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CONTINUING EDUCATION PROGRAM P10057 • RELEASE DATE: SEPTEMBER 15, 2010 • EXPIRATION DATE: SEPTEMBER 15, 2011 ESTIMATED TIME TO COMPLETE: 1.0 HOUR
ASCO 2010 Update on Chronic Myelogenous Leukemia: Payers’ and Providers’ Perspectives TARGET AUDIENCE
This activity was developed for pharmacists and other healthcare professionals. LEARNING OBJECTIVES
Upon completion of this activity, participants will be able to: • Explain the impact of key data from ASCO 2010 on payers and providers regarding chronic myelogenous leukemia (CML) • Assess potential clinical, business, and regulatory changes in CML • Discuss patient-centered, value-based care for CML
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istorically, payers have not been important participants in oncology drug utilization. As oncology costs have escalated, however, payer involvement in oncology drug management has increased. Reimbursement and coverage models are emerging to grapple with the massive financial burden associated with oncology treatment. Payers have become coparticipants with providers, and recent experience has shown that these two stakeholder groups can be poles apart in their strategic goals. A meaningful dialogue between payers and providers will occur if payers recognize provider management strategies that provide optimal outcomes. Complex issues comprise the basis for provider clinical approaches, including an understanding of the disease state, pharmacotherapeutic options, clinical objective options, adherence to guidelines, and regulatory issues. Alignment of goals—clinical and monetary—is essential for oncology care to achieve the progress made possible by the impressive advancements in therapy, and to provide patients with value-based treatments that balance cost, quality, and access.
Advances in Ph+ CML Approximately 0.6 to two cases of Philadelphia chromosome–positive chronic myelogenous leukemia (Ph+ CML) are diagnosed globally per 100,000 persons each year. In the United States, 1.5 cases per 100,000 persons are diagnosed annually.1,2 Historically, chemotherapy with alkylating agents and hydroxyurea provided a median survival of only 3 to 4 years.3 Median survival improved to 6 to 7 years in the early 1980s with the advent of interferon-alpha, but 10-year survival rates were still only between 30% and 40%, and patients had few options after the failure of first-line therapy.
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The introduction of imatinib, a selective BCR-ABL tyrosine kinase inhibitor (TKI), has revolutionized management strategies for patients with chronicphase CML.4,5 By 2007, the annual mortality rate decreased to approximately 1% to 2%, and the estimated 5-year survival rate increased to approximately 90%.2,3 This translates to an increasing disease prevalence that may exceed 200,000 cases within the next 20 years. With a median age of 65 years at diagnosis, providing treatment that maintains quality of life and valued productivity is of major concern. Optimal response and standard of care Much has been learned regarding accepted first-line therapy response milestones and the timing of those responses in patients with chronicphase CML since the introduction of imatinib to clinical practice in 2001. A key CML treatment strategy is to quickly, and as completely as possible, eradicate cells harboring the Philadelphia chromosome, thus avoiding or delaying the development of mutations in the BCR-ABL gene that result in imatinib resistance. Patients with CML who have suboptimal or no response to treatment are far more likely to experience early disease progression to advanced phase or blast crisis, in which long-term responses to TKIs are unlikely to occur.6 In the International Randomised Study of Interferon versus STI571 (IRIS), 98% of patients who had achieved a complete cytogenetic response (CCyR) and major molecular PHARMACISTS DESIGNATION
Medical Learning Institute, Inc., is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Completion of this activity provides for 1.0 contact hour (0.1 CEU) of continuing education credit. The universal activity number for this activity is 468-999910-045-H01-P. INSTRUCTIONS FOR CREDIT
1. Read the article in its entirety 2. Log on to www.TheOncologyPharmacist.com 3. Select “Continuing Education” 4. Click on this article’s title from the list shown 5. Select “Click here to complete the posttest and obtain a CE certificate online” 6. Complete and submit the CE posttest and CE Activity Evaluation 7. Print your Statement of Completion
