Before I was twelve years old, I already knew what chemotherapy was. My mother had cancer, and she was raising me alone. Every session she booked meant finding someone who could take me in for the afternoon, as a single infusion for blood cancer could stretch to seven hours in the chair due to the slow titration of the infused antibodies. Thanks to innovation and years of research, that process is much quicker and more efficient.
Drugmakers have found ways to reformulate cancer therapies for injections rather than hours-long infusions. Daratumumab, sold as Darzalex, now has a subcutaneous formulation that takes three to five minutes to administer, compared with several hours by IV. A new formulation of Pembrolizumab, sold as Keytruda, now reduces a patient’s total time in the chair by nearly half. Ocrelizumab, the multiple sclerosis drug Ocrevus, now comes in a twice-a-year injection that takes about ten minutes.
These upgrades to drug formulations and delivery mean saving hours of a patient’s life and those of their caregivers. It’s a remarkable improvement.
But a new CMS rule could jeopardize future progress on that front. This fall, the Centers for Medicare and Medicaid Services plans to finalize a rule that most patients will never read but will play an outsized role in how they experience cancer treatment, MS treatment, and everything else that used to mean an entire afternoon tethered to an IV pole. CMS released its lengthy proposal back in June, framed as a pathway to lower drug prices that also shores up the innovation pipeline by preventing Medicare price-setting from undermining the value of new drugs. The final verdict is expected this fall.
The Impact of the Inflation Reduction Act
The fight started two years ago, when the makers of the blockbuster cancer drugs Opdivo and Keytruda developed faster-acting injectable versions of their infused medicines, and critics accused the companies of trying to dodge Medicare’s negotiations through what analysts call “product hopping.” What’s at stake in CMS’s final rule, though, is whether the federal government strengthens or weakens the incentive for pharmaceutical companies to keep investing in both breakthrough treatments and the drugs that offer a real, if less dramatic, improvement to a patient’s quality of life.
For patients and their families, these breakthroughs have real meaning, and CMS should be cautious about putting this at risk.
As part of the Inflation Reduction Act, CMS reviews and expands a list of Medicare-covered drugs every year and sets so-called maximum fair prices for them. Part of that process is deciding whether a reformulation should be aggregated with the original drug’s spending for pricing purposes or counted separately. When Congress passed this, they worried that manufacturers would otherwise reformulate a product to dodge negotiation, spreading sales across versions to stay under the spending threshold that triggers selection. That’s a legitimate concern, and CMS’s own guidance has said as much.
The people who back this approach argue that reformulations are primarily predatory, a way to sidestep discounts. Sometimes that’s true. But it’s worth distinguishing that behavior from investment in research that produces a demonstrable patient benefit, the kind that took my mother’s treatment from an all-day ordeal to something closer to an inconvenience.
Let The Market Work
Reformulations don’t come free. Drug developers have to find the right dose for the new delivery method, which often differs from the original. New manufacturing lines need to be built, and safety testing is required before clinical trials can even start. Only after all of that does the FDA decide whether to approve the new formulation. Manufacturers take on this risk only when there’s a financial upside.
Treating every reformulation as functionally identical to the original drug misses that distinction. If CMS is going to allow manufacturers to demonstrate genuine patient benefit, the process needs to be as lean as possible. Turning it into a costly, bureaucratic ordeal risks discouraging companies from even trying, out of fear they’ll end up subject to maximum fair prices anyway. That, in turn, could slow the development of easier ways to get these drugs into patients.
To be fair, CMS frames this rulemaking as an effort to give manufacturers more long-term certainty, not simply to squeeze reimbursement further. But certainty only helps patients if the underlying rules leave room for real innovation to be rewarded.
It’s important we not approach this issue abstractly. Anyone who has sat in the waiting room or sat with a family member in that chair knows how long an IV drip can feel and how relieving it is when the process is cut in half or more.
As CMS finalizes its rule this fall, it should remember that time is the one thing none of us gets back, and that its rule will have very real, immediate effects on people’s lives.
Fred Roeder is a health economist and director of the Consumer Choice Center.