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The Centers for Medicare & Medicaid Services (CMS) recently announced the 2025 selection of 15 drugs covered under Medicare Part D for price “negotiations” under the Inflation Reduction Act (IRA). The list covers many therapeutic areas, from diabetes and cancer to asthma, arthritis, and more.
Patients, caregivers, and stakeholders have until March 1 to submit data to CMS, and until March 12 to register to participate in patient-focused roundtables and town hall events geared primarily towards clinicians. In anticipation of these fast-approaching deadlines, the Biotechnology Innovation Organization (BIO) discussed with four patient advocacy groups how to amplify the patient voice in these discussions during the February Patient Advocacy Coffee Chat.
“For the 2025 round of drug price negotiations that was kicked off in January, we have data submissions that are due in just a few days on March 1st,” began Karin Hoelzer, Senior Director of Patient Advocacy at BIO. “Many patient communities are actively trying to figure out how to be most helpful in these negotiations.”
The discussion focused on why is the patient perspective important, how patients can engage with CMS, and the unintended consequences of the negotiation process that patient groups are working to avoid.
Watch BIO’s February 2025 Patient Advocacy Coffee Chat
The importance of the patient perspective
“It’s really important for patients to engage in the Medicare negotiation program,” said Kirsten Sloan, Managing Director of Public Policy at the American Cancer Society Cancer Action Network (ACS CAN). “We’re doing so for two key reasons. One is that affordability is a very critical issue for cancer patients. We have wonderful new cancer medications, but in order for cancer patients to take advantage of them, patients have to be able to afford them. And the second reason that we’re engaging in this conversation with CMS is that we also want to make sure that beneficiaries have access to those medications.”
Affordability and access are key tentpoles for patients in the IRA-mandated drug price “negotiations,” explained Stewart Perry, Board Chair of the Diabetes Leadership Council.
“We believe that what gets lost, particularly inside the beltway in D.C., is the patient voice,” he said. “And the patient voice is critical and necessary when we start talking about how people are treated, how they access their medications and therapies that they need to handle their chronic disease.”
The negotiation processes can oversimplify an incredibly complex system, Tiffany Westrich-Robertson, Chief Executive Officer at AiArthritis (International Foundation for Autoimmune & Autoinflammatory Arthritis) and Executive Director of the Ensuring Access through Collaborative Health (EACH)/Patient Inclusion Council (PIC) Coalition, pointed out. This risks further exacerbating existing access issues as a result of more unfavorable formulary placement, more step therapy and other utilization management, and more non-medical switching.
“It is the patient and caregiver experiences that will bring issues and complexities into focus.”
The patient perspective and the CMS process
“We believe that any policy affecting patient access to treatment has to be shaped by the people that it impacts the most—so patients themselves,” said Shion Chang, Director of Policy at the National Health Council. “We’ve been deeply engaged in the CMS drug price negotiation process under the IRA, and while CMS has taken steps to incorporate patient perspectives, there’s an opportunity to ensure that patient input directly informs the decision-making process rather than being just a procedural step. Strengthening transparency and consistency in how CMS utilizes patient feedback remains an important goal.”
Chang explained that there are three primary ways for patients and caregivers to participate in the process.
“One of those is submitting written data to CMS,” said Chang. “This is one of the only guaranteed ways for patient organizations to really shape the negotiation process.”
Chang is not alone in his commitment to ensuring that patient input is more than procedural and that patient groups have all the tools they need to engage effectively. That, in part, starts at making the CMS forms more user-friendly, as the current form is proving to be confusing and overwhelming, especially for patients new to the input process, emphasized Westrich-Robertson. Patient organizations are working hard to help patients and caregivers navigate the process.
“Patients can also participate in patient round tables,” continued Chang, which are closed-door sessions with CMS staff. “The goal there is to provide candid and unfiltered feedback on the impact of drug pricing and access policies,” he said. However, these sessions are more limited in scope and only a select number of patient voices are usually included.
“The third opportunity is engaging in clinician town halls,” said Chang, which is new for 2025. “Those town halls focus on clinical perspectives, including how drugs compare in terms of safety, effectiveness, and patient-reported outcomes.”
The risks of unintended consequences on access and innovation
Patient groups aim to avoid unintended consequences on access and innovation.
