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CASE STUDY ON AN IPILIMUMAB COST-CONTAINMENT STRATEGY IN AN ITALIAN HOSPITAL

Published online by Cambridge University Press:  13 July 2017

Alberto Russi
Affiliation:
Hospital Pharmacy, Veneto Institute of Oncology
Vanna Chiarion-Sileni
Affiliation:
Melanoma and Esophageal Cancer Unit, Veneto Institute of Oncology
Vera Damuzzo
Affiliation:
School of Hospital Pharmacy, University of Padova
Francesca Di Sarra
Affiliation:
Hospital Pharmacy, Veneto Institute of Oncology
Jacopo Pigozzo
Affiliation:
Melanoma and Esophageal Cancer Unit, Veneto Institute of Oncology
Angelo Claudio Palozzo
Affiliation:
Hospital Pharmacy, Veneto Institute of Oncologyangelo.palozzo@iov.veneto.it

Abstract

Objectives: Ipilimumab is the first licensed immune checkpoint inhibitor for treatment of melanoma. The promising results of the registration clinical study need confirmation in real practice and its clinical success comes together with a relevant budget impact due to the high price of this drug. The aim of this work is to describe a new model of economical sustainability of ipilimumab developed in an Italian reference center for melanoma treatment.

Methods: This retrospective, observational, and monocentric study was carried out at the Veneto Institute of Oncology. Ipilimumab was administered to fifty-seven patients with advanced melanoma. Overall survival, progression free survival, and toxicity were evaluated. A local management procedure was evaluated together with the cost-saving strategies implemented by the Italian Medicines Agency (AIFA).

Results: We demonstrated that the use of ipilimumab for metastatic melanoma in real practice had an efficacy and toxicity similar to that reported in the literature. In this scenario, our management model (centralization of compounding + drug-day) permitted savings up to the 11.1 percent of the gross cost for the drug (calculated assuming that no cost saving procedures were applied) while the policy of cost containment designed by AIFA produced an additional 6.2 percent of savings.

Conclusions: In real practice conditions, the centralized administration of ipilimumab allows to replicate the results of clinical studies and in the meantime to contain the cost associated with this drug. The local strategy of management can be readily applied to most of the high cost drugs compounded in the hospital pharmacy. Impact of findings on practice: (i) We describe a new model of economic sustainability (drug-day, centralization of compounding, payback systems) of an expensive and innovative drug, ipilimumab, for treatment of melanoma within an Italian cancer center. (ii) This pivotal study demonstrated that a cost containment strategy is feasible and it needs the cooperation of all healthcare providers (oncologists, pharmacists, nurses, and technicians) to guarantee the full efficiency of the process.

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Copyright
Copyright © Cambridge University Press 2017 

