Keytruda, a leading cancer medication, currently holds the title of the world’s best-selling drug. However, with more affordable competitors expected to emerge by 2028, its manufacturer, Merck, faces the prospect of losing significant revenue.
In a strategic move to safeguard its earnings, Merck has developed an innovative version of Keytruda, administered as a subcutaneous injection. This new formulation recently gained approval from the Food and Drug Administration. Merck highlights the new injectable format as a faster and simpler option for patients, contrasting it with the original intravenous infusion therapy. Company executives have indicated plans to launch this shot, Keytruda Qlex, this autumn, anticipating that by 2027, up to 40% of current Keytruda users will have transitioned to the new formulation.
Approved for treating 18 different cancer types—including skin, lung, breast, and colon cancers—Keytruda has been a lifeline for 2.9 million patients, notably extending former President Jimmy Carter’s life for almost a decade. Since its launch in 2014, the drug has amassed an impressive $146 billion in sales, representing nearly half of Merck’s total revenue.
Many government-funded programs, such as Medicare, currently absorb a significant portion of Keytruda’s annual cost, which stands at approximately $204,000 per patient. Merck has yet to disclose the pricing for this newly approved injectable version.
Dr. Marjorie Green, a Merck executive, hailed the injection as a ‘meaningful advance,’ emphasizing its development to meet patient and provider demands by streamlining the treatment journey.
However, drug pricing specialists warn that this new shot could impede the market entry of more affordable generic infusions, thereby prolonging high drug costs. This burden would ultimately fall on American taxpayers and those paying health insurance premiums.
Dr. Benjamin Rome, a health policy researcher at Brigham and Women’s Hospital in Boston, points out that such strategies, if successful, lead to consumers collectively spending billions more on prescription medications. This situation presents a complex dilemma: while many patients favor convenient injections over lengthy infusions, Dr. Rome questions the justification of paying a premium for minor enhancements to a drug that has already generated immense profits.
The new Keytruda Qlex is the subcutaneous version of Merck’s highly successful cancer drug.
Both Senator Elizabeth Warren and Senator Bernie Sanders have publicly criticized Merck, alleging that the company is exploiting the patent system through the introduction of this new Keytruda shot.
Merck’s approach is not unique; it follows a pattern set by many pharmaceutical firms that release slightly altered versions of their drugs to sustain high prices long after initial patents would typically expire.
This tactic, often termed a ‘product hop,’ involves a company maximizing its monopoly on an existing drug before transitioning to a new, patent-protected version just as generic competition is about to emerge. A notable example is AbbVie’s reformulation of Humira, a major arthritis drug, to create a less painful and quicker injection, though AbbVie refutes claims of ‘product hopping.’
Crucially, these updated formulations typically do not offer significant improvements in safety or effectiveness, which are paramount concerns for patients.
Tahir Amin, CEO of I-MAK, a nonprofit dedicated to tracking drug patents, characterizes this as an industry strategy focused on ‘selling convenience, as opposed to something therapeutically better.’
Over recent years, similar ‘product hops’ have been observed with several other high-cost, widely-used cancer medications, including Herceptin, Darzalex, and Opdivo. These modified versions often incorporate hyaluronidase, an ingredient that facilitates rapid subcutaneous injection.
Medicare has allocated billions to cover these injectable drugs for tens of thousands of cancer patients. While the prices for these new shots remain comparable to the original infusions, they are notably higher than those offered by generic competitors.
Hospitals have embraced these new injections, as they alleviate the demand for infusion chairs, enabling more efficient patient care. Stacie Dusetzina, a drug pricing expert at Vanderbilt University, notes this as a ‘huge incentive to switch’ for healthcare providers.
Illustrating this trend, drugs like Humira (for arthritis) have also been reformulated into less painful, faster-acting injections.
The time efficiency is substantial: a Merck-funded clinical trial demonstrated that the Keytruda injection, administered to the stomach or thigh, takes merely two minutes, in stark contrast to the 30-minute intravenous infusion. This reduces a patient’s total time in the treatment room from over two hours to just over one, with dosing schedules remaining at every three or six weeks.
Both infusion and injection methods carry similar, typically minor, side effects such as localized reactions and pain.
I-MAK reports that Merck has pursued close to 300 patents for Keytruda, a figure Merck contests without offering an alternative. These numerous patents could potentially allow Merck to prevent generic infusion competitors from entering the market for years past 2028, the year its primary patents are set to expire.
Merck appears to be counting on patients adopting the convenient shot before cheaper generics become available, making them less inclined to revert to a slower infusion. Oncologists, however, prioritize patient well-being over minimizing Medicare’s long-term expenditures.
Dr. Rebecca Shatsky, a breast cancer specialist at the University of California, San Diego, highlights the challenge of asking patients to switch back: ‘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.’
Dr. Dusetzina explains that due to financial protections for high-cost cancer care, most patients incur similar out-of-pocket costs for both infusions and shots, even when cheaper generics become available. However, for those on traditional Medicare without supplemental insurance, opting for the more expensive shot could increase their financial burden, as they are responsible for 20% of the drug’s cost.
Merck emphasizes that the Keytruda shot can be administered in local doctors’ offices and clinics, bypassing the need for less accessible infusion centers. This, according to Merck executives, could significantly cut down on patient travel times, particularly for those in rural regions.
This shift from infusion to injection could also help patients save on travel expenses like gas and hotels, and reduce lost income from unpaid time off work. Additionally, it frees up valuable space in busy infusion centers.
Dr. Sonam Puri, a lung cancer specialist at Moffitt Cancer Center in Florida, agrees, noting that in her previous practice in rural Utah, some patients faced grueling 10-hour round trips for infusions. The injectable option offers a welcome respite from such burdens.
Many cancer patients receiving infusions have expressed a strong desire for treatment alternatives that minimize the 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 approximately four hours at an infusion center, receiving medication through a chest port. His regimen includes side-effect preventative drugs, an hour of Imfinzi (an immunotherapy similar to Keytruda), a washout period, and ten minutes of chemotherapy, all under constant monitoring. Hebert expresses a clear desire to reclaim some of this extensive treatment time.
However, some oncologists contend that the benefits of shots over infusions are limited for patients who still require chemotherapy or other port-administered medications. Dr. Barbara McAneny, who manages an oncology practice in New Mexico, recounts patients’ reactions: ‘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 for her rural patients, while long travel distances are a significant challenge, switching to injections hasn’t reduced their drive times, as they still undertake the same journeys.
Initially, Keytruda’s original formulation was slated for a Medicare price reduction in 2028, a provision under a Biden-era law for drug price negotiations. Yet, a Republican policy bill passed this summer granted Merck a one-year delay, pushing the price cut to 2029 due to a revised classification for drugs initially approved for rare diseases.
The applicability of this Medicare price reduction to the new Keytruda shot, beginning in 2029, remains uncertain, though federal authorities have recently suggested it might be included.