SB 957 — Prescription Drug Affordability Board and Fund; established, drug cost affordability review, etc.

D.

shallS serveE. staggered terms as required by the provisions for members in § 32.1-276.20.

The initial term for members of the stakeholder council shall be three years, and the members F.shall serve staggered terms as required by the provisions for members in § 32.1-276.20.

AE member of the stakeholder council may not receive compensation as a member of the stakeholder council but is entitled to reimbursement for expenses under standard state travel regulations promulgated pursuant to § 2.2-2823.

S A.

Nothing in this section shall be construed to prevent a manufacturer from marketing a 9 prescription drug product approved by the U.S.

Food and Drug Administration (FDA) while the pro7uctproduct is B.under review by the Board.

B.

1.B Consumer Price Index, have (i) a launch wholesale acquisition cost of $60,000 or more per year orhe course of treatment or (ii) a wholesale acquisition cost increase of $3,000 or more in any 12-month period;

Brand-nameE drugs2. or biologics that, as adjusted annually for inflation in accordance with the Consumer Price Index, have (i) a launch wholesale acquisition cost of $60,000 or more per year or course of treatment or (ii) a wholesale acquisition cost increase of $3,000 or more in any 12-month period;

2.Biosimilars that have a launch wholesale acquisition cost that is not at least 20 percent lower than the referenced brand biologic at the time the biosimilars are launched and that have been suggested for review by members of the public, medical professionals, or other stakeholders;

Biosimilars that have a launch wholesale acquisition cost that is not at least 20 percent lower suggested for review by members of the public, medical professionals, or other stakeholders;en 3.

Generic drugs that, as adjusted for inflation in accordance with the Consumer Price Index, have a wholesale acquisition cost of $100 or more for (i) a 30-day supply lasting a patient for a period of 30 consecutive days based on the recommended dosage approved for labeling by the FDA, (ii) a supply lasting a patient fewer than 30 days based on the recommended dosage approved for labeling by the FDA, or (iii) one unit of the drug if the labeling approved by the FDA does not recommend any finite dosage;

wholesaleb. acquisition cost of at least $100 for a 30-day supply or a course of treatment less than 30 a days and that increased by 200 percent or more during the immediately 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 immediately preceding 12 months;

Generic drugs that, as adjusted for inflation in accordance with the Consumer Price Index, have a wholesale acquisition cost of at least $100 for a 30-day supply or a course of treatment less than 30 days and 4.that increased by 200 percent or more during the immediately 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 immediately preceding 12 months;

Otherand prescription drug products that may create affordability challenges for the health care system in the Commonwealth and high out-of-pocket costs for patients, including drugs used to address public health emergencies.

preliminaryC. information about the cost of the product, patient cost-sharing for the product, health plan spending on the product, stakeholder input, and other information as determined by the Board, the Board shall determine whether to conduct an affordability review for each identified prescription drug product.

RelevantAfter informationidentifying forprescription conductingdrug anproducts affordabilityas reviewrequired mayby includesubsection anyB documentand orcompiling researchpreliminary relatedinformation toabout the manufacturer'scost selection of the introductoryproduct, pricepatient orcost-sharing pricefor increase of the prescription drug product, includinghealth lifecycleplan management,spending neton average prices in the Commonwealth,product, marketstakeholder competitioninput, and context,other projectedinformation revenue,as anddetermined by the estimatedBoard, value or cost effectiveness of the anBoard affordability review shall notdetermine affectwhether the Board's authority to conduct suchan aaffordability review.informationreview for SB957each 4identified ofprescription 6drug D.product.

Relevant information for conducting an affordability review may include any document or research related to the manufacturer's selection of the introductory price or price increase of the market competition and context, projected revenue, and the estimated value or cost effectiveness of the prescription drug product.

Failure of a manufacturer to provide the Board with relevant information for SB957E 4 of 7 an affordability review shall not affect the Board's authority to conduct such a review.

D.

State regulated health plans shall inform the Board of how the cost savings related to an upper of 7 payment limit amount are directed to the benefit of enrollees with a priority on enrollee cost-sharing.

of 6 I.

