On November 14, 2023, CMS held a Medicare Drug Price Negotiation Patient-Focused Listening Session for the selected drug Stelara. Eleven participants were selected to speak, including patients, patient advocates, and a provider. Participants were limited to three minutes, during which time they were asked to address:

Patients’ day-to-day experiences living with the condition(s) treated by the selected drug, including how the experience may differ for different patient populations as well as patient caregivers and families.
How the selected drug impacts patients, including both benefits and side effects, as compared to the therapeutic alternative(s), and which outcomes matter most to patients with the condition(s) treated by the selected drug.
Patient experiences of access, adherence, and affordability of the selected drug as compared to therapeutic alternative(s).
Any other information about the selected drug, the condition(s) it is used to treat, and other treatments used for that condition(s) that the speaker believes is important.

Background

Stelara is a human interleukin-12 and -23 antagonist manufactured by Janssen. It is indicated for the treatment of:

Adult patients with:
Moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.
Active psoriatic arthritis.
Moderately to severely active Crohn’s disease.
Moderately to severely active ulcerative colitis.
Pediatric patients 6 years and older with:
Moderate to severe plaque psoriasis, who are candidates for phototherapy or systemic therapy.
Active psoriatic arthritis.

Stelara was selected for Medicare drug price negotiation for the Initial Price Applicability Year 2026 based on its total Part D gross covered prescription drug costs from June 2022 – May 2023 of $2.6 billion; a total of 22,000 Medicare Part D enrollees used Stelara during this time.

Key Takeaways from Stelara Patient-Focused Listening Session

Participants spoke about the multiple indications Stelara is indicated for and how it has been akin to a miracle, allowing patients to return to a mostly normal life.
Participants expressed that Stelara made it impossible for patients to lead a normal life and had concerns that they or other patients may not be able to access Stelara in the future.
Participants expressed concern that the negotiations may harm future research and innovation.

