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ENROLLED
ACT No. 9072026 Regular Session
HOUSE BILL NO. 870
BY REPRESENTATIVE TURNER
1 AN ACT
2 To amend and reenact R.S. 44:4.1(B)(11) and to enact R.S. 22:1060.9, relative to health
3 insurance; to establish requirements for formulary placement and cost-sharing
4 obligations for specific generic drugs and biosimilars; to prohibit certain utilization
5 management practices; to provide for certain notices; to provide definitions; to
6 provide for confidentiality; to provide for exception from public records; and to
7 provide for related matters.
8 Be it enacted by the Legislature of Louisiana:
9 Section 1. R.S. 22:1060.9 is hereby enacted to read as follows:
10 §1060.9. Formulary placement; coverage requirements for certain generic drugs and
11 biosimilars
12 A. For purposes of this Section, the following terms have the meanings
13 ascribed to them in this Subsection:
14 (1) "Biosimilar" means any biological product that is licensed under 42
15 U.S.C. 262(k) and has been listed in the United States Food and Drug
16 Administration's (FDA) Database of Licensed Biological Products ("Purple Book")
17 as biosimilar to or interchangeable with a reference biological product.
18 (2) "Brand drug" means a drug for which an application has been approved
19 under 21 U.S.C. 355(c), or a biological product, other than a biosimilar, that is
20 licensed under 42 U.S.C. 262(a).
21 (3) "Formulary" means a list of prescription drugs that is developed by a
22 Pharmacy and Therapeutics (P&T) Committee or other clinical and pharmacy
23 experts and represents a health plan's prescription drugs approved for use.
24 (4) "Generic drug" means a drug for which an application has been approved
25 under 21 U.S.C. 355(j) and which has been listed in the United States Food and Drug
26 Administration's Approved Drug Products with Therapeutic Equivalence Evaluations
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1 ("Orange Book") as therapeutically equivalent to a reference drug, even if the
2 manufacturer of such drug applies a trade name to the drug.
3 (5) "Net cost calculation" means the wholesale acquisition cost minus all
4 rebates, discounts, and fees.
5 (6) "Reference listed drug" is the listed drug identified by the United States
6 Food and Drug Administration as the drug product upon which an applicant relies
7 in seeking approval of its application submitted under 21 U.S.C. 355(j).
8 (7) "Reference product" is a single biological product, licensed by the United
9 States Food and Drug Administration under 42 U.S.C. 262(a), against which a
10 proposed biosimilar or interchangeable product is compared, and listed as a reference
11 product in the United States Food and Drug Administration's Database of Licensed
12 Biological Products ("Purple Book").
13 (8) "Wholesale acquisition cost" has the same definition as "wholesale
14 acquisition cost" in 42 U.S.C. 1395w-3a(c)(6)(B).
15 B. If a generic drug is approved and marketed pursuant to Paragraph (A)(1)
16 of this Section, and has a wholesale acquisition cost that is lower than the wholesale
17 acquisition cost of its reference listed drug and any other drug sharing its reference
18 listed drug on the generic drug's initial date of marketing, a health insurance issuer
19 that provides coverage for the reference listed drug on that date shall do all of the
20 following:
21 (1)(a) Immediately make the generic drug available on the plan formulary
22 on a tier with more favorable cost-sharing, including actual out-of-pocket costs, than
23 the cost-sharing applicable to the reference listed drug.
24 (b) Not impose any prior authorization, step therapy, or any other limitation
25 on coverage of a generic drug for which formulary placement is required in
26 accordance with this Paragraph that makes it more difficult for an enrollee to obtain
27 coverage of or access to the generic drug than the reference listed drug.
28 (c) Not impose any restriction on the pharmacy through which an enrollee
29 may obtain the generic drug that makes it more difficult for an enrollee to obtain
30 coverage of or access to the generic drug than the reference listed drug.
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1 (2) The requirements of this Subsection shall remain in effect if the
2 wholesale acquisition cost of the generic drug remains lower than the wholesale
3 acquisition cost of the reference listed drug.
