SB 274 — Prescription Drug Affordability Board; established, drug cost affordability review, report.

S(i) D.the pharmaceutical business model, (ii) supply chain business models, (iii) the practice of medicine or clinical training, (iv) consumer or patient perspectives, (v) health care costs trends and Commonwealth.

clinical and health services research, or (vii) the health care marketplace in the D.

Vacancies shaE.shall be filled in the same manner as the original appointments.

TheS ChairE. of the Board shall select one member of the stakeholder council to serve as chaNr of the stakeholder council.

F.The Chair of the Board shall select one member of the stakeholder council to serve as cha2r of the stakeholder council.

No4 memberF. of the stakeholder council shall receive compensation as a member of the stakehAlder council, but members shall be entitled to reimbursement for expenses under standard state travel regulations promulgated pursuant to § 2.2-2823.

TNo A.member of the stakeholder council shall receive compensation as a member of the stakehRlder council, but members shall be entitled to reimbursement for expenses under standard state travel regulations promulgated pursuant to § 2.2-2823.

Nothing§ in32.1-276.16. this section shall be construed to prevent a manufacturer from marketing a prescription drug product approved by the U.S.

Drug cost affordability review.

prescription drug product approved by the U.S.

S1. 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;

BBrand-name 2.drugs 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;

Biosimilars2. that have a launch wholesale acquisition cost that is not at least 20 percentSlower than the referenced brand biologic at the time the biosimilars are launched and that have been sug3.

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) aTa 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 finb.finite dosage;

Genericb. 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 tEan 30 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;

systemGeneric drugs that, as adjusted for inflation in accordance with the CommonwealthConsumer andPrice highIndex, out-of-pockethave costsa wholesale acquisition cost of at least $100 for patients,a including30-day drugssupply usedor toa addresscourse publicof healthtreatment emergencies;less than 30 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;

4.

Other 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;

S C.

After identifying prescription drug products as required by subsection B, soliciting publ2cpublic input on prescription drug products thought to be creating affordability challenges, and compiling preliminary 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 sha1l determine whether to conduct an affordability review for each identified prescription drug product.

Relevant information for conducting an affordability review may include any document or research of 7 related to the manufacturer's selection of the introductory price or price increase of the prescription drug product, including life-cycle management, net average prices in the Commonwealth, market SB274S1 4 of 6 competition and context, projected revenue, patient assistance programs specific to a prescription drug product, estimated or actual manufacturer price concessions in the market, the estimated value or cost effectiveness of the prescription drug product, and other information as determined by the Board.

Such upper payment limit amount shall be exclusive of applicable pharmacy dispensing fees and provider of 7 administration fees.

E G.

The Board may adopt the Medicare maximum fair price in § 1191(c) of Title XVII of the Social ofSecurity 6Act, amount42 establishedU.S.C. pursuant to subsection E.

The§ Board1395 shallet notseq., establish an upper payment limitt amount different than the Medicare maximum fair price for anya prescription drug product includedas inthe §upper 1191(c)payment oflimit Titleamount XVIIestablished ofpursuant theto Socialsubsection SecurityE. Act, 42 U.S.C.

§The 1395Board etshall seq.not establish an upper payment limRt amount different than the Medicare maximum fair price for any prescription drug product included in § 1H.

H.

inspectionI. only to the extent required under the Virginia Freedom of Information Act (§ 2.2-3700 etblic seq.).

§Any 32.1-276.17.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 (§ 2.2-3700 et seq.).

E § 32.1-276.17.

daysB. after the decision is made.

TheAny Boardperson shallaggrieved hearby a decision of the appealBoard andmay makerequest aan finalappeal of the decision within 60030 days after the appeal is requested.requested.e Board shall hear the appeal and make a final decision within 60 C.

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

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

ES theA. Senate Committee on Education and Health, the Chair of the Senate Committee on Commerce andNir of Labor, the Chair of the House Committee on Health and Human Services, and the Chair of the House Committee on Labor and Commerce a report that includes the following:

AOn 1.or before December 31, 2025, and annually thereafter, the Board shall submit to the Ch2ir of the Senate Committee on Education and Health, the Chair of the Senate Committee on Commerce and4 Labor, the Chair of the House Committee on Health and Human Services, and the Chair of the HousR Committee on Labor and Commerce a report that includes the following:

1.

Prescription drug products that were subject to Board review during the previous 12-monthT12-month and the number and disposition of appeals and judicial reviews of Board decisions;

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

TSeThe 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 forricfor 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 listed in subsection A.ard shall report this study questions.to the Chairs of the Senate and House committees § 32.1-276.19.

TheRelation Board shall report this study to theother Chairshealth ofbenefit theplans. Senate and House commitSees listed in subsection A.

The provisions of this chapter obligate state-sponsored and state-regulated health plans and health programs to limit drug reimbursements and drug payment amounts to no more than the I Board-established upper payment limit amount.

Plans providing health care benefits pursuant to TartPart D of Title XVIII of the Social Security Act, 42 U.S.C.

§ 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 U drug products to citizens of the Commonwealth shall be bound to bill all health plan payers no more than the Board-established upper payment limit amount without regard to whether or not a MedicaEe Part D plan chooses to reimburse the provider above the 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 Part D plan chooses to reimburse the provider above the upper payment limit amount.not a Medicare § 54.1-3442.02.

"Biosimilar" means a drug that is produced or distributed pursuant to a biologics license application approved under 42 U.S.C.

§ 262(k)(3).produced262(k)(3). or distributed pursuant to a biologics license application "Brand-name drug" means a prescription drug approved under 21 U.S.C.

"Brand-name drug" means a prescription drug approved under 21 U.S.C.

262(S).262(k).

"Biosimilar," "brand-name drug," and "generic drug" have the same meanings as provided in 2 § 3"New32.1-276.12. prescription drug" means a drug or biological product receiving initial approval under an original new drug application pursuant to 21 U.S.C.

§original 355(b)new ordrug underapplication apursuant biologicsto license21 appli1ation under 42 U.S.C.

§ 355(b) or under a biologics license application under 42 U.S.C.

of 7 "Nonprofit data services organization" has the same meaning as set forth in § 32.1-23.4.

SB274S1 6 of 6 B.

and one member for a term of one year, one member for a term of two years, and one member for a term of three years, appointed byof the7 Governor.6.

6.That the provisions of the first enactment of this act shall bEcome effective on January 1, 2025.

ThatN theR provisionsO ofL theL firstE enactmentD ofB thisR act shall become effective on January 1, 2025.