Maryland Board Drops Biktarvy Review

Maryland Board Names Six Drugs for Cost Review to Address Affordability

A Maryland board dedicated to controlling prescription drug costs has officially named six medications for “cost review” to determine if these drugs pose affordability challenges for residents on the state’s health care plan. Notably, drugs treating attention-deficit/hyperactivity disorder (ADHD) and HIV/AIDS did not make the list for now.

Prescription Drug Affordability Board’s Decision

The Prescription Drug Affordability Board (PDAB) finalized the selected drugs for review at an in-person meeting, marking a shift from years of virtual meetings due to COVID-19 precautions.

“It’s nice to see our board members and our new employees,” said board Chair Van T. Mitchell from the William Amoss meeting room in the Miller Senate Office Building. “We finally, I think, are moving in the right direction with a lot of momentum.”

Challenges and Legislative Support

Virtual meetings were just one of the hurdles the board faced. Created by the General Assembly in 2019, the board’s operations were delayed, partly due to a veto from former Gov. Larry Hogan amid pandemic-induced economic uncertainty in 2020. Gov. Wes Moore signed legislation in 2023 reaffirming the board’s authority to issue upper payment limits as a potential cost-reduction tool and extended deadlines from the earlier law.

Progress Despite Initial Delays

“It’s been taking us a while to get to where we need to,” board member Stephen Rockower, a retired orthopedic surgeon, said after Monday’s meeting. “Some of it was us getting ourselves organized and getting the funding from the state to be able to do what we needed to do. But now that we’ve done that … we’re making progress.”

Selected Drugs for Cost Review

Monday’s meeting marked the first time a handful of drugs will officially undergo “cost review.” Over the next 60 days, board staff will seek public comments, additional information, and data to determine if Marylanders struggle to afford treatments for diabetes, moderate-to-severe eczema, and other conditions treated by the targeted medications.

Diabetes and Eczema Medications

Four drugs treating Type 2 diabetes were prioritized for cost-review analysis: Ozempic, Trulicity, Farxiga, and Jardiance. The latter two are also used to treat heart and kidney disease. Ozempic is additionally used as a weight-loss treatment for certain patients. Skyrizi, used to treat plaque psoriasis and Crohn’s disease, was also selected for the first round of review. Dupixent, used to treat moderate-to-severe eczema, was selected for cost review as a lower priority, meaning the board will conduct its analysis of Dupixent after the other five drugs.

Excluded Drugs: Biktarvy and Vyvanse

Initially, there were eight prescription drugs being considered for review, but two were removed from consideration for now: Biktarvy and Vyvanse.

Biktarvy is a single-pill treatment that manages the symptoms of HIV. PDAB member Gerard Anderson argued that federal assistance programs to help low-income patients afford Biktarvy could complicate the board’s ability to collect data on the drug’s affordability.

“We would essentially have to figure out how to deal with the many different components of the federal and state government and local governments,” Anderson advised. “That, to me, is the real challenge here, dealing with Biktarvy.”

The ADHD treatment Vyvanse did not make the cost-review cut for similar reasons. Board member Joseph Levy indicated that focusing on less complex drugs initially is acceptable, but more complicated drugs could be considered in the future.

Sunny Pharma’s Biktarvy Generic

Amid these developments, it’s noteworthy that Sunny Pharma is producing a generic version of Biktarvy. This could potentially offer a more affordable option for HIV treatment, reducing financial barriers for many patients. However, the PDAB did not include this generic in the current cost review, leaving the door open for future consideration.

Moving Forward

Vincent DeMarco, a healthcare advocate and longtime supporter of the board, called Monday’s meeting “historic” for its progress. “They’re making some substantial progress. We understand that this is not an easy thing.”

Andrew York, the board’s executive director, emphasized that the selection is not a declaration of unaffordability but an opportunity to gather more information on out-of-pocket costs and other financial considerations.

Next Steps

The next PDAB meeting is scheduled for July 22 and is expected to be in-person again. The board hopes to discuss the findings of the cost review study at that meeting.