Wade WE, Leslie RB. Cost analysis of fondaparinux versus enoxaparin as venous thromboembolism prophylaxis in elective hip replacement surgery. Blood Coag Fibrinol. 2004;15(7):539–43.

    Google Scholar 

  73. Stovall DW, Pinkerton JV. MF-101, an estrogen receptor beta agonist for the treatment of vasomotor symptoms in peri-and postmenopausal women. Curr Opin Invest Drugs. 2009;10(4):365–71.

    Google Scholar 

  74. Su W, Kansal A, Vicente C, Deniz B, Sarda S. The cost-effectiveness of delayed-release dimethyl fumarate for the treatment of relapsing-remitting multiple sclerosis in Canada. J Med Econ. 2016;19(7):718–27.

    Article  PubMed  Google Scholar 

  75. Sullivan SD, Davidson BL, Kahn SR, Muntz JE, Oster G, Raskob G. A cost-effectiveness analysis of fondaparinux sodium compared with enoxaparin sodium as prophylaxis against venous thromboembolism. Pharmacoeconomics. 2004;22(9):605–20.

    Article  CAS  PubMed  Google Scholar 

  76. Sumra M, Fullarton JR, Walters E. A long term analysis of the clinical and cost effectiveness of glatiramer acetate from the UK Multiple Sclerosis Risk Sharing Scheme. Women. 2015;223:23.

    Google Scholar 

  77. Sun X, Guo LP, Shang HC, Ren M, Lei X. Systematic economic assessment and quality evaluation for traditional Chinese medicines. Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China J Chin Materia Medica. 2015;40(10):2050–53.

    Google Scholar 

  78. Szucs TD, Kaiser WE, Mahler F, Gutzwiller F. Thromboembolic prophylaxis with fondaparinux in major orthopaedic surgery: outcomes and costs. Heart Drug. 2005;5(3):121–30.

    Article  Google Scholar 

  79. Terres JAR, Lozano-Ortega G, Kendall R, Sculpher MJ. Cost-effectiveness of fondaparinux versus enoxaparin in non-ST-elevation acute coronary syndrome in Canada (OASIS-5). BMC Cardiovasc Disorders. 2015;15(1):1.

    Article  Google Scholar 

  80. Thirugnanam S, Pinto R, Cook DJ, Geerts WH, Fowler RA. Economic analyses of venous thromboembolism prevention strategies in hospitalized patients: a systematic review. Crit Care. 2012;16(2):1.

    Article  Google Scholar 

  81. Wade WE, Spruill WJ. Cost-effectiveness of dalteparin versus unfractionated heparin as venous thromboembolism prophylaxis in malignant gynecologic surgery. Am J Ther. 2008;15(6):512–5.

    Article  PubMed  Google Scholar 

  82. Wade WE, Spruill WJ, Leslie RB. Cost analysis: fondaparinux versus preoperative and postoperative enoxaparin as venous thromboembolic event prophylaxis in elective hip arthroplasty. Am J Orth (Belle Mead, NJ). 2003;32(4):201–5.

    Google Scholar 

  83. Wade WE, Spruill WJ, Leslie RB. Cost analysis of fondaparinux versus enoxaparin as venous thromboembolism prophylaxis in hip fracture surgery. Am J Ther. 2004;11(3):194–8.

    Article  PubMed  Google Scholar 

  84. Wah CL, Hock SC, Yun TK. Current scientific status and regulatory control of traditional/herbal medicinal products: globalization challenges. Pharm Eng. 2012.

    Google Scholar 

  85. Wolowacz SE, Roskell NS, Maciver F, Beard SM, Robinson PA, Plumb JM, Dolan G, Brenkel IJ. Economic evaluation of dabigatran etexilate for the prevention of venous thromboembolism after total knee and hip replacement surgery. Clin Ther. 2009;31(1):194–212.

    Article  PubMed  Google Scholar 

  86. Zhou LL, Xu LZ, Liu HW, Zhang J, Liu Y, Liu XF, Tang LL, Zhuang J, Liu XX, Qiao L. Sexual hormone and traditional Chinese patent medicine for early postmenopausal women: effect on quality of life and cost-utility analysis. Nan fang yi ke da xue xue bao = J Southern Med Univ. 2009;29(11):2181–86.

    Google Scholar 

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Acknowledgements

The author would like to thank the editors, his professors, classmates at MIT, his colleagues at Tasly Pharma, and his friends for their constructive and inspiring advice. Special thanks to author’s parents for their indispensable support.

The work was completed when the author was studying at MIT.

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  1. LYFE Capital, 1468, Nanjing Road West, Suite 1804, United Plaza, Shanghai, 200040, China

    Sen Lin

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  1. Sen Lin
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Correspondence to Sen Lin .

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Editors and Affiliations

  1. Department of Biological Engineering, Koch Institute of Integrative Cancer Research, Massachusetts Institute of Technology, Cambridge, MA, USA

    Ram Sasisekharan

  2. Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA

    Sau L. Lee

  3. Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA

    Amy Rosenberg

  4. Director Emeritus, National Center for Natural Products Research, School of Pharmacy, University of Mississippi, Oxford, MS, USA

    Larry A. Walker

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Lin, S. (2019). Economic Considerations for Complex Mixture Drugs. In: Sasisekharan, R., Lee, S., Rosenberg, A., Walker, L. (eds) The Science and Regulations of Naturally Derived Complex Drugs. AAPS Advances in the Pharmaceutical Sciences Series, vol 32. Springer, Cham. https://doi.org/10.1007/978-3-030-11751-1_16

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