Delaware’s insurance regulator is stepping in to clarify rules around step therapy exceptions, especially when it comes to biologic drugs. On March 24, 2026, the Delaware Department of Insurance issued a bulletin aimed at all insurers and health plans regulated under the state law. The notice highlights concerns that some carriers might be stretching exceptions made for certain prescription drugs to cover biologics in ways that the law doesn’t support.
The rules in question date back to 2020 and set a clear process for patients and doctors to request exceptions to step therapy. Step therapy typically requires patients to try less expensive drugs before moving on to pricier options, but the law ensures doctors can override this when necessary to protect patient health. There’s a specific part of the law that allows carriers to ask patients to try an AB-rated generic equivalent before covering a brand-name drug. However, the Department says this does not apply to biologics and their biosimilars because biologics aren’t considered branded prescription drugs, nor do they have generic equivalents in the usual sense.
The Department pointed out that while biologics and biosimilars might seem similar to brand-name drugs and generics, the law’s language is clear and limits the generic-equivalent rule strictly to certain types of drugs. Insurers applying this exception to biologics are going beyond what the law allows.
This bulletin is effective immediately and will stay in place unless new laws or rules replace it. Insurers operating in Delaware are being urged to review their step therapy policies to make sure they comply and don’t wrongly treat biologics like brand-name drugs under the generic-equivalent exception.
For any questions, the Delaware Department of Insurance has provided a contact email. This move puts carriers on notice to follow the state’s step therapy rules carefully and respect the clinical decisions made by healthcare providers.