Stricken language would be deleted from and underlined language would be added to present law.
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State of Arkansas 1
95th General Assembly A Bill 2
Regular Session, 2025 SENATE BILL 140 3
4
By: Senator J. Boyd 5
By: Representative Achor 6
7
For An Act To Be Entitled 8
AN ACT TO MANDATE THE USE OF BIOSIMILAR MEDICINES 9
UNDER HEALTH BENEFIT PLANS; TO REQUIRE A HEALTHCARE 10
PROVIDER TO PRESCRIBE BIOSIMILAR MEDICINES; TO 11
IMPROVE ACCESS TO BIOSIMILAR MEDICINES; AND FOR OTHER 12
PURPOSES. 13
14
15
Subtitle 16
TO MANDATE THE USE OF BIOSIMILAR 17
MEDICINES UNDER HEALTH BENEFIT PLANS; TO 18
REQUIRE A HEALTHCARE PROVIDER TO 19
PRESCRIBE BIOSIMILAR MEDICINES; AND TO 20
IMPROVE ACCESS TO BIOSIMILAR MEDICINES. 21
22
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF ARKANSAS: 23
24
SECTION 1. Arkansas Code Title 23, Chapter 79, is amended to add an 25
additional subchapter to read as follows: 26
27
Subchapter 29 — Mandate for Use of Biosimilar Medicines 28
29
23-79-2901. Definitions. 30
As used in this subchapter: 31
(1) "Beneficiary" means an individual who is entitled to receive 32
healthcare services under the terms of a health benefit plan; 33
(2) "Biosimilar medicine" means a biological product that is: 34
(A) Licensed under 42 U.S.C.§ 262(k), as it existed on 35
January 1, 2025; and 36 SB140
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(B) Not listed as discontinued in the United States Food 1
and Drug Administration’s Database of Licensed Biological Products, commonly 2
known as the "Purple Book"; 3
(3) "Brand drug" means a drug product for which an application 4
has been approved under 21 U.S.C. § 355(c), as it existed on January 1, 2025, 5
or a biological product, other than a biosimilar medicine, that is licensed 6
under 42 U.S.C. § 262(a), as it existed on January 1, 2025; 7
(4) "Formulary" means: 8
(A) A list of prescription drug products and biological 9
products that is developed by a pharmacy and therapeutics committee or other 10
clinical and pharmacy experts; and 11
(B) Represents a health benefit plan’s prescription drug 12
products and biological products approved for use; 13
(5) "Generic drug" means a drug product: 14
(A) For which an application has been approved under 21 15
U.S.C. § 355(j), as it existed on January 1, 2025; and 16
(B) That has been listed in the United States Food and 17
Drug Administration’s Approved Drug Products with Therapeutic Equivalence 18
Evaluations, commonly known as the "Orange Book" as therapeutically 19
equivalent to a reference listed drug, even if the manufacturer of the drug 20
product applies a trade name to the drug; 21
(6)(A) "Health benefit plan" means an individual, blanket, or 22
group plan, policy, or contract for healthcare services offered, issued, 23
renewed, delivered, or extended in this state by a healthcare insurer. 24
(B) “Health benefit plan” includes: 25
(i) Indemnity and managed care plans; and 26
(ii) Nonfederal governmental plans as defined in 29 27
U.S.C. § 1002(32), as it existed on January 1, 2025, including plans 28
providing health benefits to state and public school employees under § 21 -5-29
401 et seq. 30
(C) “Health benefit plan” does not include: 31
(i) A plan that provides only dental benefits or eye 32
and vision care benefits; 33
(ii) A disability income plan; 34
(iii) A credit insurance plan; 35
(iv) Insurance coverage issued as a supplement to 36 SB140
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liability insurance; 1
(v) A medical payment under an automobile or 2
homeowners insurance plan; 3
(vi) A health benefit plan provided under Arkansas 4
Constitution, Article 5, § 32, the Workers' Compensation Law, § 11 -9-101 et 5
seq., or the Public Employee Workers' Compensation Act, § 21 -5-601 et seq.; 6
(vii) A plan that provides only indemnity for 7
hospital confinement; 8
(viii) An accident-only plan; 9
(ix) A specified disease plan; 10
(x) A long-term-care-only plan; or 11
(xi) The Arkansas Medicaid Program; 12
(7)(A) "Healthcare insurer" means an entity subject to the 13
insurance laws of this state or the jurisdiction of the Insurance 14
Commissioner that contracts or offers to contract to provide health insurance 15
coverage, including without limitation an insurance company, a hospital and 16
medical service corporation, a health maintenance organization, or a self - 17
insured governmental or church plan in this state. 18
(B) "Healthcare insurer" does not include: 19
(i) An entity that provides only dental benefits or 20
eye and vision care benefits; or 21
(ii) The Arkansas Medicaid Program; 22
(8) "Healthcare provider" means a type of provider that renders 23
healthcare services to patients for compensation including a doctor of 24
medicine or another licensed healthcare professional acting within the 25
provider's licensed scope of practice; 26
(9) "Reference listed drug" means the listed drug product 27
identified by the United States Food and Drug Administration as a drug 28
product upon which an applicant relies in seeking approval of the applicant's 29
application submitted under 21 U.S.C. § 355(j), as it existed on January 1, 30
2025; 31
(10) "Reference product" means a single biological product that 32
is licensed by the United States Food and Drug Administration under 42 U.S.C. 33
§ 262(a), as it existed on January 1, 2025, against which a proposed 34
biosimilar medicine or interchangeable biological product is compared and 35
listed as a reference product in the United States Food and Drug 36 SB140
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Administration’s Database of Licensed Biological Products, commonly known as 1
the "Purple Book"; and 2
(11) "Wholesale acquisition cost" means the same as defined in 3
section 1847A(c)(6)(B) of the Social Security Act, 42 U.S.C. § 1395w -3a, as 4
it existed on January 1, 2025. 5
6
