AN ACT TO AMEND TITLE 18 OF THE DELAWARE CODE RELATING TO THE STEP THERAPY EXCEPTION PROCESS.

Children Healthcare

Passed Legislature

This bill passed both chambers and reached final enrollment, even if later executive action is not shown here.

Sponsor: Minor-Brown
Last action: 2026-05-19
Official status: House Economic Development/Banking/Insurance & Commerce 5/19/26
Effective date: Not listed

Plain English Breakdown

The bill summary does not provide details on how insurers and health plans will implement these changes.

Act to Update Step Therapy Exception Process

The bill updates Delaware's law on the step therapy exception process by including modern medical treatments like biologics and biosimilars.

What This Bill Does

Updates Delaware’s laws about when patients can get certain medicines without trying cheaper alternatives first.
Adds new rules for interchangeable biologic drugs and biosimilar drugs, allowing insurers to require patients to try these before getting the original brand-name drug.

Who It Names or Affects

Patients who need specific medical treatments
Health insurance companies and health plans

Terms To Know

Biologics: Complex medicines made from living cells, often used to treat serious diseases.
Biosimilars: Drugs that are similar to existing biologic drugs but can be less expensive after the original drug's exclusivity period ends.

Limits and Unknowns

The bill does not specify when it will take effect.
It is unclear how insurance companies and health plans will implement these changes.

Bill History

2026-05-19 Delaware General Assembly
Introduced and Assigned to Economic Development/Banking/Insurance & Commerce Committee in House

Official Summary Text

AN ACT TO AMEND TITLE 18 OF THE DELAWARE CODE RELATING TO THE STEP THERAPY EXCEPTION PROCESS.
This Act modernizes Delaware law by adding modern medical treatment options biologics or biosimilars to the step therapy exception process. The current law was passed before biosimilars were widely available. Biosimilars are to biologics what generic drugs are to traditional drugs once their exclusivity expires.
This revision adds an exclusion to step therapy protocol exceptions for interchangeable biologics and biosimilars.

Current Bill Text

Read the full stored bill text

Legislation Document

SPONSOR:

Rep. Minor-Brown & Sen. Pinkney

Reps. Heffernan, K. Johnson, Morrison, Burns; Sen. Seigfried

HOUSE OF REPRESENTATIVES

153rd GENERAL ASSEMBLY

HOUSE BILL NO. 429

AN ACT TO AMEND TITLE 18 OF THE DELAWARE CODE RELATING TO THE STEP THERAPY EXCEPTION PROCESS.

BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF DELAWARE:

Section 1. Amend § 3381, Title 18 of the Delaware Code by making deletions as shown by strike through and insertions as shown by underline as follows:

§ 3381. Step therapy exception process [For application of this section, see 82 Del. Laws, c. 44, § 3].

(e) This section shall not be construed to prevent any of the following:

(1) An insurer, health plan, or utilization review entity

from requiring a patient to try an AB-rated generic equivalent prior to providing coverage for the equivalent branded prescription drug.

from requiring a patient to try either of the following:

a. An AB-rated generic equivalent or an interchangeable biological product as defined in 42 U.S.C. § 262(i)(3) prior to providing coverage for the equivalent branded prescription drug.

b. A biosimilar as defined in 42 U.S.C. § 262(i)(2) prior to providing coverage for the brand name prescription reference product drug or drugs.

Section 2. Amend § 3591, Title 18 of the Delaware Code by making deletions as shown by strike through and insertions as shown by underline as follows:

§ 3591. Step therapy exception process [For application of this section, see 82 Del. Laws, c. 44, § 3].

(e) This section shall not be construed to prevent:

(1) An insurer, health plan, or utilization review entity

from requiring a patient to try an AB-rated generic equivalent prior to providing coverage for the equivalent branded prescription drug.

from requiring a patient to try either of the following:

a. An AB-rated generic equivalent or an interchangeable biological product as defined in 42 U.S.C. § 262(i)(3) prior to providing coverage for the equivalent branded prescription drug.

b. A biosimilar as defined in 42 U.S.C. § 262(i)(2) prior to providing coverage for the brand name prescription reference product drug or drugs.

SYNOPSIS

This Act modernizes Delaware law by adding modern medical treatment options biologics or biosimilars to the step therapy exception process. The current law was passed before biosimilars were widely available. Biosimilars are to biologics what generic drugs are to traditional drugs once their exclusivity expires.

This revision adds an exclusion to step therapy protocol exceptions for interchangeable biologics and biosimilars.