International Journal of Health Policy and Management

International Journal of Health Policy and Management

The Economic Impact of Clinical Research in an Italian Public Hospital: The Malignant Pleural Mesothelioma Case Study

Document Type : Original Article

Authors
Roberto Ippoliti 1, 2
Greta Falavigna 3
Federica Grosso 4
Antonio Maconi 1
Lorenza Randi 1
Gianmauro Numico 4
1 Scientific Promotion, General Hospital of Alessandria, Alessandria, Italy
2 Department of Management, University of Turin, Turin, Italy.
3 Research Institute on Sustainable Economic Growth, National Research Council of Italy, Moncalieri, Italy
4 Oncology Unit, General Hospital of Alessandria, Alessandria, Italy
10.15171/ijhpm.2018.13
Abstract
Background
The current economic constraints cause hospital management to use the available public resources as rationally as possible. At the same time, there is the necessity to improve current scientific knowledge. This is even more relevant in the case of patients with malignant pleural mesothelioma (MPM), given the severity of the disease, its dismal prognosis, and the cost of chemotherapy drugs. This work aims to evaluate the standard cost of patients with MPM, supporting physicians in their decision-making process in relation to budget constraints, as well as policymakers with respect research policy.

 
Methods
The authors conducted a retrospective cost analysis on all the patients with MPM who were first admitted to a reference hospital specialized in MPM care between 2014 and 2015, collecting data on their diagnostic pathways and active treatments, as well as on the related official fees for each procedure. Then, using a multiple regression model, we estimated the overall expected cost of a patient with MPM treated in our hospital, to be born by the Regional Healthcare System based on the chosen clinical pathway.

 
Results
According to results, the economic impact of caring for a patient with MPM is mostly related to the selected active treatments, with drug and hospitalization costs as main drivers. Our analysis suggests that the expected reimbursed fee to care for a patient with MPM is equal to € 18 214.99, with chemotherapy and monitoring costs equal to € 12 861.43 and hospitalization cost equal to € 5353.55. This cost decreases to € 320.18 in the case of enrollment in an experimental trial of first-line treatment. In the other cases (second-line or third-line trials), the expected cost borne by the healthcare system for treating patients grows exponentially (€ 40,124.18 and € 59 839.94, respectively).

 
Conclusion
Experimental trials might be a solution to decrease the economic burden for the public healthcare system only in the case of first-line treatments, where the cost of chemotherapy is relevant. Nevertheless, policy-makers have to accept the sharing of this economic burden between society and the pharmaceutical industry to broaden the current scientific knowledge.

Highlights

Supplementary File (Download)

Keywords
Rare Tumors
Clinical Research
Budget Constraint
Health Planning
Malignant Pleural Mesothelioma
Subjects

 

