On October 31, 2023, CMS held a Medicare Drug Price Negotiation Patient-Focused Listening Session for the selected drug Enbrel. Fourteen participants were randomly selected and included patients, patient advocates, and a healthcare researcher. 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

Enbrel is a tumor necrosis factor blocker manufactured by Immunex/Amgen and indicated to treat Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis, Plaque Psoriasis, Polyarticular Juvenile Idiopathic Arthritis, and Juvenile Psoriatic Arthritis.

Enbrel 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 $2.8 billion; a total of 48,000 Medicare Part D enrollees used Enbrel during this time.

Key Takeaways from Enbrel Patient-Focused Listening Session

The need for choice of treatment is critical in inflammatory/autoimmune diseases. Participants emphasized that what works for one person, works for one person and that patients should be able to stay on the treatment that works for them, whether that’s Enbrel or another drug.
Participants cited some access challenges under commercial insurance, but more extreme challenges under Medicare coverage. Speakers reported having to switch to infusions to gain access under Part B, requested that patient assistance be allowed for Medicare beneficiaries, and expressed fear about aging into Medicare and losing access to Enbrel/their current medication.
Speakers raised the point that women and people of color get overlooked in medicine, and there is a need for CMS to consider patient-specific treatment decisions when weighing treatment alternatives.

