Pulmonary hypertension (PH) patients no longer have to enroll in two Risk Evaluation and Mitigation Strategy (REMS) programs for ambrisentan. Thanks to the Pulmonary Hypertension Association (PHA)’s advocacy, the PS-Ambrisentan REMS Program will merge with the Ambrisentan REMS Program.

The merge will create one program that covers all ambrisentan manufacturers. The PS-Ambrisentan REMS program will close permanently Friday, May 29.

PHA has been working to streamline REMS standards since generic ambrisentan, used to treat pulmonary arterial hypertension (PAH), came on the market in early 2019. Manufacturers require REMS protocols, such as monthly blood tests, for drugs that could cause birth defects or liver or kidney damage.

As part of the Food and Drug Administration (FDA) approval process, the agency brought together the manufacturers, known as the Ambrisentan REMS Consortium, to create a shared safety protocol they would all follow. The manufacturers couldn’t agree whether the drug could be safely distributed to retail pharmacies or should be distributed only through specialty pharmacies, so the FDA allowed them to split and develop two separate REMS programs.

Health care providers were instructed to enroll patients in both programs in case a health insurance plan or specialty pharmacy switched from a generic manufacturer that worked with one REMS program to a manufacture that worked with the other.

Medical professionals immediately began to call PHA about how the programs were confusing and difficult to navigate. They said two separate programs caused so many problems that patients sometimes ended up going without medication for several days between refills.

After educating the medical and patient communities about the two programs, PHA surveyed medical professionals. The survey identified nine categories of problems patients faced as a result of the two systems.

Based on feedback from people with PH and health care providers, PHA identified seven recommendations to place patient safety back to the center of shared REMS programs. The top recommendation was to merge the Ambrisentan and PS-Ambrisentan REMS programs. PHA presented the recommendations last fall to the FDA and the Ambrisentan REMS Consortium.

“The goal of a REMS program is to allow access to a potentially risky therapy while still maximizing patient safety, said Katherine Kroner, PHA’s senior director of advocacy and treatment access. “What PHA saw was that having two REMS programs for ambrisentan was causing so much confusion that patients were actually at increased risk of therapy disruption. PHA is proud to have been a well-regarded, patient-centered voice in discussions that lead to these changes.”

In addition to convincing the manufacturers to consolidate the REMS programs, PHA’s advocacy prompted the Ambrisentan REMS Consortium to clarify when REMS allows physicians to override pregnancy test requirements. PHA also succeed in persuading the manufacturers to improve pharmacist and clinician education about the process.

PHA continues to advocate for REMS programs that prioritize patient safety. For more information about PHA’s Treatment Access Program, email us, or call 301-565-3004 x749.