Migraine Patient Access and the Inflation Reduction Act
Advocacy Toolkit
BACKGROUND
The Inflation Reduction Act (IRA), passed in 2022, gave the Centers for Medicare & Medicaid Services (CMS) the authority to negotiate certain drug prices in Medicare. Negotiated prices, called the “Maximum Fair Price,” are intended to lower what Medicare pays for selected drugs in both Part D and Part B.
For the first time, CMS is negotiating prices for Part B medications – drugs administered in a physician’s office. Botox (onabotulinumtoxinA), an FDA-approved treatment commonly used to treat chronic migraine, is included in this cycle’s negotiation list.
Lower costs matter. But if negotiation policies lead to:
- More restrictive prior authorization
- Step therapy requirements that don’t reflect clinical reality
- Delays in in-office administration
- Reduced provider capacity to administer treatment
patients could lose access to a therapy that keeps them functional and out of crisis care.
The Alliance for Headache Disorders Advocacy supports efforts to make medications more affordable for patients. We also recognize the importance of reducing costs within Medicare. At the same time, we are focused on ensuring that implementation of these negotiations do not create unintended consequences that limit access to effective preventive treatment options for people living with chronic migraine.
This toolkit is intended to help patients, carepartners, clinicians and researchers engage in the Medicare drug price negotiation process so that CMS decisions reflect the real-world impact of chronic migraine and safeguards access to care.
HOW YOU CAN HELP
CMS is actively collecting public input. Your voice can shape how access is protected.
Patients, care partners, clinician and advocates can provide CMS with requested public input on:
- Unmet medical need addressed by Botox
- Clinical use and comparative effectiveness relative to therapeutic alternatives.
- Impacts to specific populations
Public Comment / Evidence Submission (Individuals and Organizations)
CMS collects public input during the evidence-gathering phase. For the 2028 cycle, the public submission deadline is Sunday, March 1, 2026. Submissions should focus on how chronic migraine affects patients’ lives, the need for multiple treatment options, and how coverage disruptions can increase disability and downstream costs.
All impacted individuals are encouraged to provide their individual perspective using the Public Submission FORM for Reporting Evidence about Selected Drugs and Their Therapeutic Alternatives.
CMS has grouped questions in five categories of topics:
- Questions 28-33: Patients and Caregivers
- Questions 34-39: Manufacturers
- Questions 40-45: Clinicians
- Questions 46-51: Health Researchers
- Questions 52-54: Other Public Input
All questions are optional – you can skip questions or write “no response.”
Responses must be written in narrative text and are subject to per-question character limits (including spaces and symbols). CMS reviews submissions holistically, so you don’t need to repeat the same information across multiple answers.
Comment Submission: Step-By-Step
Step 1
Go to:
https://hpms.cms.gov/app/ng/pblc_cmt/
Click “Request Survey Link.”
Step 2
Register with your email and verify.
Step 3
Select: “Botox; Botox Cosmetic”
Step 4
Answer questions based on your role:
Step 5
- Patients & caregivers: Questions 28–33
- Clinicians: Questions 40–45
Submit your comment by March 1, 2026 and retain a copy of your responses for your records.
Things to Remember:
- You do not have to answer every question.
- You may skip the questions that are not relevant to you.
- You should not include personally identifiable information as these comments will become part of a public record.
What to Include in Your Submission
Use the points below as guidance. Do not copy them word for word. CMS is looking for real-world experience and clinical perspective. The most effective submissions reflect your own voice while reinforcing consistent themes.
Strong submissions will help CMS understand that chronic migraine is a serious, disabling neurologic disease, not “just headaches,” and that prevention is what reduces disability, emergency care use, and long-term costs.
Consider addressing:
Unmet medical need
Describe what chronic migraine looks like day to day. Include disability, missed work or school, caregiving impact, mental health comorbidities, sleep disruption, medication overuse risk, ER visits, and safety concerns such as driving. Undermanaged migraine is costly and destabilizing.
Patient heterogeneity and individualized care
Patients respond differently to preventive therapies. Some cannot tolerate or have contraindications to common oral preventives. Chronic migraine includes refractory subgroups that may require individualized sequencing and, in some cases, combination approaches. One-size-fits-all policies and rigid “fail first” requirements can cause months of preventable disability.
