REMS Program Supports Use of Mavacamten in Obstructive Hypertrophic Cardiomyopathy

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Key Takeaways

Mavacamten is approved for treating obstructive hypertrophic cardiomyopathy, with real-world data supporting its safety and efficacy.
The REMS program is crucial for monitoring mavacamten's safety post-approval, ensuring comprehensive follow-up beyond standard labeling.
Initial challenges in REMS implementation included educating providers and patients, but larger HCM centers have developed effective processes.
Over time, REMS has become standard practice for centers frequently using mavacamten, indicating successful integration into clinical workflows.

The implementation of a risk evaluation mitigation strategy (REMS) program to monitor patients on mavacamten further supports its real-world use, according to Milind Desai, MD, Cleveland Clinic.

The FDA approved mavacamten (Camzyos), a cardiac myosin inhibitor, for the treatment of adult patients with New York Heart Association class II to III obstructive hypertrophic cardiomyopathy (HCM) in 2022. Milind Desai, MD, MBA, Cleveland Clinic, reported on the drug’s safety profile and efficacy at this year’s American Heart Association (AHA) Scientific Sessions. At present, he was able to speak to the real-world, 22-month data on mavacamten and the role of a risk evaluation and mitigation strategy (REMS) program for monitoring patients.

Desai discussed in more detail the process of implementing the REMS program, which their findings suggest was a valuable tool in assessing the benefits of mavacamten and its ability to improve patients’ functional lung capacity and other associated disease symptoms.

This transcript has been lightly edited for clarity and length.

Transcript

What have been the main challenges or successes in implementing the REMS monitoring for patients on mavacamten, and how has it influenced the overall safety profile in real-world use?

So the REMS program, or the risk evaluation mitigation strategy program, is something that the FDA mandates in situations where they want to ensure safety of a new drug in a postapproval phase when it is marketed to a broader audience, a broader group of patients. They want to emphasize that there is convincing follow-up in terms of beyond what a package insert can offer, so clearly, not every drug gets the REMS labeling, and not every provider is well-versed with the REMS program.

So the biggest initial challenge was [providers asking,] “What is it? How do we incorporate that in our practice? How do we operationalize this? How do we explain it to the patients?” in addition to all the challenges that come with launching or rather trialing a new drug. I think those were the initial challenges. Most places, most larger HCM centers, have learned to develop the robust processes that work in terms of implementing the REMS program, including working with the specialty pharmacies, including making the patients understand, and including making themselves—the providers, as well as their teams—understand. So, I think it was a major, steep learning curve. And pretty much the ones that use mavacamten frequently have gotten used to it, and, to use a golfing term now, it's pretty much par for the course in a lot of places.