A11256 — Requires health plan coverage to include certain generic drugs and biosimilars

Summary

Requires health plan coverage to include generic drugs and biosimilars where the wholesale acquisition cost of such generic drugs or biosimilars is lower than the brand drug's wholesale acquisition cost.

Bill Text

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Compared against the New York Consolidated Laws as published AI-generated reading aid — verify against the official bill.

This bill amends 1 section(s) of the New York Consolidated Laws: Section 3242 of the insurance law.

• Section 3242 of the insurance law

  (d) (1) For the purposes of this subsection, the following terms shall have the following meanings: (A) "Biosimilar" means any biological product that is licensed under 42 U.S.C.§ 262(k) and has been listed in the FDA's database of licensed biological products, commonly referred to as the purple book, as biosi- milar to or interchangeable with a reference biological product. (B) "Brand drug" means a drug for which an application has been approved under 21 U.S.C. § 355(c), or a biological product, other than a biosimilar, that is licensed under 42 U.S.C. § 262(a). (C) "FDA" means the U.S. Food and Drug Administration. (D) "Formulary" means a list of prescription drugs that is developed by a pharmacy and therapeutics committee or other clinical and pharmacy experts and represents a policy's prescription drugs approved for use. (E) "Generic drug" means a drug for which an application has been approved under 21 U.S.C. §355(j) and which has been listed in the FDA's approved drug products with therapeutic equivalence evaluations, common- ly referred to as the orange book, as therapeutically equivalent to a reference drug, even if the manufacturer of such drug applies a trade name to the drug. (F) "Policy" means a policy delivered or issued for delivery in this state that provides coverage for prescription drugs. (G) "Reference listed drug" is the listed drug identified by the FDA as the drug product upon which an applicant relies in seeking approval of its application submitted under 21 U.S.C. §355(j). (H) "Reference product" is a single biological product, licensed by the FDA under 42 U.S.C. § 262(a), against which a proposed biosimilar or italics interchangeable product is compared, and listed as a reference product in the FDA's database of licensed biological products, commonly referred to as the purple book. (I) "Wholesale acquisition cost" has the same meaning as defined by 42 U.S.C. § 1395w-3a(c)(6)(B). (2) (A) If a generic drug is approved by the FDA, is marketed pursuant to such approval, and has a wholesale acquisition cost that is less than the wholesale acquisition cost of the reference listed drug on such generic drug's initial date of marketing, then policies that provide coverage for such generic drug's reference listed drug at the time of such generic drug's marketing date shall: (i) immediately make such generic drug available on the formulary with more favorable cost sharing, including actual out-of-pocket costs, rela- tive to such reference listed drug; and (ii) not impose any prior authorization, step therapy, or other limi- tation on coverage of a generic drug for which formulary placement is required under clause (i) of this subparagraph, nor impose any restriction on a pharmacy through which an enrollee may obtain such generic drug, that makes it more difficult for an enrollee to obtain coverage of or access to such generic drug than the reference listed drug. (B) The provisions of subparagraph (A) of this paragraph shall apply as long as the wholesale acquisition cost of the generic drug is lower than the wholesale acquisition cost of the reference listed drug. (3) (A) If a biosimilar is licensed by the FDA, is marketed pursuant to such licensure, and has a wholesale acquisition cost that is less than the wholesale acquisition cost of the reference product of such biosimilar on the initial date of marketing, then policies that provide coverage for such biosimilar's reference product at the time of such biosimilar's marketing date shall: (i) immediately make at least one biosimilar available on the formu- lary on a tier with more favorable cost sharing, including actual out- of-pocket costs, relative to the reference product; and (ii) not impose any prior authorization, step therapy, or other limi- tation on coverage of a biosimilar for which formulary placement is required under clause (i) of this subparagraph, nor impose any restriction on a pharmacy through which an enrollee may obtain such biosimilar, that

  added

Action History

1. May 04, 2026

   REFERRED TO INSURANCE

Sponsors

• Josh Jensen · Primary

Subjects