Additional Participant[1] Points

Disease Burden
Life without a biologic is extremely difficult. My pain intensifies, and my joints stiffen. Day to day becomes more difficult because not only does my RA worsen but so do my multiple comorbidities. – Lisa, Patient/Patient Advocate
Untreated inflammation damages joints and causes chronic pain, and joint deformities, and affects the skin and other organs – these are all associated with pain and utter exhaustion. – Candace DeMatteis, Partnership to Fight Chronic Disease
For many years I lived with constant joint and tendon pain. I then faced damage to my joint, and by my late forties, I needed a total knee replacement. – Penny, Patient
Life without a biologic makes everything difficult: pain, fatigue – getting ready for doctor appointments feels like running a marathon. – Tracie, Patient
I have lived with RA for forty plus years and am still fixing damage created in the first twenty years from being on less effective medications. – Deb, Patient
I started experiencing symptoms at the age of fourteen. Throughout my teens and twenties, I had bouts, until I was diagnosed at age 31 with a connective tissue disease. Until this point, I had been using braces and canes. – Kelly, Patient
Enbrel Benefit
Enbrel allows me to feel more normal. I truly believe that Enbrel works better than the previous six biologics I’ve been on in the last 20 years. Enbrel is my miracle drug. I’ve been told by several specialists that getting my RA under control will help control those comorbidities. Sleep apnea, high cholesterol, high blood pressure, GERD, and several others – I have noticed improvements in several since starting on Enbrel. Being on a drug that works is important. The injection mechanism is easy on my arthritic hands. Enbrel allows me to be me. – Lisa, Patient/Patient Advocate
With Enbrel, my pain markers returned to normal. – Penny, Patient
The American College of Rheumatologists recommends TNF inhibitors [like Enbrel] as the first line of treatment. One in ten people live with AR arthritis diseases, and for certain subgroups, there is data to show that Enbrel may work better in them than others. – Tiffany Westrich-Robertson, Patient Advocate – CEO of AiArthritis
Enbrel was my favorite. Enbrel was the only biologic I’ve been on that had no side effects. All others have been infusions which are time-consuming and can come with negative side effects. – Tracie, Patient
My PsA ended my career as a poker dealer in Las Vegas due to pain. Methotrexate did not work and hurt my liver. When I was on Enbrel [for 10 years], my swelling went down and the damage to my joints stopped. When I had to come off Enbrel in 2019 for four to five months due to surgery, I didn’t have any pain in my joints. I don’t know if I was in remission, but I wasn’t progressing. After the pandemic, I needed a job, and I was able to go back to poker because of Enbrel. Enbrel is a good part of staying productive in your life and a productive part of society. I’m able to sit, stand, and do all the little things you can’t do when you suffer from these diseases. You need to keep people on Enbrel if they are on Enbrel. – Michael, Patient
(Of autoimmune treatment in general) I have gone from not being able to work to being able to live and start a family. – John, Patient Advocate
(Of autoimmune treatment in general) Since the onset of biologics, my last twenty years have been significantly better, and my quality of life is so much better – I am actually able to be an active participant in life. – Deb, Patient
When I was diagnosed with RA and prescribed my first biologic, the difference in pain was drastic. I went from needing braces to not needing them at all and no longer needing a cane to walk. After two years that biologic stopped working and I switched to Enbrel. After two months on Enbrel, my joints were flaring, I returned to wearing braces, and I could not work. But Enbrel is still an effective treatment for many people – the difference in their quality of life is life-changing. – Kelly, Patient
Before Enbrel, I missed a hundred-plus hours of work over a year due to fatigue. After a few months on Enbrel, my inflammation reduced so much that I was able to move, walk, and look over my shoulder with a normal range of motion. I could take my first few steps in the morning without excruciating pain. Starting Enbrel felt like being given a second chance. My symptoms improved so much; I can do yoga and run again. My kids had lost a sense of having a normal mom who could do normal weekend activities. Enbrel has had a huge effect on my happiness to be able to do chores again and go on hikes with my kids. – Brandi, Patient
Unique Patient Considerations & The Need for Options 
Individualized care decisions and treatment flexibility must be preserved throughout the process; they are critical to a patient’s ability to function and how long they will live. Patients are individuals so what works for many may not work for everyone. – Elizabeth Helms, Patient Advocate – Founder & Director Chronic Care Policy Alliance
Our diseases are heterogeneous, they are unique to individuals and subgroups because they happen at the molecular level and can be triggered by something environmental. People won’t respond the same way to any given drug approved by the FDA, the process to find the right medication is an extremely complicated, trial-and-error process. Over half of us will develop multiple comorbidities as a result of not being matched to the right treatment. Once a patient finds the right drug, there should be no alternatives. – Tiffany Westrich-Robertson, Patient Advocate – CEO of AiArthritis
Every single one of us is different, there is no one-size-fits-all for autoimmune issues. You find the best biologic that works for you, you stick with it. Medication hopping can cause issues, so diagnosis and quick aggressive treatment is a must for quality of life. – Tracie, Patient
Because I’m running out of options, it’s so important to have Enbrel as an option so that every person can find the right one for them. Many patients have been on Enbrel for over 10 years; it is not the drug for me, but it may be the drug for someone else. – Dianne, Patient
The symptomology of these diseases can vary significantly, and diagnosis can involve multiple specialists over many years. Patients, namely women, are often not believed, and disparities are common in non-white individuals with RA. Many patients suffer from treatment delays and face hurdles in accessing treatments; stories of having to do step therapy are common. Most Medicare plans receive failing scores on access to medications for RA and PsA. Having options between drug administration and drug choice is important. Arthritis may limit the ability of patients to perform self-injections, and patients living in rural areas may be limited to only self-injections. How is CMS going to consider these patient-specific treatment decisions when weighing treatment alternatives? People may present the same clinically but will perform differently under the same treatment. – Candace DeMatteis, Partnership to Fight Chronic Disease
I have been on every biologic, Enbrel was my first. It sadly did not work for me, but I want to express that we’re all individuals, and every one of us will react differently. What is my miracle medication may not be someone else’s miracle medication. – Deb, Patient
It took several years, three medications, and navigation through prior authorization for me to find Enbrel. – Brandi, Patient
Cost Concerns
Enbrel has a list price of $7k a month. Before retirement, I had private insurance, took advantage of a patient assistance program, and had an OOP cost of $0-60 a month. I was able to afford the medication I needed at no cost to me. In 2019, I enrolled in an MA program. Currently, my copay is $339/month; however, at the beginning of each year, my copays are extremely high due to the donut hole in Medicare’s coverage. This year alone, my first refill in January was $2k, and my second in February was $1,100. This type of pricing unfairly takes advantage of people on Medicare, many of whom like me live on a fixed income. I fear what the future may bring if insurance fails to protect me. The reality is that I cannot cut Enbrel from my medical treatment plan as it has prevented me from having any serious arthritic flare for quite some time now. We have had to make some large sacrifices to deal with the financial stresses of medical bills: I have skipped doses here and there to ration the medication a little bit longer. I have to carefully monitor my expenses and rarely do my husband and I treat ourselves with unnecessary indulgences. Seeing Enbrel on the list of drugs to be negotiated allows me to take a deep breath and gives me hope. – Judy, Patient
[Before Medicare] my $400 copay was covered through a pharmaceutical assistance program; the total cost was $120 per year. The Medicare monthly cost for Enbrel is $12k. I wish I was wealthy enough to afford it, I instead had to switch to an infusion covered by Part B. That medication initially worked but caused issues with my immune system. I switched to a new infusion medication that takes 1.5 hours every 8 weeks. So far it is working, but if it stops working, I’m out of options – this leaves me terrified. – Penny, Patient
[When I was failing on Enbrel,] my doctor submitted a change of biologic, but the payer rejected it, and I was required to continue taking Enbrel every week for another four months instead of the recommended bi-weekly dose because it was more cost-effective for the health insurance. I’m lucky that I have private insurance, but it has created challenges. Most often, it has been a challenge to keep payers covering my current biologic. I am on my ninth biologic, and I am doing better than ever. My current insurance is through my employer, but as I’m getting closer to retirement, my biggest fear is being able to pay for a drug I need. – Kelly, Patient
Considerations and Concerns Regarding Negotiation
A real concern is that the negotiation process might save Medicare money, but patients will have to fight harder to access the treatments they need with formularies that prioritize negotiated drugs above all options. We urge CMS to consider whether the price negotiations protect patients while preserving access to alternatives that work. CMS should ensure that the negotiation process/other policies support ongoing research into products and new indications. – Elizabeth Helms, Patient Advocate – Founder & Director Chronic Care Policy Alliance
Amgen’s unfair exploiting of patent loopholes has cost Medicare $1B so far. Amgen gamed the system by buying out Immunex – this new agreement gave Amgen ownership, but due to the licensing arrangement, Amgen was not double patenting. Amgen is the effective owner of Enbrel but not the effective owner of [patents]. When negotiating MFP, CMS should consider patent abuses that deprive the public/patent gaming, the prices that should be in place under proper competition and should not include acquisitions as R&D expenditures. – Peter, Academic Researcher, Public Citizen
CMS should consider other factors besides straight cost (formularies, step therapy) – Enbrel is the first drug that is often recommended, so it’s possible its high costs are due to wide use. – Tiffany Westrich-Robertson, Patient Advocate – CEO of AiArthritis

[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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