On November 15, 2023, CMS held a Medicare Drug Price Negotiation Patient-Focused Listening Session for the selected drug Xarelto. Nine participants were selected to speak, including patients, patient advocates, and physicians. 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

Xarelto is a factor Xa inhibitor manufactured by Janssen and Bayer. It is indicated:

To reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation.
For treatment of deep vein thrombosis (DVT).
For treatment of pulmonary embolism (PE).
For reduction in the risk of recurrence of DVT or PE.
For the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery.
For prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients.
To reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD).
To reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD.
For treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years.
For thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure.

Xarelto 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 $6 billion; a total of 1.3 million Medicare Part D enrollees used Xarelto during this time.

Key Takeaways from Xarelto Patient-Focused Listening Session

Xarelto is novel and provides several benefits over Warfarin, such as less need for monitoring, easier self-administration, and fewer complications.
Access to this drug is a health equity issue, as Black Americans have a much higher rate of heart disease and death from heart disease – both of which Xarelto helps reduce.
Fears about access issues are very pressing for patients and advocates. There is great worry that CMS has not put in any safeguards against utilization management tactics that may stem from negotiations.

Additional Participant[1] Points

Xarelto Benefit and Disease Burden
Given that stroke reduces mobility in over half of survivors 65+, it is essential this policy improves access to Xarelto. Anticoagulant drugs are not interchangeable. I encourage CMS to ensure access to the right drug at the right time. – John Clymer, Patient Advocate, Executive Director, National Forum for Heart Disease & Stroke Prevention
Since approval, Xarelto has been approved for eleven indications, five of which it is the only direct oral anti-coagulant (DOAC) with that approval. In addition to AFib, which affects more than five million people in the US, Xarelto is also approved to treat peripheral artery disease, coronary artery disease, and clot prevention for hospital patients, including the majority of Medicare beneficiaries hospitalized during their lifetime. Twenty-one percent of beneficiaries have PAD, and 13% have CAD. Xarelto has a lot of benefits over Warfarin such as reduced safety risks, less need for blood tests, dose adjustments, and dietary restriction. Xarelto is a go-to choice for providers and patients. – Candace DeMatteis, Patient Advocate, Policy Director, Partnership to Fight Chronic Disease
Xarelto and other DOACs have changed cardiovascular care. I used to be on Warfarin and needed regular clinic visits and constant dose adjustments, eventually leading to an ER visit, until I switched to Xarelto. – Scott Leezer, Patient Advocate, Mended Hearts
I have asked 1,000+ patients in the community about their experiences with Xarelto and other DOACs: It has changed their lives. – Mellanie True Hills, Patient Advocate, CEO & Founder of StopAfib.org
DOACs hold massive importance for treating deep vein thrombosis, heart disease, and stroke, with major improvements over the inconveniences of Warfarin. – Raj, Patient Advocate, Doctors for America
Warfarin and DOACs are not the same; Warfarin needs vigilant monitoring and negatively interacts with other medications. It may also have clinical costs due to testing – that may be difficult especially in Medicare, since the patient population is older and travel and self-administration may be more difficult. – Michael, Alliance for Aging Research
Xarelto is the only drug selected that treats PAD. Patients are at risk of losing limbs; 50% of patients who have an amputation die within one year. – Dharmesh, Healthcare Practitioner
Issues In Health Equity
Black people have higher rates of stroke and death due to stroke; CMS should work with the Office of Minority Health on this issue. – John Clymer, Patient Advocate, Executive Director, National Forum for Heart Disease & Stroke Prevention
Amputation is common in patients with PAD. Amputations are four times as likely in Black patients with PAD compared to White patients. PAD is underdiagnosed and undertreated, leading to preventable amputations and death, disproportionally among Black patients. Black people are 30% more likely to die of heart disease than White and Hispanic people. How will CMS factor health disparities into considerations of unmet medical needs? In its health equity framework, CMS promises to adjust its policies to address inequities. It is important to consider this and the fact that Xarelto meets the unmet needs of underserved populations. – Candace DeMatteis, Patient Advocate, Policy Director, Partnership to Fight Chronic Disease
Direct stroke costs in the United States exceeded $71 billion in 2012 – that is projected to triple by 2030. Black people have almost double the risk of first stroke and an increased risk of stroke death. This is a massive health equity issue. The underserved are being penalized. – Mellanie True Hills CEO and founder of StopAfib.org
Underrepresented communities have the highest rates of heart disease. Twenty percent of the state of Mississippi’s population is on Medicare, and around 8,000 Mississippians die from heart disease each year. I have seen innovative new drugs save patients’ lives; I have also seen the country fail in its fight against heart disease, particularly in underserved and underrepresented communities. Price is a critical issue, but it does not equate to value. The negotiation program scope is too narrow. – Dharmesh, Healthcare Practitioner 
Unique Patient Considerations & The Need for Options
Every patient is unique and relies on the medical miracles discovered every day. The development of life-saving medications must continue. My husband has heart conditions, so this is an issue personal to me. DOACs may be safer and more effective than older blood thinners; patients with chronic conditions have varying needs, but all chronic conditions can be life-threatening. They may destroy our ability to make a livelihood, to move, to work, to play, to participate with our families. We need to lower costs to ensure better access, but not interrupt innovation. – Elizabeth Helms, Patient Advocate, Founder & Director, Chronic Care Policy Alliance
