Medlior Health Outcomes Research’s work examining the treatment landscape for patients with Multiple Myeloma.
Introduction
Medlior Health Outcomes Research was engaged by Celgene Canada (now a subsidiary of Bristol-Myers Squibb Company) to examine the treatment landscape for patients with multiple myeloma (MM) and the effects of lenalidomide (REVLMID®) as an immunomodulatory imide drug for both newly-diagnosed MM patients and relapsed/refractory MM patients.
Celegene is a global biopharmaceutical company committed to improving the lives of patients worldwide. They seek to deliver innovative and life-changing treatments for patients.
“From the onset this project was exciting because we were able to examine the treatment landscape for patients with MM has been rapidly evolving, changing the course of MM from a disease with a very short life expectancy to a disease with improved response and survival rates.” said Tara Cowling, Direct and Managing Principal of Medlior Health Outcomes Research.
Challenges
“In recent years, the treatment landscape for patients with MM has been rapidly evolving, changing the course of MM from a disease with a very short life expectancy to a disease with improved response and survival rates,” said Cowling.
The use of autologous stem cell transplant (ASCT) in combination with proteasome inhibitors (PIs) and immunomodulatory imide drugs (IMiDs) as induction and consolidation/maintenance therapies has become an integral part of treatment for newly-diagnosed MM (NDMM) patients and resulted in improved progression-free survival and overall survival.
Lenalidomide (REVLMID®) is an IMiD agent that is indicated for both NDMM and relapsed/refractory MM (RRMM) patients, and is used in the maintenance setting; real-world evidence on the use of lenalidomide in NDMM and RRMM patients is sparse, although recent research using administrative health data from the United States suggest that lenalidomide is associated with high adherence in NDMM patients, as well as longer duration of treatment (DoT) and time-to-next-treatment (TTNT) compared to cyclophosphamide, when both are combined with bortezomib and dexamethasone.
The real-world treatment patterns, healthcare costs, and survival outcomes of these two cohorts (NDMM and RRMM patients) have not yet been examined in the Canadian setting. The Alberta treatment setting provides a unique opportunity to investigate these outcomes due to the province-wide health records with over 10 years of longitudinal data under a single health authority, Alberta Health Services. Alberta is Canada’s fourth largest province, providing universal healthcare coverage for over 4.3 million Albertans. Administrative data include province-wide inpatient, ambulatory care (including emergency department visits), pharmaceutical dispenses and laboratory services data (including cytogenetics data).
Solution
The “Identifying Outcomes in Real-World Multiple Myeloma” (INFORMM) Study identified n=1,729 NDMM patients in Alberta between the 2011-2016 fiscal years. Of these, n=1,377 patients were treated with myeloma therapy, and 24% of the treated patients received ASCT within the first year of diagnosis.
Among all treated patients, regardless of ASCT status, 742 (53.9%) patients advanced to second-line therapy, 341 (24.8%) advanced to third-line therapy, and 251 (18.2%) patients had ≥4 lines of therapy. Patients who received ASCT had longer mean DoT/TTNT in the line of therapy in which the ASCT was performed compared to non-ASCT patients. Those who received maintenance monotherapy had a longer mean DoT/TTNT than those who did not receive maintenance therapy. Following ASCT, the mean TTNT became comparable to non-ASCT patients in subsequent lines of therapy, regardless of whether patients were on maintenance monotherapy.
Healthcare utilization rates and costs were higher in ASCT patients compared to non-ASCT patients, likely due to the ASCT procedure itself. Within ASCT patients, there were no significant differences in healthcare utilization rates or costs when comparing those who received maintenance monotherapy compared to those who did not. Lastly, results from the survival analyses showed a significant decrease in one-year mortality (or increase in one-year survival) in the later years of the overall study cohort (2006-2015) compared to the years prior to the introduction of novel agents (1998-2005).
“This study demonstrated the real-world treatment patterns, healthcare utilization and survival in MM patients in Alberta. There were some differences noted between real-world practice and clinical trials/treatment guidelines, particularly in the use of maintenance monotherapy,” said Cowling.
As an independent, community-based research organization, Medlior is able to conduct ethically-approved research studies using administrative health data available through Alberta Health. The INFORMM study leveraged province-wide data on health services (inpatient hospitalizations, ambulatory care, physician visits), and the Pharmaceutical Information Network database that collects data on dispenses from all community pharmacies, including the Tom Baker Cancer Centre pharmacy. This study also used province-wide lab data, capturing information on bone marrow biopsies and cytogenetics results from fluorescence in situ hybridization tests, data that are not commonly available in administrative health studies.
Result
Results from the INFORMM study have been presented at multiple different scientific conferences and include authorship from all collaborators, including clinical advisors from the Tom Baker Cancer Centre, Dr. Jason Tay and Dr. Victor Jiminez-Zepeda, and the Celgene project lead, Fei Fei Liu. The study methodology was presented at the 2019 CADTH Symposium, while early mortality results were published online from the 2019 ASCO Annual Meeting and treatment landscape results were presented at the 25th EHA Congress (2019).
“Our results have demonstrated the real-world use of lenalidomide in the treatment of NDMM patients in Alberta as front-line therapy, as well as maintenance therapy in ASCT patients,” said Cowling.
Medlior’s multidisciplinary team is looking forward to offering valuable insights to a myriad of projects in 2020. With our expertise stemming from roles in health systems, academia and industry, we can bring value through our robust research methodology to any project. Contact us today to see how we can help you!
References
The following publications were associated with this research study (Medlior co-authors bolded):
- Jimenez-Zepeda VH, Chen G, Cowling T, Shaw E, Farris MS, Liu FF, Tay J. Multiple Myeloma Treatment Landscape from 2011 to 2017 in Alberta, Canada: Results from the Population-Based “Identifying Outcomes in Real-World Multiple Myeloma” (INFORMM) Study. Presented at the 24th Congress of the European Hematology Association (EHA); June 13–16, 2019; Amsterdam, Netherlands.
- Tay J, Chen G, Cowling T, Shaw E, Farris MS, Liu FF, Jimenez-Zepeda VH. Early mortality following diagnosis of multiple myeloma from 2011 to 2016 in Alberta, Canada: Initial results from the population-based Identifying Outcomes in Real-World Multiple Myeloma (INFORMM) study. Accepted for the 2019 ASCO Annual Meeting. J Clin Oncol 37, 2019 (suppl; abstr e19509)
- Shaw E, Liu F, Tay J, Jimenez-Zepeda VH, Chen G. Identifying Outcomes in Real-World Multiple Myeloma (INFORMM): Insights in Methodology for Using Administrative Health Data in Alberta. Presented at the 2019 CADTH Symposium; April 14–16, 2019; Edmonton, AB, Canada.
- Farris M, White K, Liu FF, Cowling T. A Rapid Literature Review of Real-World Evidence in Multiple Myeloma: Patient Characteristics and Health Outcomes. Presented at ISPOR Europe 2018, November 2018; Barcelona, Spain.
