Catherine Reitzel’s multiple sclerosis drugs cost nearly $100,000 a year. Kris Garcia relies on a drug for a blood clotting disorder that costs $10,000 for a three-day supply. And Mariana Marquez-Farmer would likely die within days without her monthly $300 vial of insulin.
At best, a group of Colorado medical and pharmaceutical experts looking to cut the costs of expensive drugs will be able to help only one of them.
Beginning this summer, the state’s Prescription Drug Affordability Board will screen up to 18 high-cost drugs for review over the next three years to determine whether the drugs are unaffordable and whether to limit what health plans and consumers pay for them.
But with hundreds of expensive drugs to choose from, board members have to make tough decisions about who will get help now and who will wait.
Are they facing extremely high cost drugs taken by only a handful of patients or simply very high cost drugs taken by a larger group? Should they only consider the out-of-pocket costs paid by consumers, such as for insulin, which copays Colorado caps at $50 a month, or the total cost of the drug to the healthcare system? Will they just weigh drug prices or will they try to right social wrongs with their choices?
And what does convenient even mean?
That question alone is much harder to answer than it might seem at face value, said Jennifer Reck, project director for the National Academy for State Health Policys Center for State Prescription Drug Pricing. You immediately realize how extremely complex our drug supply chain is, how opaque it is, how many different pricing there are, she said.
Maryland was the first state to establish a drug affordability committee in 2019, but funding strains and the pandemic have slowed progress. Colorado has passed a bill creating its council in 2021 and has already passed Maryland in the process. Washington followed in 2022, but is still in its early stages of implementation.
Maine, New Hampshire, Ohio and Oregon have also established boards of directors, but lack the power to limit drug payments. And at the federal level, the Inflation Reduction Act of 2022 included a provision requiring the Secretary of Health and Human Services to negotiate prices with drug companies for a small number of the most expensive drugs covered by Medicare.
It took years for board members in Colorado and Maryland to create all the rules and regulations to govern their work before they got to the point of looking at specific drugs.
It’s just a long, tortuous government process to get things going, said Gerard Anderson, a professor of health policy and management at Johns Hopkins University and a member of the Maryland board of trustees. Basically you have to punt every i and cross every t to not get sued.
Setting priorities
On May 12, Colorado released its first list of hundreds of drugs eligible for review, primarily because each one costs more than $30,000 for a course of treatment. Next month, they’re releasing a dashboard that ranks those drugs according to board priorities. The dashboard can also be used to examine which drugs have the highest prices, which have had the largest price increases, and which the state spends the most on. That would allow the board to begin affordability reviews this summer and set payment caps for the top four to eight drugs in 2024. But board members will first need to set their priorities, which could change from year to year. year.
Maybe one year we focus on the impact on the system, and another year we focus on out-of-pocket costs, and one year we focus on a life-saving drug that has a smaller use, said Lila Cummings, Colorado board director.
Such approaches could pit one group of patients against others in search of cost reductions. But Cummings said not all groups are eager to see payout limits.
Some of them said, “We want the board to focus on our drugs,” and others said, “Please leave us alone,” he said.
Such reluctance likely reflects the close ties some patient groups have with the manufacturers of their drugs, including funding from drug companies.
We’ve seen cases in public hearings that seem counterintuitive or surprising where a group of patients, instead of being excited about being able to access drugs at a lower price, are instead arguing against maximum payment limits, Reck said. But in most cases, there’s a clear financial connection to the drug makers.
Maryland has also been receiving input from patient groups as it finalizes its regulations.
So far it hasn’t been, Choose me! Pick me up! Pick me up! said Anderson. But that could change once the Maryland council begins its accessibility reviews this fall.
The drug that Garcia, 47, of Denver, takes has not been placed on the list of recommendations. Diagnosed with four bleeding disorders, including von Willebrand disease, he needs the drug Humate-P, made by CSL Behring, to replace one of the missing clotting factors in his blood. This winter, while driving home from his job at the airport, Garcia hit a patch of black ice, spun and slammed into a concrete barrier at 120 km/h. He needed the expensive drug every day for the first five days after the accident, and then every other day for an entire month.
