Call to Action to Engage in the CMS Public Submission Process for Austedo and Vraylar Medicare Price Negotiation

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.

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, including neurochemical pathways and biomarkers for diagnosis.
• Extreme variability in how mental illnesses manifest, making it harder to develop targeted, one-size-fits-all treatments.
• 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.
• CNS medicines take 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.

What You Can Do

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

Select the drug for which you are submitting information

Answer the relevant questions (more info on that here)

Required Sections

I28: Respondent Information — Name, organization, email, respondent description, any affiliation with the manufacturer or selected drug

J: Certification of Submission of Section – Certify the submission is truthful and made in good faith

Optional Sections

Answer any relevant questions you wish – you are not required to fill out every question. 

Save and submit your response. CMS will not review saved responses unless they are submitted.

How to Submit Your Input

The public submission portal can be accessed by requesting a link at https://hpms.cms.gov/app/ng/pblc_cmt/. Submissions can include personal experiences, research data, clinical perspectives, and any other information relevant to the evaluation of Austedo and Vraylar.

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.