response (MMR) by 12 months were free from progression to advanced phase or blast crisis at 4 years compared with 90% of patients who achieved CCyR without MMR by 12 months and 75% of patients who did not achieve CCyR by 12 months.7 Another significant piece of evidence from the IRIS trial came from the 8-year follow-up (Figure 1).8 By year 8, patients responding to imatinib had a low overall risk of progression to advanced phase or blast crisis.8 As seen in Figure 1, imatinib was effective in preventing risk of prospective progression events but not loss of response or progression events that occur early (within years 1-4). A large proportion of patients who fail to achieve adequate or optimal response to first-line imatinib harbor resistance-conferring BCR-ABL mutations.9,10 Therefore, to improve longterm outcomes, treatment strategies should be more contingent on prompt and early optimal response than on the identification of patients who develop resistance and relapse. Second-generation TKIs designed to overcome imatinib resistance include nilotinib, dasatinib, bosutinib, and others.11 Although these agents have proved to be effective second-line or “salvage” options, patients already harboring BCR-ABL mutations have been shown to have an increased likelihood of relapse, as a result of the development of additional mutations.12 Because the goals of first-line therapy should include preventing the emergence of therapy resistance and providing the best possible option for longThis activity is provided free of charge to participants. Upon completion of the evaluation and scoring 70% or better on the posttest, you will immediately receive your certificate online. If you do not achieve a score of 70% or better on the posttest, you will be asked to take it again. Please retain a copy of the certificate for your records. FACULTY DISCLOSURES
Before the activity, all faculty will disclose the existence of any financial interest and/or relationship(s) they might have with the manufacturer(s) of any commercial product(s) to be discussed during their presentation(s): honoraria, expenses, grants, consulting roles, speaker’s bureau membership, stock ownership, or other special relationships. Presenters will inform participants of any off-label discussions. The associates of Medical Learning Institute, Inc., and Center of Excellence Media, LLC, have no financial relationships to disclose. Michael Mauro, MD, has received research grants
term survival, researchers have hypothesized that early diagnosis of CML, paired with immediate treatment with more potent TKIs, may improve the rate of early CCyR and further MMR (3-log reduction in BCR-ABL transcripts below standard baseline), and thus improve long-term outcomes in patients with CML. Key presentations on CML at ASCO 2010 The 2010 American Society of Clinical Oncology (ASCO) annual meeting provides the perfect forum for the discussion of emerging data that affect patient outcomes and treatment strategies, as well as the changing paradigm of standard of care. This article provides a review of several key presentations that may provide the basis for future decisions and policies as more agents become available for the treatment of CML. First-line treatment strategies: nilotinib The Evaluating Nilotinib Efficacy and Safety in Clinical Trials of Newly Ph+ CML Patients (ENESTnd) trial is a global, multicenter, randomized, phase 3 trial comparing nilotinib 300 mg twice daily and 400 mg twice daily with imatinib 400 mg/day as first-line therapy in newly diagnosed patients with chronic-phase CML (N = 846).13,14 Patients were stratified by the Sokal risk score, with 28% of patients in each arm in the high-risk category.15 The primary end point is the MMR rate at 12 months, and a key secondary end point is the durability of from, and is a consultant to, Bristol-Myers Squibb and Novartis Oncology. Gary M. Owens, MD, is a consultant to Auxilium, Genzyme, GlaxoSmithKline, and Eli Lilly and Company. DISCLAIMER
The information provided in this CE activity is for continuing education purposes only and is not meant to substitute for the independent medical judgment of a healthcare provider relative to diagnostic and treatment options of a specific patient’s medical condition. SPONSOR
This activity is jointly sponsored by Medical Learning Institute, Inc., a nonprofit medical accreditation company, and Center of Excellence Media, LLC. COMMERCIAL SUPPORT ACKNOWLEDGMENT
This activity is supported by an educational grant from Novartis Pharmaceuticals.
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