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Changing the Cost of Care for Chronic Myeloid Leukemia: The Availability of Generic Imatinib in the USA and the EU

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Chronic Myeloid Leukemia

Part of the book series: Hematologic Malignancies ((HEMATOLOGIC))

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Abstract

Imatinib is an oral tyrosine kinase inhibitor and considered to be the most successful targeted anticancer agent yet developed given its substantial efficacy in treating chronic myeloid leukemia (CML) and other malignant diseases. In the USA and the EU, Novartis’ composition of matter patent on imatinib will expire in 2016. The potential impact on health system spending levels for CML after generic imatinib becomes available is the subject of considerable interest among stakeholders including physicians, payers, and patients. The extent of the potential savings largely depends on whether and to what extent prices decline and use stays the same or even increases. These are also empirical questions since the likely spending implications following generic imatinib’s availability are predicated on multiple factors: physicians’ willingness to prescribe generic imatinib, molecule characteristics, and health system priorities. This article discusses each of these issues in turn and their implications for the development of country-specific cost-effectiveness models to predict the implications for cost and quality of care from generic imatinib. Finally, we present a US-specific empirical analysis of the potential impact of generic imatinib on the cost-effective treatment of incident chronic myeloid leukemia in chronic phase (CML-CP). In the year following generic entry in the USA, imatinib’s price is expected to drop 70–90 %. We hypothesized that initiating treatment with generic imatinib in these patients and then switching to the other tyrosine kinase inhibitors (TKIs) dasatinib or nilotinib because of intolerance or lack of effectiveness (i.e., “imatinib-first”) would be cost-effective compared to the current standard of care – “physician’s choice” of initiating treatment with any one of the 3 TKIs. We find that the imatinib-first ($277,401; 3.87 quality-adjusted life years, QALYs) strategy offered patients nearly equivalent benefit at a savings of $88,343 over 5 years to US payers compared to the physician’s choice strategy ($365,744; 3.97 QALYs). The imatinib-first incremental cost-effectiveness ratio was approximately $884,000/QALY. The results were robust to multiple sensitivity analyses. We conclude that when imatinib loses patent protection and its price declines in the USA, its use will be the cost-effective initial treatment strategy for CML-CP. We look forward to observing the actual responses of US and EU stakeholders to imatinib’s loss of patent exclusivity over the next several years.

Parts of this chapter have formerly been published within the journal Annals of Hematology in Volume 94, Issue 2, supplement, April 2015, “Chronic Myeloid Leukemia”, doi: 10.1007/s00277-015-2319-x.

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Acknowledgments

A panel of CML experts, all members of the European LeukemiaNet (ELN) CML Working Party, substantially contributed to the conception and execution of this chapter. The panel includes Jane F. Apperley, Michele Baccarani, Ekkehard Eigendorff, Francois Guilhot, Joelle Guilhot, Rudiger Hehlmann, Francois-Xavier Mahon, Giovanni Martinelli, Jiri Mayer, Martin C. Müller, Dietger Niederwieser, Susanne Saussele, Charles A. Schiffer, Richard T. Silver, and Bengt Simonsson.

Disclosures

The information reported in this manuscript was previously presented at the American Society of Hematology annual meeting, December 8, 2014, San Francisco, CA: Richard A. Larson, Rena M. Conti, William V. Padula, Jane F. Apperley, Michele Baccarani, Ekkehard Eigendorff, Francois Guilhot, Joelle Guilhot, Francois-Xavier Mahon, Giovanni Martinelli, Jiri Mayer, Martin C. Müller, Dietger Niederwieser, Susanne Saussele, Charles A. Schiffer, Richard T. Silver, Bengt Simonsson, and Rudiger Hehlmann. “What Is the Most Cost-Effective Strategy for Treating Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia (CML) after Imatinib Loses Patent Exclusivity?” Blood 2014; 124: [abstr 738]; and Padula WV, Larson RA, Conti RM. Is it cost-effective to start all new chronic phase CML patients on imatinib when it loses patent exclusivity? Miami, FL: Society of Medical Decision Making, 2014 Oct.

Parts of this chapter have been previously published as Conti RM, WV Padula, RA Larson. “Changing the cost of care for chronic myeloid leukemia: the availability of generic imatinib in the U.S. and the E.U.,” Annals of Hematology. 2015 Apr; 94 Suppl 2: S249–57. doi: 10.1007/s00277-015-2319-x. Epub 2015 Mar 27; and WV Padula et al. “Estimating the cost-effectiveness of tyrosine kinase inhibitor treatment strategies for newly diagnosed chronic myeloid leukemia in chronic phase following imatinib’s generic entry in the U.S.” Journal of the National Cancer Institute, in press, 2016.

The following sources of unrestricted funding are to be noted: A F32-HS023710 National Research Service Award from AHRQ supported WVP’s participation in this research. A K07-CA138906 award from the National Cancer Institute funded RMC’s participation in this research. AHRQ, NCI, the University of Chicago, nor any other organization is responsible for the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. RAL has been a consultant to and received honoraria from Ariad Pharmaceuticals, Bristol Myers Squibb, Novartis, and Pfizer. No financial support or proprietary information from the pharmaceutical industry was received for this work.

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  1. Departments of Pediatrics, Medicine and Public Health Sciences, Comprehensive Cancer Center, University of Chicago, Chicago, IL, USA

    Rena M. Conti PhD

  2. Department of Health Policy & Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA

    William V. Padula PhD

  3. Department of Medicine and the Comprehensive Cancer Center, University of Chicago, Chicago, IL, USA

    Richard A. Larson MD

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Correspondence to Rena M. Conti PhD .

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    Rüdiger Hehlmann

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Conti, R.M., Padula, W.V., Larson, R.A. (2016). Changing the Cost of Care for Chronic Myeloid Leukemia: The Availability of Generic Imatinib in the USA and the EU. In: Hehlmann, R. (eds) Chronic Myeloid Leukemia. Hematologic Malignancies. Springer, Cham. https://doi.org/10.1007/978-3-319-33198-0_15

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