Chronic Myeloid Leukemia (CML)
RFP Issued: April 7, 2022
Applications Due to Novartis: May 9, 2022 by 5 PM EST
Notification of Grant Decisions: June 2022
Educational Programming Starts: Q3 2022
Chronic myeloid leukemia (CML) is a type of cancer affecting the blood-forming cells of the bone marrow with an incidence of 1.9 cases per 100,000 in the United States (US). In approximately 95% of CML cases, a balanced chromosomal translocation between chromosomes 9 and 22 results in a shortened chromosome 22 (called the Philadelphia chromosome) carrying the abnormal BCR-ABL1 fusion gene. While CML is typically diagnosed in the chronic phase (CML-CP), CML can progress into the accelerated phase (AP) and eventually the terminal state of blast crisis (BC) in approximately 5% of patients if effective medical intervention is not received.
The advent of small molecule tyrosine kinase inhibitors (TKIs) revolutionized the treatment landscape of this disease, particularly in patients with CP-CML, by prolonging the life of patients approaching a normal life expectancy with 10-year survival rates improving from about 20% to 80%-90%. For some patients with durable deep molecular responses, treatment free remission can be considered in selected settings. The TKIs currently available for management of CML are:
- the first-generation TKI imatinib
- the second-generation TKIs bosutinib dasatinib and nilotinib
- the third-generation TKI, ponatinib
Despite the availability of TKIs, there remains a remarkable proportion of the CML-CP population that is refractory/intolerant to these medications and therefore cycles through multiple lines of therapy. Sequential treatment with TKIs often leads to the development of mutations in the BCR-ABL1 gene, with the T315I mutation conferring resistance to all approved TKIs other than asciminib and ponatinib. Further complicating CML treatment is the lack of standard of care or treatment guidance from guidelines beyond the second line. As such, treatment failure is common and is associated with progressively poorer clinical outcomes, especially on or after third-line (3L) therapy. Moreover, even with treatment, some patients unfortunately develop refractory disease eventually progressing to advanced phases of the disease AP or BC which is associated with particularly poor clinical outcomes. For eligible patients with refractory or advanced disease, allogeneic hematopoietic stem cell transplantation (HSCT) may be recommended, but its high costs must be considered with its benefits.
Prior studies have also demonstrated higher healthcare resource utilization (HRU) and healthcare costs associated with treatment failure.
OGE has identified the need for innovative continuing medical education programs that strive to optimize patient outcomes through education on:
- Current and emerging treatment landscape in earlier and later line settings in CML
- Sequencing of treatments
- Potential issues prompting physicians to consider treatment switch from 2nd line (2L) to 3rd line (3L) therapy
- Current unmet medical needs (resistant mutations such as T315I) in CML patients in earlier and later lines of treatment
- Mechanism of action of CML treatments
- Healthcare resource utilization (HCRU) in CML patients in later lines of treatment
- Molecular monitoring/mutation testing, treatment milestones as recommended by the National Comprehensive Cancer Network (NCCN) guidelines and deep molecular response (DMR)/ Treatment free remission (TFR) for patients with CML
- How to manage adverse events, dose optimization and adherence to treatments to help optimize patient outcomes
OGE is seeking to support innovative and engaging programs including, but not limited to, the following:
- Community-based educational series of case-based programs held in community hospitals/institutions, hem/onc centers, along with an enduring component which may include decision-making tools for healthcare professionals to use with their patients
- Web based curriculum programs
Note: Program placement is independent of Novartis. Program placement should reflect nationwide distribution in locations in which patients with CML obtain treatment.
Primary geography of interest: United States (National, Regional, and/or Local)
Note: Applications for this RFP must be US focused for the audience, expert faculty, educational needs, and standards of care.
Healthcare providers who are involved in the care of patients with CML, including but not limited to: Community based Hematologists/Oncologists, Academic-based Hematologists/Oncologists, Pediatric Hematologists, Nurse Practitioners, Hem/Onc Nurses, Physician Assistants, Pharmacists, Payers
Educational providers should include target number of participants. Further, please include details on proposed audience recruitment.
Programs with a global reach are welcomed. Please clearly specify this in your proposal.
Please note: Novartis will not participate in the distribution of invitations to the CME/CE event.
Multiple single-support or multi-support initiatives may be funded; Up to 200 000 USD in total support is available for 2022.
If working with an Accredited Provider and/or Educational Partner, they should be listed in the Novartis grant application. Grant requests must be submitted by the Office of CME (if from an Academic Institution/Hospital) via the Online Portal by 5 PM EST on May 9, 2022 to be considered.
The grant application should include “RFP Response” within the Program Title [example: “RFP Response: Program Title”].
Proposals that include collaborations with third parties, including (but not limited to), community-based hospitals, medical societies, health education companies/centers, not-for-profit organizations, and academic institutions, are encouraged, as appropriate.