Skip to content
The Centers for Medicare & Medicaid Services (CMS) announced their 2025 selection of 15 drugs covered under Medicare Part D for price “negotiations” under the Inflation Reduction Act (IRA) on January 17. The list includes therapies covering a wide range of therapeutic areas from diabetes and cancer to asthma, arthritis and more.
Patients, caregivers, and other stakeholders have until March 1 to submit data to CMS and until March 12 to register for participation in patient-focused roundtables and townhall events geared primarily towards clinicians. In anticipation of these fast-approaching deadlines, the Biotechnology Innovation Organization (BIO) welcomed four representatives from patient advocacy groups to discuss how the patient voice can be highlighted in the conversation during their February BIO Patient Advocacy Coffee Chat: Patient Voice in CMS Drug Price “Negotiation.”
“As we all are aware, 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. “And so I know that many patient communities are actively trying to figure out how to be most helpful in these negotiations.”
Much of the discussion focused on why is the patient perspective important, how can patients engage with the CMS, and what are some of the unintended consequences to the negotiation process that patient groups are working to avoid?
Why the patient perspective matters so much
“It’s really important for patients to engage in the Medicare negotiation program,” began Kirsten Sloan, Managing Director of Public Policy at 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.”
Indeed, affordability and access are key tentpoles for patients when it comes to the issue around the IRA-mandated drug price “negotiations,” as Stewart Perry, Board Chair of the Diabetes Leadership Council explained.
“We believe that what gets lost, particularly inside the beltway in DC, 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.”
His comments highlight the trickle-down effects that such “negotiations” have on patients. As 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 during the conversation, such negotiation processes risk oversimplifying an incredibly complex system. 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. “
How the patient perspective factors into 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”
“CMS created three primary ways for patients and caregivers to participate,” explained Chang. “One of those is submitting written data to CMS. And that deadline is, as you mentioned, March 1—so it’s coming up very quickly. 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 patient groups have all the tools they need to effectively engage. That, in part, starts at making the CMS forms more user friendly and easy to navigate, as the current form is proving to be confusing and overwhelming for patients, especially those new to the input process emphasized Westrich-Robertson. She and the patient organizations she and the other panelists are collaborating with are working hard to help patients and caregivers navigate the process, as was pointed out extensively during the conversation.
The data form is not the only way for patients and patient groups to engage. “Patients can also participate in patient round tables,” said Chang. “These are closed door sessions that allow patients and patient organizations to speak directly 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. “So that’s new for this year. 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
The paramount reason why some of the patient groups represented on the panel engage in this tenuous process is to avoid the 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 when it comes to 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’
The issue of access to specific drugs is a key element that often gets lost in the conversation.
“There are four cancer drugs on the list this time,” notes Sloan. “So 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?”
Whether it is formulary exclusion, step therapy, non-medical switching, or the use of “therapeutic alternatives,” all of these issues come into play when it comes to 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.”
She continued, “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.”
“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 together 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.”
Looking ahead—how patients can have their voices heard in the process
“Never give up. Never give up. Never give up. Never give up,” was the mantra that Perry ended with. “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 a diabetes, nothing’s going to happen.”
And, in closing Westrich-Robertson reminded that even if patients miss the March 1 deadline, all is not lost.
“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, because they want all voices,” 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.” This was iterated by all the other panelists. While the March 1st and March 12th deadlines are undoubtedly very important, there are many additional ways to engage throughout the process.
And patient groups seeking to engage in the process are not alone. Each of the four patient groups represented on the panel is actively working with patients and fellow patient advocacy organizations to prepare ahead of the upcoming deadlines. For instance, this Patient Inclusion Council (PIC) patient-led webinar explains CMS IRA negotiations, concerns, need for all patients and caregivers to share their experiences, and opportunities to have their voices counted. A number of other patient groups also shared resources during the webinar such as the American Brain Coalition’s Medicare Prescription Drug Resources.
