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How one insurer is working with the FDA to ensure drug safety

Feb 22 2016
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Stocksy_txp1803d305NOW000_Medium_648071The Food and Drug Administration (FDA) is working to streamline its approval process. That can be good news for patients waiting for new and, they hope, better treatments. At the same time, a faster approval process will increase the importance of monitoring drug safety once a medication is in use.

Enter the Sentinel Initiative, a drug safety project from the FDA in collaboration with insurance companies. It allows the FDA to quickly receive information about safety problems that can be seen in insurance claims data so the FDA can determine if a medical treatment is worthy of further study. (Note that this information exchange strictly adheres to patient privacy regulations.)

Dr. Ed Pezalla, Aetna vice president for pharmaceutical policy and strategy, explains, “The big evolution at the FDA is what they call ‘accelerated pathways,’ where they have combined or streamlined the way that a drug is approved. So as the FDA balances the need to get therapies to patients faster, the FDA also wants to continue to get information on these drugs. The Sentinel Initiative enables the FDA to look at the safety issues very, very closely, even after the drug comes to market. So we work with the FDA and furnish data that helps them further analyze a drug’s safety and performance in actual use among much larger populations than any study.”

We look for patterns in our claims data. If people using the same medication arrived in an emergency department, a doctor’s office, or a hospital with a diagnosis that’s compatible with that sort of safety problem, then we make a note of it.

The FDA receives reports from doctors, patients, pharmacists, and others that an issue has been noted for a patient taking a particular medicine. If it is an issue they didn’t anticipate—or if they’re getting reports for a particular issue much more frequently than they expected—the FDA turns to Sentinel.

“We look for patterns in our claims data. If people using the same medication arrived in an emergency department, a doctor’s office, or a hospital with a diagnosis that’s compatible with that sort of safety problem, then we make a note of it,” Pezalla said.

The FDA does not see the actual Aetna data, or any identifiable data about Aetna members. What they receive is a direct answer to the question of whether the use of a specific pharmaceutical is associated with a given set of safety issues. With this analysis, the FDA makes a determination of whether  they are going to request a special study by the drug manufacturer on that issue.

“The Sentinel Initiative enables the FDA to look at the safety issues very, very closely, even after the drug comes to market.”