23-79-2902. Mandate to prescribe biosimilar medicines. 7
(a) If a prescription biological product drug therapy is initiated to 8
treat a beneficiary enrolled in a health benefit plan and the beneficiary has 9
not previously been treated with the prescribed biological product drug 10
therapy, the healthcare provider treating the beneficiary shall prescribe a 11
biosimilar medicine to the beneficiary, if a biosimilar medicine is 12
available. 13
(b) A healthcare provider may appeal the application of this section 14
for a beneficiary with step therapy protocols under § 23 -79-2101 et seq. 15
16
23-79-2903. Formulary. 17
(a) A health benefit plan shall publish in a manner that is easily 18
accessible to a beneficiary, a prospective beneficiary, the state, and the 19
public an up-to-date, accurate, and complete list of all covered drug 20
products and biological products on the health benefit plan's formulary, 21
including without limitation: 22
(1) A tiering structure that has been adopted for the health 23
benefit plan; and 24
(2) Any restrictions on the manner in which a drug product or 25
biological product can be obtained. 26
(b) A formulary is easily accessible under subsection (a) of this 27
section if: 28
(1) The formulary can be viewed on the health benefit plan’s 29
public website through a clearly identifiable link or tab without requiring 30
an individual to create or access an account or enter a policy number; and 31
(2) An individual can easily discern which formulary list 32
applies to which health benefit plan if a healthcare insurer offers more than 33
one (1) health benefit plan. 34
(c) If a change is made to the formulary of a health benefit plan 35
during the plan year, the easily accessible formulary shall: 36 SB140
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(1) Be updated within thirty (30) calendar days; and 1
(2) Contain, in bold type, the date of the update, with the 2
updates clearly identifiable. 3
4
23-79-2904. Generic drugs. 5
(a) If a generic drug is marketed pursuant to such approval, and has a 6
wholesale acquisition cost that is less than the wholesale acquisition cost 7
of the reference listed drug on the generic drug’s initial date of marketing, 8
then a health benefit plan that provides coverage for the generic drug’s 9
reference listed drug at the time of the generic drug’s marketing date shall: 10
(1) Immediately make the generic drug available on the formulary 11
with more favorable cost sharing, including without limitation actual out -of-12
pocket costs, relative to the reference listed drug; and 13
(2) Not impose: 14
(A) A prior authorization, a step therapy requirement, or 15
other limitation on coverage of a generic drug for which formulary placement 16
is required under this section; or 17
(B) A restriction on a pharmacy through which a 18
beneficiary may obtain the generic drug that makes it more difficult for the 19
beneficiary to obtain coverage of or access to the generic drug than to 20
obtain coverage of or access to the reference listed drug. 21
(b) This section shall remain in force as long as the wholesale 22
acquisition cost of a generic drug is lower than the wholesale acquisition 23
cost of the generic drug's reference listed drug. 24
25
23-79-2905. Biosimilar medicines. 26
(a) If a biosimilar medicine is marketed pursuant to such licensure, 27
and has a wholesale acquisition cost that is less than the wholesale 28
acquisition cost of the reference product of the biosimilar medicine on the 29
initial date of marketing, then a health benefit plan that provide coverage 30
for the biosimilar medicine’s reference product at the time of the biosimilar 31
medicine’s marketing date shall: 32
(1) Immediately make at least one (1) biosimilar medicine 33
available on the formulary on a tier with more favorable cost sharing, 34
including actual out -of-pocket costs, relative to the reference product; and 35
(2) Not impose: 36 SB140
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(A) A prior authorization, a step therapy requirement, or 1
other limitation on coverage of a biosimilar medicine for which formulary 2
placement is required under this section; or 3
(B) A restriction on a pharmacy through which a 4
beneficiary may obtain the biosimilar medicine that makes it more difficult 5
for a beneficiary to obtain coverage of or access to the biosimilar medicine 6
than to obtain coverage of or access to the reference product. 7
(b) This section shall remain in force as long as the wholesale 8
acquisition cost of a biosimilar medicine is lower than the wholesale 9
acquisition cost of the biosimilar medicine's reference product. 10
11
23-79-2906. Purpose and construction of subchapter. 12
(a) A health benefit plan is not required under this subchapter to: 13
(1) Continue providing coverage for a brand drug after a generic 14
drug or biosimilar medicine is approved or licensed, as applicable, and 15
marketed; or 16
(2) Provide coverage for a brand drug, generic drug, biological 17
product, or biosimilar medicine if the pharmacy and therapeutics committee or 18
the clinical and pharmacy experts that develop the health benefit plan’s 19
formulary determines that the brand drug, generic drug, biological product, 20
or biosimilar medicine is no longer medically appropriate or cost -effective. 21
(b) The application of this subchapter shall not interfere with or 22
prevent a pharmacy from the practice of pharmacy as defined in § 17 -92-101. 23
24
23-79-2907. Rules. 25
(a) The Insurance Commissioner may promulgate rules necessary to 26
implement this subchapter. 27
(b) The State Board of Finance may promulgate rules necessary to 28
implement this subchapter that may apply to the State and Public School Life 29
and Health Insurance Program. 30
31
SECTION 2. DO NOT CODIFY. Effective date. This act is effective on 32
and after January 1, 2026. 33
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