US FDA Seeking More ‘Open Access’ To Real World Data From Payers

Agency is paying “enormous sums” to access postmarket information from payers, Commissioner Gottlieb says, suggesting public-private partnerships to enhance access.

FDA is hoping payers will “do more” to share data on real-world outcomes of drugs, including cancer drugs, Commissioner Scott Gottlieb says.

The agency needs “help from industry, especially the payers, who sit on mountains of data that can inform the sort of real-world evidence that we’re increasingly dependent on as part of our post-market work,” Gottlieb told the National Comprehensive Cancer Care Network policy conference June 25.

FDA has “a real interest in seeing payers share more post-market data on long-term patient outcomes in oncology patients, and especially adverse effects associated with targeted drugs, including checkpoint inhibitors,” he explained.

Better access to the data will aid developers in bringing new therapies to market, inform FDA’s pre- and post-market efforts and help patients and provider assess benefit and risk of treatments, he said.

“As development costs and timelines fall, we should expect more products, even in oncology, to compete based on price and value,” Gottlieb noted.“Better postmarket assessment is a key to this competition. And so, I’d ask the broader community, don’t just criticize. Put your data where your arguments are. Let’s look for new ways to collaborate around these post-market efforts.”

He complained that the data is often very expensive to source from payers.

“A lot of this data remains in silos controlled by the payers,” Gottlieb said. “It’s sold at high prices.” But “this data can help inform our view of the long-term outcomes that some in the payer community say FDA isn’t doing enough to demand from drug makers.”

Gottlieb’s comments reflect the agency’s emphasis on the use of real-world data to supplement drug regulation and advance patient care. (Also see "Real-World Data Could Get Boost From Trial Replication Project" - Pink Sheet, 26 Apr, 2018.) He noted the information also helps advance value-based contracting.

“The speed of advance, particularly in immunotherapies, across a wide range of tumor types and combination treatment approaches, each with a different profile of adverse events has created a need for reliable databases for optimizing patient outcomes and minimizing safety risks. These are systems that no single provider, manufacturer, or insurer can create alone.”

Public-Private Partnerships

He suggested payers consider new partnerships with government to facilitate access.

“More public-private collaboration to share outcomes data from electronic health records and other real-world sources, such as claims data for tracking adverse events, could provide all stakeholders with information needed to advance the standard of care,” Gottlieb said.

“It could allow payers to better relate price to value, including from reduced hospitalizations, physician visits, or other impacts on health care costs and patients’ quality of life.”

“Right now, FDA pays enormous sums of money to payers for access to just a fraction of this kind of postmarket information,” he pointed out.

FDA’s 10 year-old Sentinel postmarket surveillance system involves a public-private partnership with several payers. And the Reagan-Udall Foundation for FDA’s Innovation in Medical Evidence Development and Surveillance program enables stakeholders outside the agency to tap the Sentinel network. (Also see "Lilly's Olumiant Resubmission Includes Safety Data From US FDA's Sentinel Network" - Pink Sheet, 22 Feb, 2018.)