Increasingly, Canadian payers and regulators find value in outcomes-based evidence beyond randomized controlled trials in regulatory and reimbursement decision-making through the utilization of real-world evidence (RWE). For example, last year, CDA[1] (previously CADTH) in association with Health Canada and INESSS, has produced guidance for regulatory and health technology assessment agencies to advance the integration of RWE in healthcare decision making; and payers continue to look to RWE for reimbursement decisions, all providing opportunities for RWE that did not exist years ago.
As these trends have taken shape, there are efforts to generate data from real-world settings through Patient Support Programs (PSPs) upon manufacturer and patient consent. This is exemplified by the ongoing “Real-World Readiness Framework for PSP Data” initiative led by CPHIN[2] which focuses on developing a framework for PSP data in Canada and validate its use cases with stakeholders, including CDA, to build confidence in PSP data as decision-grade RWE.
As the payer landscape gets more complex, there is also an increasing need to look at sources of real-world data that can supplement the PSP data to support reimbursement across the drug life cycle:
- Clinical data from provider-site electronic medical records or patient charts
- Claims data from payers (public or private)
- Patient-reported data from validated questionnaires
- Pharmacy dispensing data and wholesale data
- Patient registries
- Third-party health data sets (e.g. provincial health databases)
- Lab testing
- Digital data sources, including mobile healthcare apps and wearables
Despite the promise of data diversity and robustness, joining disparate sources into a unified aggregated data set can be challenging. Solving these challenges requires a data enrichment strategy that is able to aggregate the different types of RWE across the care ecosystem. For example, this could involve the analysis of prescriptions along with reporting of adverse events, or the analysis of adherence and its impact on long-term patient health outcomes. Linking together these sources helps manufacturers and providers alike to assemble a more holistic view of the patient and expand the set of questions that can be answered on overall value of treatments.
Another opportunity in data linkage comes from public sources, as the healthcare model itself creates new opportunities for analysis. Through this linkage to governmental datasets with information on health service utilization (such as physician visits), manufacturers can glean more insights that are invaluable to understand the patient journey.
While payers and regulators seek to facilitate the adoption of RWE, manufacturers are taking a leadership position in finding, generating, and contextualizing that evidence.
PSPs are an integral part of a complex patient journey – these programs focus on enhancing care for patients who are managing complex medical conditions that are treated with high-cost specialty drugs. They enrich existing information because of the enrollment/patient capture and multiple touchpoints with patients, which are all opportunities to collect data. PSPs also have direct communication with patients’ healthcare teams and physicians, payers, and caregivers, representing even more opportunities for data collection.
Successful commercialization strategies will incorporate real-world evidence across the product life cycle, and utilize data linkage to forecast and track outcomes over time. RWE will be critical in measuring and understanding the long-term impact of the disease, which in turn will help create a treatment roadmap and expedite the process to launching therapies across Canada.
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Disclaimer: The contents of this piece may contain marketing statements and do not include business or legal advice.
[1] Canada’s Drug Agency
[2] Canadian Personalized Healthcare Innovation Network, which Innomar Strategies is a member.
