By The Bureau of Investigative Journalism

By Fiona Walker, Andela Milivojevic, Sydney P. Freedberg and Brenda Medina

In brief:

• Keytruda is a game-changing cancer drug that brings in £30bn a year for pharma firm Merck Sharp & Dohme (MSD).
• The company has built a “patent wall” around Keytruda and recommends doses that experts say could be much lower.
• Studies show that the U.K.’s depleted National Health Service (NHS) is vastly overpaying for the drug — to the detriment of the population’s overall health.

Keytruda is the world’s bestselling drug. It is also a medicine so expensive that many cancer patients whose lives it might save cannot afford it.

Those prices are charged by its manufacturer, the U.S. pharma giant MSD, which has made eye-watering sums from its flagship product. All in all, Keytruda brings in more money than the McDonald’s corporation — about $30 billion (£22bn) a year.

MSD rightly says that immunotherapy medicines like Keytruda have revolutionized cancer care, turning previously terminal diseases into manageable conditions. But while Keytruda can transform the life of a patient, the cost of giving it to them is astoundingly high.

In the U.K., research shows that the NHS has been paying up to five times as much for the drug as it should. We found one patient whose Keytruda treatment cost the health service over £180,000.

The numbers matter, especially when the NHS is on its knees. Nearly 20,000 patients are estimated to have died while waiting for treatment in Accident and Emergency, or A&E, in 2024. Resident doctors in England have once again been striking over pay. “Corridor care” has become a routine part of life in Britain’s overcrowded hospitals.

National Institute for Health and Care Excellence (NICE), the body that recommends which drugs the NHS can purchase in England and Wales, told us that its decisions strike a balance between making innovative treatments available to patients and ensuring the best use of public money.

Yet some experts told us that the health of the population is actually suffering due to the amount being spent on Keytruda.

MSD told us that it’s confident that its medicines deliver “cost-effective health benefits for patients in the UK.” It added that it has been part of the U.K.’s life sciences and healthcare ecosystem for nearly a century and that it “engages openly and appropriately” with the NHS, patient groups, the government and the public.

The company’s profit margins, however, remain vast. Now, as part of a major global investigation led by the International Consortium of Investigative Journalists in collaboration with 48 media outlets, we can reveal how MSD has employed aggressive but legal tactics to ensure Keytruda continues to bring in big money.

Our year-long project exposes the power plays that keep both price and profit high. We lift the lid on a system that leaves health services paying over the odds — and desperate patients priced out.

Wonder drug

Keytruda (scientific name: pembrolizumab) is an immunotherapy drug: it primes a patient’s own immune cells to recognize and attack cancer cells. It’s used to treat forms of skin, lung, breast and colon cancer, among others, and is approved for use in 106 countries. But it doesn’t come cheap.

The company has defended its pricing, telling us: “We firmly believe Keytruda reflects its value to patients and healthcare systems, especially given our unmatched clinical development programme and the significant investment we have made in evaluating Keytruda across a broad range of cancer types.”

It’s certainly true that developing medicines is a laborious and risky process. Clinical trials, which are required to prove a drug’s safety and efficacy, are expensive. Getting a new drug onto the market can take a lot of time and money. So the patent system protects drug companies against the possibility of rivals profiting from their legwork.

A drug patent prevents competitors from making a product using the same formula. This exclusivity generally lasts 20 years and allows the company that devised the drug to recover research and development (R&D) costs as well as earn profits to fund future research. Only once the patent expires can competitors make and sell their own cheaper versions.

Keytruda’s primary patents are set to expire in 2028. That loss of exclusivity would open the floodgates to lower-priced equivalents entering the market — and threatening an annual revenue MSD predicts will by then have hit $35 billion.

To keep that from happening, MSD has exploited the system to build a patent fortress around its lucrative drug. We found more than 1,200 patents for Keytruda across 53 countries, regions and territories. The majority are owned by MSD.

This investigation found 211 granted patents that help protect Keytruda through to at least 2042 — a full 14 years after the originals expire. There are also at least another 337 “pending” patents that, if granted, could also extend the drug’s reign. The vast majority of the applications came after the drug’s initial approval in 2014.

Unprovable numbers

When justifying the pricing of their drugs, pharma companies often point to their substantial R&D costs. As MSD CEO Robert Davis said in an address to the U.S. Senate last year: “These remarkable advances have not come cheaply.” He said his company has invested over $46 billion to research, develop and scale up the manufacture of Keytruda.

But a new analysis by Public Eye, a Swiss-based nonprofit advocating for corporate accountability, estimates Keytruda’s R&D costs at $4.8 billion — 3% of the drug’s revenue since launching. Patrick Durisch, Public Eye’s pharma specialist, said he based his numbers on a review of Keytruda clinical trials and their average costs, which account for the largest share of R&D expenses.

