HB 429

                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.