SB45,1410,23 (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.

SB45,2893 Section 2893. 601.79 of the statutes is created to read:

SB45,1411,3 601.79 Drug cost affordability review. (1) Identification of drugs. The board shall identify prescription drug products that are any of the following:

SB45,1411,7 (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.

SB45,1411,11 (b) 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 wholesale acquisition cost that has increased by at least $3,000 during a 12-month period.

SB45,1411,14 (c) A biosimilar 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.

SB45,1411,18 (d) 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:

SB45,1412,2 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 federal food and drug administration, a supply lasting a patient for a period of 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.

SB45,1412,6 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.

SB45,1412,9 (e) 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.

SB45,1412,14 (2) Affordability review. (a) After identifying prescription drug products under sub. (1), the board shall determine whether to conduct an affordability review for each identified prescription drug product by seeking stakeholder input about the prescription drug product and considering the average patient cost share of the prescription drug product.

SB45,1412,20 (b) The information used to conduct an affordability review under par. (a) may include any document and research related to the manufacturer’s selection of the introductory price or price increase of the prescription drug product, including life cycle management, net average price in this state, market competition and context, projected revenue, and the estimated value or cost-effectiveness of the prescription drug product.

SB45,1412,23 (c) The failure of a manufacturer to provide the board with information for an affordability review under par. (b) does not affect the authority of the board to conduct the review.

SB45,1413,8 (3) Affordability challenge. When conducting an affordability review of a prescription drug product under sub. (2), the board shall determine whether use of the prescription drug product that is fully consistent with the labeling approved by the federal food and drug administration or standard medical practice has led or will lead to an affordability challenge for the health care system in this state, including high out-of-pocket costs for patients. To the extent practicable, in determining whether a prescription drug product has led or will lead to an affordability challenge, the board shall consider all of the following factors:

SB45,1413,10 (a) The wholesale acquisition cost for the prescription drug product sold in this state.

SB45,1413,14 (b) The average monetary price concession, discount, or rebate the manufacturer provides, or is expected to provide, to health plans in this state as reported by manufacturers and health plans, expressed as a percentage of the wholesale acquisition cost for the prescription drug product under review.

SB45,1413,18 (c) The total amount of the price concessions, discounts, and rebates the manufacturer provides to each pharmacy benefit manager for the prescription drug product under review, as reported by the manufacturer and pharmacy benefit manager and expressed as a percentage of the wholesale acquisition cost.

SB45,1413,20 (d) The price at which therapeutic alternatives to the prescription drug product have been sold in this state.

SB45,1413,23 (e) The average monetary concession, discount, or rebate the manufacturer provides or is expected to provide to health plan payors and pharmacy benefit managers in this state for therapeutic alternatives to the prescription drug product.

SB45,1414,3 (f) The costs to health plans based on patient access consistent with labeled indications by the federal food and drug administration and recognized standard medical practice.

SB45,1414,5 (g) The impact on patient access resulting from the cost of the prescription drug product relative to insurance benefit design.

SB45,1414,7 (h) The current or expected dollar value of drug-specific patient access programs that are supported by the manufacturer.

SB45,1414,10 (i) The relative financial impacts to health, medical, or social services costs that can be quantified and compared to baseline effects of existing therapeutic alternatives to the prescription drug product.

SB45,1414,12 (j) The average patient copay or other cost sharing for the prescription drug product in this state.

SB45,1414,13 (k) Any information a manufacturer chooses to provide.

SB45,1414,14 (L) Any other factors as determined by the board by rule.

SB45,1414,18 (4) Upper payment limit. (a) If the board determines under sub. (3) that use of a prescription drug product has led or will lead to an affordability challenge, the board shall establish an upper payment limit for the prescription drug product after considering all of the following:

SB45,1414,19 1. The cost of administering the drug.

SB45,1414,20 2. The cost of delivering the drug to consumers.