New studies presented at the American Society of Clinical Oncology’s annual conference suggest that reducing the dosage of anti-cancer medicines — including Keytruda, the world’s bestselling drug — could drastically cut global health costs by billions of dollars a year and improve access for patients.
The U.S. Food and Drug Administration approved the initial dosage of Keytruda in 2014 based on a patient’s body weight, at 2 milligrams per kilogram. But Merck & Co., the maker of the drug, later changed to a fixed dosage with the FDA’s approval. Now Merck recommends 200 mg every three weeks or 400 mg every six weeks, regardless of the patient’s weight.
The studies discussed last week at the ASCO conference in Chicago, however, indicate that patients are receiving more of Keytruda and similar cancer drugs than necessary, which dramatically pushes up consumer costs and corporate profits — and that smaller doses work just as well. One study estimated the savings at more than $30 billion annually.
We found that by lowering the dose, we can expand access by 50 to 60%.
— Kumar Prabhash, oncologist at Tata Memorial Hospital in Mumbai.
Merck disagrees with that finding, saying in a statement to ICIJ that the FDA-approved doses “are based upon wide-ranging preclinical data and extensive clinical evidence.”
Meanwhile, an official from the U.S. Department of Health and Human Services told ICIJ that the agency supports scaling back cancer treatments if evidence shows it is safe to do so. Emily G. Hilliard, the agency’s senior press secretary, said the FDA “will continue to work with oncologic drug developers to determine the appropriate dosages that are safe and effective for patients.”
“[The National Cancer Institute] supports efforts to de-escalate cancer therapies when the evidence shows that fewer drugs or lower doses can be administered safely and effectively,” Hilliard said in a statement. “Receiving less treatment while maintaining efficacy can improve a patient’s quality of life, lower costs, require fewer clinic visits, and, most importantly, reduce treatment-related toxicity. Our goal is to ensure patients receive the most effective treatment with the fewest possible side effects.”
The Cancer Calculus , an investigation by ICIJ and 47 media partners published in April, shows how Merck has kept the price of the lifesaving drug sky-high by building a fortress of patents to deter competition and through opaque pricing. In the U.S., for example, a 200 mg dose of Keytruda costs $12,000, according to an ICIJ analysis.
As soaring prescription drug costs remain a major concern in America and throughout the world, President Donald Trump has repeatedly promised sweeping reductions in costs, including for cancer treatments. Last year, Trump signed confidential deals with dozens of pharmaceutical companies, including Merck, to lower the price of some prescription drugs. But a recent Senate report found that high-cost medications have only become more expensive.
The cost of Keytruda, which accounts for nearly half of Merck’s revenue, rose to $210,000 for one year of treatment under Trump — a 6% increase since last year, the Senate report found. The price of its main competitor, Bristol Myers Squibb’s Opdivo, rose by 4% under Trump, and Johnson & Johnson’s Darzalex, another immunotherapy drug, saw a 6% price increase.
Such high prices have contributed to vast disparities in access and affordability worldwide as cancer rates keep escalating globally.
Billions in savings
A preliminary study submitted during the ASCO conference by researchers at the University of Chicago looked into Keytruda and other high-cost cancer immunotherapies and targeted therapies. The researchers found that 21 out of 29 FDA-approved drugs might work just as well with lower doses or less frequent treatment. This could save an estimated $40,000 to $240,000 per patient each year and up to $31.1 billion worldwide.
The study is based largely on publicly available information about the drugs, including data published by the FDA, which was used to analyze how the medications behave in the body, explained post-doctoral researcher Mohammed Ali, one of the authors. The analysis showed that some cancer antibody drugs — drugs that help the body find and attack cancer cells — stay in the body for a long time. This suggests that, in some cases, patients could take treatment less often while still maintaining high enough drug levels to work effectively.
Ali said the project is part of larger research efforts on optimizing cancer drug dosing and is funded by Arnold Ventures, a U.S.-based philanthropy. The researchers plan to extend the analysis to dozens more cancer drugs, said Mark J. Ratain, a professor of medicine at the University of Chicago and coauthor of the study.
The preliminary study across major cancer drugs found the biggest potential savings from using lower or less frequent doses in four medicines. A combined $6.63 billion could be save…
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