Oncologists’ evolving perspectives on real-world evidence: Findings from Oncology Insights

The use of real-world evidence (RWE) among pharmaceutical companies, payers, regulators and clinicians has significantly expanded over the past several years. Driven in large part by the passage of the 21^st Century Cures act in 2016 – which required the FDA to incorporate RWE in drug and device applications – RWE is now being widely used in regulatory submissions and increasingly, providers are being asked to provide RWE data in value-based reimbursement models such as the Oncology Care Model. However, questions still exist about the degree to which oncologists are using RWE in their treatment decisions.

In the first edition of Oncology Insights – a series of research-based reports sponsored by Cardinal Health Specialty Solutions – published in 2017, oncologists were surveyed to determine their attitudes on RWE. In the latest edition, oncologists were again asked for their perspectives on this topic. Although oncologists’ views on the importance of RWE has remained consistent, the findings indicate providers remain somewhat skeptical and its use and adoption are still somewhat limited. Here are some of the key viewpoints shared by more than 170 oncologists nationwide.

Overall, more than two-thirds of oncologists surveyed said RWE is necessary to inform treatment decisions due to the limitations of clinical trials, consistent with the results of the 2017 survey. However, when presented with a broad definition, less than half of participating oncologists could correctly identify evidence gained outside of a clinical trial as RWE.

Additionally, when given a list of data sources including health insurance data bases, patient-powered research networks and social media, less than one-third of oncologists correctly recognized these sources as RWE.

Participating oncologists indicated that RWE is widely used to inform treatment decisions, with more than 60 percent indicating that is being used to inform decision-making at least “somewhat frequently.” Less than one in ten respondents indicated that they are not using RWE. The use of RWE has grown significantly since 2017, when many participating oncologists admitted to being unsure of its value and RWE data was being consumed at a low level.

Despite broader usage and acceptance, RWE is primarily being used only for select patient populations underrepresented in clinical trials. Oncologists said they are primarily using RWE to influence treatment decisions for elderly patients and poor performance status patients. Furthermore, only 15 percent of respondents said RWE is used to inform most or all treatment decisions, and 14 percent find no value in using RWE for decision-making.

Interestingly, responses indicated that RWE might be used more often than oncologists realize. More than 60 percent said that they often begin poor performance status patients at chemotherapy doses lower than the FDA recommended dose. This finding indicates that many oncologists are incorporating observational data into treatment decision-making without recognizing it as RWE. Overall, the report’s findings indicate that some skepticism about RWE persists.

While oncologists may be cautious when it comes to using RWE in practice, their fluency with RWE will likely grow over time, as RWE becomes more prominent in product approvals and gains importance in value-based reimbursement models.

Former FDA commissioner Scott Gottlieb recently commented that the use of RWE in drug approvals is at an “inflection point” and will accelerate rapidly, because the agency now has both financial and regulatory obligations to demonstrate they are using practical data to answer regulatory questions.

RWE data is also being heavily used in value-based contract design. Among the life science companies that participated in Deloitte’s 2018 RWE Benchmarking Survey, 65 percent are using RWE in value-based contract design and support and the vast majority of respondents believe their organizations will increase the use of value-based contracts over the next 2-3 years.

The increasing use of RWE to demonstrate the effectiveness of a drug will likely influence oncology care in several ways. Real-world data that shows a treatment’s long-term cost and its ability to improve outcomes may be used in formulary placement decisions. Payers are also beginning to use this data to inform coverage decisions and price negotiations. Additionally, RWE may be used to develop guidelines and decision support frameworks in clinical practice.

Given that RWE is being adopted more broadly by key stakeholder groups, a deeper understanding of how this data is collected and wider use in clinical decision making will not only benefit oncologists in the future, but also enable them to provide more efficient and effective care for their patients.

For additional findings about how oncologists are using RWE, as well as research on the value of oncologists’ interactions with pharmaceutical companies, download a copy of the full report here.