Why Your Input Matters
Austedo and Vraylar are essential treatments that help individuals with movement disorders, schizophrenia, bipolar disorder, and major depressive disorder manage their conditions and live fuller, more independent lives. The outcome of these CMS negotiations could determine whether patients continue to have access to the therapies they need—or face new barriers that limit their ability to function and thrive.
While the Inflation Reduction Act (IRA) aims to lower costs, its implementation could unintentionally restrict access to critical medications. The IRA’s approach to price setting has already raised serious concerns within the research and pharmaceutical communities, particularly for small molecule medications like Austedo and Vraylar. The “pill penalty” discourages investment in these treatments, potentially slowing down innovation and reducing treatment options for patients.
CMS has specifically requested public comment on unmet medical needs and the impact of these medications on specific populations. This is an opportunity to shape policy decisions by ensuring that CMS understands the clinical, scientific, and real-world value of these treatments.
Submit public comment by March 1, 2025.
How to Submit a Comment:
Click here: Medicare Drug Price Negotiation Program Public Submission Form
Register with a valid email address
Check your email for access to the submission form and follow the link sent.
Question 28 is mandatory and simply requires your basic information.
Since all respondents can answer any and all questions, the respondent type does not significantly impact the form.
• Select the drug for which you are submitting information
• Fields to complete include your name, the name of the selected drug you are providing input on, your organization’s name (if applicable), and your email.
• Checkbox on the category of person completing the form. You can select more than one box.
- Respondents who select “patient” or “caregiver” will be asked and may choose to respond to demographic questions in Question 42.
- If “Other” is selected, CMS requests a brief description.
You can choose to answer (or decline to answer) the majority of questions in Section I. Questions 28, 36-42 and 57-62 are likely to be most relevant to patients and caregivers. Clinicians will likely wish to focus on Questions 28, 43-49, and 61-62. (For help filling out these sections, see links on right).
But if you only want to answer ONE SECTION, you can skip to Questions 57-
When CMS asks, “What information should we be aware of as we evaluate these selected drugs?” the answer is clear: the voices of those who rely on these treatments must be heard—especially those who cannot speak for themselves.
Individuals living with schizophrenia, bipolar disorder, and other serious mental illnesses often face cognitive challenges—disorganized thinking, difficulty focusing, and impaired decision-making—that make it more difficult for them to directly participate in this process. That makes it even more critical for patient advocates, caregivers, and the public to step forward and ensure their needs are not overlooked.
Austedo and Vraylar are more than medications; they are lifelines. These therapies enable individuals with movement disorders, schizophrenia, bipolar disorder, and major depressive disorder to manage their conditions, maintain stability, and lead fuller, more independent lives. Without access to these treatments, many people could lose the ability to work, engage with their families, or even perform basic daily tasks—pushing them toward crisis situations that could burden healthcare systems, social services, and communities.
You are welcome to click here for more info on responding to this question.
Finally, Section J is mandatory. You’ll need to certify that the information you provided is true — Answer “Yes”.
(It’s not clear what the consequences of checking “No” are, but conceivably CMS might not consider your response if you check ‘No’.
• After the checkbox, respondents must provide contact information and a signature, then click the SUBMIT button on the right side of the form.
Resources:
Sample Vraylar Submission
Sample Austedo Submission
Excellent Instructions from American Brain Coalition
Info to help fill out CMS submission
– Toolkit – Navigating the Inflation Reduction Act: What it Means for Movement Disorder Patients & Advocates
– Blog – Feds Target 15 More Drugs for Price Negotiations
IRA Impact on Mental Illness
Factsheet Medicare Drug Price Negotiation Program Selected Drug List
Mental Health Fact Sheet
CMS Drug Price Negotiation Program Memo
This is not just a procedural step; it is a pivotal moment that could determine the future accessibility of critical mental health medications. People living with mental illness or movement disorders need access to medication options to allow them to reclaim their daily functioning and engage more fully in their communities.
Submit public comment by March 1, 2025.
How to Submit a Comment:
Click here: Medicare Drug Price Negotiation Program Public Submission Form
Register with a valid email address
Check your email for access to the submission form and follow the link sent.
The outcome of CMS’s negotiations may determine whether patients continue to access these essential therapies—or face new, insurmountable barriers to care. If cost-cutting measures lead to new access restrictions, those living with severe mental illness may suffer devastating consequences, including worsening symptoms, hospitalizations, and loss of autonomy.
This is not just about numbers on a balance sheet. It is about real people—mothers, fathers, siblings, friends—who depend on these medications to stay stable, to function, and to live.
We must speak up now for those who cannot before the choices available to them disappear.
By participating in this public input process, we can collectively advocate for the inclusion of mental health treatments in the CMS negotiation list, ensuring that these essential medications remain accessible and affordable for all those in need. Your participation is key to shaping a supportive environment where mental health is prioritized and treated with the urgency it deserves.
Mental Health Research Already Faces Steep Challenges
Developing effective treatments for serious mental illnesses (SMIs) is already one of the most complex and high-risk areas of pharmaceutical research.
Unlike other disease areas, mental health drug development faces unique scientific, clinical, and regulatory hurdles, including limited understanding of brain mechanisms that drive mental illness, extreme variability in how mental illnesses manifest, making it harder to develop targeted, one-size-fits-all treatments, and clinical trial recruitment and retention challenges, as many patients struggle with adherence due to the nature of their illnesses.
As a result:
It takes 20% longer to develop a CNS drug than other types of medications and 38% longer to receive regulatory approval due to the complexities of mental health research. Clinical trial success rates for CNS drugs are just 6.2% – less than half the success rate of medicines for other conditions (13.3%).
The added risk and uncertainty introduced by government price setting under the IRA may deter further investment in this area – threatening progress, halting innovation, and limiting future treatment options for those who need them most.
We Must Act Now—
March 1, 2025, Deadline Approaching
This is a rare opportunity to influence policy decisions that could impact the most vulnerable among us. We encourage all members of the STARR community to lend your voices and ensure that not only do Austedo and Vraylar remain accessible for those who need them most, but also to send a message to CMS that including medications for mental illnesses will be met with a powerful response.
Mental health conditions are already among the most difficult to treat, and the challenges of developing new therapies are immense. Now is not the time to introduce additional barriers.
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