Therapeutic context
Clarify the difference between chronic and episodic migraine, preventive versus acute treatment, and self-administered versus office-administered therapies. Botox is an established in-office preventive option that requires trained clinicians and reliable appointment access.
Access realities
Explain how prior authorization delays, step therapy, appointment wait times, and reimbursement disruptions can destabilize disease control and increase reliance on acute medications and crisis care. Payment and operational policies can affect whether clinics are able or willing to provide office-based treatment.
Medicare-specific considerations
Discuss the impact on Medicare disability beneficiaries under age 65, rural patients, those facing transportation barriers, caregiver burdens, and specialist shortages. Affordability matters, but implementation should not create access cliffs or site-of-care disruptions that harm patients.
Additional Opportunities to Make Your Voice Heard: CMS will host “Public Engagement events” to seek input from patients and other interested parties. These events will consist of roundtables and a town hall.
CMS Patient Roundtable – Wednesday, April 8th, 11 AM – 1 PM ET)
Patient Roundtables provide patients, advocates and caregivers the opportunity to provide in-depth patient and caregiver perspectives about living migraine and utilizing Botox as a treatment for the disease. The focus should be on real-world experience, unmet needs, and treatment impact. Roundtables are designed for sharing lived experience and how Botox specifically treats chronic migraine.
Who Participates
- Patients currently or previously using the selected drug
- Caregivers
- Patient advocacy organizations
Format
- Moderated, structured discussion
- Limited number of speakers
- Often virtual
- CMS may ask guided questions
Topics Covered
- How the condition affects daily life – work, driving, caregiving, co-morbid conditions such as anxiety / depression), and treatment goals / outcomes that matter most
- How the drug compares to alternatives – distinguishing preventive treatment options such as CGRP’s, mAbs, oral preventives, gepants in prevention) vs. Botox’s role in chronic migraine.
- Side effects and tolerability – including patients who fail / cannot tolerate other preventives.
- Financial burden and access barriers – including documenting real-world switching patterns, combination therapy, and what happens when patients lose access (ER/urgent care visits, acute medication overuse, and disability).
Participation is pre-registered and curated, with a smaller group to allow deeper discussion. CMS chooses participants for the Roundtable and will notify selected participants by March 9, 2026.
Register HERE.
CMS Botox Town Hall – Wednesday, April 22nd (10:30 AM – 12 PM ET)
Town Halls are designed to allow broad public input on the selected drug and therapeutic alternatives as part of the negotiation process.
Who Participates
- Clinicians
- Researchers
- Manufacturers
- Advocacy groups
- General public
Participation is broader and less curated than roundtables.
Format
- Public meeting/accessible
- Speakers register in advance
- Time-limited remarks (often ~2–3 minutes each)
Topics Covered
- Clinical evidence
- Comparative effectiveness
- Market context
- Access and affordability
- Broader policy implications
Town halls are formal public comment forums and are part of the official negotiation record. Register HERE.
SOCIAL MEDIA GUIDE
Hashtags
- #PatientAccess
- #Migraine
- #ChronicMigraine
- #Medicare
- #IRA
Sample posts (customize and localize)
- Chronic migraine is a disabling neurologic disease – not “just headaches.” Medicare price policies must protect access to effective prevention, but they need to hear from patients and caregivers. Submit your comments here: https://hubs.ly/Q042N-4S0 #Migraine #PatientAccess #IRA
- Patients respond differently to migraine preventives. One-size-fits-all coverage rules don’t work. CMS should hear from patients and clinicians. Submit your comments here: https://hubs.ly/Q042N-4S0 #ChronicMigraine #PatientAccess
- Botox is an established preventive option for chronic migraine. Affordability matters – but delays and denials can drive disability and ER visits. Submit your comment to CMS here: https://hubs.ly/Q042N-4S0 #Migraine #Medicare #IRA
- If you live with chronic migraine – or care for someone who does – your experience matters. Share how prevention affects function and quality of life. Submit your comments here: https://hubs.ly/Q042N-4S0 #PatientAccess #Migraine
- CMS is gathering input on selected drugs and their impact on patients. Let’s make sure chronic migraine realities are on the record. #Medicare #PatientAccess
- CMS invites patients, caregivers and members of the public to share written feedback about the drugs selected for negotiation. This input can include information about how a medication is used in real life, what treatment options exist or do not exist, where needs remain unmet and how different patient populations are affected. Submit your comments here: https://hubs.ly/Q042N-4S0
WHY THIS MATTERS / WHAT TO EXPECT
Chronic migraine can make it difficult for patients to complete everyday tasks and can significantly impact quality of life. Patients, caregivers, and clinicians should share their perspectives to guide policy decisions that affect access to prevention.
