SB718,8,2
11. A direct financial benefit deriving from a determination, or a finding of a
2study or review, by the board relating to the prescription drug product.
SB718,8,53 2. A financial benefit in excess of $5,000 in a calendar year from any person who
4owns, manufactures, or provides a prescription drug product to be studied or
5reviewed by the board.
SB718,8,96 (b) A conflict of interest under this subsection shall be disclosed by the board
7when hiring board staff, by the appointing authority when appointing members to
8the board, and by the board when a member of the board is recused from any decision
9relating to a review of a prescription drug product.
SB718,8,1310 (c) A conflict of interest under this subsection shall be disclosed no later than
115 days after the conflict is identified, except that, if the conflict is identified within
125 days of an open meeting of the board, the conflict shall be disclosed prior to the
13meeting.
SB718,8,1714 (d) The board shall disclose a conflict of interest under this subsection on the
15board's website unless the chair of the board recuses the member from a final
16decision relating to a review of the prescription drug product. The disclosure shall
17include the type, nature, and magnitude of the interests of the member involved.
SB718,8,2018 (e) A member of the board or a 3rd-party contractor may not accept any gift or
19donation of services or property that indicates a potential conflict of interest or has
20the appearance of biasing the work of the board.
SB718,8,22 21601.79 Drug cost affordability review. (1) Identification of drugs. The
22board shall identify prescription drug products that are any of the following:
SB718,9,223 (a) A brand name drug or biologic that, as adjusted annually to reflect
24adjustments to the U.S. consumer price index for all urban consumers, U.S. city

1average, as determined by the U.S. department of labor, has a launch wholesale
2acquisition cost of at least $30,000 per year or course of treatment.
SB718,9,63 (b) A brand name drug or biologic that, as adjusted annually to reflect
4adjustments to the U.S. consumer price index for all urban consumers, U.S. city
5average, as determined by the U.S. department of labor, has a wholesale acquisition
6cost that has increased at least $3,000 during a 12-month period.
SB718,9,97 (c) A biosimilar that has a launch wholesale acquisition cost that is not at least
815 percent lower than the referenced brand biologic at the time the biosimilar is
9launched.
SB718,9,1310 (d) A generic drug that has a wholesale acquisition cost, as adjusted annually
11to reflect adjustments to the U.S. consumer price index for all urban consumers, U.S.
12city average, as determined by the U.S. department of labor, that meets all of the
13following conditions:
SB718,9,1914 1. Is at least $100 for a supply lasting a patient for a period of 30 consecutive
15days based on the recommended dosage approved for labeling by the federal food and
16drug administration, a supply lasting a patient for a period of fewer than 30 days
17based on the recommended dosage approved for labeling by the federal food and drug
18administration, or one unit of the drug if the labeling approved by the federal food
19and drug administration does not recommend a finite dosage.
SB718,9,2220 2. Increased by at least 200 percent during the preceding 12-month period, as
21determined by the difference between the resulting wholesale acquisition cost and
22the average of the wholesale acquisition cost reported over the preceding 12 months.
SB718,9,2523 (e) Other prescription drug products, including drugs to address public health
24emergencies, that may create affordability challenges for the health care system and
25patients in this state.
SB718,10,5
1(2) Affordability review. (a) After identifying prescription drug products
2under sub. (1), the board shall determine whether to conduct an affordability review
3for each identified prescription drug product by seeking stakeholder input about the
4prescription drug product and considering the average patient cost share of the
5prescription drug product.
SB718,10,116 (b) The information used to conduct an affordability review under par. (a) may
7include any document and research related to the manufacturer's selection of the
8introductory price or price increase of the prescription drug product, including life
9cycle management, net average price in this state, market competition and context,
10projected revenue, and the estimated value or cost-effectiveness of the prescription
11drug product.
SB718,10,1412 (c) The failure of a manufacturer to provide the board with information for an
13affordability review under par. (b) does not affect the authority of the board to
14conduct the review.
SB718,10,22 15(3) Affordability challenge. When conducting an affordability review of a
16prescription drug product under sub. (2), the board shall determine whether use of
17the prescription drug product that is fully consistent with the labeling approved by
18the federal food and drug administration or standard medical practice has led or will
19lead to an affordability challenge for the health care system in this state, including
20high out-of-pocket costs for patients. To the extent practicable, in determining
21whether a prescription drug product has led or will lead to an affordability challenge,
22the board shall consider all of the following factors:
SB718,10,2423 (a) The wholesale acquisition cost for the prescription drug product sold in this
24state.
SB718,11,4
1(b) The average monetary price concession, discount, or rebate the
2manufacturer provides, or is expected to provide, to health plans in this state as
3reported by manufacturers and health plans, expressed as a percent of the wholesale
4acquisition cost for the prescription drug product under review.
SB718,11,85 (c) The total amount of the price concessions, discounts, and rebates the
6manufacturer provides to each pharmacy benefit manager for the prescription drug
7product under review, as reported by the manufacturer and pharmacy benefit
8manager and expressed as a percent of the wholesale acquisition cost.
SB718,11,109 (d) The price at which therapeutic alternatives to the prescription drug product
10have been sold in this state.
SB718,11,1311 (e) The average monetary concession, discount, or rebate the manufacturer
12provides or is expected to provide to health plan payors and pharmacy benefit
13managers in this state for therapeutic alternatives to the prescription drug product.
SB718,11,1614 (f) The costs to health plans based on patient access consistent with labeled
15indications by the federal food and drug administration and recognized standard
16medical practice.
SB718,11,1817 (g) The impact on patient access resulting from the cost of the prescription drug
18product relative to insurance benefit design.
SB718,11,2019 (h) The current or expected dollar value of drug-specific patient access
20programs that are supported by the manufacturer.
SB718,11,2321 (i) The relative financial impacts to health, medical, or social services costs that
22can be quantified and compared to baseline effects of existing therapeutic
23alternatives to the prescription drug product.
SB718,11,2524 (j) The average patient copay or other cost sharing for the prescription drug
25product in this state.
SB718,12,1
1(k) Any information a manufacturer chooses to provide.
SB718,12,22 (L) Any other factors as determined by the board by rule.
SB718,12,6 3(4) Upper payment limit. (a) If the board determines under sub. (3) that use
4of a prescription drug product has led or will lead to an affordability challenge, the
5board shall establish an upper payment limit for the prescription drug product after
6considering all of the following:
SB718,12,77 1. The cost of administering the drug.
SB718,12,88 2. The cost of delivering the drug to consumers.
SB718,12,99 3. Other relevant administrative costs related to the drug.
SB718,12,1510 (b) For a prescription drug product identified in sub. (1) (b) or (d) 2., the board
11shall solicit information from the manufacturer regarding the price increase. To the
12extent that the price increase is not a result of the need for increased manufacturing
13capacity or other effort to improve patient access during a public health emergency,
14the board shall establish an upper payment limit under par. (a) that is equal to the
15cost to consumers prior to the price increase.
SB718,12,1916 (c) 1. The upper payment limit established under this subsection shall apply
17to all purchases and payor reimbursements of the prescription drug product
18dispensed or administered to individuals in this state in person, by mail, or by other
19means.
SB718,13,520 2. Notwithstanding subd. 1., while state-sponsored and state-regulated
21health plans and health programs shall limit drug reimbursements and drug
22payment to no more than the upper payment limit established under this subsection,
23a plan subject to the Employee Retirement Income Security Act of 1974 or Part D of
24Medicare under 42 USC 1395w-101 et seq. may choose to reimburse more than the
25upper payment limit. A provider who dispenses and administers a prescription drug

