Amgen has launched a new direct-to-patient program, beginning with Repatha. The decision follows positive results from Repatha during the Phase III Vesalius-CV clinical trial, in which Repatha met its dual primary endpoints demonstrating that the medicationcan significantly reduce the risk of major adverse cardiovascular events (MACE) in individuals without a prior history of heart attack or stroke.¹

"Amgen is committed to finding new ways to help patients benefit from our medicines," said Murdo Gordon, executive vice president of Global Commercial Operations at Amgen. "Repatha has already helped more than 5 million patients1, and the AmgenNow program will make it easier for uninsured patients or those who choose to pay out-of-pocket to access treatment. This will allow even more Americans at increased risk of major adverse cardiovascular events to benefit from this effective medicine."

Who will have access to AmgenNow?

Starting October 6, 2025, AmgenNow will be available to all Repatha patients, including patients who are involved in government programs such as Medicare and Medicaid.¹ Patients involved in AmgenNow are not subject to insurer requirements for step therapy, or prior authorization. Amgen is also planning on making AmgenNow available through the TrumpRx website. ¹

According to Amgen, the release of AmgenNow is in support of the Trump Administration's efforts to lower drug prices for Americans.¹ To show its support, Amgen decided to make Repatha available through AmgenNow at a monthly price of $239, which is nearly 60% lower than the current U.S. list price of $572.70. Amgen will open the program to all patients, including those who are uninsured, in high-deductible health plans, or prefer to pay with cash or out of pocket.¹ According to Amgen, the new direct-to-patient price is the lowest among the economically developed countries, and will be offered exclusively for the first time to U.S. patients.¹

What was the Vesalius-CV Phase III trial?

The Phase III Vesalius-CV trial enrolled upwards of 12,000 high-risk patients, with an estimated 85% of participants being maintained on a high-intensity or moderate low-density lipoprotein cholesterol (LDL-C) reducing therapy.¹ Patients were studied for a median estimate of 4.5 years, with the trial’s primary endpoints being time to first occurrence of a composite of coronary heart disease (CHD) death, heart attack or ischemic stroke, as well as time to first occurrence of a composite of CHD death, heart attack, ischemic stroke or any ischemia-driven arterial revascularization.¹ Trial results displayed that the primary endpoints were both statistically and clinically significant, with no new safety signals being observed.

"These results mark an important milestone in the fight against cardiovascular disease, the leading cause of death worldwide. The benefit across endpoints and established safety profile underscore Repatha's role as a cornerstone therapy in comprehensive lipid management," said Jay Bradner, M.D., executive vice president of Research and Development at Amgen. "Repatha is known as a highly effective LDL-C lowering treatment and is now the first and only PCSK9 inhibitor shown to reduce cardiovascular events in high-risk adults without prior heart attack or stroke. These additional data demonstrate that Repatha has the potential to reach tens of millions more patients earlier in their journey, before a life-altering event occurs."

Sources

1. AMGEN MAKES REPATHA® AVAILABLE THROUGH AMGENNOW, A DIRECT-TO-PATIENT PROGRAM IN THE U.S. Amgen October 6, 2025 https://investors.amgen.com/news-releases/news-release-details/amgen-makes-repathar-available-through-amgennow-direct-patient
2. LANDMARK PHASE 3 TRIAL (VESALIUS-CV) MEETS PRIMARY ENDPOINTS IN A CARDIOVASCULAR PRIMARY PREVENTION STUDY OF 12,000 PATIENTS Amgen October 2, 2025 https://wwwext.amgen.com/newsroom/press-releases/2025/10/landmark-phase-3-trial-vesaliuscv-meets-primary-endpoints-in-a-cardiovascular-primary-prevention-study-of-12000-patients