With the passage of the Inflation Reduction Act (IRA) and the growing number of prescription drug affordability boards (PDABs), patients and the biotech industry are worried about access to medicines, especially within the rare disease space.
The double whammy of federal and state price controls is concerning. PDABs are state boards that aim to cap, control, and dictate the price of drugs that manufacturers can charge. This year, the Colorado PDAB began implementing its review of certain drugs to determine whether the state will impose an upper payment limit (UPL), or reimbursement limit, for drugs provided in markets regulated by the state. Meanwhile, states are looking at the IRA’s Maximum Fair Prices (MFPs) as a mechanism for establishing drug price controls.
During the 2024 BIO International Convention in San Diego, patients and industry spoke about this issue in a panel, PDABs and the IRA: The Impact of Federal Legislation on State-Level Prescription Pricing Practices.
The problem with PDABs
When it comes to the IRA and PDABs, governments “hadn’t thought about the questions they were asking patients regarding affordability,” said Tiffany Westrich-Robertson, Chief Executive Officer and Co-Founder of AiArthritis, which is dedicated to education, advocacy, and research for those impacted by autoimmune and autoinflammatory arthritis (AiArthritis). “And it was almost like the PDABs were just ticking a box when it came to getting patients involved,” leading to “severely compromised the data.”
“It is extremely challenging for a patient to respond to a question that isn’t worded correctly,” she added.
“I think if you look at the PDABs framework that’s been adopted in many states, you definitely don’t see any sort of guarantee or any sort of clarification of the relationship between what they’re doing and actually reducing patients out-of-pocket costs,” said Brett Johnson, JD, Director of State Government Affairs at Amgen. He also noted the role of pharmacy benefit managers (PBMs) in not just driving up the cost of drugs for patients but also pocketing those incurred costs.
“The affordability-for-who question hasn’t yet been solved,” Westrich-Robertson explained. “But we have to come together and educate everyone and invite all perspectives.”
Interview with Tiffany Westrich-Robertson, Chief Executive Officer and Co-Founder of AiArthritis
“I think it’s important to note, from a patient perspective, that the advertisements and promotions for PDABs very largely promote that they will save out-of-pocket costs for all patients in the state, and neither one is true,” she added in an interview after the session. “We are here to help those boards, as their allies, with patient input, so that we can help them fill in the blanks where patients need to have a say.”
What’s happening with the IRA?
- Alice Valder Curran, JD, Partner at Hogan Lovells, and Brett Johnson, JD, Director, State Government Affairs at Amgen, speaking at the 2024 BIO International Convention in San Diego.
The conversation also touched on the effects of the IRA price controls.
“We are in the middle of that negotiation process. It is scheduled to end by August 1,” said Alice Valder Curran, JD, Partner at Hogan Lovells. This means the first tranche of MFPs is expected to be published by September 1.
“We’re all waiting to see that,” she added. “By the way, we’re not going to see the justifications or the explanations of those prices until 2025.”
In addition, the second round of guidance on negotiations for the second year of the program is out for stakeholder comments, she noted.
“One of the biggest pieces of that draft guidance is about effectuating the MFP,” Valder Curran said. “And how do we make sure that patients actually get drugs based on the MFP price at whatever pharmacy they go to any place in the United States, and how do we make sure that they can access that price?” After all: “It took CMS about 50 pages to describe how they might do it.”
There is also concern about the IRA’s impact on orphan drug development. However, the panel noted that legislative understanding of that misstep is improving.
How can patients get involved?
Patients and caregivers can help shape policy by “sharing their stories,” said Westrich-Robertson in the interview. But it’s more than just sharing a story. It’s also important to share data “very specific” to a patient’s experience with affordability and access.
Patient advocacy groups are helping to collect this data, which is “what’s really going to turn the table.”
“If the questions are being asked in a way that patients can answer them and also the data that’s being collected is appropriate and usable to get a real affordability decision,” she concluded.
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- Source: https://bio.news/state-policy/pdabs-and-ira-inflation-reduction-act-price-controls-2024-bio-international-convention/