Submit public comment by March 1, 2026.

How to Submit a Comment:

Click the link on the left-side column to request a survey link. → → →

Once you’ve requested the link to the survey, you will be taken to the next page. Click the ‘Start Survey’ button.

Once you click the ‘Start Survey’ button, you will be taken to a new page where you can download instructions (HERE) and select the drug on which you are submitting comments.

The following page includes instructions (below) and an area for your information (name, organization, email, and respondent type). THIS INFORMATION IS MANDATORY and simply requires your basic information.

Before proceeding, be sure to read the General Instructions

• All questions are optional except Question 27 and the mandatory Certification in Section J.
• You may answer some or all of the questions. If you do not wish to respond to a given question you may skip the question or enter “no response.”
• Submissions can be saved while work is in progress.
• The questions are broken down into the following sections:• Section I
  • Respondent Information (Question 27)
  • Patient- or Caregiver-Focused Input (Questions 28 – 33)
  • Manufacturer-Focused Input (Questions 34 – 39)
  • Clinical-Focused Input (Questions 40 – 45)
  • Health Research-Focused Input (Questions 46 – 51)
  • Other Public Input (Questions 52 – 54)
  • Questions for Anyone that Responds to One or More Questions in Section I (Question 57)

• Section J: Certification of Submission of Section I for All Respondents

Questions 28 through 33: Patient, Caregiver, Advocacy Section

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.

But if you only want to answer ONE QUESTION, you can skip to Questions 54-

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.

Here is The STARR Coalition’s response to Question 24 for your reference:

When evaluating Rexulti relative to potential therapeutic alternatives, CMS should carefully consider the clinical reality that antipsychotic medications are not interchangeable. Although multiple antipsychotics are available, individual response varies significantly [1], [2], [3], [4], [5]. A medication that is effective and well tolerated for one person may be ineffective or cause intolerable side effects for another [1], [3], [4]. As a result, the existence of other antipsychotics does not mean they are therapeutically equivalent for a given patient. [1], [2], [3], [5]

CMS should also consider the clinical risk associated with switching stable patients from one antipsychotic to another. Changing medications is not a routine or neutral substitution [1], [3], [6]. Transitions can lead to symptom destabilization, relapse, psychiatric crisis, hospitalization, and loss of functional independence [7], [8], [9]. For individuals who have spent years identifying a medication that provides stability, maintaining uninterrupted access to that specific treatment is essential [1], [6], [9].

In addition, many individuals living with schizophrenia or major depressive disorder require multiple medication trials over several years before finding an effective and tolerable regimen [1], [10], [11]. For some, medications such as Rexulti provide meaningful benefit after other treatments have failed [1], [3], [4], [9]. Therapeutic alternatives may exist on paper, but in practice, options are limited by prior treatment history, side effect burden, comorbid conditions, and individual variability in response [1], [3], [4], [9], [10], [11].

CMS should also consider the broader impact of treatment stability on Medicare beneficiaries. Effective antipsychotic treatment reduces relapse risk, prevents hospitalization [8], [9], [12], supports housing stability, and enables individuals to remain in the community rather than requiring more intensive and costly levels of care [5], [12], [13], [14]. Caregiver burden is also significantly reduced when individuals are stable on effective medication [15], [16].

Finally, CMS should recognize the unique challenges associated with developing treatments for serious mental illness. Psychiatric drug development has among the lowest success rates in medicine [17], [18], [23], and sustained private-sector investment is essential to translating government-funded scientific discoveries into approved treatments [19], [20], [21]. Policy decisions that affect the long-term viability and predictability of antipsychotic treatment markets may influence future investment in this already high-risk area [19], [20], [22].

It is critical for CMS to recognize that treatments for serious mental illness face significantly greater scientific, clinical, and investment challenges than treatments in most other areas of medicine. Psychiatric drug development has among the lowest success rates of any therapeutic area, due to the complexity of brain disorders, lack of objective biomarkers, and the highly individualized nature of treatment response [17], [18], [23], [44]. As a result, investment in serious mental illness treatments has historically lagged behind other disease areas despite the enormous burden of these conditions [19], [20], [21], [43], [45].

The development of treatments for serious mental illness depends on a unique and essential partnership between government and industry, with each playing fundamentally different but complementary roles. Public institutions such as the National Institutes of Health and National Institute of Mental Health provide the foundational scientific discoveries that identify biological targets and enable innovation. However, the private pharmaceutical industry provides the vast majority of the financial investment required to translate those discoveries into actual treatments through large-scale clinical trials, regulatory approval, and commercialization [19], [20], [21], [45]. Industry investment per approved drug is estimated at $1.5 billion to $2.8 billion, and private sector spending on clinical development far exceeds public investment in bringing individual treatments to patients [18], [19], [22], [46]. For example, Bristol Myers Squibb’s recent $14 billion acquisition of Karuna Therapeutics to advance a novel schizophrenia treatment illustrates the scale of private-sector investment required to bring new treatment options forward.

Analyses of FDA-approved therapies demonstrate that NIH funding provided approximately $670 million in foundational research, while private sector investment totaled approximately $44.3 billion to bring the same therapies to market—a ratio of approximately 66-to-1 private-to-public investment [18], [47], [48].  These findings illustrate the essential complementary partnership between public and private sectors, with government funding enabling early scientific discovery and private industry providing the vast majority of financial investment required for clinical development, regulatory approval, and patient access [18], [21], [47], [48].

When policies, such as CMS’ price negotiation program, introduce uncertainty about the long-term viability or value of psychiatric treatments, it can undermine investor confidence and discourage future investment in this already high-risk therapeutic area. Given the historically low success rates and limited pipeline for serious mental illness treatments, preserving a stable and trustworthy environment is essential to ensuring continued innovation, so that individuals living with schizophrenia, major depressive disorder, and related conditions have access not only to existing treatments like Rexulti, but also to the next generation of urgently needed therapies.

For these reasons, when evaluating Rexulti relative to therapeutic alternatives, CMS should consider not only clinical trial data, but also real-world variability in patient response, the risks of medication switching, the importance of maintaining stability once achieved, and the need to preserve access to a full range of antipsychotic treatment options for Medicare beneficiaries living with serious mental illness.

(Click here for the References & Citations)

Finally, Section J is mandatory. You’ll need to certify that the information you provided is true.

Resources:

Sample Rexulti Submission

Excellent Instructions from PHRMA

The National Pharmaceutical Council (NPC) doc

National Health Council’s IPAY 2028 Toolkit

  CMS Public Submission Instructions

IRA Impact on Mental Illness