  1. Marinaccio A, Binazzi A, Bonafede M, et al. Malignant mesothelioma due to non-occupational asbestos exposure from the Italian national surveillance system (ReNaM): epidemiology and public health issues. Occup Environ Med. 2015;72(9):648-655. doi:10.1136/oemed-2014-102297
  2. Magnani C, Bianchi C, Chellini E, et al. III Italian Consensus Conference on Malignant Mesothelioma of the Pleura. Epidemiology, Public Health and Occupational Medicine related issues. Med Lav. 2015;106(5):325-332.
  3. Magnani C, Dalmasso P, Biggeri A, Ivaldi C, Mirabelli D, Terracini B. Increased risk of malignant mesothelioma of the pleura after residential or domestic exposure to asbestos: a case-control study in Casale Monferrato, Italy. Environ Health Perspect. 2001;109(9):915-919.
  4. De Vos P, Ordunez-Garcia P, Santos-Pena M, Van der Stuyft P. Public hospital management in times of crisis: lessons learned from Cienfuegos, Cuba (1996-2008). Health Policy. 2010;96(1):64-71. doi:10.1016/j.healthpol.2010.01.005
  5. Quaglio G, Karapiperis T, Van Woensel L, Arnold E, McDaid D. Austerity and health in Europe. Health Policy. 2013;113(1):13-19. doi:10.1016/j.healthpol.2013.09.005
  6. Casagranda I, Costantino G, Falavigna G, Furlan R, Ippoliti R. Artificial Neural Networks and risk stratification models in Emergency Departments: The policy maker's perspective. Health Policy. 2016;120(1):111-119. doi:10.1016/j.healthpol.2015.12.003
  7. Gelber RD, Goldhirsch A. Can a clinical trial be the treatment of choice for patients with cancer? J Natl Cancer Inst. 1988;80(12):886-887.
  8. Peppercorn JM, Weeks JC, Cook EF, Joffe S. Comparison of outcomes in cancer patients treated within and outside clinical trials: conceptual framework and structured review. Lancet. 2004;363(9405):263-270. doi:10.1016/s0140-6736(03)15383-4
  9. Ippoliti R. The market of human experimentation. Eur J Law Econ. 2013;35(1):61-85. doi:10.1007/s10657-010-9190-y
  10. Kondola S, Manners D, Nowak AK. Malignant pleural mesothelioma: an update on diagnosis and treatment options. Ther Adv Respir Dis. 2016;10(3):275-288. doi:10.1177/1753465816628800
  11. Tang PA, Hay AE, O'Callaghan CJ, et al. Estimation of drug cost avoidance and pathology cost avoidance through participation in NCIC Clinical Trials Group phase III clinical trials in Canada. Curr Oncol. 2016;23(Suppl 1):S7-s13. doi:10.3747/co.23.2861
  12. Bredin C, Eliasziw M, Syme R. Drug cost avoidance resulting from cancer clinical trials. Contemp Clin Trials. 2010;31(6):524-529. doi:10.1016/j.cct.2010.09.004
  13. Shen LJ, Chou H, Huang CF, Chou GM, Chan WK, Wu FL. Economic benefits of sponsored clinical trials on pharmaceutical expenditures at a medical center in Taiwan. Contemp Clin Trials. 2011;32(4):485-491. doi:10.1016/j.cct.2011.04.003
  14. Rogers SD, Lampasona V, Buchanan EC. The financial impact of investigational drug services. Top Hosp Pharm Manage. 1994;14(1):60-66.
  15. McDonagh MS, Miller SA, Naden E. Costs and savings of investigational drug services. Am J Health Syst Pharm. 2000;57(1):40-43.
  16. Grossi F, Genova C, Gaitan ND, et al. Free drugs in clinical trials and their potential cost saving impact on the National Health Service: a retrospective cost analysis in Italy. Lung Cancer. 2013;81(2):236-240. doi:10.1016/j.lungcan.2013.03.021
  17. Elting LS, Shih YC. The economic burden of supportive care of cancer patients. Support Care Cancer. 2004;12(4):219-226. doi:10.1007/s00520-003-0513-1
  18. Jonsson B, Wilking N. The burden and cost of cancer. Ann Oncol. 2007;18(suppl_3):iii8-iii22. doi:10.1093/annonc/mdm097
  19. Meropol NJ, Schrag D, Smith TJ, et al. American Society of Clinical Oncology guidance statement: the cost of cancer care. J Clin Oncol. 2009;27(23):3868-3874. doi:10.1200/jco.2009.23.1183
  20. Emanuel EJ, Schnipper LE, Kamin DY, Levinson J, Lichter AS. The costs of conducting clinical research. J Clin Oncol. 2003;21(22):4145-4150. doi:10.1200/jco.2003.08.156
  21. Fireman BH, Fehrenbacher L, Gruskin EP, Ray GT. Cost of care for patients in cancer clinical trials. J Natl Cancer Inst. 2000;92(2):136-142.
  22. Goldman DP, Berry SH, McCabe MS, et al. Incremental treatment costs in national cancer institute-sponsored clinical trials. Jama. 2003;289(22):2970-2977. doi:10.1001/jama.289.22.2970
  23. Gerber DE, Lakoduk AM, Priddy LL, Yan J, Xie XJ. Temporal Trends and Predictors for Cancer Clinical Trial Availability for Medically Underserved Populations. Oncologist. 2015;20(6):674-682. doi:10.1634/theoncologist.2015-0083
  24. Ippoliti R, Falavigna G. Efficiency of the medical care industry: Evidence from the Italian regional system. Eur J Oper Res. 2012;217(3):643-652. doi:10.1016/j.ejor.2011.10.010
  25. Fattore G, Torbica A. Inpatient reimbursement system in Italy: how do tariffs relate to costs? Health Care Manag Sci. 2006;9(3):251-258. doi:10.1007/s10729-006-9092-2
  26. France G, Taroni F, Donatini A. The Italian health-care system. Health Econ. 2005;14(Suppl 1):S187-202. doi:10.1002/hec.1035
  27. De Nicola A, Gitto S, Mancuso P, Valdmanis V. Healthcare reform in Italy: an analysis of efficiency based on nonparametric methods. Int J Health Plann Manage. 2014;29(1):e48-e63. doi:10.1002/hpm.2183
  28. Varian HR. Microeconomic analysis. WW Northon; 1978.
  29. Carlton DW, Perloff JM. Modern industrial organization. Pearson Higher Ed; 2015.
  30. Ceresoli GL, Zucali PA, Favaretto AG, et al. Phase II study of pemetrexed plus carboplatin in malignant pleural mesothelioma. J Clin Oncol. 2006;24(9):1443-1448. doi:10.1200/jco.2005.04.3190
  31. Castagneto B, Botta M, Aitini E, et al. Phase II study of pemetrexed in combination with carboplatin in patients with malignant pleural mesothelioma (MPM). Ann Oncol. 2008;19(2):370-373. doi:10.1093/annonc/mdm501
  32. Nipp RD, Powell E, Chabner B, Moy B. Recognizing the Financial Burden of Cancer Patients in Clinical Trials. Oncologist. 2015;20(6):572-575. doi:10.1634/theoncologist.2015-0068
  33. Lara PN, Jr., Higdon R, Lim N, et al. Prospective evaluation of cancer clinical trial accrual patterns: identifying potential barriers to enrollment. J Clin Oncol. 2001;19(6):1728-1733. doi:10.1200/jco.2001.19.6.1728
International Journal of Health Policy and Management
Volume 7, Issue 8
2018
Pages 728-737

  • Received Date 23 February 2017
  • Revised Date 12 January 2018
  • Accepted Date 05 February 2018
  • First Published Date 01 August 2018
  • Published Date 01 August 2018