Any information submitted to the Board in accordance with this section shall be subject to public inspection only to the extent required under the Virginia Freedom of Information Act (§ 2.2-370I2.2-3700 et seq.).

N A.

T B.

Any person aggrieved by a decision of the Board may request an appeal of the decision witRinwithin 30 days after the decision of the Board is made.

OE C.

Any person aggrieved by a final decision of the Board may petition for judicial review asDas provided by the Administrative Process Act (§ 2.2-4000 et seq.).

ThereN is§ hereby32.1-276.18. created in the state treasury a special nonreverting fund to be known as theU Prescription Drug Affordability Fund, referred to in this section as "the Fund," which shall beC established on the books of the Comptroller.

AllPrescription fundsDrug appropriatedAffordability for such purpose and any giEts, donations, grants, bequests, and other funds received on its behalf shall be paid into the state treasury and credited to the Fund.

InterestG earnedPrescription onDrug moneysAffordability Fund, referred to in thethis Fundsection shallas remain"the inFund," thewhich Fundshall andbe beDestablished creditedon tothe it.books of the Comptroller.

All funds appropriated for such purpose and any gifts, donations, grants, bequests, and other funds received on its behalf shall be paid into the state treasury and credited to the Fund.

Interest earned on moneys in the Fund shall remain in the Fund and be credited to it.

Moneys in the Fund shallshalS be used solely for the purposes of providing funding for the Board and implementing the purposes of the Board established under this chapter, including reimbursing any costs expended by any state agency in implementingmade by the provisionsState Treasurer on warrants issued by the Comptroller upon written request signed by the chair of thisthe chapter.Board.

Expenditures and disbursements from the Fund shall be made by the State Treasurer on warrants issued by the Comptroller upon written request signed by the chair of the Board.

S A.

On or before December 31, 2024, and annually each year thereafter, the Board shall submit9tosubmit to the Chair of the Senate Committee on Education and Health, the Chair of the Senate Committee on7on Commerce and Labor, the Chair of the House Committee on Health, Welfare and Institutions, and the Chair of the House Committee on Commerce and Energy a report that includes the following:

and the 1.

2.B period, including the number of prescription drug projects subject to review, the results of the reviews, and the number and disposition of appeals and judicial reviews of Board decisions;

Prescription drug products that were subject to Board review during the previous 12-month period, including the number of prescription drug projects subject to review, the results of the reviews, and the7 number3. and disposition of appeals and judicial reviews of Board decisions;

andAny 3.recommendations the Board may have regarding further legislation needed to improve E prescription drug affordability in the Commonwealth.

AnyB. recommendations the Board may have regarding further legislation needed to improve prescription drug affordability in the Commonwealth.

On or before July 1, 2024, and annually thereafter, the Board shall study the operations of the generic drug market in the United States, including a review of physician-administered drugs.

The study shall consider (i) the prices of generic drugs on a year-over-year basis, (ii) the degree to which generic drug prices affect yearly insurance premium changes, (iii) annual changes in insurance cost-sharing for generic drugs, (iv) the potential for and history of generic drug shortages, (v) the degree to which generic drug prices affect yearly Medicaid spending in the Commonwealth, and (vi) any other relevant study questions.

§ 32.1-276.20.

Terms of office;

initial Board and stakeholder council members.

B.

The terms of the initial members of the stakeholder council shall expire as follows:

Three members in 2027;2027;al members of the stakeholder council shall expire as follows:

and §3. 32.1-276.21.

Four members in 2029.

§ 32.1-276.21.

§ 1395 et seq., known as Medicare Part D, shall not be bound by decisions of the Board, and any such plans may choose to reimburse more than the Board-established upper payment limit amount.

Providers who dispense and administer prescription drug products to citizens of the Commonwealth shall be bound to bill all health plan payers no more SB957E 6 of 7 than the Board-established upper payment limit amount without regard to whether or not a MedicarereMedicare SB957 6 of 6 Part D plan chooses to reimburse the provider above the upper payment limit amount.

of 7 the purposes of this act is included in a general appropriation act passed in 2023 by the Generaling Assembly that becomes law.

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