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

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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: 2026-06-24
Official status: Passed 6/24/26
Effective date: Not listed

Plain English Breakdown

The bill passed both chambers but has no listed effective date yet; it is ready for Governor action.

HB429: Updating Step Therapy Rules for Biologics

This bill updates Delaware law so that insurance companies can require patients to try certain lower-cost biological drugs before covering more expensive brand-name versions.

What This Bill Does

Updates the state code to include biologics and biosimilars in step therapy rules.
Allows insurers, health plans, or utilization review entities to require a patient to try an interchangeable biological product before providing coverage for the equivalent branded prescription drug.
Permits these entities to require trying a biosimilar before covering a brand-name reference product.

Who It Names or Affects

Insurance companies and health plans operating in Delaware
Utilization review entities that check drug coverage requests

Terms To Know

Step therapy exception process: A legal rule regarding when insurance must cover a specific medicine without requiring the patient to try other options first.
Biosimilar: A drug that is very similar to an existing brand-name biological product, comparable to how generic drugs relate to traditional drugs once exclusivity expires.

Limits and Unknowns

The official text does not state the effective date for these new rules.
The source material describes what insurers can require but does not detail the specific steps patients or doctors must take to request an exception if they cannot use these lower-cost options.

Bill History

2026-06-24 Delaware General Assembly
Passed By Senate. Votes: 21 YES
2026-06-23 Delaware General Assembly
Reported Out of Committee (Banking, Business, Insurance & Technology) in Senate with 5 On Its Merits
2026-06-11 Delaware General Assembly
Passed By House. Votes: 38 YES 1 NO 2 ABSENT
2026-06-11 Delaware General Assembly
Assigned to Banking, Business, Insurance & Technology Committee in Senate
2026-06-09 Delaware General Assembly
Reported Out of Committee (Economic Development/Banking/Insurance & Commerce) in House with 3 Favorable, 6 On Its Merits
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, Harris, Berry, Carson, Lambert, Ross Levin, Snyder-Hall; Sens. Seigfried, Poore

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.