Prior Authorization of New Drug Entities or New Drug Dosage Form

PURPOSE: This rule outlines how new drugs or new drug dosage forms of existing drugs may be subject to prior authorization before payment by MO HealthNet Division (MHD). (1) New drug entities and new drug product dosage forms of existing drug entities are eligible to be covered, as defined in 13 CSR 70-20.030, and shall comply with prior authorization requirements imposed by MHD, in compliance with federal law. (2) Prior authorization shall continue on new drug entities and new drug product dosage forms of existing drugs until reviewed by MHD and MHD eliminates the prior authorization or makes a final determination to require continued prior authorization. MHD shall consider known cost and utilization data, medical and clinical criteria, and prudent utilization of state funds in the review. Interested parties may present clinical data to MHD. (3) The review referenced in section (2) shall begin within thirty (30) business days after MHD receives notice through the weekly national compendia file of the availability of the drug entity on the market and if the drug is eligible to be covered as defined in 13 CSR 70-20.030, whichever is later. The review shall take no more than forty-five (45) business days from the start of the review. Upon completion of the review, MHD shall remove the prior authorization requirements or refer the new drug or new drug dosage form to the Prior Authorization Committee with a recommendation for continued prior authorization. MHD recommendations regarding continued prior authorization of a new drug or new drug dosage form shall be made in writing to the Prior Authorization Committee. A copy shall be available to the public before the Prior Authorization Committee meeting in which the continued prior authorization is to be discussed. (4) The Prior Authorization Committee shall consider any recommendations related to continued prior authorization requirements of a new drug or new drug dosage form no later than one hundred ninety (190) calendar days after the new drug review is completed. The Prior Authorization Committee shall allow three (3) minutes for any interested parties who have notified MHD before the scheduled meeting to comment about such proposed prior authorization requirements. (5) If the Prior Authorization Committee finds that utilization and cost data, pharmacoeconomic information, and medical and clinical implications of restriction are documented and prior authorization is warranted, the Prior Authorization Committee shall make a recommendation to MHD. Such recommendation shall be provided to MHD prior to MHD making a final determination. MHD shall provide notice of the final determination through the Department of Social Services, MHD website at https://mydss.mo.gov/mhd/pharmacy-clinicaledits-pdl. (6) If, after the hearing referenced in section (5) above, prior authorization of the new drug or new drug dosage form is required, the prior authorization requirement shall be reviewed at least once every twelve (12) months by the Prior Authorization Committee. AUTHORITY: sections 208.201 and 660.017, RSMo 2016, and section 208.153, RSMo Supp. 2024.* Emergency rule filed May 22, 2002, effective June 1, 2002, expired Nov. 27, 2002. Original rule filed June 3, 2002, effective Nov. 30, 2002. Amended: Filed Sept. 16, 2013, effective March 30, 2014. Amended: Filed Jan. 20, 2021, effective July 30, 2021. Amended: Filed Oct. 16, 2024, effective May 30, 2025. *Original authority: 208.153, RSMo 1967, amended 1967, 1973, 1989, 1990, 1991, 2007, 2012, 2024; 208.201, RSMo 1987, amended 2007; and 660.017, RSMo 1993, amended 1995.