ASCOT: A Case Study in Generating Timely and Meaningful Canadian Real-World Evidence To Support the Data Infrastructure Necessary for Innovative Patient Access
Author(s)
Rana Qadeer, MSc1, Iqra Syed, MSc1, YongJin Kim, PhD1, Amyn Sayani, MSc, PhD1, Eon Ting, MBA, MSc1, Allison Wills, MA2, Winson Cheung, MD, MPH3;
1AstraZeneca Canada, Mississauga, ON, Canada, 220Sense, Toronto, ON, Canada, 3University of Calgary, Oncology Outcomes, Calgary, AB, Canada
1AstraZeneca Canada, Mississauga, ON, Canada, 220Sense, Toronto, ON, Canada, 3University of Calgary, Oncology Outcomes, Calgary, AB, Canada
Presentation Documents
OBJECTIVES: In recent years, healthcare systems stakeholders have been investigating the use of outcomes-based agreements (OBAs) to accelerate timely access to innovative therapeutics. However, potential barriers have prevented the adoption of OBAs, including the effective use of real-world data/evidence (RWD/E), alignment on relevant outcomes, and the necessary data infrastructure to report outcomes on a regular basis. This case study provides a practical demonstration to show that RWD/E can be leveraged to support OBAs.
METHODS: Using RWD from Alberta Health Services, a retrospective observational study was conducted (ASCOT study) with the following objectives: to understand the patient characteristics, real-world treatment patterns, and clinical outcomes of patients with extensive stage-small cell lung cancer (ES-SCLC) receiving durvalumab between July 2021 and July 2022, and to assess the feasibility of current data infrastructure in Alberta to support future OBAs. A series of quarterly retrospective analyses were conducted, reporting on demographic/clinical characteristics and outcomes that could potentially be suitable for an OBA. A steering committee was also established to support data evaluation, ensure relevance of elements in quarterly reports, and understand opportunities/challenges of OBA RWD implementation.
RESULTS: 63 patients diagnosed with ES-SCLC who received durvalumab were followed (median follow-up: 11.3 months (95% confidence interval [CI]: 5.6-19.1). Quarterly reports were feasible to generate and assessed patient numbers continuing treatment, demographic/clinical characteristics, and meaningful outcomes including discontinuation rates, reasons for discontinuations, time to next treatment/death (TTNT-D), and overall survival (OS). Aligned with the CASPIAN clinical trial, median OS was 11.3 months (95% CI: 8.5-14.6]) and TTNT-D was 8.2 months (95% CI: 6.1-9.3).
CONCLUSIONS: Although there are challenges (e.g., early inclusion of payers and patients, need for appropriate infrastructure/process), this practical case study demonstrates that RWD can provide timely and meaningful reports to support innovative access pathways, such as OBAs, for select drugs/indications in appropriate situations.
METHODS: Using RWD from Alberta Health Services, a retrospective observational study was conducted (ASCOT study) with the following objectives: to understand the patient characteristics, real-world treatment patterns, and clinical outcomes of patients with extensive stage-small cell lung cancer (ES-SCLC) receiving durvalumab between July 2021 and July 2022, and to assess the feasibility of current data infrastructure in Alberta to support future OBAs. A series of quarterly retrospective analyses were conducted, reporting on demographic/clinical characteristics and outcomes that could potentially be suitable for an OBA. A steering committee was also established to support data evaluation, ensure relevance of elements in quarterly reports, and understand opportunities/challenges of OBA RWD implementation.
RESULTS: 63 patients diagnosed with ES-SCLC who received durvalumab were followed (median follow-up: 11.3 months (95% confidence interval [CI]: 5.6-19.1). Quarterly reports were feasible to generate and assessed patient numbers continuing treatment, demographic/clinical characteristics, and meaningful outcomes including discontinuation rates, reasons for discontinuations, time to next treatment/death (TTNT-D), and overall survival (OS). Aligned with the CASPIAN clinical trial, median OS was 11.3 months (95% CI: 8.5-14.6]) and TTNT-D was 8.2 months (95% CI: 6.1-9.3).
CONCLUSIONS: Although there are challenges (e.g., early inclusion of payers and patients, need for appropriate infrastructure/process), this practical case study demonstrates that RWD can provide timely and meaningful reports to support innovative access pathways, such as OBAs, for select drugs/indications in appropriate situations.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
RWD164
Topic
Real World Data & Information Systems
Disease
SDC: Oncology