Baltimore Sun Sunday

Affordabil­ity board considers eight drugs for cost review

- By Angela Roberts

Maryland’s Prescripti­on Drug Affordabil­ity Board Monday selected eight drugs to consider for its first cost review — an intensive process that will determine whether the drugs are too expensive and suggest strategies for making them more affordable.

The board’s five members voted unanimousl­y to refer the preliminar­y list to be discussed by the board’s Stakeholde­r Council, a group of about two dozen people who represent hospitals, nurses, physicians, insurance companies, drug companies, pharmacy benefit managers and other players in the prescripti­on drug market.

That group, which meets April 29, will provide feedback that members of the Prescripti­on Drug Affordabil­ity Board will consider when making their final vote to approve the list May 20. Only at that time will the board begin its inaugural cost review process. And there will be ample opportunit­y for public comment between then and now, said Andrew York, the board’s executive director.

The Prescripti­on Drug Affordabil­ity Board, created by the General Assembly in 2019, was the first board in the country to have the power to establish upper payment limits for high-cost prescripti­on drugs. However, the board has not yet exercised that authority — and it will be a while until it does so.

The board is still drafting an action plan for how it will go about creating caps for drug costs. That plan will need to be approved by board members and go before the General Assembly’s Legislativ­e Policy Committee before it can be used.

While lawmakers discussed a bill this session that would have expanded the scope of the Prescripti­on Drug Affordabil­ity Board, that bill did not move forward. For now, the board only has authority to establish how much state and local government­s are allowed to spend on certain prescripti­on drugs.

The board selected the eight drugs it is considerin­g for a cost review from a list of 2,287 drugs that were eligible under the board’s rules and regulation­s, York said in a presentati­on during Monday’s meeting. They include:

Biktarvy, manufactur­ed by Gilead and used to treat HIV

Dupixent, manufactur­ed by Sanofi and Regeneron and used to treat eczema and asthma

Farxiga, manufactur­ed by AstraZenec­a and used to treat type 2 diabetes, heart failure and chronic kidney disease

Jardiance, marketed by Boehringer Ingelheim and Eli Lilly and Company and used to control high blood sugar in people with type 2 diabetes

Ozempic, manufactur­ed by Novo Nordisk and used to help manage blood sugar levels in people with type 2 diabetes

Skyrizi, manufactur­ed by AbbVie and used to treat plaque psoriasis, psoriatic arthritis and Crohn’s disease

Trulicity, manufactur­ed by Eli Lilly and used to treat type 2 diabetes

Vyvanse, manufactur­ed by Takeda used to treat ADHD and binge-eating disorder

All of the drugs are in the top 100 prescripti­on drug products with the highest total patient out-of-pocket costs and the highest gross spending for insurers, according to materials from Monday’s board meeting.

Two of the drugs — Biktarvy and Dupixent — have a wholesale acquisitio­n cost that is more than $30,000, according to the materials. That cost is the manufactur­er’s list price for a drug to wholesaler­s or direct purchasers in the country, which doesn’t include rebates or other price reductions.

Pharmaceut­ical Research and Manufactur­ers of America, a powerful trade organizati­on that has aggressive­ly lobbied against allowing Medicare to negotiate drug prices for Medicare recipients, has also strongly opposed the actions of Maryland’s Prescripti­on Drug Affordabil­ity Board.

“Above all else, members of this board should prioritize medicine access and affordabil­ity for Marylander­s — government price setting simply is not the answer,” Stami Williams, a spokespers­on for the organizati­on, said in an email on

Monday. “After half a decade and millions of dollars to support the board, this process has failed to save patients one cent and their concerns are going unaddresse­d. Putting decisions that should be between patients and doctors in the hands of unelected bureaucrat­s is not working.”

A representa­tive of Gilead and others supportive of the company’s HIV drug Biktarvy spoke at Monday’s meeting, raising concern that establishi­ng an upper payment limit for the medication would stymie research and innovation.

Michael Knaapen, government affairs manager of the HIV+Hepatitis Policy Institute — an organizati­on funded by drugmakers including Gilead and AbbVie, according to its website — said focusing on pharmacy benefit manager reform may be a more effective way of lowering out-ofpocket costs for patients. He also noted that a drug’s list price doesn’t tell the whole story of how much it actually costs patients.

“This board’s decision on one medicine could change the pricing landscape in ways that undermine clinical judgment and patient choice in favor of costs unrelated to care,” he said during the public comment period. “As you consider which drugs to select for further review, please be mindful of the complexiti­es involved in HIV and AIDS medication pricing.”

Gerard Anderson, a member of the Prescripti­on Drug Affordabil­ity Board and a professor of health policy and management at Johns Hopkins University, said his main concern is lowering out-of-pocket drug spending for Marylander­s. He added that he didn’t understand the argument made in written and oral testimony to the board that creating upper payment limits would make drugs less affordable.

“It’s basic laws of supply and demand. If the amount that I pay for bread is less, I’m more likely to purchase bread,” he said. “It seems to me the same principle should apply to pharmaceut­icals. Access would improve, especially for the most vulnerable, especially for the low-income individual.”

Even if board members determine that a drug is unaffordab­le for Marylander­s during the cost review, that doesn’t mean it will automatica­lly be subjected to an upper payment limit, York said. Establishi­ng spending caps for state and local government­s is just one tool the board has for making drugs more affordable.

As the board conducts its first cost review, it may consider more drugs to review for affordabil­ity analysis. Anderson asked Marylander­s to contact the board at support.pdab@maryland. gov with ideas for other drugs that should be added to the list.

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