The International Consortium of Investigative Journalists recently revealed how pharmaceutical giant Merck & Co. widened the use of its blockbuster cancer drug, Keytruda, while maintaining a fixed 200 milligram dose for all patients. This strategy has strained health systems worldwide, prompting a major investigation by 47 media partners across 37 countries, from Finland to Brazil.
Keytruda, known generically as pembrolizumab, is an immunotherapy drug. It helps the body's immune system fight cancer cells by disrupting a process where some cancers evade detection. Specifically, Keytruda targets the PD-1 protein on white blood cells, preventing it from binding with PD-L1 or PD-L2 proteins found on cancer cells. This action allows the immune system to recognize and attack the cancer. Dutch scientists first developed pembrolizumab in the early 2000s. Merck later acquired the company responsible for its invention. The U.S. Food and Drug Administration approved the drug for medical use in September 2014.
Oncologist Dr. Daniel Goldstein suggests Merck's fixed 200mg dose policy may contribute to faster consumption and higher costs. His research, shared with Der Spiegel, ZDF, and Paper Trail Media, indicates Keytruda could be equally effective at 25% lower doses. This finding has significant implications for public health budgets and insurers globally. Merck originally submitted studies to regulators using a weight-based dosing system. Such a system would allow for individualized, potentially lower doses for some patients, contrasting with the current universal 200mg dose.
The financial burden on national health systems is substantial. Austria provides a clear example. There, Keytruda costs 6,800 euros, about $8,000, per dose without discounts. It is the country's single largest medication expense. The ICIJ investigation found Austria is the only European Union country without a price ceiling for hospital drugs. This absence of regulation leaves the public system vulnerable to high pharmaceutical prices. The AIM Institute, drawing on research from the advocacy organization Public Eye, calculated a fair price for Keytruda at 80 euros, about $94, per dose, highlighting the vast disparity.
High costs force many cancer patients into difficult legal battles. Insurers frequently deny coverage for the life-saving drug, citing its exorbitant price. Patients report grueling fights to access Keytruda, which can top $200,000 annually per patient. These denials leave individuals and families struggling to pay for a drug that often represents their best chance at survival. Many patients face the choice between financial ruin and foregoing critical treatment. Courts and regulatory bodies often become the final arbiters in these disputes, adding stress and delays for those already battling severe illness.
Merck also employs aggressive patent strategies to protect its market position and high pricing. This practice, often termed "evergreening," involves securing new patents on minor modifications to the drug, new formulations, or new uses for existing drugs. These new patents extend the drug's exclusivity beyond the original patent's expiration, delaying the entry of generic versions. Such tactics effectively block competition, allowing Merck to maintain its monopoly and dictate the drug's exorbitant cost for longer periods. Patent experts interviewed by the ICIJ partners noted that these strategies exploit existing legal frameworks to maximize profits rather than genuinely advancing pharmaceutical innovation.
The investigative findings across 37 countries point to systemic issues beyond just Keytruda's pricing. They expose deeper dysfunctions within healthcare systems, from regulatory gaps in pricing control to the intense pressure on public budgets. Patients are caught in a system where access to life-saving medication is often dictated by legal battles and financial capacity.
The cost of Keytruda without discounts in Austria reaches 6,800 euros per dose.