Cost Concerns
Xarelto costs less than $400 per month before rebates. Anti-coagulants are some of the most highly rebated medicines in Medicare, but beneficiaries do not see those rebates at the counter. – Candace DeMatteis, Patient Advocate, Policy Director, Partnership to Fight Chronic Disease
Cost is an issue, between Medicare disallowing coupons and patients going into the donut hole earlier each year, many are forced to stretch or forgo medications. – Mellanie True Hills, Patient Advocate, CEO & Founder of StopAfib.org
PBM & Plan Concerns
I urge CMS to guard against unintended consequences, such as utilization management, which may hinder access. Price ceilings, intended to benefit consumers, could cause PBMs to drop medications from formularies or move them to higher price tiers, reducing access. – John Clymer, Patient Advocate, Executive Director, National Forum for Heart Disease & Stroke Prevention
The role PBMs have in our healthcare system must also be addressed. -Elizabeth Helms, Founder and Director, Chronic Care Policy Alliance – Scott Leezer, Patient Advocate, Mended Hearts
I have concerns about the new law. Without safeguarding preferential access or rectifying formulary tiering issues that may arise due to negotiation, there is a risk that Xarelto may be moved to a non-preferred formulary [tier]. I urge CMS to assuage concerns that the new law will not subject patients to unnecessary utilization management practices or have it move to a non-preferred formulary. – Scott Leezer, Patient Advocate, Mended Hearts
Patients need lower costs, but that may not happen as payers have said they will increase utilization management in order to compensate for the IRA. Patients and clinicians should not be forced to take weeks to get the medications they need. I have personally had to forgo the medications since the prior authorization for my heart medicine was denied after having been approved in the past. Stable patients should not be taken off medications that work for their conditions. – Mellanie True Hills, Patient Advocate, CEO & Founder of StopAfib.org
The role PBMs have in our healthcare system must also be addressed. – Elizabeth Helms, Patient Advocate, Founder & Director, Chronic Care Policy Alliance
It is imperative that CMS establish appropriate protections to ensure that there is not inappropriate utilization management. – Michael, Alliance for Aging Research
Patients will have [more barriers] to access since CMS has not promised to deal with utilization management issues once the program has begun. Please ensure that this program does not force patients to endure step therapy, that stable patients are not taken off their medications, and that prior authorizations do not delay necessary care. – Dharmesh, Healthcare Practitioner
Considerations and Concerns Regarding Negotiation
CMS sets the standards for the entire healthcare ecosystem. Lowering prices is not as simple as saying “Let’s drop that price to $XXX dollars per month.” Some questions to keep in mind as these negotiations continue: Is one of these medications the most advanced medication available and serves patients much better than what came before? Will there be interest in pursuing continued research if you drop the price too far? Will research into sures be disrupted? Will formularies be disrupted, and access changed? Will patients who use the product off label, or in a different dose, have their care interrupted? – Elizabeth Helms, Patient Advocate, Founder & Director, Chronic Care Policy Alliance
CMS must stand firm on its principles and negotiate the best price possible for patients and take advantage of the unique opportunity provided by two medications in the same therapeutic class – both Xarelto and Eliquis. Xarelto was approved in 2011, but in 2018, Bayer and Janssen won a suit to prevent generic competition until 2024, but they have been involved with multiple lawsuits with generic manufacturers since then to proactively extend their patent. – Raj, Patient Advocate, Doctors for America
CMS should use head-to-head studies when comparing treatments and avoid using the equal value of life years gained methodology as that may discriminate against older adults and people with disabilities, CMS’s main patient population. Pricing should also acknowledge that ambiguity exists. Different studies show varying side effects on Eliquis versus Xarelto. – Michael, Alliance for Aging Research
The negotiation process will have rippling effects on the healthcare system in the long and short term – John Clymer, Patient Advocate, Executive Director, National Forum for Heart Disease & Stroke Prevention
This law jeopardizes access for many cardiovascular patients. I am apprehensive about the law’s potential ripple effects on the cardiovascular sector. Five of the ten drugs selected are used in treating heart patients. This could inhibit new drug development and may hinder programs and trials that would benefit rare diseases. – Scott Leezer, Patient Advocate, Mended Hearts
I urge CMS to look into the funding sources of speakers in the listening sessions, to ensure there are no conflicts of interest. – Raj, Patient Advocate, Doctors for America
We want to ensure CMS receives feedback during these sessions; CMS needs to be able to ask clarifying questions and have an ongoing dialogue. – Michael, Alliance for Aging
CMS must consider relevant pricing and outcomes on secondary indications for establishing prices, given the agency’s moiety policy. – Michael, Alliance for Aging Research
This program is already slowing innovation. All the previous patients in this and other sessions have spoken about how vital the medications discussed are to their well-being. Patients require a flowing pipeline of new drugs since some patients with the same conditions require different medications, and some people have adverse reactions. 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 a hard task, to hurt the people it has sworn to protect – I ask that CMS protects patients’ hope. – John Czwartacki, Patient Advocate, Founder, Survivors for Solutions

[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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