4 C. If a biosimilar is licensed and marketed pursuant to Paragraph (A)(3) of
5 this Section and has a wholesale acquisition cost that is lower than the wholesale
6 acquisition cost of its reference product and any other biosimilar sharing its reference
7 product on the biosimilar's initial date of marketing, a health insurance issuer that
8 provides coverage for the reference product on that date shall do all of the following:
9 (1)(a) Immediately make at least one biosimilar available on the plan
10 formulary on a tier with more favorable cost-sharing, including actual out-of-pocket
11 costs, than the cost-sharing applicable to the reference product.
12 (b) Not impose any prior authorization, step therapy, or any other limitation
13 on coverage of the biosimilar drug for which formulary placement is required in
14 accordance with this Paragraph that makes it more difficult for an enrollee to obtain
15 coverage of or access to the biosimilar drug than the reference listed drug.
16 (c) Not impose any restriction on the pharmacy through which an enrollee
17 may obtain the biosimilar that makes it more difficult for an enrollee to obtain
18 coverage of or access to the biosimilar than to the reference product.
19 (2) The requirements of this Subsection shall remain in effect if the
20 wholesale acquisition cost of the biosimilar remains lower than the wholesale
21 acquisition cost of the reference product.
22 D.(1) A health insurance issuer may utilize net cost calculation in lieu of
23 wholesale acquisition cost for purposes of determining placement on the drug
24 formulary pursuant to this Section.
25 (2) A health insurance issuer shall notify the commissioner in writing within
26 thirty days if the health insurance issuer if the health insurance issuer opts to utilize
27 the net cost calculation for a branded prescription drug in a drug formulary.
28 (3) For each National Drug Code (NDC), the notification shall provide the
29 following information for both the branded prescription drug and any available
30 generic or biosimilar:
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1 (a) Wholesale acquisition cost.
2 (b) Net cost.
3 (4) The health insurance issuer shall provide the branded prescription drug
4 cost-sharing amount and the cost-sharing amount if the generic or biosimilar was
5 added to the drug formulary at a more favorable coverage tier.
6 (5) The health insurance issuer shall include in the notification how the
7 issuer is utilizing the rebate provided by the manufacturer of the branded prescription
8 drug.
9 E.(1) To ensure transparency regarding formulary decisions, the
10 commissioner shall provide an annual report, providing a summary of the
11 notifications pursuant to this Section, including an analysis of the overall impact on
12 patient costs.
13 (2) All information and data obtained by the department pursuant to this
14 Subpart that is not otherwise publicly available is considered to be a trade secret,
15 confidential, and proprietary, is not subject to disclosure pursuant to the Public
16 Records Law, R.S. 44:1 et seq., and shall not be disclosed directly or indirectly.
17 (3) The Department of Insurance shall impose the confidentiality protections
18 of this Section on any third party that may receive or otherwise have access to this
19 information.
20 Section 2. R.S. 44:4.1(B)(11) is hereby amended and reenacted to read as follows:
21 §4.1. Exceptions
22 * * *
23 B. The legislature further recognizes that there exist exceptions, exemptions,
24 and limitations to the laws pertaining to public records throughout the revised
25 statutes and codes of this state. Therefore, the following exceptions, exemptions, and
26 limitations are hereby continued in effect by incorporation into this Chapter by
27 citation:
28 * * *
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1 (11) R.S. 22:2, 14, 31, 42.1, 88, 244, 263, 265, 461, 550.7, 550.22, 550.29, 550.30,
2 571, 572, 572.1, 572.2, 574, 601.3, 618, 639, 691.4, 691.5, 691.6, 691.7, 691.8, 691.9,
3 691.9.1, 691.10, 691.38, 691.56, 732, 752, 753, 771, 834, 972(D), 976, 1008, 1019.2, 1060.9,
4 1203, 1276, 1460, 1464, 1466, 1483.1, 1488, 1546, 1559, 1566(D), 1644, 1656, 1657.1,
5 1660.7, 1723, 1796, 1801, 1808.3, 1869, 1927, 1929, 1983, 1984, 2036, 2045, 2056, 2085,
6 2091, 2293, 2303, 2508
7 * * *
SPEAKER OF THE HOUSE OF REPRESENTATIVES
PRESIDENT OF THE SENATE
GOVERNOR OF THE STATE OF LOUISIANA
APPROVED:
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