Additional Participant[1] Points

Disease Burden
Painful cramping kept me home; I experienced multiple bowel recessions. – Terri, Patient
A Crohn’s flare-up in 2012 left me disabled, unable to walk across the street. I cycled through five different treatments before Stelara was approved for Crohn’s. – Jaime Weinstein Holland, IBD Moms Board Member, Patient
As a veteran who suffers multiple illnesses from burn pits, including Crohn’s, Crohn’s took a toll on my life. I could not leave the house or bathroom most days. – Brandy, Patient
I have psoriasis and psoriatic arthritis. I became alienated from my peers in school and could not do physical activities – Brittney, Patient
Up to 45% of people with ulcerative colitis and 75% of people with Crohn’s will need surgery. – Candace DeMatteis, Policy Director, Partnership to Fight Chronic Disease
I had to retire due to Crohn’s disease and diabetes after being misdiagnosed with IBS for fifteen to twenty years. I ended up having colorectal surgery and have tried a range of biologics to help my condition. – Douglas, Patient
Some patients have chronic pain that does not go away. Patients deal with physical and emotional pain every day. – Elizabeth Helms, Founder and Director, Chronic Care Policy Alliance
Stelara Benefit
I was diagnosed with Crohn’s disease 56 years ago; the condition is chronic. I tried many biologic treatments that all failed, [but] Stelara helped alleviate my symptoms. I am now able to lead an active life and eat normal food. I feel the best I ever have at 77 years old. – Terri, Patient
A Stelara loading dose helped change my life. I always knew pain from diseases until I found Stelara. I went from being unable to walk across the street to being able to walk five miles straight. It is not just a miracle for me, it is a miracle for many others. – Jaime Weinstein Holland, IBD Moms Board Member, Patient
I tried Humira but had enormous side effects. When I came off Humira, my Crohn’s symptoms returned. Stelara relieved all my symptoms without the side effects [I experienced with Humira]. I went from being very dependent to very independent again. – Brandy, patient
Stelara has positive impacts on moderate and severe Crohn’s disease. Many users claim that with Stelara, 99.9% of symptoms are gone in a few days. Stelara is a miracle drug when it works, and it works for multiple diseases. Stelara improves quality of life, has a good safety profile, strong study results, and is easily taken. – Anika Rahman, Patient Advocate, International Advocacy & Policy Director, AiArthritis
Stelara is in the guidelines for medications advised to people with moderate to severe Crohn’s. – Tiffany Westrich-Robertson, CEO/Co-founder, International Foundation for Autoimmune & Autoinflammatory Arthritis
Stelara reduces the rate of needing surgery and allows patients to be in remission for months or years; remission allows people to heal. – Candace DeMatteis, Policy Director, Partnership to Fight Chronic Disease
My initial treatments did not help; Humira made my symptoms worse. I have had seven years of positive effects without issues [on Stelara]. – Brittney, Patient
Stelara is an example of a medication that can help people with many conditions, including Ulcerative colitis (UC), Crohn’s Disease, and psoriasis. – Elizabeth Helms, Founder and Director, Chronic Care Policy Alliance
Unique Patient Considerations
The need for choices in drugs is necessary, as many drugs’ effects wear off. – Candace DeMatteis, Policy Director, Partnership to Fight Chronic Disease
The diseases Stelara is indicated for have a high prevalence of comorbidities. There are many biologics and biosimilars on the market, but the mechanism of action and how it acts with each individual is important to understand. There is no such thing as an alternative therapy if there is a drug that works for a patient unless it targets the same mechanism of action. I implore CMS to not have people lose access to the one miracle drug that works for them. – Tiffany Westrich-Robertson, CEO/Co-founder, International Foundation for Autoimmune & Autoinflammatory Arthritis
Biologics sometimes burn when used, so it is important to consider side effects. – Anika Rahman, Patient Advocate, International Advocacy & Policy Director, AiArthritis
It took six years to find the right medications. – Brandy, patient
Every patient is unique and relies on the medical miracles discovered every day. – Elizabeth Helms, Founder and Director, Chronic Care Policy Alliance
Patients require a flowing pipeline of new drugs since some patients with the same conditions require different medications. Some people have adverse reactions. – John Czwartacki, Founder, Survivors for Solutions
Cost Concerns
I have copay assistance, but that only works with private insurance. Medicare will not cover the cost (of Stelara). Between my wife and I, we are on five of the ten selected drugs. We will not be able to afford the drugs without price negotiations since copay coupons are not usable on Medicare. Drugs do not work when people cannot afford them. – Douglas, Patient
Stelara is delivered to my front door free of charge via the Veteran’s Administration; I hope everyone can get the opportunity to get the medication they need to get their life back without going broke. – Brandy, patient
PBM & Plan Concerns
Many [beneficiaries] cannot affordably obtain Stelara due to the donut hole (the Coverage Gap), or due to their Medicare plan removing it from formulary. Though Stelara can be locally purchased for $26,000 – $29,000, my PBM marks it up to $54,000. I hope CMS can help. – Jaime Weinstein Holland, IBD Moms Board Member, patient
Considerations and Concerns Regarding Negotiation 
Stelara received approval for additional indications seven and ten years after approval – after it would have been selected for price negotiation. We should encourage these efforts by valuing them. – Candace DeMatteis, Policy Director, Partnership to Fight Chronic Disease
Patients need medications to be improved and discovered. We need to make sure the IRA supports research into new treatments and indications. CMS should take care to protect patients who are using the medication off-label or in a different dose from being penalized or having their care interrupted, as interruptions can cause progression of the disease and increased use of the healthcare system. – Elizabeth Helms, Founder and Director, Chronic Care Policy Alliance
All the previous patients in this and other sessions have spoken about how vital the medications discussed are to their well-being. Saying you are targeting one drug is like saying you want cream in only half of your cup of coffee. Innovation comes out of a wide range of investigations. CMS has been given the hard task of hurting the people it has sworn to protect. I would like to know how feedback from these listening sessions will be used, and I ask CMS to protect patients’ hope. – John Czwartacki, Founder, Survivors for Solutions
I am grateful that CMS decided to include patients in the conversation. – Tiffany Westrich-Robertson, CEO/Co-founder, International Foundation for Autoimmune & Autoinflammatory Arthritis
Access to medications is critical for quality of life; I encourage [a negotiation process] that allows access. – Brittney, Patient
The inclusion of provider-administered drugs filled by specialty pharmacy under the negotiation program could have unintended consequences, reducing patient access to medications. The “white bagging” of Part B drugs falsely elevates Part D usage, which could result in the loss of many medications for Part B beneficiaries who cannot administer due to disability. – Madelyn, Provider

[1] Note: Participants were asked to not share their last names for confidentiality purposes; some patient advocates identified full names, titles, and organizations. 

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