PURPOSE: This rule outlines the process by which new drugs or new drug dosage forms of existing drugs may be subject to prior authorization prior to payment by Missouri’s medical assistance program.

1. (1) New drug entities, and new drug product dosage forms of existing drug entities, that have been approved by the Food and Drug Administration and are available on the market, shall comply with prior authorization requirements imposed by the division, in compliance with federal law.
2. (2) Prior authorization restrictions shall continue on new drug entities and new drug product dosage forms of existing drugs until reviewed by the division and the division eliminates the restriction or makes a final determination to require restriction. The division shall consider known cost and use data, medical and clinical criteria, and prudent utilization of state funds in the review. Interested parties may present clinical data to the division.
3. (3) The review referenced in section (2) shall occur within thirty (30) business days after the division receives notice through pricing updates of the availability of the drug entity on the market. Upon completion of the review, the division shall make the drug available for use by all MO HealthNet participants or refer the new drug or new drug dosage form to the MO HealthNet Drug Prior Authorization Committee (MDPAC) with a recommendation for continued prior authorization. Staff recommendations regarding continued prior authorization of a new drug or new drug dosage form shall be made in writing to the MDPAC. A copy shall be available to the public prior to the MDPAC meeting in which the continued prior authorization is to be discussed.
4. (4) The MDPAC shall consider any recommendations related to continued prior authorization of a new drug or new drug dosage form at the next scheduled MDPAC meeting. The division and the MDPAC may actively seek comments about the proposed restrictions. The MDPAC shall include a minimum of fifteen (15) minutes for any interested parties who have notified the division in advance of the scheduled meeting to comment about such proposed restrictions.
5. (5) If the MDPAC finds that use and cost data, pharmacoeconomic information, along with medical and clinical implications of restriction, are documented and restriction is warranted, the MDPAC shall hold a public hearing regarding the continued restriction and make a recommendation to the division. Such recommendation shall be provided to the division, in writing, prior to the division making a final determination. The division shall provide notice of the final determination through the Department of Social Services, MO HealthNet Division website at dss.state.mo.gov/mhd, provider bulletins, and updates to the provider manual.
6. (6) If, after the hearing referenced in section
7. (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 MDPAC.

AUTHORITY: sections 208.153 and 208.201, RSMo Supp. 2013.* 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. *Original authority: 208.153, RSMo 1967, amended 1967, 1973, 1989, 1990, 1991, 2007, 2012 and 208.201, RSMo 1987, amended 2007.