Davis’ figures are “absolutely unverifiable,” says Durisch. “MSD could throw any figure they want — as high as possible to justify the exorbitant price tag.”

MSD did not respond to these claims.

MSD has filed for new patents to cover changes in dosage amounts and dosing schedules. It has filed for new patents to cover various combinations of Keytruda and other medicines.

The company denies that subsequent patents will extend the life of earlier ones, saying that the earliest anticipated date for a U.S. competitor to Keytruda is late 2028.

It also says these applications have all been made in good faith to protect new discoveries.

“We continue to evaluate Keytruda in the hopes of expanding its use to other forms of cancer and increasing access to the treatment,” the company told us. “This includes innovations around formulation, dosing and novel uses, including combinations with other agents.”

But Tahir Amin, founder of the Initiative for Medicines, Access and Knowledge (I-MAK), a nonprofit group that examines inequities in how medicines are developed, described MSD’s strategy as a “multi-pronged patent abuse scheme” designed to prolong its monopoly and high prices.

He said each patent application is “a potential landmine” that could create a costly and lengthy legal challenge for anyone trying to market a similar drug.

He added: “The goal is to carpet-bomb the competitor with as many patents as possible to either deter them, make the cost of entering [the market] as costly as possible, or hope the more patents a competitor has to litigate their way through will result in a settlement.”

MSD said I-MAK and “similar organisations” were propagating a “common myth” about pharma companies “gaming the patent system,” and it “has been repeatedly shown that patent counts do not predict timing of generic entry.” It added that I-MAK’s reporting contained serious errors around the cataloging and description of MSD’s practices. I-MAK denies this.

This tangle of patents could help the pharma giant to maintain its high prices and continue to make billions in revenue, for longer.

“This is standard practice in the business today,” said Amin. “In fact, if you’re a pharmaceutical company and you are not doing this, your investors will get the CEO fired.”

The Association of British Pharmaceutical Industry (ABPI), which represents pharma, did not respond to this claim.

Too much of a good thing?

The amount spent on Keytruda also depends on how much is used per patient — and how often. Dosage recommendations are given under a drug’s license.

But there are major questions over whether the doses promoted by the company are higher than patients really need.

MSD recommends 200 milligrams (mg) of Keytruda every three weeks or 400mg every six. That’s the amount given in the U.K., yet one clinical trial in India gave patients weight-based dosing: 2mg per kilogram of body weight every three weeks.

So far, results show that lower doses in some indications can be as effective as the larger standard dosage recommended by MSD. Hospitals in Singapore, Malaysia and Taiwan have arrived at a similar conclusion.

The World Health Organization modeled expanding access to Keytruda for patients with a type of lung cancer. They found that the projected costs to 2040 would be $5 billion cheaper if weight-based dosing were used in place of the fixed amount recommended by MSD.

Keytruda’s dosage instructions were approved by the U.S. Food and Drug Administration. MSD told us: “In a life-threatening and challenging disease such as cancer, it is critical that the dosing for a cancer therapy is established through well-designed clinical trials.”

Mark Ratain, professor of medicine at the University of Chicago, said: “MSD has cleverly designed trials in a way that basically doesn’t really allow you to know what you need to prescribe.”

He explains how it works for a type of lung cancer:

“You give pre-operative Keytruda with chemotherapy. Then you do surgery and then, after surgery, you give chemo and more Keytruda.

“The trials that were done only looked at doing that versus giving no Keytruda at all. And there’s immense controversy as to whether you need to give the Keytruda after the surgery, or whether just giving it before is sufficient.”

He says that tactic is not unique to MSD. (The ABPI did not respond to this comment.)

MDS told us: “We reject any assertions that suggest we have fallen short of the high standards of transparency and integrity that govern how we deliver care to patients.”

In the U.K., another trial is underway, aiming to assess whether the doses can be administered further apart. Duncan Gilbert, a clinical oncologist who is leading the trial, is trying to establish if giving it less often is just as effective.

“The price point of the immunotherapy drugs is too high — absolutely — and it’s demonstrably too high for the global population,” he said. “I don’t begrudge the pharmaceutical industry for doing an amazing job. But it’s got to be sustainable and should be value and merit based overall.”

Who really pays?

Exactly how much the NHS pays for its hospital drugs is a closely guarded secret. Doctors prescribing them don’t know. Nor do politicians or health economists. A new deal agreed by the U.K. government commits the NHS to spend more on expensive new medicines and also to pay more for drugs it is already buying (read our piece on how the deal was done for more).

While we might not like to think of healthcare in terms of cold economics, that’s how governments decide which treatments to buy and which not to.

In the U.K., once the regulator has decided a drug is safe, NICE assesses its cost-effectiveness. Separately, the NHS negotiates a price.

But using a number of sources that were publicly available in 2021, researchers at the University of York’s Centre for Health Economics were able to identify the prices paid at the time by the NHS for 10 different drugs, including Keytruda.

