Amgen has launched a direct-to-patient program designed to broaden access to its PCSK9 inhibitor,evolocumab (Repatha),as sweeping US drug pricing reforms take effect. The initiative aims to navigate the complexities of the Inflation Reduction Act and a recent executive order from the Trump administration targeting pharmaceutical pricing practices.
The program arrives amid significant shifts in the pharmaceutical landscape.The Inflation Reduction Act allows Medicare to negotiate prices for certain high-cost drugs, while the Trump administration’s “most favored nation” order sought to tie US drug prices to those in other developed countries. These changes create both challenges and opportunities for manufacturers like Amgen, prompting innovative approaches to ensure patient access to vital medications. The direct-to-patient model bypasses conventional pharmacy benefit manager (PBM) hurdles, potentially lowering out-of-pocket costs for some patients and streamlining medication delivery.
Evolocumab is indicated to reduce the risk of cardiovascular events in adults with established cardiovascular disease or those at high risk. Amgen’s program will offer eligible patients home delivery of the medication, along with support services to assist with adherence and administration.
Recent developments influencing this launch include a September 30, 2025, news release from Pfizer announcing a landmark agreement with the US government to lower drug costs for American patients. This agreement, alongside the Trump administration’s directive-outlined in an article from AJMC published on the same topic-highlights the growing pressure on pharmaceutical companies to address affordability concerns. Further details on Amgen’s program, including eligibility criteria and enrollment data, are available directly from the company.
