<?xml version='1.0' encoding='utf-8'?>
<regulation prefix="Regulation" num=".12" citation="COMAR 10.09.03.12" title_num="10" subtitle_num="09" chapter_num="03" heading="Preferred Drug Program.">
  <paragraph num="A.">
    <text>The Department may establish a Pharmacy and Therapeutics Committee (Committee).</text>
  </paragraph>
  <paragraph num="B.">
    <text>The Committee shall consist of the following 12 members:</text>
    <paragraph num="(1)">
      <text>Five members of the Committee shall be Maryland licensed pharmacists residing in the State, including a pharmacist with expertise with mental health drugs;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Five members of the Committee shall be Maryland licensed physicians residing in the State, including a psychiatrist; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Two members of the Committee shall be consumer representatives residing in the State.</text>
    </paragraph>
  </paragraph>
  <paragraph num="C.">
    <text>Consideration for membership on the Committee shall be given to appointing physicians and pharmacists participating in the Program or with experience in developing or practicing under a preferred drug list.</text>
  </paragraph>
  <paragraph num="D.">
    <text>The Committee members shall:</text>
    <paragraph num="(1)">
      <text>Be appointed by the Secretary;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Have 3 year terms;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Be allowed to serve more than one term; and</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Elect a chairman and vice chairman.</text>
    </paragraph>
  </paragraph>
  <paragraph num="E.">
    <text>The Committee shall:</text>
    <paragraph num="(1)">
      <text>Meet at least twice a year;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>To the extent feasible, review all drug classes included on the list at least once every 12 months;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Develop recommendations for a preferred drug list for the Program by considering the:</text>
      <paragraph num="(a)">
        <text>Clinical efficacy of the drug;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Cost effectiveness of the drug, including any supplemental rebates from manufacturers; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Needs of Program recipients, such as the ease of drug therapy administration, rate of compliance with drug therapy instructions, and frequency of prior authorization;</text>
      </paragraph>
    </paragraph>
    <paragraph num="(4)">
      <text>Recommend:</text>
      <paragraph num="(a)">
        <text>The addition or deletion of existing drugs as necessary;</text>
      </paragraph>
      <paragraph num="(b)">
        <text>Preauthorization criteria; and</text>
      </paragraph>
      <paragraph num="(c)">
        <text>Conditions or illnesses to be exempted from prior authorization based on clinical data; and</text>
      </paragraph>
    </paragraph>
    <paragraph num="(5)">
      <text>Consider medically accepted off-label use of U.S. Food and Drug Administration (FDA) approved drugs.</text>
    </paragraph>
  </paragraph>
  <paragraph num="F.">
    <text>The Department shall:</text>
    <paragraph num="(1)">
      <text>Inform the Committee of any decisions regarding the preferred drug list;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Annually publish the preferred drug list;</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Maintain an updated preferred drug list that is available electronically;</text>
    </paragraph>
    <paragraph num="(4)">
      <text>Ensure, based upon timely notice from the manufacturer, that any new products are reviewed at the next regularly scheduled meeting of the committee;</text>
    </paragraph>
    <paragraph num="(5)">
      <text>Provide an expedited review process for newly approved drugs designated as priority by the FDA; and</text>
    </paragraph>
    <paragraph num="(6)">
      <text>Provide manufacturers and the public an opportunity to submit written material to the committee.</text>
    </paragraph>
  </paragraph>
  <paragraph num="G.">
    <text>The preferred drug list developed by the Department based on the recommendations of the Pharmacy and Therapeutics Committee:</text>
    <paragraph num="(1)">
      <text>May not include certain therapeutic classes including antiretroviral medications used to treat the AIDS virus, which are exempt from preauthorization as indicated in Regulation .06A(12) of this chapter;</text>
    </paragraph>
    <paragraph num="(2)">
      <text>Shall, for therapeutic classes other than those described in §G(1) of this regulation, include at least one drug approved by the FDA for use in the specific therapeutic class, in every therapeutic class for which the FDA has approved three or fewer drugs for use; and</text>
    </paragraph>
    <paragraph num="(3)">
      <text>Shall, in every therapeutic class other than those described in §G(1) of this regulation, offer a choice of at least two pharmaceutical or biological entities without an administrative preference for each therapeutic class in which there are four or more pharmaceutical or biological entities approved by the FDA.</text>
    </paragraph>
  </paragraph>
  <paragraph num="H.">
    <text>The Department may negotiate and collect supplemental rebates from manufacturers.</text>
  </paragraph>
</regulation>