What Happens When Imatinib Goes Generic?

Restricted access

Jean McDougall, PhD, MPH, is in the Pharmaceutical Outcomes Research and Policy Program at the University of Washington, and Hutchinson Institute for Cancer Outcomes Research, Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington. Trained in epidemiology and health economics, Dr. McDougall's research focuses on access to cancer care, including pretreatment genomic testing, the economics of targeted therapy, and participation in clinical trials. She is specifically interested in designing interventions to reduce the patient-level financial burden of cancer care. Dr. McDougall is a postdoctoral fellow in the Pharmaceutical Outcomes Research and Policy Program at the University of Washington and with the Hutchinson Institute for Cancer Outcomes Research at the Fred Hutchinson Cancer Research Center.

Scott D. Ramsey, MD, PhD, is a general internist and health economist. He is a Full Member in the Cancer Prevention Program, Public Health Sciences Division at the Fred Hutchinson Cancer Research Center, where he directs Hutchinson Institute for Cancer Outcomes Research, a multidisciplinary team devoted to clinical and economic evaluations of new and existing cancer prevention, screening, and treatment technologies. In addition, Dr. Ramsey is a Professor in the School of Medicine, School of Pharmacy, and the Institute for Public Health Genetics at the University of Washington. Trained in Medicine and economics, Dr. Ramsey's research focuses on economic evaluations in cancer. He has published widely on patterns of care, costs, and cost-effectiveness of treatments. His research portfolio and interests include large scale SEER-Medicare/Cancer Registry data linkages, patient-reported outcomes, economic modeling of health care interventions, and cost-effectiveness analysis, among others. Ongoing and recent research projects include an NCI study partnering with the Southwest Oncology Group to bring comparative effectiveness principles to cooperative group trials; examining bankruptcy among persons with cancer; and developing a genetic screening policy model for colorectal cancer. Dr. Ramsey is co-Chair of the Outcomes and Comparative Effectiveness Committee of the Southwest Oncology Group, past President of the International Society of Pharmacoeconomics and Outcomes Research (ISPOR), and has served on the IOM Cancer Policy Forum.

Jerald Radich, MD, is a member of the Clinical Research Division, the Director the Molecular Oncology Lab at the Fred Hutchinson Cancer Research Center, and Professor of Medicine at the University of Washington School of Medicine. He is Chair of the Leukemia Translational Medicine Committee of the Southwest Oncology Group, co-chair of the NCI/NIH Leukemia Steering Committee, and is on the Board of Scientific Counselors, NIH Genome Research Institute. He is the Chair of the NCCN Chronic Myelogenous Leukemia (CML) Panel, a member of the European LeukemiaNet CML committees, and is on the Scientific Board of the International CML Foundation and the Max Foundation. Dr. Radich's laboratory work centers on the molecular biology of response, resistance, and progression in adult and chronic leukemia

The ideas and viewpoints expressed in this editorial are those of the author and do not necessarily represent any policy, position, or program of NCCN.

  • 1.

    Jabbour E. Chronic myeloid leukemia: first-line drug of choice. Am J Hematol 2016;91:5966.

  • 2.

    SEER Stat Fact Sheets: Chronic Myeloid Leukemia (CML). NCI SEER Web site. Available at: http://seer.cancer.gov/statfacts/html/cmyl.html. Accessed January 22, 2016.

    • Search Google Scholar
    • Export Citation
  • 3.

    Gambacorti-Passerini C, Antolini L, Mahon FX. Multicenter independent assessment of outcomes in chronic myeloid leukemia patients treated with imatinib. J Natl Cancer Inst 2011;103:553561.

    • Search Google Scholar
    • Export Citation
  • 4.

    Ohanian M, Cortes J, Kantarjian H, Jabbour E. Tyrosine kinase inhibitors in acute and chronic leukemias. Expert Opin Pharmacother 2012;13:927938.

    • Search Google Scholar
    • Export Citation
  • 5.

    Zafar SY, Abernethy AP. Financial toxicity, part I: a new name for a growing problem. Oncology (Williston Park) 2013;27:8081, 149.

  • 6.

    Experts in Chronic Myeloid Leukemia. The price of drugs for chronic myeloid leukemia (CML) is a reflection of the unsustainable prices of cancer drugs: from the perspective of a large group of CML experts. Blood 2013;121:44394442.

    • Search Google Scholar
    • Export Citation
  • 7.

    Radich JP, Deininger M, Abboud CN. NCCN Clinical Practice Guidelines in Oncology: Chronic Myelogenous Leukemia. Version 1.2016. Available at: NCCN.org. Accessed January 22, 2016.

    • Search Google Scholar
    • Export Citation
  • 8.

    Baccarani M, Deininger MW, Rosti G. European LeukemiaNet recommendations for the management of chronic myeloid leukemia: 2013. Blood 2013;122:872884.

    • Search Google Scholar
    • Export Citation
  • 9.

    Druker BJ, Guilhot F, O'Brien SG. Five-year follow-up of patients receiving imatinib for chronic myeloid leukemia. N Engl J Med 2006;355:24082417.

    • Search Google Scholar
    • Export Citation
  • 10.

    Kantarjian HM, Talpaz M, O'Brien S. Survival benefit with imatinib mesylate versus interferon-alpha-based regimens in newly diagnosed chronic-phase chronic myelogenous leukemia. Blood 2006;108:18351840.

    • Search Google Scholar
    • Export Citation
  • 11.

    Kantarjian H, Shah NP, Hochhaus A. Dasatinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med 2010;362:22602270.

    • Search Google Scholar
    • Export Citation
  • 12.

    Radich JP, Kopecky KJ, Appelbaum FR. A randomized trial of dasatinib 100 mg versus imatinib 400 mg in newly diagnosed chronic-phase chronic myeloid leukemia. Blood 2012;120:38983905.

