BeOne Medicines reaches voluntary agreement with U.S. government to expand cancer drug access

BeOne Medicines recently entered into a voluntary agreement with the U.S. government aimed at broadening American patients' access to cancer treatments while expanding the company's domestic manufacturing footprint, the oncology company announced in a news release.

BeOne Medicines, a global oncology company with a portfolio spanning hematology and solid tumor, employs more than 12,000 people across six continents, including more than 2,000 in the U.S. BeOne describes its pipeline as one of the industry's broadest, running 93 clinical trials at roughly 1,100 sites in 45 states and one U.S. territory, supported by more than 650 investigators.

The agreement centers on three commitments, according to the news release. The first, BeOne will participate in CMS’ GENEROUS (GENErating cost Reductions fOr U.S. Medicaid) Model, which aims to lower what state Medicaid programs pay for prescription drugs. The company also pledged to price future FDA-approved products in line with other major developed markets. Lastly, it entered into an onshoring agreement with the federal government that exempts BeOne from Section 232 pharmaceutical tariffs in recognition of the company's continued investment in U.S. manufacturing.

BeOne said the arrangement is meant to improve patient access to its oncology medicines while strengthening the supply continuity and manufacturing flexibility behind them, two issues payers and health systems have flagged amid ongoing drug shortages and tariff uncertainty.

The agreement builds on a $300 million onshoring investment BeOne recently announced for its Hopewell, New Jersey, manufacturing and research site, bringing the company's total U.S. manufacturing investment to more than $1 billion. That expansion is expected to add small-molecule manufacturing capacity and create about 120 full-time jobs, while supporting a pipeline of more than 35 clinical- and commercial-stage oncology assets. In 2025, BeOne said it generated nearly $2 billion in direct U.S. economic impact and invested $1 billion in U.S. research and development.

The organization joins a growing number of drugmakers negotiating directly with the Trump administration over drug pricing and tariffs this year. CMS opened the GENEROUS Model last fall as a voluntary, most-favored-nation-style pricing arrangement open to manufacturers of all sizes, letting participating state Medicaid programs buy drugs at prices closer to what other wealthy countries pay. CMS has since pushed the model's application deadline to April 30 and its participation deadline to June 30, according to a CMS news release. Separately, the Trump administration's Section 232 tariffs on imported patented pharmaceuticals took effect this summer, and the Commerce Department has since released a process for manufacturers to apply for onshoring agreements, similar to BeOne's, in exchange for tariff relief.

Cancer drugs are also a growing driver of that Medicaid spending pressure. Net Medicaid spending on outpatient prescription drugs, after rebates, rose 46% between fiscal year 2019 and fiscal year 2024, climbing from $31 billion to $46 billion, according to a KFF analysis. Spending per prescription grew even faster than prescription volume over that stretch, and KFF pointed to high-cost specialty drugs, including cancer treatments, cell and gene therapies and GLP-1 medications, as the main drivers of that growth. Rebates still offset more than half of gross Medicaid drug spending, but state Medicaid programs have increasingly leaned on supplemental rebates to manage costs, the analysis found.

For payers and health systems, the practical question is whether voluntary deals such as BeOne's translate into lower net costs and steadier supply for cancer drugs, or mainly shift where and how those costs show up. The company has not disclosed pricing details tied to the agreement.

“At BeOne, we believe every patient should benefit from innovative cancer therapies,” John V. Oyler, co-founder, chairman and CEO of BeOne Medicines, said in the news release. “We appreciate the Trump Administration’s commitment to advancing solutions that broaden access and scientific progress for American patients. This agreement reflects our purpose to reach more patients as we expand our U.S. investment in additional research, development, and manufacturing to deliver breakthrough cancer treatments worldwide.”