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AB544,8,10 9601.79 Drug cost affordability review. (1) Identification of drugs. The
10board shall identify prescription drug products that are any of the following:
AB544,8,1511 (a) A brand name drug or biologic that, as adjusted annually to reflect
12adjustments to the U.S. consumer price index for all urban consumers, U.S. city
13average, as determined by the U.S. department of labor, has a launch wholesale
14acquisition cost of at least $30,000 per year or course of treatment or whose wholesale
15acquisition cost increased at least $3,000 during a 12–month period.
AB544,8,1816 (b) A biosimilar drug that has a launch wholesale acquisition cost that is not
17at least 15 percent lower than the referenced brand biologic at the time the biosimilar
18is launched.
AB544,8,2219 (c) A generic drug that has a wholesale acquisition cost, as adjusted annually
20to reflect adjustments to the U.S. consumer price index for all urban consumers, U.S.
21city average, as determined by the U.S. department of labor, that meets all of the
22following conditions:
AB544,9,323 1. Is at least $100 for a supply lasting a patient for a period of 30 consecutive
24days based on the recommended dosage approved for labeling by the U.S. food and
25drug administration, a supply lasting a patient for fewer than 30 days based on the

1recommended dosage approved for labeling by the federal food and drug
2administration, or one unit of the drug if the labeling approved by the federal food
3and drug administration does not recommend a finite dosage.
AB544,9,64 2. Increased by at least 200 percent during the preceding 12–month period, as
5determined by the difference between the resulting wholesale acquisition cost and
6the average of the wholesale acquisition cost reported over the preceding 12 months.
AB544,9,97 (d) Other prescription drug products, including drugs to address public health
8emergencies, that may create affordability challenges for the health care system and
9patients in this state.
AB544,9,14 10(2) Affordability review. (a) After identifying prescription drug products
11under sub. (1), the board shall determine whether to conduct an affordability review
12for each identified prescription drug product by seeking stakeholder input about the
13prescription drug product and considering the average patient cost share of the
14prescription drug product.
AB544,9,2015 (b) The information 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.
AB544,9,2221 (c) The failure of a manufacturer to provide the board with information for an
22affordability review does not affect the authority of the board to conduct the review.
AB544,9,25 23(3) Affordability challenge. When conducting an affordability review of a
24prescription drug product, the board shall determine whether use of the prescription
25drug product that is fully consistent with the labeling approved by the federal food

1and drug administration or standard medical practice has led or will lead to an
2affordability challenge for the health care system in this state, including high
3out–of–pocket costs for patients. To the extent practicable, in determining whether
4a prescription drug product has led or will lead to an affordability challenge, the
5board shall consider all of the following factors:
AB544,10,76 (a) The wholesale acquisition cost for the prescription drug product sold in this
7state.
AB544,10,118 (b) The average monetary price concession, discount, or rebate the
9manufacturer provides, or is expected to provide, to health plans in this state as
10reported by manufacturers and health plans, expressed as a percent of the wholesale
11acquisition cost for the prescription drug product under review.
AB544,10,1512 (c) The total amount of the price concessions, discounts, and rebates the
13manufacturer provides to each pharmacy benefit manager for the prescription drug
14product under review, as reported by the manufacturer and pharmacy benefit
15manager and expressed as a percent of the wholesale acquisition costs.
AB544,10,1616 (d) The price at which therapeutic alternatives have been sold in this state.
AB544,10,1917 (e) The average monetary concession, discount, or rebate the manufacturer
18provides or is expected to provide to health plan payors and pharmacy benefit
19managers in this state for therapeutic alternatives.
AB544,10,2220 (f) The costs to health plans based on patient access consistent with labeled
21indications by the federal food and drug administration and recognized standard
22medical practice.
AB544,10,2423 (g) The impact on patient access resulting from the cost of the prescription drug
24product relative to insurance benefit design.
AB544,11,2
1(h) The current or expected dollar value of drug–specific patient access
2programs that are supported by the manufacturer.
AB544,11,53 (i) The relative financial impacts to health, medical, or social services costs that
4can be quantified and compared to baseline effects of existing therapeutic
5alternatives.
AB544,11,76 (j) The average patient copay or other cost sharing for the prescription drug
7product in the state.
AB544,11,88 (k) Any information a manufacturer chooses to provide.
AB544,11,99 (L) Any other factors as determined by the board by rule.
AB544,11,13 10(4) Upper payment limit. (a) If the board determines under sub. (3) that use
11of a prescription drug product has led or will lead to an affordability challenge, the
12board shall establish an upper payment limit for the prescription drug product after
13considering all of the following:
AB544,11,1414 1. The cost of administering the drug.
AB544,11,1515 2. The cost of delivering the drug to consumers.
AB544,11,1616 3. Other relevant administrative costs related to the drug.
AB544,11,2217 (b) For a prescription drug product identified in sub. (1) (d), the board shall
18solicit information from the manufacturer regarding the price increase. To the
19extent that the price increase is not a result of the need for increased manufacturing
20capacity or other effort to improve patient access during a public health emergency,
21the board shall establish an upper payment limit under par. (a) that is equal to the
22cost to consumers prior to the price increase.
AB544,12,223 (c) 1. The upper payment limit established under this subsection shall apply
24to all purchases and payor reimbursements of the prescription drug product

1dispensed or administered to individuals in this state in person, by mail, or by other
2means.
AB544,12,133 2. Notwithstanding subd. 1., while state-sponsored and state-regulated
4health plans and health programs shall limit drug reimbursements and drug
5payment to no more than the upper payment limit established under this subsection,
6a plan subject to the Employee Retirement Income Security Act of 1974 or Part D of
7Medicare under 42 USC 1395w-101 et seq. may choose to reimburse more than the
8upper payment limit. A provider who dispenses and administers a prescription drug
9product in this state to an individual in this state may not bill a payor more than the
10upper payment limit to the patient regardless of whether a plan subject to the
11Employee Retirement Income Security Act of 1974 or Part D of Medicare under 42
12USC 1395w-101
et seq. chooses to reimburse the provider above the upper payment
13limit.
AB544,12,15 14(5) Public inspection. Information submitted to the board under this section
15shall be open to public inspection only as provided under ss. 19.31 to 19.39.
AB544,12,19 16(6) No prohibition on marketing. Nothing in this section may be construed to
17prevent a manufacturer from marketing a prescription drug product approved by the
18federal food and drug administration while the prescription drug product is under
19review by the board.
AB544,12,24 20(7) Appeals. A person aggrieved by a decision of the board may request an
21appeal of the decision no later than 30 days after the board makes the determination.
22The board shall hear the appeal and make a final decision no later than 60 days after
23the appeal is requested. A person aggrieved by a final decision of the board may
24petition for judicial review in a court of competent jurisdiction.
AB544,4 25Section 4. Nonstatutory provisions.
AB544,13,6
1(1) Staggered terms for board. Notwithstanding the length of terms specified
2for the members of the board under s. 15.735 (1) (b) to (e), 2 of the initial members
3shall be appointed for terms expiring on May 1, 2023; 2 of the initial members shall
4be appointed for terms expiring on May 1, 2024; 2 of the initial members shall be
5appointed for terms expiring on May 1, 2025; and 2 of the initial members shall be
6appointed for terms expiring on May 1, 2026.
AB544,5 7Section 5. Effective date.
AB544,13,98 (1) This act takes effect on the first day of the 7th month after the day of
9publication.
AB544,13,1010 (End)
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