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References

REFERENCES

1. Navarria, A, Drago, V, Gozzo, L, Longo, L, Mansueto, S, Pignataro, G, et al. Do the current performance-based schemes in Italy really work? “Success fee”: A novel measure for cost-containment of drug expenditure. Value Health. 2015;18:131-136.Google Scholar
2. Fasola, G, Aprile, G, Marini, L, Follador, A, Mansutti, M, Miscoria, M. Drug waste minimization as an effective strategy of cost-containment in oncology. BMC Health Serv Res. 2014;14:57.CrossRefGoogle ScholarPubMed
3. Baldo, P, Bertola, A, Basaglia, G, Moneghini, M, Sorio, R, Zibardi, E, et al. A centralized pharmacy unit for cytotoxic drugs in accordance with Italian legislation. J Eval Clin Pract. 2007;13:265-271.CrossRefGoogle ScholarPubMed
4. Hyeda, A, da Costa, ES. A preliminary analysis of the reduction of chemotherapy waste in the treatment of cancer with centralization of drug preparation. Rev Assoc Med Bras. 2015;61:368-374.Google Scholar
5. Bach, PB, Conti, RM, Muller, RJ, Schnorr, GC, Saltz, LB. Overspending driven by oversized single dose vials of cancer drugs. BMJ. 2016;352:i788.Google Scholar
6. AIFA Agenzia Italiana del Farmaco. http://www.agenziafarmaco.gov.it/ (accessed December 22, 2015).Google Scholar
7. Messori, A, De Rosa, M, Fadda, V, Pani, L. Effectiveness and cost effectiveness of bevacizumab in metastatic colorectal cancer. J Clin Oncol. 2015;33:3838-3839.CrossRefGoogle ScholarPubMed
8. Messori, A, De Rosa, M, Pani, L. Alternative pricing strategies for cancer drugs. JAMA. 2015;313:857.Google Scholar
9. van Harten, WH, Wind, A, de Paoli, P, Saghatchian, M, Oberst, S. Actual costs of cancer drugs in 15 European countries. Lancet Oncol. 2016;17:18-20.CrossRefGoogle ScholarPubMed
10. Deliberazione della Giunta Regionale DGR n 1335 del 28 luglio 2014.Google Scholar
11. Determina AIFA n. 139/2013, Gazzetta Ufficiale Serie Generale n.45 del 22-2-2013.Google Scholar
12. Hodi, FS, O'Day, SJ, McDermott, DF, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010;363:711-723.CrossRefGoogle ScholarPubMed
13. Delyon, J, Mateus, C, Lefeuvre, D, et al. Experience in daily practice with ipilimumab for the treatment of patients with metastatic melanoma: An early increase in lymphocyte and eosinophil counts is associated with improved survival. Ann Oncol. 2013;24:1697-1703.Google Scholar
14. Ahmad, S, Qian, W, Ellis, S, et al. Ipilimumab in the real world: The UK expanded access programme experience in previously treated advanced melanoma patients. Melanoma Res. 2015;25:432-442.Google Scholar
15. Schadendorf, D, Hodi, FS, Robert, C, et al. Pooled analysis of long-term survival data from phase II and phase III trials of Ipilimumab in unresectable or metastatic melanoma. J Clin Oncol. 2015;33:1889-1894.Google Scholar
16. Valpione, S, Moser, JC, Parrozzani, R, et al. Development and external validation of a prognostic nomogram for metastatic uveal melanoma. PLoS One. 2015;10:e0120181.Google Scholar
17. Diem, S, Kasenda, B, Martin-Liberal, J, et al. Prognostic score for patients with advanced melanoma treated with ipilimumab. Eur J Cancer. 2015;51:2785-2791.CrossRefGoogle ScholarPubMed
18. Ferrucci, PF, Ascierto, PA, Pigozzo, J, et al. Baseline neutrophils and derived neutrophil-to-lymphocyte ratio: Prognostic relevance in metastatic melanoma patients receiving ipilimumab. Ann Oncol. 2016;27:732-738.Google Scholar
19. Damuzzo, V, Pinton, L, Solito, S, et al. Clinical implication of tumor-associated and immunological parameters in melanoma patients treated with ipilimumab. Oncoimmunology. 2016;5:e1249559.Google Scholar
20. Postow, MA, Chesney, J, Pavlick, AC, et al. Nivolumab and ipilimumab versus ipilimumab in untreated melanoma. N Engl J Med. 2015;372:2006-2017.CrossRefGoogle ScholarPubMed
21. Robert, C, Schadendorf, D, Messina, M, Hodi, FS, O'Day S; MDX010-20 investigators. Efficacy and safety of retreatment with ipilimumab in patients with pretreated advanced melanoma who progressed after initially achieving disease control. Clin Cancer Res. 2013;19:2232- 2239.Google Scholar
22. Tarhini, A. Immune-mediated adverse events associated with ipilimumab ctla-4 blockade therapy: The underlying mechanisms and clinical management. Scientifica (Cairo). 2013;2013:857519.Google ScholarPubMed
23. NCPE. www.ncpe.ie (accessed December 15, 2015).Google Scholar
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