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Frequently Asked Questions
Q1) What is the purpose of the CML Alliance program?A1) The purpose of CML Alliance is to help healthcare providers who treat Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) and their patients to fully optimize CML therapy. Q2) Why is the program called CML Alliance?A2) Novartis sees the program as a true alliance between healthcare providers, patients, and Novartis, dedicated to optimizing therapy in all Ph+ CML patients worldwide. Q3) Specifically what services are provided through the program?A3) CML Alliance is a global program that provides CML resources and services to physicians and Ph+ CML patients and is customized in each country in which it is offered. The CML Alliance resources provided in each country vary depending on local legal and regulatory specifications. For specific CML Alliance information and services available in each country, please contact your local Novartis organization. CML Alliance is an integrated program that builds on support and educational materials that Novartis has provided to healthcare professionals and patients over the years. For healthcare professionals, the CML Alliance program aims to provide or facilitate access to:
For patients, the CML Alliance program aims to provide or facilitate access to:
Q4) Is the program only for patients receiving Glivec?A4) Depending on local rules and regulations in each country, CML Alliance is available to all patients with Ph+CML or just those on Glivec. Q5) Why is Novartis initiating this program now?A5) CML Alliance is an integrated program that builds on the support and educational materials that Novartis has provided to healthcare professionals and patients over the years. CML Alliance aims to offer healthcare professionals and patients a wealth of resources, including patient education, standardized molecular testing, access to reimbursement support services and information on clinical trials with investigational agents and existing therapies in CML. CML Alliance is part of a broad effort by Novartis to help physicians achieve the best possible outcomes for their Ph+ CML patients receiving targeted therapy. Q6) Where is CML Alliance being offered?A6) CML Alliance is a global healthcare professional and Ph+ CML patient support program—the US is the first country in which it is being implemented. CML Alliance is customized to best meet the needs and regulatory and legal requirements of each country. Q7) Aren’t a lot of the services offered through CML Alliance already available?A7) Some of the program elements were previously available. Novartis believes that the best way to optimize therapy in all CML patients worldwide is to provide these CML resources and services as part of a single, integrated CML Alliance program. Q8) What about patient confidentiality?A8) CML Alliance fully complies with all privacy and confidentiality regulations of the countries in which it is implemented. For example, in the US, CML Alliance complies with all HIPAA regulations. Q9) Are there any costs associated with enrolling in CML Alliance?A9) No. There are no costs associated with enrolling in the CML Alliance. Q10) How can Ph+CML patients and their healthcare providers find out more about CML Alliance or enroll in it?A10) For general information about the program, please visit the global CML Alliance website at CMLAlliance.net. For specific enrollment into the program, please contact your local Novartis office. Enrollment in CML Alliance is voluntary. Healthcare providers and patients are under no obligation to enroll or maintain their participation in the program. Q11) What is the issue with nonadherence?A11) Targeted oral therapies such as Glivec (imatinib) are relatively new in oncology—and it has only recently begun to be recognized that adherence to therapy may be an issue with targeted oral oncology drugs. A large study of adherence to oral cancer medication was conducted with Glivec.1 This study showed that:
In another study, it was shown that patients may overestimate their adherence to oral cancer therapies by a factor of 2 in discussions with their physicians.2 This may be an even more significant issue in diseases where many patients on therapy never had, or no longer experience any overt symptoms of their disease and may, over time, forget how important it is to take their therapy exactly as prescribed. Q12) Why measure molecular response in patients with Ph+ CML?A12) Ph+CML patients treated with Glivec as first-line therapy tend to achieve high overall rates of complete hematologic and cytogenetic response.3 The degree of Glivec efficacy was therefore explored by measuring trace levels of Bcr-Abl transcripts4(molecular response) to assess whether a patient with Ph+ CML has achieved or is trending towards a desired response to therapy and to ensure that a patient’s treatment is optimized over time. Molecular response has been found to correlate with both cytogenetic response5,6 and long-term progression-free survival.7,8 In the IRIS trial, 53% of Ph+ CML patients who had complete cytogenetic response achieved major molecular response after one year on Glivec and at 4 years, 80% of these patients had reached this milestone.9 Q13) How is molecular response to Ph+ CML therapy tested?A13) The best way to assess whether a patient has achieved and is maintaining a molecular response is by “real-time” quantitative polymerase chain reaction (RQ-PCR).10 However, currently results can differ considerably between labs, making interpretation and practical application difficult. Q14) How does the CML Alliance plan to test molecular response?A14) For specific information and services available in each country, please contact your local Novartis organization. Where permissible under local laws and regulations, CML Alliance will offer PCR testing in certified laboratories with significant expertise in PCR, based on a standardized molecular monitoring and reporting standards for PCR testing so that physician can have access to consistent and easily interpretable PCR results for better management of Ph+ CML patients. Q15) Are these tests available globally as part of this program?A15) CML Alliance is a global program that will be customized to best meet the needs and regulatory and legal requirements of each country. References
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See European Summary of Product Characteristics Glivec® 100 mg film coated tablets (PDF) Glivec® 400 mg film coated tablets (PDF) Glivec® 50 mg capsules, hard (PDF) Glivec® 100 mg capsules, hard (PDF)
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