ICIJ details Keytruda tactics

Merck turned Keytruda into a $31.7 billion franchise in 2025 while building a global patent and lobbying strategy that could keep cheaper rivals out for years. (icij.org) The International Consortium of Investigative Journalists reported April 13 that Merck and related entities filed at least 1,212 Keytruda patent applications across 53 jurisdictions. Its analysis said those filings could help preserve high prices for 14 years after the original patents expire. (icij.org) Keytruda, or pembrolizumab, is an immune checkpoint drug that blocks the programmed death receptor-1 brake cancer uses to hide from the immune system. The Food and Drug Administration first approved it on September 4, 2014, for advanced melanoma. (fda.gov) Merck’s own 2025 annual report said Keytruda generated $31.7 billion last year, nearly half of company revenue. ICIJ said Merck has made about $163 billion in Keytruda sales since 2014 and that more than 3 million patients have received the drug worldwide. (merck.com) (icij.org) The pricing gap is wide. ICIJ said list prices for a typical year of treatment run about $208,000 in the United States, about $80,000 in Germany, about $130,000 in Colombia and about $65,000 in South Africa. (icij.org) Merck’s patient cost page lists Keytruda at $12,031.36 every three weeks or $24,062.72 every six weeks, not including infusion-center charges or other treatment costs. Merck said those figures were current as of September 2025. (keytruda.com) The timing is critical because Medicare has now pulled Keytruda into price negotiations. The Centers for Medicare and Medicaid Services said on March 13, 2026, that Merck chose to participate in the third cycle, with negotiated prices set to take effect on January 1, 2028. (cms.gov) Merck is also still expanding the franchise. The company said the Food and Drug Administration approved a subcutaneous version, Keytruda Qlex, on September 19, 2025, for adults across most solid-tumor indications, allowing administration in about one minute instead of an intravenous infusion. (merck.com) ICIJ said Merck used regulatory shortcuts, secrecy around pricing and a global lobbying campaign to defend the drug’s position, while also paying U.S. doctors and health care professionals tens of millions of dollars in Keytruda-related consulting fees, travel costs and other payments. (icij.org) Merck rejected the thrust of the reporting in an April 2 letter to ICIJ. The company said Keytruda “has transformed the treatment paradigm” in multiple cancers, reflects its value to patients and health systems, and has reached more than 3 million patients since 2014. (documentcloud.org) That leaves Keytruda at the center of two fights at once: who gets the drug now, and who gets to sell a cheaper version later. ICIJ’s reporting says Merck has spent years shaping both answers. (icij.org)