Under step therapy, a plan covers the preferred treatment first. Only if it fails, is not tolerated, or is clinically inappropriate will the plan cover the next option. A brand placed behind a competitor in a step edit may lose most new patients in that plan, even though it is technically covered.
Plans use step therapy to manage costs, often in favor of products for which they receive larger rebates, or in favor of generics and biosimilars. Clinicians and patient groups often criticize it for delaying the right treatment.
Many US states have passed laws requiring health plans they regulate to offer a clear, timely process for requesting an exception, for example when a patient has already tried the preferred drug or it would be harmful. The rules vary by state and do not apply to all types of plans.
For market access teams, step edits are among the most consequential changes to watch. A new step edit that favors a competitor, or the removal of one that favored you, can shift a brand’s share within a quarter.