PHA Advocacy Makes REMS Program Safer and Easier

When generic ambrisentan became available in 2019, the Food and Drug Administration (FDA) allowed the Ambrisentan REMS Consortium to create two Risk Evaluation and Mitigation Strategy (REMS) programs. Patients had to enroll in both programs in case their health insurance or specialty pharmacy switched manufacturers.

Health care professionals soon started telling the Pulmonary Hypertension Association (PHA) that the programs were confusing and difficult to navigate.

“The existence of two Ambrisentan REMS program resulted in shipment delays, confusion and extra bureaucracy that not only exponentially increased the burden on PH clinical staff, but ultimately prevented timely patient access to medical therapy,” said Juliana Liu, R.N., M.S.N., ANP-c, of the Stanford Pulmonary Hypertension Program.

PHA began working to streamline the standards to improve patient safety. Based on feedback from people with pulmonary hypertension (PH) and health care providers, PHA presented seven recommendations to the FDA and the manufacturers consortium. The top recommendation was to merge the two REMS programs to cover all ambrisentan manufacturers.

Juliana, who had a leading role in crafting and presenting PHA’s REMS recommendations, said the merger, which was approved and completed in spring 2020, was the best outcome the PH community could have hoped for. “With this merge, we know that the work of the clinical staff at the PH centers will greatly decrease, and as a result, access to care will become easier and ultimately prevent needless delay in care.”

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

“The newly merged Ambrisentan REMS program will allow patients access to their medications and reduce the administrative load placed on PH centers,” said Jeffrey S. Sager, M.D., M.Sc., FACP, FCCP, director, Cottage Pulmonary Hypertension Center, Santa Barbara, California.

Dr. Sager

“We will continue to work to streamline this process so that patients are not left without medication and … protect our patients who are of child-bearing potential, “ said Dr. Sager, who helped craft and present the PHA recommendations.