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<section article="ghg" article_name="Health - General" number="21-2C-08" title_number="21" title_name="Food, Drugs, and Cosmetics" subtitle_number="2C" subtitle_name="Prescription Drug Affordability Board">
  <level label="a">
    <text>On or before December 31, 2021, the Board shall:</text>
    <level label="1">
      <text>Collect and review publicly available information regarding prescription drug product manufacturers, health insurance carriers, health maintenance organizations, managed care organizations, wholesale distributors, and pharmacy benefits managers; and</text>
    </level>
    <level label="2">
      <level label="i">
        <text>Identify states that require reporting on the cost of prescription drug products; and</text>
      </level>
      <level label="ii">
        <text>Initiate a process of entering into memoranda of understanding with the states identified under item (i) of this item to aid in the collection of transparency data for prescription drug products.</text>
      </level>
    </level>
  </level>
  <level label="b">
    <text>Based on the information collected under subsection (a)(1) of this section and obtained through memoranda of understanding under subsection (a)(2) of this section, the Board, in consultation with the Stakeholder Council, shall adopt regulations to:</text>
    <level label="1">
      <text>Establish methods for collecting additional data necessary to carry out its duties under this  subtitle; and</text>
    </level>
    <level label="2">
      <text>Identify circumstances under which the cost of a prescription drug product may create or has created affordability challenges for the State health care system and patients.</text>
    </level>
  </level>
  <level label="c">
    <text>The Board shall use the information collected under subsection (a)(1) of this section and obtained through memoranda of understanding under subsection (a)(2) of this section to identify prescription drug products that are:</text>
    <level label="1">
      <text>Brand name drugs or biologics that, as adjusted annually for inflation in accordance with the Consumer Price Index, have:</text>
      <level label="i">
        <text>A launch wholesale acquisition cost of $30,000 or more per year or course of treatment; or</text>
      </level>
      <level label="ii">
        <text>A wholesale acquisition cost increase of $3,000 or more in any 12–month period, or course of treatment if less than 12 months;</text>
      </level>
    </level>
    <level label="2">
      <text>Biosimilar drugs that have a launch wholesale acquisition cost that is not at least 15% lower than the referenced brand biologic at the time the biosimilars are launched;</text>
    </level>
    <level label="3">
      <text>Generic drugs that, as adjusted annually for inflation in accordance with the Consumer Price Index, have a wholesale acquisition cost:</text>
      <level label="i">
        <text>Of $100 or more for:</text>
        <level label="1">
          <text>A 30–day supply lasting a patient for a period of 30 consecutive days based on the recommended dosage approved for labeling by the United States Food and Drug Administration;</text>
        </level>
        <level label="2">
          <text>A supply lasting a patient for fewer than 30 days based on the recommended dosage approved for labeling by the United States Food and Drug Administration; or</text>
        </level>
        <level label="3">
          <text>One unit of the drug if the labeling approved by the United States Food and Drug Administration does not recommend a finite dosage; and</text>
        </level>
      </level>
      <level label="ii">
        <text>That increased by 200% or more during the immediately preceding 12–month period, as determined by the difference between the resulting wholesale acquisition cost and the average of the wholesale acquisition cost reported over the immediately preceding 12 months; and</text>
      </level>
    </level>
    <level label="4">
      <text>Other prescription drug products that may create affordability challenges for the State health care system and patients, in consultation with the Stakeholder Council.</text>
    </level>
  </level>
</section>