Timeline of Activities / Deadlines:
- By March 1, 2026: submit public comments (addressing unmet need, heterogeneity, therapeutic alternatives, and population impacts).
- March 6, 2026: Register for Roundtable / Town Hall
- Participants notified by March 10, 2026
- Spring 2026: participate in CMS public engagement sessions (patient-focused roundtable / town hall).
- Wednesday, April 8th – Patient Roundtable (11 AM – 1 PM ET)
- Wednesday, April 22 – Town Hall (10:30 AM – 12 PM ET)
- By June 1, 2026: CMS issues initial offer (closed-door negotiation phase begins).
- Summer – Fall 2026: provide memos and clarifications after CMS engagement events.
- By Nov 30, 2026: CMS publishes negotiated prices (MFPs) if agreement is reached.
- By Mar 1, 2027: CMS publishes explanation of MFPs; begin implementation risk assessment (UM, access bottlenecks).
- 2027: monitor coverage and access in the field; document and elevate issues quickly if restrictions increase.
- Jan 1, 2028: negotiated MFP becomes effective.
Appendix:
Patient Questions
Patient & Caregiver Experience Questions (28–33)
Before you start: Please don’t include private info like your full name, address, or medical record number.
Question 28: Background
Have you (or someone you care for) ever taken this medicine (the selected drug, Botox)?
☐ Yes
☐ No
Question 29: Your condition and daily life
How does your condition affect your daily life and well-being?
(You can include what a “good day” vs. “bad day” looks like, and how it affects sleep, work, school, family, chores, or hobbies.)
How has your condition changed over time?
(Has it gotten better or worse? Do symptoms happen more often or less often?)
What matters most to you when managing your condition?
(Examples: fewer symptoms, less pain, fewer attacks, better sleep, fewer side effects, fewer doctor/hospital visits, lower costs, less worry, being able to work or do daily tasks.)
What challenges do you face in managing your condition?
(Examples: finding the right treatment, side effects, cost, insurance barriers, access to specialists, missed work/school, stigma, transportation, time.)
Question 30: Medicines you take now
Are you (or someone you care for) taking any medicine right now to manage this condition?
☐ Yes
☐ No
Question 31: Medicines you tried before
Have you (or someone you care for) taken other medicines in the past for this condition?
☐ Yes
☐ No
Question 32: Anything else CMS should know
What else should CMS consider about your chronic migraine or Botox? (Anything you think is important that isn’t covered above.)
Question 33: Optional background questions
Age: __________________
Where do you live (region/state): __________________
Are you (or the person you care for) a Medicare beneficiary?
☐ Yes
☐ No
☐ Not sure
Clinician Questions
CMS is collecting information to support its evaluation of Botox for chronic migraine relative to its potential therapeutic alternative(s). CMS is interested in obtaining the perspectives of health care providers who have clinical experience with prescribing or managing use of the selected drug and/or its potential therapeutic alternative(s) for chronic migraine.
Question 40: Background Questions
Question 40a: Are you a health care provider (i.e., a person who is trained and licensed to give health care)?
☐ Yes
☐ No
Question 40b: Do you have experience prescribing or managing the use of the selected drug?
