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Physician, Regulatory, and Payer Perspectives on the Value of Real-World Data

Surabhi Dangi-Garimella, PhD
One of the kickoff sessions on the first day of the 2017 American Society of Clinical Oncology Annual Meeting in Chicago, Illinois, was a lively discussion on ensuring that the data used to inform patient care and create healthcare policies holds value.
Alan Rosenberg, MD, vice president of clinical pharmacy and medical policy, Anthem, spoke about how payers view nonrandomized data when making coverage determinations.

“Quality, access, efficiency, equity remain challenges with healthcare in our country, compared with the rest of the world,” said Rosenberg. “This is a real issue for us as healthcare providers.”

He believes that the variation in care stems from socioeconomic and geographic differences. “However, a lot of this variation remains unexplained,” Rosenberg added. “We as payers, are aware of the origins in knowledge gap, and also understand the cost associated with running RCTs. But we do expect well-designed trials that provide significant outcomes.”

At the same time, we know that real-world adherence is much lower than RCT adherence. So, the number-needed-to-treat in RCTs is much higher, considering adherence issues.

Payers do consider non–clinical trial data when making coverage decisions and the process involves:
  • Examination of relevant peer-reviewed data, which are used with caveats
  • There’s recognition that there is significant difference in quality of non-clinical trial data
  • Recognition of the difference between quantum and small incremental results
  • Recognition of the difference between RCT and developing treatment for ultra-rare diseases
Rosenberg also emphasized that FDA approval is necessary but may not be sufficient for making coverage decisions.


 
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