AB544,5,23 (11) “Prescription drug product” means a brand name drug, a generic drug, a biologic, or a biosimilar.

AB544,6,3 601.785 Prescription drug affordability review board. (1) Mission. The purpose of the board is to protect state residents, the state, local governments, health plans, health care providers, pharmacies licensed in this state, and other stakeholders of the health care system in this state from the high costs of prescription drug products.

AB544,6,4 (2) Powers and duties. (a) The board shall do all of the following:

AB544,6,7 1. Meet in open session at least 4 times per year to review prescription drug product pricing information, except that the chair may cancel or postpone a meeting if there is no business to transact.

AB544,6,9 2. To the extent practicable, access and assess pricing information for prescription drug products by doing all of the following:

AB544,6,12 a. Accessing and assessing information from other states by entering into memoranda of understanding with other states to which manufacturers report pricing information.

AB544,6,13 b. Assessing spending for specific prescription drug products in this state.

AB544,6,14 c. Accessing other available pricing information.

AB544,6,15 (b) The board may:

AB544,6,16 1. Promulgate rules for the administration of this subchapter.

AB544,6,21 2. Enter into a contract with an independent 3rd party for any service necessary to carry out the powers and duties of the board. Unless written permission is granted by the board, any person with whom the board contracts may not release, publish, or otherwise use any information to which the person has access under the contract.

AB544,6,25 (3) Meeting requirements. (a) Pursuant to s. 19.84, the board shall provide public notice of each board meeting at least 2 weeks prior to the meeting and shall make the materials for each meeting publicly available at least one week prior to the meeting.

AB544,7,3 (b) Notwithstanding s. 19.84 (2), the board shall provide an opportunity for public comment at each open meeting and shall provide the public with the opportunity to provide written comments on pending decisions of the board.

AB544,7,6 (c) Notwithstanding subch. V of ch. 19, any portion of a meeting of the board concerning proprietary data and information shall be conducted in closed session and shall in all respects remain confidential.

AB544,7,8 (d) The board may allow expert testimony at any meeting, including when the board meets in closed session.

AB544,7,12 (4) Conflicts of interest. (a) A member of the board shall recuse himself or herself from a decision by the board relating to a prescription drug product if the member or an immediate family member, as defined in s. 97.605 (4) (a) 2., has received or could receive any of the following:

AB544,7,14 1. A direct financial benefit deriving from a determination, or a finding of a study or review, by the board relating to the prescription drug product.

AB544,7,17 2. A financial benefit in excess of $5,000 in a calendar year from any person who owns, manufactures, or provides a prescription drug product to be studied or reviewed by the board.

AB544,7,21 (b) A conflict of interest shall be disclosed by the board when hiring board staff, by the appointing authority when appointing members to the board, and by the board when a member of the board is recused from any final decision resulting from a review of a prescription drug product.

AB544,7,24 (c) A conflict of interest shall be disclosed no later than 5 days after the conflict is identified, except that, if the conflict is identified within 5 days of an open meeting of the board, the conflict shall be disclosed prior to the meeting.

AB544,8,5 (d) The board shall disclose a conflict of interest under this subsection on the board's Internet site unless the chair of the board recuses the member from a final decision resulting from a review of the prescription drug product. The disclosure shall include the type, nature, and magnitude of the interests of the member involved.

AB544,8,8 (e) A member of the board or a 3rd-party contractor may not accept any gift or donation of services or property that indicates a potential conflict of interest or has the appearance of biasing the work of the board.

AB544,8,10 601.79 Drug cost affordability review. (1) Identification of drugs. The board shall identify prescription drug products that are any of the following:

AB544,8,15 (a) A brand name drug or biologic that, as adjusted annually to reflect adjustments to the U.S. consumer price index for all urban consumers, U.S. city average, as determined by the U.S. department of labor, has a launch wholesale acquisition cost of at least $30,000 per year or course of treatment or whose wholesale acquisition cost increased at least $3,000 during a 12–month period.

AB544,8,18 (b) A biosimilar drug that has a launch wholesale acquisition cost that is not at least 15 percent lower than the referenced brand biologic at the time the biosimilar is launched.

AB544,8,22 (c) A generic drug that has a wholesale acquisition cost, as adjusted annually to reflect adjustments to the U.S. consumer price index for all urban consumers, U.S. city average, as determined by the U.S. department of labor, that meets all of the following conditions:

AB544,9,3 1. Is at least $100 for a supply lasting a patient for a period of 30 consecutive days based on the recommended dosage approved for labeling by the U.S. food and drug administration, a supply lasting a patient for fewer than 30 days based on the recommended dosage approved for labeling by the federal food and drug administration, or one unit of the drug if the labeling approved by the federal food and drug administration does not recommend a finite dosage.

AB544,9,6 2. Increased by at least 200 percent during the preceding 12–month period, as determined by the difference between the resulting wholesale acquisition cost and the average of the wholesale acquisition cost reported over the preceding 12 months.

AB544,9,9 (d) Other prescription drug products, including drugs to address public health emergencies, that may create affordability challenges for the health care system and patients in this state.