☐ Yes
☐ No
Question 41: Treatment-related Questions
Question 41a: What are goals of treatment for the condition(s) treated by the selected drug? Examples of treatment goals may include but are not limited to disease remission, symptom management, quality of life improvement, or cure. (max. 18,000 characters)
Question 41b: What outcomes do you use to assess improvement or treatment response for this indication(s)? Please provide specific clinical, functional, or patient-reported outcomes. (max. 18,000 characters)
Question 41b1: What would you consider to be a meaningful improvement or treatment response for the outcomes listed in Question 41b? (no more than 12000 characters)
Question 41b2: Would you assess improvement or treatment response differently in certain patient subpopulations? If so, which subpopulations and why? (max. 36,000 characters)
Question 41c: Are there widely used evidence-based clinical practice guidelines for the condition(s) treated by the selected drug? If so, please cite these guidelines and explain how they are used to support clinical decision-making. For off-label use, please also reference any citations listed in Question 56 for major drug compendia, authoritative medical literature, and/or accepted standards of medical practice. (max. 36,000 characters)
Question 42: Additional Treatment-related Questions
Question 42a: How does the selected drug fit into the current treatment paradigm for patients with the conditions(s) treated by the selected drug? (max. 18,000 characters)
Question 42b: At what point in treatment might the selected drug be considered as a treatment option for patients with the condition(s) treated with the selected drug? What other treatments might be considered before the selected drug is considered a clinically appropriate treatment option, if any? (max. 18,000 characters)
Question 42c: What medications would you consider to be potential therapeutic alternatives for the selected drug for treatment of the condition(s) treated with the selected drug? For the list of potential therapeutic alternatives and indications, provide a brief explanation of the reason for the identification of the potential therapeutic alternative(s) of the selected drug and any indication(s). Reference any citations listed in Question 56 where applicable. (max. 12,500 characters)
Question 42d: What considerations drive treatment selection among the selected drug and its potential therapeutic alternative(s) for the indication(s)? For example, relative efficacy, safety profile, route of administration, patient characteristics, patient preferences, cost, formulary placement, etc. (max. 18,000 characters)
Question 42e: Are there notable differences between how the selected drug or the potential therapeutic alternative(s) identified in Question 42c are prescribed or managed in your practice setting and how these drugs are used in broader clinical practice and/or treatment recommendations in current clinical guidelines for the condition(s) treated with the selected drug? For example, are there general debates or uncertainties related to selection or use of these drugs for the indication(s)? (max. 18,000 characters)
Question 42f: How would you characterize the benefits and risks associated with the selected drug? (max. 18,000 characters)
Question 42f1: What side effects or risks, common or serious, or other safety concerns would you take into consideration when selecting a treatment option from among the selected drug or its potential therapeutic alternative(s) for the condition(s) treated with the selected drug? (max. 18,000 characters)
Question 42f2: In your opinion, how do the benefits and risks associated with the selected drug differ from the benefits and risks associated with its potential therapeutic alternative(s) for the indication(s)? (max. 18,000 characters)
Question 42f3: What specific populations or patient subgroups may derive greater benefits or be at risk for greater harms by using the selected drug or any of its potential therapeutic alternative(s) for the indication(s)? (max. 18,000 characters)
Question 42g: How would you assess whether a patient is tolerating and/or responding to the selected drug or any of its potential therapeutic alternative(s) when used for each indication(s)? (max 18,000 characters)
- When might you consider discontinuing a medication?
- When might you consider switching to a different medication?
- When might you consider adding another medication to the regimen?
Question 43: Access and Patient Experience
Question 43: What health insurance coverage or access issues do patients experience when trying to obtain the selected drug and its potential therapeutic alternative(s) for the condition(s) treated by the selected drug? (max. 36,000 characters)
Question 44: Therapeutic Advance and Unmet Medical Need
Question 44a: For the condition(s) treated by the selected drug, describe the extent to which the selected drug currently represents (or does not represent) a therapeutic advance as compared to its potential therapeutic alternative(s). (max. 36,000 characters)
Question 44b: For the condition(s) treated by the selected drug, describe the extent to which the selected drug currently addresses (or does not address) an unmet medical need. (max. 36,000 characters)
Question 44c: What unmet medical needs do you believe persist among patients with the condition(s) treated by the selected drug, if any? (max. 36,000 characters)
Question 45: What other information about the selected drug, its potential therapeutic alternative(s), or the indication(s) do you think CMS should consider in its evaluation of the selected drug? Reference any citations listed in Question 56 when applicable.