Addressing REMS protocol challenges with the BrightInsight Disease Management Solution

Blog addressing rems protocol challenges with the brightinsight disease management solution

For many cancer patients—especially those living with blood cancers like leukemia—cell therapy has been a literal life saver. CAR-T therapy in particular has a demonstrated remission rate of 76%. Unfortunately, serious complications can arise in the wake of cell therapies like CAR-T, including cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).

Currently, all six FDA-approved CAR-T therapies require REMS protocol to ensure that the benefits of these treatments outweigh the risk of adverse events. And REMS protocols aren’t only required in cancer treatments.

There are 60 prescription drugs and biologics that currently require REMS protocol, representing a significant clinical and administrative burden to care providers and a lot of added stress on patients and caregivers.

"I felt overwhelmed," one caregiver says. "It was 30 days of 24/7 monitoring. My role as the caregiver was to monitor for neurotoxicity and take his temperature three times a day. We taped the printout the nurse had given us near his bed. I had to Google a lot of it. There was always some anxiety. I was the most worried about neurotoxicity. The doctors said it was irreversible with more long-term damage."

Because of the challenges in both adhering to complex REMS requirements and preventing serious complications, digital health solutions provide a unique opportunity for biopharma companies in this space to truly impact the patient experience while decreasing patient risk and encouraging adherence.

In our newest white paper, “Remote Patient Monitoring to simplify risk evaluation and mitigation strategy (REMS) protocols,” we outline the unique challenges in this use case and show how the BrightInsight Disease Management Solution can simplify REMS adherence and help detect symptoms of adverse events before the escalate.

We showcase the power of the Disease Management Solutions for REMS, with features including:

To learn more about REMS and the Disease Management Solution, read the white paper or visit our REMS monitoring page.

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