A state board tasked with controlling prescription drug prices for Maryland workers said that they are likely to identify the first set of medications for cost reduction efforts in early next year, and the panel is finalizing procedures in order to get their work underway.
The Prescription Drug Affordability Board put the final stamp on two rules outlining the initial procedures to start evaluating which drugs are not affordable for state workers during a virtual meeting Monday.
The board’s current authority only covers prescription drugs under state and local government health care plans, but health advocates want to expand the board’s authority in 2024 so that more Marylanders see savings, not just state workers.
The Prescription Drug Affordability Board was created by the General Assembly in 2019. The board has been slow to begin operating, due in part to a veto from former Gov. Larry Hogan (R) amid pandemic-induced economic uncertainty in 2020.
Gov. Wes Moore (D) signed additional legislation this year that reaffirms the board’s authority to issue upper payment limits and extends deadlines from the earlier law. In addition, the General Assembly carved out an additional $1 million in the 2024 state budget for the board’s operations.
One of the rules finalized Monday sets out a list of definitions for the board, so everyone is on the same page when discussing terms such as “active ingredient,” “out-of-pocket costs,” “therapeutic alternative” and dozens of other industry-specific jargon. The first finalized rule also sets out a procedure for public comments and how the board will handle sensitive medical information or trade secrets.
The other rule approved Monday outlines the cost review process. Initially, the board will determine a substantial lists of drugs that could be evaluated for price-lowering efforts.
Board members will be able to nominate a prescription drug to consider for evaluation at future board meetings and the drugs under consideration will be open for public comment.
After the board determines which drugs will be evaluated, there will be an additional 30-day public comment period and the board will begin gathering information to determine affordability.
The rules were first approved in July, but the two rules had to go through some administrative procedures and a 30-day comment period before they were finalized.
During the public comment period, PhRMA, a trade group representing companies in the pharmaceutical industry, submitted letters in opposition, saying that the rules do not “provide clear definitions and standards for significant areas of the Board’s cost review process,” a criticism they’ve expressed before.
The National Organization for Rare Disorders (NORD), a coalition of nonprofits and health organizations advocating for people with rare disease, submitted a letter urging the board to protect personal medical data as the board collects information on certain drugs for evaluations.
“NORD appreciates the PDAB providing forums for patients to submit information on a drug or drugs that have caused or are causing affordability issues for the individual,” the letter reads. “However, we are concerned that the lack of clarity on how patient data will be treated could limit individual participation. To ensure that patients feel comfortable that their data will be protected, we recommend clarifying explicitly that patient submitted information will be treated as ‘proprietary data and information’ and not subject to public availability.”
NORD also wants the board to be mindful of the data limitations that come with therapies and medications aiming to treat a wide range of rare diseases as PDAB begins to target drugs for price controls. NORD hopes to be a resource for the board in this effort
“NORD is an umbrella organization for more than 330 rare disease-specific patient advocacy groups and does not engage in disease-specific or treatment-specific policy or advocacy work,” the letter states.
“Therefore, NORD is not seeking an opportunity to discuss the specifics of any of the potential selected products, but wants to more broadly discuss issues such as data scarcity that can make it challenging to conduct a comprehensive affordability review and/or set an upper payment limit, the access challenges many of our patients face, as well as the significant unmet medical need that necessitates continued investment in drug development.”
PDAB also published its annual report to the General Assembly about the state of prescription drug prices and efforts that the board took over the course of the year.
Andrew York, executive director for the affordability board, said that the report is light this year because the board has not yet begun evaluations, but he hopes that next year’s report will be more substantive.
“We work with the information that we have available,” York said. “So we did a quick review of the literature and some general findings on the overall drug pricing trends…We’ll be starting our cost reviews next year, so we don’t have any cost reviews this year.”
Meanwhile, the Maryland Health Care for All Coalition is urging lawmakers to expand the authority of the board’s authority limit costs for all Marylanders, not just state employees, in the upcoming 2024 Legislative Session.
The coalition held a series of community forums across the state to discuss the efforts of the affordability board, raise awareness of the legislative efforts to expand the board’s authority and hear from the community about how high drug prices affect them.
“We do need to get that board additional authority to get high-cost drugs affordable for everyone, and that will be the top priority for Maryland Health Care for All,” said the coalition’s president, Vincent DeMarco, during the last forum located at the Liberty Senior Center in Baltimore County on Nov. 15.
Also in attendance of the Baltimore County forum were Comptroller Brooke Lierman (D), Baltimore County Executive Johnny Olszewski (D) and House Speaker Adrienne Jones (D-Baltimore County).
“As policy makers, we need to consider all the opportunities and options to available to us… Together, we can help make drugs more affordable to more Marylanders,” Jones said.