AN ACT TO AMEND TITLE 18 OF THE DELAWARE CODE RELATING TO THE STEP THERAPY EXCEPTION PROCESS.
HB429 amends Delaware insurance law governing the step therapy exception process. The bill updates two sections of Title 18 to clarify that insurers, health plans, and utilization review entities may require a patient to first try an AB-rated generic equivalent, an interchangeable biological product, or a biosimilar before covering the corresponding brand-name prescription drug or reference product.
The measure is intended to modernize existing law by incorporating newer biologic drug categories that were not widely available when the current step therapy provisions were enacted. In practical terms, it aligns the statute with current federal definitions for interchangeable biologics and biosimilars and preserves the ability of payers to use step therapy protocols for these products.
HB429 changes Delaware’s insurance code by amending §§ 3381 and 3591 of Title 18, expanding the express list of drugs that may be required before coverage of a more expensive brand-name medication. It affects insurers, health plans, utilization review entities, and patients seeking coverage for prescription drugs, especially biologics and biosimilars. The bill does not eliminate step therapy exceptions; rather, it updates the statute to reflect modern drug categories and coverage practices.
The bill appears generally favorable and technical in nature, with the synopsis framing it as a modernization of outdated law rather than a major policy shift. No committee transcript or vote record was provided, so there is no documented opposition or recorded debate in the supplied materials. The overall tone of the bill text suggests support for aligning Delaware law with current pharmaceutical terminology and market realities.
The main policy issue is whether step therapy should explicitly include interchangeable biologics and biosimilars alongside AB-rated generics before brand-name coverage is required. Supporters would view this as a sensible update that reflects current medical and insurance practice, while any concern would likely come from patient advocates or providers worried about delays in access to preferred therapies. However, no specific objections, amendments, or recorded dissent are included in the provided materials.