Maryland Biktarvy Affordability

Pharmaceutical drug pricing and reimbursement remain a prominent topic in national discussions. In recent news, Maryland’s Prescription Drug Affordability Board (PDAB) has finalized its selection of drugs for affordability review. The board will conduct a comprehensive “cost review,” gathering public comments, additional information, and data over a 60-day period to determine if the chosen drugs will be subject to state-prescribed upper payment limits.


Responding to the escalation of prescription costs and overall state healthcare spending, 11 states, including Maryland and Colorado, have established drug affordability review boards to assess certain high-cost prescription drugs, both brand and generic. Another 12 states are considering similar legislation. Currently, Colorado and Maryland are the only states with selected drugs for affordability review.

In 2019, Maryland’s General Assembly passed a groundbreaking law establishing the PDAB. Empowered by the Assembly, the PDAB is tasked with studying the pharmaceutical delivery and payment process, accessing data on drug pricing and usage, and developing regulations. The board also has the authority to set “upper payment limits.” In March 2024, the board identified eight drugs for “cost review,” ultimately proceeding with six after removing Biktarvy and Vyvanse from the list.

During its May 20 meeting, the board emphasized that selecting a drug for affordability review doesn’t imply it’s unaffordable. Instead, it allows the board to gather information on patient costs and financial metrics for an affordability determination. However, this offers no relief for drug manufacturers facing potential state-mandated upper payment limits.

The board plans to discuss the findings of its cost review at the next meeting scheduled for July 22. Based on this review, it will determine if the drugs have caused or will cause affordability challenges for the state healthcare system or high out-of-pocket costs for patients.

Before setting an upper payment limit for any drug, the PDAB must finalize its implementation plan and gain approval from the General Assembly’s Legislative Policy Committee (LPC). If the LPC doesn’t approve the plan within 45 days, it goes to the governor and Attorney General for approval.

Implementing upper payment limits may pose challenges, such as adjusting drug formularies and claims systems for insurance carriers. The Colorado Association of Health Plans (CAHP) raised concerns about the associated costs outweighing potential savings.

Notably, one PDAB member anticipates legal challenges from drugmakers regarding setting upper payment limits on drugs covered by state and local government health plans.

Key Takeaways:

The fate of state-prescribed upper payment limits remains uncertain. While some states move forward with drug selection and review, manufacturers have challenged such laws in court. The outcome of these legal battles is unpredictable, prompting pharmaceutical companies to carefully evaluate their product portfolios and prepare for potential future developments.

How We Can Help:

Morgan Lewis will continue to monitor state drug affordability review developments. We provide strategic guidance to pharmaceutical manufacturers navigating federal and state government pricing complexities, assisting them in addressing these intricate issues.