Keytruda, Merck’s groundbreaking cancer medication, currently reigns as the world’s top-selling drug. Yet, with cheaper competitors expected to hit the market by 2028, Merck faces the daunting prospect of losing billions in revenue.
In a classic pharmaceutical strategy, Merck has unveiled a new, injectable form of Keytruda, recently approved by the Food and Drug Administration. This move aims to protect the drug’s lucrative sales.
Merck highlights the new version’s convenience, touting it as a quicker and simpler alternative to the original intravenous infusion.
Approved for 18 cancer types, including skin, lung, breast, and colon cancers, Keytruda has already treated 2.9 million patients. Notably, it helped former President Jimmy Carter live nearly a decade longer. Since its 2014 launch, Keytruda has amassed an astounding $146 billion for Merck, representing almost half of the company’s total revenue.
With an annual list price around $204,000, much of Keytruda’s cost is covered by government programs like Medicare. Merck has not disclosed pricing for the new injectable version.
Merck executives plan to launch Keytruda Qlex this fall, anticipating 40% adoption among users by 2027. Dr. Marjorie Green of Merck praises it as ‘a meaningful advance’ designed to ‘simplify the treatment experience’ for patients and providers.
However, drug pricing experts warn that this new shot will likely delay the uptake of less expensive generic infusions, ensuring higher prices persist, ultimately burdening taxpayers and those paying health insurance premiums.
Dr. Benjamin Rome, a health policy researcher, notes that such tactics mean ‘we’re all spending billions more dollars on prescription drugs.’
This presents a complex dilemma: while many patients favor quick injections over lengthy infusions, Dr. Rome questions whether such ‘small additions’ to an already massively profitable drug warrant exorbitant ongoing costs.
Senators Elizabeth Warren and Bernie Sanders have publicly criticized Merck, accusing the company of manipulating the patent system with its new Keytruda shot to maintain market dominance.
Merck’s approach is not new; many pharmaceutical companies introduce updated versions of drugs just before original patents expire, allowing them to extend high prices.
This tactic, dubbed ‘product hopping,’ involves a company enjoying its monopoly on an existing drug, then, just as generic competition looms, launching a new, patent-protected version. A notable example is AbbVie’s reformulation of Humira for arthritis, making it less painful and quicker to inject. (AbbVie disputes the ‘product hopping’ label).
Crucially, these changes typically offer no significant improvements in patient safety or drug effectiveness.
Tahir Amin, CEO of I-MAK, a nonprofit monitoring drug patents, states that the industry has perfected a strategy of ‘selling convenience, as opposed to something therapeutically better.’
Similar ‘product hops’ have occurred with other costly and widely used cancer drugs such as Herceptin, Darzalex, and Opdivo. These modified versions incorporate hyaluronidase, an enzyme that facilitates rapid subcutaneous injection.
Medicare has allocated billions to cover these injectable versions for countless cancer patients. While their prices mirror the original infusions, they remain higher than the more affordable generic infusions offered by competitors.
Hospitals welcome these new injections, as they free up valuable infusion chairs, allowing them to serve more patients. Stacie Dusetzina, a drug pricing expert, calls this ‘a huge incentive to switch.’
The time efficiency is remarkable. A Merck-funded trial demonstrated that the Keytruda shot, administered in the stomach or thigh, takes only about two minutes, a significant reduction from the 30-minute infusion. Patients receiving the shot spend just over an hour in the treatment room, compared to over two hours for the infusion, with both regimens administered every three or six weeks.
Both injection and infusion methods can lead to side effects such as local reactions and pain, though these are typically mild.
I-MAK reports that Merck has pursued almost 300 patents for Keytruda (a number Merck contests). These patents could potentially allow Merck to delay cheaper generic infusions from entering the market for years after the drug’s primary patents expire in 2028.
Merck’s strategy relies on patients already using the convenient shot by the time generic alternatives appear, making them reluctant to switch back to a slower infusion. Oncologists confirm their priority is patient well-being, not Medicare cost-cutting.
Dr. Rebecca Shatsky, a breast cancer specialist, acknowledges 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.’”
While financial protections mean similar out-of-pocket costs for most patients, regardless of infusion or shot, those on traditional Medicare without supplemental insurance could face higher burdens. If cheaper generic infusions become available, choosing the more expensive shot could mean paying a higher 20% co-pay, according to Dr. Dusetzina.
Merck states that the Keytruda shot can be administered in local doctors’ offices and clinics, unlike infusions, which often require visits to specialized, less accessible infusion centers. This could significantly reduce travel for patients, particularly those in rural communities.
Dr. Sonam Puri, a lung cancer specialist, confirms that the shift to shots could save patients money on travel and lost wages. She recounts how, in her previous practice in Utah, some rural patients faced 10-hour round trips for infusions.
Patients undergoing Keytruda infusions expressed a strong desire for treatment options that minimize their time spent in clinics.
Chris Hebert, a 49-year-old lung cancer patient, describes spending approximately four hours every three weeks at his Baton Rouge infusion center, where medicines are administered via a chest port.
His treatment regimen involves pre-medications like Benadryl, Pepcid, and steroids, followed by an hour of Imfinzi immunotherapy, a brief washout period, and then 10 minutes of chemotherapy. Hebert, who is continuously monitored for side effects, states, ‘It would be very valuable to have some of that time back.’
However, some oncologists point out that for patients still requiring chemotherapy or other port-infused medications, switching to shots offers no additional benefit.
Dr. Barbara McAneny, an oncologist in New Mexico, observes, ‘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 notes that while long travel distances are a burden for her rural patients, the shots haven’t changed that; patients who switched still face the same commute.
Keytruda’s original version was slated for a Medicare price reduction starting in 2028, a provision of a Biden-era law on drug price negotiations. However, a Republican policy bill passed this summer granted Merck a one-year delay, altering the rules 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 suggested it might apply.