It’s not like I can just sit there and say no to this drug, because my bleeding gets so much worse, she said.
According to Perry Jowsey, executive director of the National Hemophilia Foundations Colorado chapter, about 300 to 400 people are being treated for von Willebrand disease in Colorado. That’s far fewer than the approximately 10,000 Coloradans with MS or the 74,000 who manage their diabetes with insulin.
In my shoes, I would target what would help the most people, Garcia said. You have to find a balance, especially in the beginning. You won’t be able to help everyone.
The Colorado and Maryland boards will rely on data from state databases showing how much various public and private health plans pay for drugs. That data, however, doesn’t capture how much uninsured patients pay, and it doesn’t provide any insight into how much manufacturers pay for research and development.
The goal isn’t to stifle innovation, Anderson said. But we can’t get public data, so we have to ask the pharmaceutical industry, and they don’t have to give us the data.
Boards want to ensure that patients like Reitzel still have access to new and better therapies. Reitzel, 38, of Highlands Ranch, was diagnosed with multiple sclerosis in 2008 and switched medications several times looking for one whose side effects she could tolerate. They’re all terrible in their own way, she said.
In 2021, she began taking a relatively new drug from Biogen and Alkermes called Vumerity, which was included on Colorado’s Eligible Drug List. But the cost of a three-month supply was nearly $24,000, including a copay of more than $7,000. Biogen provides up to $20,000 in copay assistance annually via a debit card that you can use at your pharmacy. But now his health plan no longer credits those payments to his deductible. It makes it nearly impossible for her to reach her plan’s maximum of $25,000.
Mainly for this reason, I no longer take any medications, Reitzel said, and I just have to hope my disease doesn’t progress.
Colorado lawmakers passed a bill to require health plans to count copay assistance programs to deductible patients for drugs without generic equivalents, but that provision won’t go into effect until 2025.
Insulin as an outlier?
Just a couple of years ago, insulin might have been a higher priority for drug accessibility committees, but that’s not so clear now. Both Colorado and Maryland have established insulin coverage limits that provide relief to the wallet, at least for patients with coverage. And manufacturers are making their own moves to lower insulin prices. This could prompt boards to bypass insulin and focus their limited resources on other high-cost drugs.
Copay caps do not lower the actual cost of insulin, but instead distribute it among health plan members through higher premiums. Colorado’s copay limits don’t help new state residents and initially didn’t help those without insurance either. Both of these hurdles would apply to Marquez-Farmer when she moved from California to Colorado Springs a couple of years ago.
I got married to my husband during covid because I didn’t have insurance, she said. I loved him and everything worked out, but a big reason to marry him was because I couldn’t afford insulin.
Marquez-Farmer, 34, said that while insulin may not be the most expensive drug on the market, many Colorado residents, especially those in marginalized communities that have higher rates of diabetes, are struggling to afford it.
I’m not saying the other meds aren’t important, because they obviously are, she said. The reality is that there are more people who are affected by not being able to afford their insulin and many people who die from insulin rationing.
Andrew York, executive director of the Maryland board, said payment caps should be seen as a last resort, a tool that can be used when other cost-control measures haven’t worked.
The goal is for people to never say they can’t afford their insulin. And I think we might get there pretty soon just because of what’s happening in that space, she said. So if that’s the case, maybe the boards don’t need to use the higher payout limit tool.
At least one form of insulin was included in Colorado’s list of drugs eligible for review, but not the most commonly taken brand-name insulins. This prevents the Colorado council from addressing insulin costs more broadly.
The pharmaceutical industry has rejected the concept of payment limits, warning that drug makers could back out of states that set payment limits.
The boards of directors are well aware of this talking point. The interest and purpose of these commissions is to increase access to drugs, not reduce it, York said. But there’s sort of this game theory element of, how are the producers going to react?
Reck discounted the notion that a payment cap would cause a manufacturer to leave a lucrative market.
Unfortunately, it’s kind of a scary message and it can impact patients, he said.
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