Maryland PDAB Sets First Upper Payment Limits for Diabetes Drugs as State-Level Price Control Model Gains Momentum
核心洞察
Maryland's Prescription Drug Affordability Board has recommended upper payment limits of $197 for Jardiance and $178.50 for Farxiga, marking the first concrete price controls under the state's expanded PDAB authority.
The Board has deemed four major diabetes (搜索) drugs "unaffordable" including Boehringer Ingelheim's Jardiance, AstraZeneca's Farxiga, Novo Nordisk's Ozempic, and Eli Lilly's Trulicity following extensive public consultations and data reviews.
Maryland's PDAB model is being closely watched by other states as a potential solution to drug affordability challenges, with the Board's authority recently expanded to cover all state residents rather than just state employees.
Maryland's Prescription Drug Affordability Board has taken a significant step toward implementing the nation's first state-level drug price controls, recommending upper payment limits for two widely prescribed diabetes (搜索) medications. The Board proposed a maximum fair price of $197 for Jardiance (empagliflozin) and $178.50 for Farxiga (dapagliflozin) for a monthly supply, following an extensive review process that has positioned Maryland as a test case for state-level pharmaceutical price regulation.
Expanding Authority Beyond State Employees
The Maryland PDAB (搜索)'s current actions represent a substantial evolution from its original 2019 mandate. Initially established through HB 768, the Board could only set upper payment limits for drugs purchased by state hospitals, facilities, correctional institutions, and state employee health plans. However, Governor Wes Moore recently approved legislation expanding the Board's authority to set limits for "payors that have led to or will lead to an affordability challenge," effectively extending coverage to all Maryland residents.
"One lesson for other state PDABs is to not limit the target population to only state employee health plan as Maryland had initially done," says Jane Horvath, an independent health policy expert. "If the Board's recommendations apply to all residents, the state can have market leverage, especially since the process is voluntary for the manufacturer."
This expansion will take effect only after the upper payment limit has been operational for one year, allowing the Board to collect data on the policy's impact before broader implementation.
Comprehensive Drug Review Process
The Maryland PDAB (搜索) has identified four diabetes (搜索) medications as "unaffordable" following an intensive review process: Boehringer Ingelheim's Jardiance, AstraZeneca's Farxiga, Novo Nordisk's Ozempic (semaglutide), and Eli Lilly's Trulicity (dulaglutide). The Board's determination followed extensive public consultations and data analysis that took longer than initially anticipated.
"As an advocate, sometimes I feel like I'm getting impatient that it's taken so long, but the Board is going out of its way to be fair and open and transparent," says Leonard Lucchi, a patient advocate who helped draft the original PDAB proposal and is himself a diabetes (搜索) patient on Jardiance.
Andrew York, executive director of the Maryland PDAB (搜索), explains that the Board conducted review studies and accessed non-publicly available data to address the challenge of determining actual patient costs. These findings were compiled into publicly available review dossiers that analyze drug prices through multiple metrics including wholesale acquisition cost, average sales price, average wholesale price, and patient copays.
Federal Framework Influences State Pricing
The Board's recommended prices for Jardiance and Farxiga align with the Centers for Medicare and Medicaid Services (搜索)' Maximum Fair Price framework under the Inflation Reduction Act. York indicates that CMS's process ranks highest among the various pricing frameworks the Board considers, which also include index pricing, reference pricing, and budget-based pricing approaches.
The Board evaluates multiple factors when determining whether a drug is unaffordable, including disease prevalence in Maryland, available alternatives, drug shortage status, and comparative effectiveness data.
Addressing Access Concerns
Patient advocacy organizations have consistently raised concerns during Board meetings that price limits could reduce drug access within the state. However, Board members maintain that lower prices should improve rather than restrict access.
"It doesn't strike me that if you have a UPL, it impacts access. Lower prices result in better access to pharmaceuticals," says Gerard Anderson, a Maryland PDAB (搜索) member and professor at Johns Hopkins Bloomberg School of Public Health. Anderson acknowledges the Board recognizes these concerns and is working to mitigate potential adverse effects.
Dr. Benjamin Rome, assistant professor of Medicine at Brigham and Women's Hospital, cautions against broad extrapolations from formulary changes to state and federal policies, emphasizing the need to consider changing market factors such as biosimilar competition.
National Implications and Future Outlook
Maryland's approach offers potential advantages over federal drug price negotiations. While CMS negotiates prices for only a limited number of drugs meeting specific criteria, such as market tenure requirements, Anderson notes that state PDABs have greater flexibility to review expensive medications not covered by Medicare negotiations.
The Maryland model is being observed by other states implementing similar boards. Colorado's PDAB recently set an upper payment limit of $600 per 50mg/1ml for Enbrel, effective January 1, 2027, while Oregon and Washington continue developing their respective programs.
Dr. Kate Sugarman, a primary care physician in Maryland, captures the clinical reality driving these policy initiatives: "I can be the most brilliant doctor and prescribe all the best medicines. But if they can't afford it, then we're all just wasting our time."
As Maryland moves forward with implementing upper payment limits for Farxiga and Jardiance following the conclusion of public comment periods, the state's experience will likely influence the broader national conversation about pharmaceutical affordability and state-level price regulation mechanisms.