AB50,1409,622. Enter into a contract with an independent 3rd party for any service 3necessary to carry out the powers and duties of the board. Unless written 4permission is granted by the board, any person with whom the board contracts may 5not release, publish, or otherwise use any information to which the person has 6access under the contract. AB50,1409,97(c) The board shall establish and maintain a website to provide public notices 8and make meeting materials available under sub. (3) (a) and to disclose conflicts of 9interest under sub. (4) (d). AB50,1409,1310(3) Meeting requirements. (a) Pursuant to s. 19.84, the board shall provide 11public notice of each board meeting at least 2 weeks prior to the meeting and shall 12make the materials for each meeting publicly available at least one week prior to 13the meeting. AB50,1409,1614(b) Notwithstanding s. 19.84 (2), the board shall provide an opportunity for 15public comment at each open meeting and shall provide the public with the 16opportunity to provide written comments on pending decisions of the board. AB50,1409,1917(c) Notwithstanding subch. V of ch. 19, any portion of a meeting of the board 18concerning proprietary data and information shall be conducted in closed session 19and shall in all respects remain confidential. AB50,1409,2120(d) The board may allow expert testimony at any meeting, including when the 21board meets in closed session. AB50,1410,222(4) Conflicts of interest. (a) A member of the board shall recuse himself 23or herself from a decision by the board relating to a prescription drug product if the
1member or an immediate family member of the member has received or could 2receive any of the following: AB50,1410,431. A direct financial benefit deriving from a determination, or a finding of a 4study or review, by the board relating to the prescription drug product. AB50,1410,752. A financial benefit in excess of $5,000 in a calendar year from any person 6who owns, manufactures, or provides a prescription drug product to be studied or 7reviewed by the board. AB50,1410,118(b) A conflict of interest under this subsection shall be disclosed by the board 9when hiring board staff, by the appointing authority when appointing members to 10the board, and by the board when a member of the board is recused from any 11decision relating to a review of a prescription drug product. AB50,1410,1512(c) A conflict of interest under this subsection shall be disclosed no later than 135 days after the conflict is identified, except that, if the conflict is identified within 145 days of an open meeting of the board, the conflict shall be disclosed prior to the 15meeting. AB50,1410,2016(d) The board shall disclose a conflict of interest under this subsection on the 17board’s website unless the chairperson of the board recuses the member from a 18final decision relating to a review of the prescription drug product. The disclosure 19shall include the type, nature, and magnitude of the interests of the member 20involved. AB50,1410,2321(e) A member of the board or a 3rd-party contractor may not accept any gift or 22donation of services or property that indicates a potential conflict of interest or has 23the appearance of biasing the work of the board. AB50,2893
1Section 2893. 601.79 of the statutes is created to read: AB50,1411,32601.79 Drug cost affordability review. (1) Identification of drugs. 3The board shall identify prescription drug products that are any of the following: AB50,1411,74(a) A brand name drug or biologic that, as adjusted annually to reflect 5adjustments to the U.S. consumer price index for all urban consumers, U.S. city 6average, as determined by the U.S. department of labor, has a launch wholesale 7acquisition cost of at least $30,000 per year or course of treatment. AB50,1411,118(b) A brand name drug or biologic that, as adjusted annually to reflect 9adjustments to the U.S. consumer price index for all urban consumers, U.S. city 10average, as determined by the U.S. department of labor, has a wholesale acquisition 11cost that has increased by at least $3,000 during a 12-month period. AB50,1411,1412(c) A biosimilar that has a launch wholesale acquisition cost that is not at 13least 15 percent lower than the referenced brand biologic at the time the biosimilar 14is launched. AB50,1411,1815(d) A generic drug that has a wholesale acquisition cost, as adjusted annually 16to reflect adjustments to the U.S. consumer price index for all urban consumers, 17U.S. city average, as determined by the U.S. department of labor, that meets all of 18the following conditions: AB50,1412,2191. Is at least $100 for a supply lasting a patient for a period of 30 consecutive 20days based on the recommended dosage approved for labeling by the federal food 21and drug administration, a supply lasting a patient for a period of fewer than 30 22days based on the recommended dosage approved for labeling by the federal food
1and drug administration, or one unit of the drug if the labeling approved by the 2federal food and drug administration does not recommend a finite dosage. AB50,1412,632. Increased by at least 200 percent during the preceding 12-month period, as 4determined by the difference between the resulting wholesale acquisition cost and 5the average of the wholesale acquisition cost reported over the preceding 12 6months. AB50,1412,97(e) Other prescription drug products, including drugs to address public health 8emergencies, that may create affordability challenges for the health care system 9and patients in this state. AB50,1412,1410(2) Affordability review. (a) After identifying prescription drug products 11under sub. (1), the board shall determine whether to conduct an affordability 12review for each identified prescription drug product by seeking stakeholder input 13about the prescription drug product and considering the average patient cost share 14of the prescription drug product. AB50,1412,2015(b) The information used to conduct an affordability review under par. (a) may 16include any document and research related to the manufacturer’s selection of the 17introductory price or price increase of the prescription drug product, including life 18cycle management, net average price in this state, market competition and context, 19projected revenue, and the estimated value or cost-effectiveness of the prescription 20drug product. AB50,1412,2321(c) The failure of a manufacturer to provide the board with information for an 22affordability review under par. (b) does not affect the authority of the board to 23conduct the review. AB50,1413,8
1(3) Affordability challenge. When conducting an affordability review of a 2prescription drug product under sub. (2), the board shall determine whether use of 3the prescription drug product that is fully consistent with the labeling approved by 4the federal food and drug administration or standard medical practice has led or 5will lead to an affordability challenge for the health care system in this state, 6including high out-of-pocket costs for patients. To the extent practicable, in 7determining whether a prescription drug product has led or will lead to an 8affordability challenge, the board shall consider all of the following factors: AB50,1413,109(a) The wholesale acquisition cost for the prescription drug product sold in 10this state. AB50,1413,1411(b) The average monetary price concession, discount, or rebate the 12manufacturer provides, or is expected to provide, to health plans in this state as 13reported by manufacturers and health plans, expressed as a percentage of the 14wholesale acquisition cost for the prescription drug product under review. AB50,1413,1815(c) The total amount of the price concessions, discounts, and rebates the 16manufacturer provides to each pharmacy benefit manager for the prescription drug 17product under review, as reported by the manufacturer and pharmacy benefit 18manager and expressed as a percentage of the wholesale acquisition cost.