They examined each for cost-effectiveness via a method that takes into account not just the cost of making the drug but also of allowing the company to invest in future R&D — and make a profit.

Keytruda topped the list of drugs for which the NHS was overpaying. In fact, for one type of lung cancer treated by Keytruda, they found that the NHS had been spending almost five times more than it should have.

“We’d be better off saying no to the manufacturer or negotiating a lower price than going ahead with this current policy,” said Beth Woods, one of the study’s researchers. “By paying these prices for Keytruda, the overall health of the population actually gets worse.”

Asked about this work, NICE told us that it “takes such analysis seriously.” It added that, when it recommends a medicine, including pembrolizumab, it is because its independent committees have concluded, based on the best available evidence, that a drug’s cost-effectiveness makes it “an acceptable use of NHS resources.”

NHS England told us it has a dedicated team that negotiates confidential commercial agreements with pharmaceutical companies to further safeguard value for money for the public.

To try and find out what the NHS is actually paying for Keytruda, we requested information from 40 public bodies, health trusts and boards. Most denied our request, many citing commercial confidentiality.

The responses we did get, from 12 Scottish NHS boards, show that Keytruda is among the handful of medicines that hospitals across the country spend the most money on.

In 2023–24, Greater Glasgow and Clyde, Scotland’s biggest health board, spent £16.6m on Keytruda treatment for 738 patients. On average, Scottish hospitals have been spending around £20,000 on Keytruda per patient — or about two-thirds of a junior nurse’s annual salary.

Research shows that many NHS treatments, like flu vaccines or blood pressure drugs, deliver a healthy year of life at a fraction of the price of some costly branded medicines.

MSD did not respond to specific claims about its profit margins, telling us: “We are confident that our medicines and vaccines deliver cost-effective health benefits for patients in the UK.”

But if the price of Keytruda was what health economists like Woods say it should be, the NHS could save over half a billion pounds during the drug’s patent period. And if this half a billion was invested in other NHS services, such as more staff, early diagnosis and different treatments, Woods thinks it could avoid nearly 3,000 deaths.

A government spokesperson told us they do not recognize these figures. “They are based on assumptions and projections that the government does not share, and do not reflect how decisions on medicines funding and access are made in practice.”

Public subsidies

Before MSD bought the company that was developing what became Keytruda, the U.K. public money paid for a crucial part of the drug’s research. A British scientist even won a Nobel prize for it. And the company has reaped the benefits from basing a lot of its R&D in the U.K.

Between 2021 and 2025, MSD’s innovation centre company in the U.K. was guaranteed nearly £10m of public money through tax credits. MSD told us it invested £81.2m in R&D here in 2022–2023. But in September last year, MSD scrapped its billion-pound R&D investment in London. More than 100 scientists and other staff lost their jobs.

So why does the U.K. approve drugs like Keytruda?

Sir David Haslam, former chair of NICE, outlined the pressures it faces around its decisions. “The debate is always, ‘Such and such a drug has been developed, and it’s incredibly expensive, but it’s really beneficial to patients. How dare you not provide that?’

“But the question that’s never asked is, ‘Wouldn’t it be better investing in school nurses, health visitors, many [other] aspects of prevention?’

“We cannot afford everything for everyone. Of course, if it was my son, my daughter, my wife, my grandchildren, I would want 100% of the United Kingdom’s GDP spent on keeping them healthy,” he said. “So you have to depersonalise this. You have to look at it from the point of view of the ultimate benefit for the healthcare system.

“You have to recognise there is only a limited amount of money to go around. You have to spend that in the best possible way.”

This investigation is part of the Cancer Calculus, an investigation coordinated by the ICIJ across 37 countries.

Reporters: Fiona Walker, Andjela Milivojevic, Sydney P. Freedberg and Brenda Medina
Additional reporting: Delphine Reuter and Denise Ajiri
Global Health editor: Fiona Walker
Deputy editor: Chrissie Giles
Editor: Franz Wild
Production editor: Alex Hess
Fact checkers: Frankie Goodway and Sasha Baker
Illustrator: Chelsea Conrad / ICIJ

Originally published by The Bureau of Investigative Journalism. 

Fiona Walker is an award-winning journalist, documentary-maker and podcaster.

Andela Milivojevic is an award-winning investigative journalist specializing in global health at The Bureau of Investigative Journalism.

Sydney P. Freedberg is the International Consortium of Investigative Journalists’ chief reporter, based in St. Petersburg, Florida.

Brenda Medina is a bilingual investigative reporter with the International Consortium of Investigative Journalists.

The post Merck’s Keytruda Is a $30 Billion Cancer Drug — Are Patients Over-Paying? appeared first on Children’s Health Defense.

 

IPAK-EDU is grateful to The Defender as this piece was originally published there and is included in this news feed with mutual agreement. Read More