FDA OKs New Keytruda Shot for Cancer

The cancer medication Keytruda is the world’s best-selling drug. But with lower-priced competition set to arrive as soon as 2028, Keytruda’s manufacturer, Merck, is on the brink of losing tens of billions of dollars in sales.

To keep Keytruda revenue flowing, Merck followed a well-worn playbook. It developed a new version of the drug, given as a shot under the skin, which the Food and Drug Administration approved on Friday.

The company is talking up the new version as quicker and easier for patients than the original therapy, which is given through tubes as an intravenous infusion.

Keytruda is approved to treat 18 types of cancer, including of the skin, lung, breast and colon. It has been given to 2.9 million patients and helped former President Jimmy Carter extend his life by nearly a decade. Since arriving in 2014, Keytruda has generated $146 billion in sales for Merck. The drug accounts for nearly half of Merck’s revenue.

Government-funded programs like Medicare cover much of the cost of the cancer drug, which has a sticker price of about $204,000 a year. Merck has not yet said how much it plans to charge for the new shot version.

Company executives have said they plan to debut the shot, Keytruda Qlex, this fall and expect up to 40 percent of Keytruda users to be on it by 2027. Dr. Marjorie Green, an executive at Merck, called the new version “a meaningful advance” and said the company developed it “to address patient and provider needs and help simplify the treatment experience.”

Drug pricing experts say that Merck’s new shot will most likely slow the adoption of cheaper copycat infusions, keeping prices higher for longer at the expense of Americans who pay in the form of taxes and health insurance premiums.

When strategies like Merck’s succeed, the result is that “we’re all spending billions more dollars on prescription drugs,” said Dr. Benjamin Rome, a health policy researcher at Brigham and Women’s Hospital in Boston.

Senators Elizabeth Warren, Democrat of Massachusetts, and Bernie Sanders, Independent of Vermont, have accused Merck of abusing the patent system with the new Keytruda shot.

Merck is just the latest in a long line of drug companies that have introduced new versions of their medicines that allow them to keep charging high prices even as their original patents expire.

The strategy is known as a product “hop.” A company rides out its monopoly on the original drug, and then, a few years before competition reaches the market, the drugmaker “hops” to a new version that remains protected by patents. For example, AbbVie reformulated its blockbuster drug Humira, used for conditions like arthritis, to make it less painful and faster to inject. (AbbVie has denied engaging in product “hopping.”)

The changes generally do not improve the metrics patients care about most, safety and effectiveness.

“The industry has come up with this perfect strategy of selling convenience, as opposed to something therapeutically better,” said Tahir Amin, chief executive of the Initiative for Medicines, Access & Knowledge, or I-MAK, a nonprofit that tracks drug patents.

In the past several years, drugmakers have carried out product hops for a handful of expensive and widely used cancer drugs, like Herceptin, Darzalex and Opdivo. The tweaked versions use an ingredient known as hyaluronidase that breaks down the drug and allows it to be quickly injected under the skin.

Medicare has spent billions of dollars paying for the shot versions for tens of thousands of cancer patients. Prices for the new shots have been similar to those of the original infusions, but higher than the copycat infusions introduced by competitors.

The new injections have proved popular with hospitals, because they free up infusion chairs for patients receiving chemotherapy and allow them to treat more patients. “That’s a huge incentive to switch if you can,” said Stacie Dusetzina, a drug pricing expert at Vanderbilt University.

The time savings can be significant. In a clinical trial funded by Merck, the Keytruda shot, injected into the stomach area or thigh, took about two minutes to administer, compared with 30 minutes for the original infusion. Patients getting the shot spent just over an hour in the treatment room, compared with over two hours for the infusion. Either way, patients get the drug every three or six weeks.

Both ways of giving the drug can cause side effects like reactions and pain, though they are usually not serious.

Merck has sought nearly 300 patents related to Keytruda, according to I-MAK. (Merck disputed I-MAK’s count but declined to provide a different figure.) Some of those patents might give Merck leverage to block the arrival of copycat infusions from competitors for years beyond 2028, when the drug’s core patents expire.

Merck is banking on the fact that many patients will already be receiving the convenient shot by the time that cheaper versions are available, and they would be unlikely to switch back to a slow infusion. Oncologists say they are focused on what is best for their patients, not on what will minimize Medicare’s long-term cost.

Dr. Rebecca Shatsky, a breast cancer specialist at the University of California, San Diego, said: “It would be very difficult to tell a patient, ‘Hey, you have to go back to an infusion now.’ They’re not going to want to do that.”

For most cancer patients, the infusions and shots carry similar out-of-pocket costs, thanks in part to financial protections that kick in for expensive cancer care, Dr. Dusetzina said. That remains the case even when competitors introduce cheaper infusions. But when less expensive copycats are available, taking a shot version instead could burden patients on traditional Medicare who do not have supplementary insurance, because they are on the hook for 20 percent of a drug’s cost and pay more when a drug is more expensive.

The Keytruda shot can be given in satellite doctors’ offices and clinics, according to the company, rather than in infusion centers, which tend to be fewer and farther between. Merck executives have said that could reduce patients’ drive times for Keytruda, especially in rural areas.

In that scenario, switching from an infusion to a shot could allow patients to avoid expenses like gas, hotels and unpaid time off work, said Dr. Sonam Puri, a lung cancer specialist at Moffitt Cancer Center in Florida. She said that when she previously practiced in Utah, some of her rural patients drove 10 hours round trip to get their infusions.

Cancer patients who receive infusions like Keytruda said in interviews that they would welcome options that reduce the time they spent getting treatment.

Chris Hebert, 49, a lung cancer patient in Baton Rouge, La., said that every three weeks, he spends about four hours at a nearby infusion center. He gets his medicines infused through a port installed in his chest.

First, he gets drugs like Benadryl, Pepcid and steroids to prevent side effects. Next, he gets an hour of Imfinzi, which works in a similar way as Keytruda to unleash the immune system to fight cancer. After a washout, he gets chemotherapy for 10 minutes. He is monitored during and after the process, in case he experiences side effects. “It would be very valuable to have some of that time back,” he said.

But some oncologists said that many patients do not benefit more from shots rather than infusions, particularly if they still have to get chemotherapy or other infused medicines through a port.

“When we’ve offered it, we have patients who say, ‘I’ve got a port. Why would I want you to stick me?’” said Dr. Barbara McAneny, who runs an oncology practice in New Mexico.

She added that while long drive times are a hardship for many of her rural patients, the shots do not alleviate that. Her patients who have switched to shots from infusions are still making the same drive, she said.

The original version of Keytruda had been expected to have its price cut for Medicare starting in 2028, under a Biden-era law subjecting certain medicines to price negotiations. But in a win for Merck, the Republican policy bill that became law this summer delayed that timetable by one year for Keytruda because of a change in the way it dealt with products originally approved for rare diseases.

It is not clear whether the Medicare price cut starting in 2029 will also apply to the new Keytruda shot; the federal government recently hinted that it might.