“When we start talking about drug negotiations, the question is who gets the benefit of that,” asked Perry. “Do the patients get the benefit? Normally, patients get left out in the cold when it comes to health plan designs. When it comes to our pocketbooks at the pharmacy counter, we’re left out in the cold. That can’t be. People have to have access to their medications in an affordable way, or they tend not to take them or ration them, and we know that that is not in the best interest of the patient.”
“CMS also needs to hear from patients about the impact of these decisions on insurers,” said Sloan. “There’s a lot of mischief going on right now among insurers and health plans in terms of where they put drugs on the formulary and how they steer patients towards or away from specific drugs. I was really pleased that after last year’s guidance came out, CMS acknowledged that this is an issue and that that’s something that they would be monitoring. They heard beneficiaries, and so I think that was evidence that they’re listening to what the community is saying.”
The panel also called for a deeper conversation on patient perspectives about unmet medical need and the types of therapies that are better and easier for patients to handle—especially when considering the treatment of life-altering treatments like cancer, for example.
“CMS needs to understand from patients what the impact is on innovation,” said Sloan. “We need drugs in the pipeline. What will the impact of negotiation be on that in the future?”
Improving the process—rethinking CMS’s interpretation of ‘therapeutic alternatives’ and ‘Qualifying Single Source Drugs’
Access to specific drugs often gets lost in the conversation.
“There are four cancer drugs on the list this time,” notes Sloan. “We need to make sure that CMS fully understands the patient experiences when they take a drug. How does it interact with their daily life? How does it help manage their symptoms? What does it mean to have that drug available to them, and potentially, what could it mean if that drug was no longer available to them or was made expensive because of formulary placement and limited their access?”
Issues like formulary exclusion, step therapy, non-medical switching, or the use of “therapeutic alternatives” all come into play in the drug price negotiation process.
“Is there any way we can change the name of ‘therapeutic alternatives’?” Westrich-Robertson begged. “Because the name inherently says, Non-medical switching is okay. There is no alternative. When a drug works for you, it works.”
“When I look at the CMS definition of therapeutic alternatives (drugs that are used to treat the same condition or disease state as the selected drug), the IRA directs CMS to consider how the selected drug compares to therapeutic alternatives. It says nothing about cost,” she continues.
“We have to be very unified in the fact that precision medicine is here. It’s not on the horizon,” added Westrich-Robertson. “It’s here for cancer. It’s here for many of our diseases. I don’t care if it’s autoimmune, cancer, or diabetes. Diseases, for the most part, are heterogeneous. They’re unique for an individual. There are subgroups. And I think we have to find a way to scream from the mountain tops.”
Another issue that hampers innovation and risks harming patients is how CMS interprets the term “Qualifying Single Source Drugs”—which determines what drugs are selected for the negotiation process. CMS’ overly broad interpretation combines drugs with the same active moiety or active ingredient for purposes of negotiation—even if these drugs are used to treat very different diseases.
As Chang explained, “CMS’ broad definition of Qualifying Single Source Drugs may not fully account for differences in mechanisms of action and clinical benefits, even among drugs treating the same condition. While the intent is to manage costs, we must ensure that decisions about which drugs are grouped together do not inadvertently limit access for patients who rely on specific therapies. The goal should be a patient-centered approach that balances affordability with the need for individualized treatment.”
How patients’ voices can be heard in the process
“Never give up. Never give up. Never give up. Never give up,” concluded Perry. “We’re trying to train patients that while the wheels of government move very slowly, and sometimes seem to never move, without constant and consistent input, just like the constant management of diabetes, nothing’s going to happen.”
Even if patients miss the March 1 deadline, all is not lost, noted Westrich-Robertson.
“They did specifically say they will take patient organization and patient voices all the way through the negotiation process, even if they don’t participate in the focus groups or in the town halls,” she said. “Don’t let the March 1 deadline freak you out. It’s important that we get the information in, but it’s also important to note there’s still time.”
While the March 1 and March 12 deadlines are undoubtedly important, the panelists agreed that there are many additional ways to engage throughout the process.
Patient groups seeking to engage in the process are not alone. Each of the four groups represented on the panel is actively working with patients and other patient advocacy organizations to prepare. As one example, a Patient Inclusion Council (PIC) patient-led webinar explains CMS IRA negotiations, concerns, the need for all patients and caregivers to share their experiences, and opportunities to engage. A number of other patient groups also shared resources during the webinar, such as the American Brain Coalition’s Medicare Prescription Drug Resources.
