Patient Access & the Inflation Reduction Act - Alliance for Patient Access

Patient Access & the Inflation Reduction Act: Advocacy Toolkit

Background

The Inflation Reduction Act, or IRA, passed in 2022, gave the Centers for Medicare and Medicaid Services the authority to negotiate drug prices in Medicare for the first time. Starting in 2026, Medicare can negotiate drug prices for both Part D and Part B medications.

The aim is to lower the amount the government, through Medicare, pays for prescription drugs. But these changes may come with unintended consequences for patient access.

These include:

Reduced innovation. Many conditions don’t yet have a treatment, making innovation and the development of new medications critical for the patient community. However, research shows that IRA drug negotiation may actually slow innovation, leading to fewer new treatments for those who need them.

Decreased access. Utilization management tools like prior authorization, step therapy and non-medical switching undermine optimal care for patients. Research has shown that patients may actually experience more utilization management for medications that undergo Medicare price negotiation.  And, Part B negotiation may result in fewer available provider-administered therapies.

IRA and Patient Access

In January 2026, CMS announced the next 15 medications that are up for negotiation. The list includes medicines used to treat:  

Autoimmune diseases

Cancer

Mental health
Neurological conditions
Respiratory conditions

CMS needs to hear from patients, providers and care partners on why these medications are important options for you – and why patients need continued access to all appropriate therapies.

What You Can Do:

1. Submit public comment.
Patients, care partners, health care providers and others can submit comment on their perspectives with the health condition selected medications treat. Specifically, CMS is seeking input on unmet medical need and impacts to specific populations. Submissions must be made by 11:59 PM PST on March 1, 2026. 

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 questions
- Required Sections
  - I27: Respondent Information 
  - J: Certification of Submission of Sections
- 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.

ARE YOU A PATIENT, CAREGIVER OR PATIENT ADVOCACY GROUP?
Questions I28-33 are most appropriate for you. You can answer as many – or as few – questions as you’d like. Please be prepared to answer questions I28-33. CMS wants to hear from you on topics including:  

- Your experience with the selected drug
- Your experience living with the disease treated by the medication, and the impact on your life and well-being
- Why the medication is valuable to you
- Demographic information

ARE YOU A CLINICIAN?
Questions I40-45 are most appropriate for you. You can answer as many – or as few – questions as you’d like. Please be prepared to answer questions I40-45. CMS wants to hear from you on topics including:

- Your area of specialization
- Your experience with the selected drug
- How it fits into disease treatment
- Unmet medical need and how the treatment addresses that
- You are able to submit up to 20 tables, charts and/or graphs that support your responses, as well as up to 250 citations. CMS asks that you include NLM style citations for declarative statements. This information can be submitted in questions I55-56.

ARE YOU A RESEARCHER?
Questions I46-51 are most appropriate for you. You can answer as many – or as few – questions as you’d like. Please be prepared to answer questions I46-51. CMS wants to hear from you on: 

- Relevant evidence on the patient experiences with the selected drug, along with the condition the drug treats
- Impact of the treatment and its alternatives on specific patient populations
- Comparative clinical evidence
- Key considerations for CMS in evaluating the drug

ARE YOU A CONCERNED PUBLIC INDIVIDUAL?
Questions I52-54 are most appropriate for you. You can answer as many – or as few – questions as you’d like. Please be prepared to answer questions I52-54. CMS wants to hear from you on: 

- Your experience with the selected drug
- Any important information CMS should consider

2. Join a patient roundtable.

If you’re a patient, care partner or patient advocacy organization, you can register to speak in a patient-focused roundtable related to your medication. These virtual sessions, which will not be livestreamed, are intended to collect patient-focused input related to the patient experience. These roundtables will be held between at the dates seen below. To register, click here.

Anoro Ellipta: Monday, April 6 from 11 a.m. – 1 p.m. ET
Biktarvy: Monday, April 6 from 2:30 – 4:30 p.m. ET
Botox; Botox Cosmetic: Wednesday, April 8 from 11 a.m. – 1 p.m. ET
Cimzia: Wednesday, April 8 from 2:30 – 4:30 p.m. ET
Cosentyx: Thursday, April 9 from 11 a.m. – 1 p.m. ET
Entyvio: Thursday, April 9 from 2:30 – 4:30 p.m. ET
Erleada: Friday, April 10 from 12 – 2 p.m. ET
Kisqali: Monday, April 13 from 11 a.m. – 1 p.m. ET
Lenvima: Monday, April 13 from 2:30 – 4:30 p.m. ET
Orencia: Tuesday, April 14 from 11 a.m. – 1 p.m. ET
Rexulti: Tuesday, April 14 from 2:30 – 4:30 p.m. ET
Trulicity: Wednesday, April 15 from 11 a.m. – 1 p.m. ET
Verzenio: Wednesday, April 15 from 2:30 – 4:30 p.m. ET
Xeljanz; Xeljanz XR: Thursday, April 16 from 11 a.m. – 1 p.m. ET
Xolair: Thursday, April 16 from 2:30 – 4:30 p.m. ET
Tradjenta: Friday, April 17 from 12 – 2 p.m. ET

3. Join a clinician town hall.

Clinicians, researchers and other from the public may also register to participate in a clinically oriented virtual town hall later to be held on April 22 and 23. These will be livestreamed to the public. To register, click here.

Wednesday, April 22, 2026:
- Session 1 from 10:30 a.m. – 12 p.m. ET
  - Anoro Ellipta
  - Biktarvy
  - Botox; Botox Cosmetic
  - Rexulti
- Session 2 from 2 – 3:30 p.m. ET
  - Kisqali
  - Verzenio
  - Erleada
  - Lenvima
Thursday, April 23, 2026:
- Session 3 from 10:30 a.m. – 12 p.m. ET
  - Xolair
  - Cosentyx
  - Orencia
  - Xeljanz; Xeljanz XR
- Session 4 from 2 – 3:30 p.m. ET
  - Cimzia
  - Entyvio
  - Trulicity
  - Tradjenta

Key Messages:

1. Many of the conditions treated by these medications are serious, debilitating conditions.

Many of these conditions don’t have cures.

The medications that have been selected for negotiation are valuable treatment options that must remain accessible.

2. Each patient needs tailored treatment.

Different patients respond to treatments differently, making it critical to have multiple accessible treatment options.

A one-size-fits-all approach to care will harm patients and keep them from managing their condition.

3. Innovation is needed for all patients.

Price negotiations could deter companies from investing in new treatments, leaving patients with fewer options for disease management and less hope of a cure.

4. Access to clinician-administered therapies must bemaintained.