(1) The board may choose to conduct an affordability review of up to 24 legend drugs or biologics per year and consider the following:

(a) The class of the prescription drug and whether any therapeutically equivalent prescription drugs are available for sale;

(b) Input from relevant advisory groups as listed in this chapter; and

(c) The out-of-pocket cost for the drug.

(2) For drugs chosen for the affordability review, the board must determine whether the drug has led or will lead to excess costs to patients. Additionally, the board will determine whether a drug has led to or will lead to excess costs as defined in RCW 70.405.010. The board may examine publicly available and confidential information from the prescription drug manufacturer and other sources.

(3) The board, or the authority as directed by the board, may request information from the manufacturer. The requested information must be sent to the authority in the form and manner as published by the authority within 30 calendar days of the date on the request.

(4) The authority may assess a fine against a manufacturer for each failure to comply with a request for information from the board or the authority on behalf of the board. See WAC 182-52-0075 for information on notification of violation and fine(s).