Prescribing shifts away from me-too drugs

Clinical takeaway: The long-familiar agent in a crowded class may no longer be the easiest one to get covered. Confirming coverage before committing a patient can spare a denial and a switch.

Coverage in a crowded drug class has become hard to predict. When several agents do roughly the same thing, none is indispensable to a formulary, and the one a plan covers this year may not be the one it covers next. A drug with no close substitute rarely poses that problem.

A new analysis scored about 600 branded small-molecule drugs approved and marketed between 2000 and 2019 for novelty, comparing molecular structure, biological target, and how each drug is delivered and absorbed, then followed prescriptions and revenue. Me-too drugs, ones with incremental improvements on existing options, steadily lost ground.

The post-2013 run-up in drug spending has usually been pinned on a handful of expensive launches, the hepatitis C cures above all. If spending growth traces to a few outlier prices, price caps are the obvious remedy. But if it traces instead to steady movement toward drugs that stand alone in their class, the lever is coverage design, and clinicians absorb the consequences of that lever directly.

The divergence starts around 2013. Among drugs aimed at biological targets few other approved drugs share, mean gross revenue per drug rose to about $1.6 billion from about $400 million by 2019, while revenue for less novel drugs in that category stayed relatively flat. The gap largely held after accounting for the rebates manufacturers pay health plans and pharmacy benefit managers.

Prescriptions for the most novel drugs rose across the period while prescriptions for less novel drugs fell, pointing to wider use rather than higher prices. The pattern appeared on all three novelty measures, not one. Revenue also climbed among novel drugs approved well before 2013.

The retrospective analysis matched a public database of drug characteristics to FDA approval records, then linked spending from the Medical Expenditure Panel Survey, a nationally representative survey of US health care use, to pricing and rebate data. That let researchers track revenue per drug before and after discounts, with each drug rated low, medium, or high on each novelty measure.

If the pattern holds, what shapes the available option set is formulary design rather than price regulation, and it operates long before a prescription is written. Coverage committees weigh agents against each other by substitutability, and that reasoning surfaces at the point of care as a denial with no clinical rationale attached. The denial is a statement about the class, not about the patient.

"Market forces and government policies appear to be evolving in ways that better reward pharmaceutical innovation. As policymakers continue to scrutinize drug spending, our findings suggest this spending is increasingly on treatments more likely to represent true scientific advances," said study coauthor Darius N. Lakdawalla, chief scientific officer at the USC Schaeffer Center for Health Policy & Economics.

Source: Jiao B, et al (2026 Aug 3). Health Aff. Highly novel drugs outperformed less novel drugs in gross and net revenues in the US, driven primarily by utilization, 2013-19