.12 Preferred Drug Program.

A. The Department may establish a Pharmacy and Therapeutics Committee (Committee).

B. The Committee shall consist of the following 12 members:

(1) Five members of the Committee shall be Maryland licensed pharmacists residing in the State, including a pharmacist with expertise with mental health drugs;

(2) Five members of the Committee shall be Maryland licensed physicians residing in the State, including a psychiatrist; and

(3) Two members of the Committee shall be consumer representatives residing in the State.

C. 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.

D. The Committee members shall:

(1) Be appointed by the Secretary;

(2) Have 3 year terms;

(3) Be allowed to serve more than one term; and

(4) Elect a chairman and vice chairman.

E. The Committee shall:

(1) Meet at least twice a year;

(2) To the extent feasible, review all drug classes included on the list at least once every 12 months;

(3) Develop recommendations for a preferred drug list for the Program by considering the:

(a) Clinical efficacy of the drug;

(b) Cost effectiveness of the drug, including any supplemental rebates from manufacturers; and

(c) Needs of Program recipients, such as the ease of drug therapy administration, rate of compliance with drug therapy instructions, and frequency of prior authorization;

(4) Recommend:

(a) The addition or deletion of existing drugs as necessary;

(b) Preauthorization criteria; and

(c) Conditions or illnesses to be exempted from prior authorization based on clinical data; and

(5) Consider medically accepted off-label use of U.S. Food and Drug Administration (FDA) approved drugs.

F. The Department shall:

(1) Inform the Committee of any decisions regarding the preferred drug list;

(2) Annually publish the preferred drug list;

(3) Maintain an updated preferred drug list that is available electronically;

(4) Ensure, based upon timely notice from the manufacturer, that any new products are reviewed at the next regularly scheduled meeting of the committee;

(5) Provide an expedited review process for newly approved drugs designated as priority by the FDA; and

(6) Provide manufacturers and the public an opportunity to submit written material to the committee.

G. The preferred drug list developed by the Department based on the recommendations of the Pharmacy and Therapeutics Committee:

(1) 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;

(2) 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

(3) 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.

H. The Department may negotiate and collect supplemental rebates from manufacturers.