SECTION 354.1924. Preferred Drug List

(a) Purpose. This section implements the provisions of §531.072, Government Code, which directs the Health and Human Services Commission (HHSC) to develop and implement a preferred drug list (PDL) for the Texas Medical Assistance Program.

(b) Applicability. This section applies to drugs included in the Texas Drug Code Index (TDCI) established under §354.1921 of this title (relating to Addition of Drugs to the Texas Drug Code Index).

(c) Selection of drugs for the PDL. HHSC will include a drug listed on the TDCI in the PDL on the basis of:

(1) The recommendations of the Drug Utilization Review Board (DUR Board) established under §354.1941 of this subchapter (relating to Drug Utilization Review Board);

(2) The clinical efficacy of the drug, consistent with the determination of the Food and Drug Administration and the recommendations of the DUR Board;

(3) Comparison of the price of the drug and the price of competing drugs. For purposes of this section, the price of a drug is determined by reference to the reimbursement for the drug established under §355.8541 of this title (relating to Legend and Nonlegend Medications) and after deducting Texas and federal rebates;

(4) A program benefit offered by the manufacturer or labeler of the drug and accepted by HHSC in accordance with §531.070, Government Code; and

(5) Written evidence offered by a manufacturer or labeler supporting the inclusion of a product on the PDL.

(d) Distribution of PDL. HHSC will publish the PDL on its Internet website (http://www.hhsc.state.tx.us/). A health care provider may also request a copy of the PDL from HHSC by sending a written request to the HHSC or its designee.

(e) Revisions to the PDL. Within 10 days following HHSC's decision on the recommendations of the DUR Board, HHSC will publish the revised PDL.

(f) Exclusion of a drug from the PDL. A drug that is not included in the PDL will be subject to prior authorization by HHSC or its designee in accordance with §354.1832 of this title (relating to Prior Authorization Procedures).

(g) Agreement on supplemental rebate necessary. HHSC will only include on the PDL drugs provided by a manufacturer or labeler that reaches an agreement on a supplemental rebate with HHSC in accordance with §531.070 of the Government Code. Such agreement may provide for a program benefit offered by the manufacturer or labeler of the drug and accepted by HHSC in accordance with §531.070, Government Code.

(h) Notwithstanding subsection (g) of this section, the preferred drug list may contain a drug provided by a manufacturer or labeler that has not reached a supplemental rebate agreement with HHSC if HHSC determines that inclusion of the drug on the preferred drug list will have no negative cost impact to the state, in accordance with §531.072 of the Government Code.

Source Note: The provisions of this §354.1924 adopted to be effective November 16, 2003, 28 TexReg 9802; amended to be effective June 9, 2010, 35 TexReg 4659; amended to be effective February 9, 2016, 41 TexReg 960