    • Search Google Scholar
    • Export Citation
  • 13.

    Saglio G, Kim DW, Issaragrisil S. Nilotinib versus imatinib for newly diagnosed chronic myeloid leukemia. N Engl J Med 2010;362:22512259.

  • 14.

    O'Brien SG, Guilhot F, Larson RA. Imatinib compared with interferon and low-dose cytarabine for newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med 2003;348:9941004.

    • Search Google Scholar
    • Export Citation
  • 15.

    le Coutre PD, Giles FJ, Hochhaus A. Nilotinib in patients with Ph+ chronic myeloid leukemia in accelerated phase following imatinib resistance or intolerance: 24-month follow-up results. Leukemia 2012;26:11891194.

    • Search Google Scholar
    • Export Citation
  • 16.

    Shah NP, Guilhot F, Cortes JE. Long-term outcome with dasatinib after imatinib failure in chronic-phase chronic myeloid leukemia: follow-up of a phase 3 study. Blood 2014;123:23172324.

    • Search Google Scholar
    • Export Citation
  • 17.

    Cortes JE, Kim DW, Pinilla-Ibarz J. A phase 2 trial of ponatinib in Philadelphia chromosome-positive leukemias. N Engl J Med 2013;369:17831796.

    • Search Google Scholar
    • Export Citation
  • 18.

    Gambacorti-Passerini C, Brummendorf TH, Kim DW. Bosutinib efficacy and safety in chronic phase chronic myeloid leukemia after imatinib resistance or intolerance: minimum 24-month follow-up. Am J Hematol 2014;89:732742.

    • Search Google Scholar
    • Export Citation
  • 19.

    Gambacorti-Passerini C, Kantarjian HM, Kim DW. Long-term efficacy and safety of bosutinib in patients with advanced leukemia following resistance/intolerance to imatinib and other tyrosine kinase inhibitors. Am J Hematol 2015;90:755768.

    • Search Google Scholar
    • Export Citation
  • 20.

    Jabbour E, Cortes J, Santos FP. Results of allogeneic hematopoietic stem cell transplantation for chronic myelogenous leukemia patients who failed tyrosine kinase inhibitors after developing BCR-ABL1 kinase domain mutations. Blood 2011;117:36413647.

    • Search Google Scholar
    • Export Citation
  • 21.

    Nicolini FE, Basak GW, Soverini S. Allogeneic stem cell transplantation for patients harboring T315I BCR-ABL mutated leukemias. Blood 2011;118:56975700.

    • Search Google Scholar
    • Export Citation
  • 22.

    Policy Summit: Value, Access, and Cost of Cancer Care. National Comprehensive Cancer Network Web site. Available at: http://www.nccn.org/professionals/meetings/oncology_policy_program/value_access_cost_cancer_care.aspx. Accessed January 12, 2016.

    • Search Google Scholar
    • Export Citation
  • 23.

    Li J, Asabere A, Kelly S. Application of ASCO value framework evaluations of net health benefit for oncology drugs launched in the United States between 2013 and 2015. Value Health 2015;18:A489.

    • Search Google Scholar
    • Export Citation
  • 24.

    Dusetzina SB, Winn AN, Abel GA. Cost sharing and adherence to tyrosine kinase inhibitors for patients with chronic myeloid leukemia. J Clin Oncol 2014;32:306311.

    • Search Google Scholar
    • Export Citation
  • 25.

    Ibrahim AR, Eliasson L, Apperley JF. Poor adherence is the main reason for loss of CCyR and imatinib failure for chronic myeloid leukemia patients on long-term therapy. Blood 2011;117:37333736.

    • Search Google Scholar
    • Export Citation
  • 26.

    Marin D, Bazeos A, Mahon FX. Adherence is the critical factor for achieving molecular responses in patients with chronic myeloid leukemia who achieve complete cytogenetic responses on imatinib. J Clin Oncol 2010;28:23812388.

    • Search Google Scholar
    • Export Citation
  • 27.

    Ganesan P, Sagar TG, Dubashi B. Nonadherence to imatinib adversely affects event free survival in chronic phase chronic myeloid leukemia. Am J Hematol 2011;86:471474.

    • Search Google Scholar
    • Export Citation
  • 28.

    Olson LM, Wendling BW. The effect of generic drug competition on generic drug prices during the Hatch-Waxman 180-day exclusivity period. Available at: https://www.ftc.gov/reports/estimating-effect-entry-generic-drug-prices-using-hatch-waxman-exclusivity. Accesssed January 12, 2016.

    • Search Google Scholar
    • Export Citation
  • 29.

    Simoens S. Interchangeability of off-patent medicines: a pharmacoeconomic perspective. Expert Rev Pharmacoecon Outcomes Res 2008;8:519521.

    • Search Google Scholar
    • Export Citation
  • 30.

    Novartis. Novartis settles patent litigation on Gleevec® (imatinib mesylate) with Sun Pharma subsidiary. 2014. Available at: https://www.novartis.com/news/media-releases/novartis-settles-patent-litigation-gleevec%C2%AE-imatinib-mesylate-sun-pharma. Accessed January 22, 2016.

    • Search Google Scholar
    • Export Citation
  • 31.

    Conti RM, Padula WV, Larson RA. Changing the cost of care for chronic myeloid leukemia: the availability of generic imatinib in the USA and the EU. Ann Hematol 2015;94(Suppl 2):S249257.

    • Search Google Scholar
    • Export Citation
All Time Past Year Past 30 Days
Abstract Views 0 0 0
Full Text Views 194 143 5
PDF Downloads 34 25 4
EPUB Downloads 0 0 0