1product in this state to an individual in this state may not bill a payor more than the
2upper payment limit to the patient regardless of whether a plan subject to the
3Employee Retirement Income Security Act of 1974 or Part D of Medicare under 42
4USC 1395w-101
et seq. chooses to reimburse the provider above the upper payment
5limit.
SB718,13,7 6(5) Public inspection. Information submitted to the board under this section
7shall be open to public inspection only as provided under ss. 19.31 to 19.39.
SB718,13,11 8(6) No prohibition on marketing. Nothing in this section may be construed to
9prevent a manufacturer from marketing a prescription drug product approved by the
10federal food and drug administration while the prescription drug product is under
11review by the board.
SB718,13,16 12(7) Appeals. A person aggrieved by a decision of the board may request an
13appeal of the decision no later than 30 days after the board makes the determination.
14The board shall hear the appeal and make a final decision no later than 60 days after
15the appeal is requested. A person aggrieved by a final decision of the board may
16petition for judicial review in a court of competent jurisdiction.
SB718,5 17Section 5 . Nonstatutory provisions.
SB718,13,2318 (1) Office of prescription drug affordability. The office of the commissioner
19of insurance shall establish an office of prescription drug affordability in the office
20of the commissioner of insurance. The office of prescription drug affordability shall
21be responsible for prescription drug affordability programming within the office of
22the commissioner of insurance and shall oversee the operations of the prescription
23drug affordability review board established under s. 15.735.
SB718,14,424 (2) Staggered terms; prescription drug affordability review board.
25Notwithstanding the length of terms specified for the members of the board under

1s. 15.735 (1) (b) to (e), 2 of the initial members shall be appointed for terms expiring
2on May 1, 2025; 2 of the initial members shall be appointed for terms expiring on May
31, 2026; 2 of the initial members shall be appointed for terms expiring on May 1, 2027;
4and 2 of the initial members shall be appointed for terms expiring on May 1, 2028.
SB718,6 5Section 6 . Fiscal changes.
SB718,14,146 (1) Office of prescription drug affordability. In the schedule under s. 20.005
7(3) for the appropriation to the office of the commissioner of insurance under s. 20.145
8(1) (g), the dollar amount for fiscal year 2024-25 is increased by $1,701,000 to provide
9$500,000 in onetime implementation costs for establishing an office of prescription
10drug affordability in the office of the commissioner of insurance and $1,201,000 to
11authorize 16.0 PR positions within the office of prescription drug affordability,
12including 5.0 insurance examiners, 4.0 policy initiatives advisors, 2.0 attorneys, 1.0
13insurance program manager, 2.0 insurance administrators, and 2.0 operations
14program associates.
SB718,7 15Section 7 . Effective date.
SB718,14,1716 (1) This act takes effect on the first day of the 7th month beginning after
17publication.
SB718,14,1818 (End)
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