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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:
1 Section 1. Amend § 3381, Title 18 of the Delaware Code by making deletions as shown by strike through and
2 insertions as shown by underline as follows:
3 § 3381. Step therapy exception process [For application of this section, see 82 Del. Laws, c. 44, § 3].
4 (e) This section shall not be construed to prevent any of the following:
5 (1) An insurer, health plan, or utilization review entity from requiring a patient to try an AB-rated generic
6 equivalent prior to providing coverage for the equivalent branded prescription drug. from requiring a patient to try
7 either of the following:
8 a. An AB-rated generic equivalent or an interchangeable biological product as defined in 42 U.S.C. §
9 262(i)(3) prior to providing coverage for the equivalent branded prescription drug.
10 b. A biosimilar as defined in 42 U.S.C. § 262(i)(2) prior to providing coverage for the brand name
11 prescription reference product drug or drugs.
12 Section 2. Amend § 3591, Title 18 of the Delaware Code by making deletions as shown by strike through and
13 insertions as shown by underline as follows:
14 § 3591. Step therapy exception process [For application of this section, see 82 Del. Laws, c. 44, § 3].
15 (e) This section shall not be construed to prevent:
16 (1) An insurer, health plan, or utilization review entity from requiring a patient to try an AB-rated generic
17 equivalent prior to providing coverage for the equivalent branded prescription drug. from requiring a patient to try
18 either of the following:
19 a. An AB-rated generic equivalent or an interchangeable biological product as defined in 42 U.S.C. §
20 262(i)(3) prior to providing coverage for the equivalent branded prescription drug.
21 b. A biosimilar as defined in 42 U.S.C. § 262(i)(2) prior to providing coverage for the brand name
22 prescription reference product drug or drugs.
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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.
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