Keytruda, a leading cancer drug, currently holds the title of the world’s best-seller. However, with more affordable alternatives expected by 2028, its maker, Merck, faces the prospect of significant revenue loss.
In a strategic move to maintain its market dominance, Merck has developed an innovative new version of Keytruda: an injectable shot administered under the skin. This convenient new form recently received approval from the Food and Drug Administration.
Merck highlights the new shot as a quicker and simpler treatment option compared to the original, which requires a lengthy intravenous infusion.
Keytruda is a broad-spectrum treatment, approved for 18 different cancers, including melanoma, lung, breast, and colon cancers. It has been administered to 2.9 million patients worldwide, famously helping former President Jimmy Carter prolong his life by almost a decade. Since its introduction in 2014, Keytruda has amassed an astounding $146 billion in sales, representing nearly half of Merck’s total revenue.
While government programs like Medicare typically cover a large portion of Keytruda’s substantial annual cost – currently around $204,000 – Merck has yet to announce pricing for the new injectable form. Company leaders project the new shot, named Keytruda Qlex, will launch this fall and anticipate that up to 40% of Keytruda patients will transition to it by 2027.
Dr. Marjorie Green, a Merck executive, hailed the new version as a “meaningful advance,” emphasizing that its development aimed “to address patient and provider needs and help simplify the treatment experience.”
However, drug pricing specialists warn that Merck’s new shot could inadvertently hinder the uptake of more affordable, generic infusion alternatives. This strategy, they contend, may prolong high drug prices, ultimately burdening American taxpayers and those paying health insurance premiums.
If successful, such tactics mean “we’re all spending billions more dollars on prescription drugs,” noted Dr. Benjamin Rome, a health policy researcher at Brigham and Women’s Hospital in Boston.
This presents a complex trade-off: while many patients would undoubtedly prefer a quick injection over a prolonged infusion, Dr. Rome suggests it’s questionable whether we should continue “paying so much for these small additions on the tail end of a product that has already made billions of dollars.”
The controversy extends to Capitol Hill, where Senators Elizabeth Warren (D-Massachusetts) and Bernie Sanders (I-Vermont) have publicly accused Merck of manipulating the patent system with the introduction of the Keytruda shot.
Merck’s move is part of a broader pattern seen across the pharmaceutical industry, where companies introduce slightly modified versions of drugs, often known as “product hops,” to circumvent patent expirations and maintain high prices.
This “product hop” strategy involves a company leveraging its monopoly on an original drug, then, just before generics can enter the market, shifting to a new, patent-protected version. A notable example is AbbVie’s reformulation of Humira, a widely used arthritis drug, into a less painful, faster-injecting form. (AbbVie, however, denies that this constitutes product hopping.)
Crucially, these modified versions typically offer no significant improvements in the core aspects most vital to patients: safety and effectiveness.
“The industry has devised a perfect strategy of marketing convenience, rather than genuine therapeutic advancements,” stated Tahir Amin, CEO of I-MAK, a nonprofit dedicated to monitoring drug patents.
In recent years, several pharmaceutical companies have implemented similar “product hops” for other prominent cancer treatments such as Herceptin, Darzalex, and Opdivo. These revised formulations often incorporate hyaluronidase, an enzyme that facilitates rapid subcutaneous injection.
Billions have been spent by Medicare to cover the injectable versions of these drugs for tens of thousands of cancer patients. While prices for these new shots have mirrored their original infusion counterparts, they remain notably higher than the more affordable generic infusions offered by competitors.
Hospitals, too, find these new injections appealing, as they free up valuable infusion chairs, allowing them to serve a greater number of patients. “That’s a huge incentive to switch if you can,” explained Stacie Dusetzina, a drug pricing expert at Vanderbilt University.
The time savings are indeed substantial. A Merck-funded clinical trial demonstrated that the Keytruda shot, administered in the stomach or thigh, takes merely two minutes to inject, a stark contrast to the 30 minutes required for the original infusion. Consequently, patients receiving the shot spend just over an hour in the treatment room, compared to over two hours for the infusion. The treatment schedule remains the same, with doses every three or six weeks.
Both injection and infusion methods can lead to side effects such as local reactions and discomfort, though these are generally mild.
I-MAK reports that Merck has filed nearly 300 patents for Keytruda, a figure Merck disputes without offering an alternative. These patents could potentially extend Merck’s exclusive market control, delaying the entry of generic infusion competitors for years past Keytruda’s original patent expiration in 2028.
Merck’s strategy relies on patients already being accustomed to the convenience of the shot by the time cheaper generic infusions become available, making them less likely to revert to the slower infusion method. Oncologists emphasize their priority is patient well-being, not minimizing Medicare’s long-term expenses.
Dr. Rebecca Shatsky, a breast cancer specialist at the University of California, San Diego, articulated the challenge: “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 the majority of cancer patients, out-of-pocket costs for both infusions and shots are similar due to financial safeguards for expensive cancer treatments, Dr. Dusetzina noted. This holds true even with the arrival of cheaper generic infusions. However, patients on traditional Medicare without supplemental insurance could face higher burdens by choosing the more expensive shot, as they are responsible for 20% of the drug’s cost.
Merck also highlights that the Keytruda shot can be administered in local doctors’ offices and clinics, offering a significant advantage over often-scarce infusion centers. This decentralized access, executives claim, could drastically reduce travel times for patients, particularly those in rural communities.
Such a shift from infusion to injection could help patients avoid considerable expenses, including gas, hotel stays, and lost wages from time off work, explained Dr. Sonam Puri, a lung cancer specialist. She recounted instances where her rural patients in Utah faced 10-hour round trips for their infusions.
Many cancer patients currently receiving infusions like Keytruda expressed strong interest in treatment options that could cut down their time spent in clinics.
Chris Hebert, a 49-year-old lung cancer patient from Baton Rouge, Louisiana, shares his experience: every three weeks, he dedicates about four hours at a local infusion center, receiving his medications via a chest port.
His routine begins with pre-medications like Benadryl, Pepcid, and steroids to avert side effects. This is followed by an hour-long Imfinzi infusion, a drug similar to Keytruda that stimulates the immune system to combat cancer. After a brief ‘washout’ period, he undergoes 10 minutes of chemotherapy. Throughout, he is closely monitored for any adverse reactions. Hebert remarked, “It would be very valuable to have some of that time back.”
However, some oncologists point out that not all patients would significantly benefit from switching to shots, especially if they still require other infused medications or chemotherapy through a port.
Dr. Barbara McAneny, who manages an oncology practice in New Mexico, noted, “When we’ve offered it, we have patients who say, ‘I’ve got a port. Why would I want you to stick me?’”
She further explained that while extensive travel remains a burden for many of her rural patients, the new shots haven’t resolved this issue; patients who transitioned from infusions to shots are still undertaking the same long drives.
The original Keytruda was slated for a Medicare price reduction starting in 2028, as mandated by a Biden-era law on drug price negotiations. However, a Republican policy bill passed this summer granted Merck a one-year reprieve, delaying the price cut until 2029 due to revised regulations for drugs initially approved for rare diseases.
The applicability of the 2029 Medicare price cut to the new Keytruda shot remains uncertain, though the federal government has recently suggested it could apply.