Ask anyone who has been through cancer treatment how long an infusion day really is. There's the drive to the hospital or infusion center, the wait, the hours connected to an IV line, and the ride home, often with someone else behind the wheel because the patient is too exhausted or nauseated to drive. Work gets missed. Childcare gets arranged. A spouse or friend gives up their day, too. For many patients, that routine repeats every few weeks for months at a time.
Thankfully, that routine has started to change. Some of the most widely used cancer immunotherapies now come in versions given as an injection that takes a matter of minutes, rather than through an infusion that can take hours. The core medicines are the same, but the products are not. They generally contain a new ingredient that allows the therapy to be injected under the skin, and each has to earn its own FDA approval, backed by rigorous clinical trials.
These improvements give patients valuable time back over the course of their treatment plan.
But now, a Medicare proposal is putting that progress at risk.
The Centers for Medicare & Medicaid Services will soon finalize rules for the next round of the Medicare Drug Price Negotiation Program. One provision would treat a newer injectable version as the same drug as the older IV version made by the same company. The injectable would fall under the IV product's negotiated price, even though it was approved years later on the strength of its own clinical evidence.
CMS is attempting to close a legal loophole that allows companies to dodge a negotiated price with a trivial change, such as introducing a 15mg dose of a 10mg drug that is given the same way. The agency is right to do so. While the law that created Medicare price negotiations is flawed, CMS has the authority and responsibility to implement it well.
But the current provision is too broad. It does not differentiate between a trivial change and a genuinely new way of delivering care.
CMS knows this. When the agency considered a similar policy last year, it set the idea aside, explaining that it needed more time to develop objective criteria. The revised version still doesn't contain them.
The objective line already exists. When the FDA -- the agency Congress charged with deciding what a medicine is -- approves a product on the strength of its own clinical trial against the original, that is evidence that the new drug is not a minor modification.
Proving that an injection is as effective and safe as an infusion takes years of formulation work and new clinical trials. That's exactly the kind of work policymakers should encourage, because when it succeeds, patients benefit.
Moreover, price is not the same thing as a cost. Negotiation is meant to make medicines more affordable for patients. But if a lower price on paper means the next injectable version is never developed, patients keep paying in other ways: the cost-sharing that comes with longer facility visits, gas and parking, their own lost wages, and the lost wages of the person who drove them. Rural patients and working families, who often travel farther and have less flexibility at work, feel those costs first.
This isn't only about cancer. Some injectable treatments have emerged for neurological and autoimmune conditions like myasthenia gravis, a neuromuscular autoimmune disease. But many others are still IV infusions. Each of those treatments is an opportunity to give patients the same kind of win.
Yet if Medicare prices the improved treatment exactly as it would a trivial dosage tweak, there is little incentive for companies to go through years of work and a new round of clinical trials to develop these treatments. Why invest all that time when the finished product will be treated as though it were simply a new label on the old vial?
CMS can still get this right. As it finalizes the rule, the agency should withdraw the fixed-dose combination provision in its current form, since it cannot reliably distinguish gaming from genuine, separately approved therapies that patients rely on. If the agency proceeds, it should narrow the policy to target actual evasion, using separate FDA approval as the test, and assess the impact on site of care, treatment stability, and patients' total cost of care before the policy takes effect.
Medicare negotiation was sold as a way to make treatment more affordable for patients. It should not, through a definitional technicality, keep them in an infusion chair.
Terry Wilcox is Chief Patient Advocate at Patients Rising.
