Insights,

ADVI Instant: IRA Implementation: CMS Patient-Focused Listening Session on Eliquis

On October 30, 2023, CMS held its first Medicare Drug Price Negotiation Patient-Focused Listening Session for the selected drug Eliquis. Seventeen participants were randomly selected and included patients, patient advocates, and healthcare professionals. During introductory remarks, CMS claimed promoting transparency and engagement continues to be at the core of Inflation Reduction Act implementation, and the listening sessions are part of an effort to hear from patients directly. 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

Eliquis is a factor Xa inhibitor manufactured by BMS and indicated to reduce the risk of stroke in patients with nonvalvular atrial fibrillation, treat blood clots in patients with deep vein thrombosis or pulmonary embolism, and decrease the risk of deep vein thrombosis blood clots after hip or knee replacement surgery.

Eliquis 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 which totaled $16.5 billion; a total of 3,706,000 Medicare Part D enrollees used Eliquis during this time period.

Key Takeaways from Eliquis’ Patient-Focused Listening Session

  • Patient participants claimed they had a better response to Eliquis compared to other anticoagulant drugs, such as Warfarin.
  • Patients expressed hope that the negotiation process will lead to Eliquis being more affordable and accessible, but are concerned that PBMs will make formulary changes resulting in the opposite (i.e., less affordable, less accessible).
  • Several speakers raised the point that Eliquis qualified for negotiation based on its large patient volume in Medicare, rather than its price.

Additional Participant[1] Points

  • Eliquis Benefit
    • Direct oral anticoagulants like Eliquis ended a nightmare. – Mellanie True Hills, Patient Advocate/Founder of stopafib.org
    • Eliquis for me, has been a godsend. Warfarin caused multiple life-threatening bleeds; oral anticoagulants are a game-changer. – Seth, Patient/Health Care Professional
    • When switching from commercial insurance to Medicare, Eliquis became unaffordable (90-day supply was $700). Within a week of stopping Eliquis, developed deep vein thrombosis, which resolved when Eliquis was resumed. – Joe, Patient
    • Switching from Eliquis to Warfarin resulted in bruising, bleeding, and the inability to retain INR (international normalized ratio) scores; Eliquis yielded no side effects. – Charles, Patient
    • Previous treatment with Warfarin caused severe bleeding. Eliquis has saved countless hours in travel and millions in costs due to Warfarin’s unpredictable nature. – Scott, Patient/Patient Advocate – Mended Hearts
    • During one year of treatment with Eliquis, there have been no side effects. – Bruce, Patient
    • Warfarin caused severe bleeding, nose bleeds, and an unstable INR. After switching to Eliquis, there have been no side effects or issues. – Linda, Patient
    • Factors in negotiation should include the patient experience. Eliquis is such a better patient experience than Warfarin. – Richard, Patient
    • Warfarin causes a lot of issues (e.g., reaction with antibiotics used to treat an infection, resulting in an INR off the charts). – Barbara, Patient
    • 98% of people with AFib have at least one other co-morbidity. Eliquis made CMS’s list because a lot of people are on it and physicians and beneficiaries favor it. – Candace DeMatteis, Patient Advocate – Vice President, Partnership to Fight Chronic Disease
  • Cost Concerns
    • Patients need lower costs; those on fixed incomes cannot afford huge copays. As a result, patients often split pills or skip doses altogether. – Mellanie True Hills, Patient Advocate/Founder of stopafib.org
    • Patients with AFib are less likely to pick up medications if they cost more than $60. Some patients are unable to afford Eliquis, e.g., one patient found out Eliquis would cost $500/month and they could not get patient assistance or coupons. Drug costs are a contributing factor to racial inequities, and hopefully, the negotiation of Eliquis will lead to lower costs for patients. – Hussain, Healthcare Practitioner
    • Strong support for the negotiation process, acknowledging that these drugs were selected based on the highest drug spending, but that the average monthly copay for Eliquis is $55/month according to BMS. – Raj, Patient Advocate/Medical Student on behalf of Doctors for America
    • Eliquis for $70 for a 3-month supply is more expensive than other medications that cost $30 for a 3-month supply. – Bruce, Patient
    • A friend is currently on Eliquis under his work insurance but he’s retiring soon and won’t be eligible for patient assistance; he is worried about his future. – Linda, Patient
    • The BMS patient assistance program helps offset the cost of Eliquis under Part D. – Linda, Patient
    • The negotiation process captures drugs that serve beneficiaries rather than drugs that induce sticker shock. The ICER report on Eliquis is payer-centric and lacks certain disclosures on conflict of interest. – Sue Peschin, President & CEO, Alliance for Aging Research
    • Hoping that Eliquis becomes more affordable because of issues with Warfarin. Eliquis is less affordable in Medicare due to a lack of qualification for the patient assistance programs. It is upsetting that people under 65 have no issue accessing Eliquis, but people over 65 have lots of issues. – Barbara, Patient
    • Patients do not see rebates at the counter. – Candace DeMatteis, Patient Advocate – Vice President, Partnership to Fight Chronic Disease 
  • PBM & Plan Concerns
    • Part D premiums have doubled, and there is concern that PBMs could move medicines to higher tiers or exclude them. The GAO has recommended that CMS monitor the effects of rebates. More protections are needed from tactics that may end up making drugs cost more – this is a health equity issue. – Mellanie True Hills, Patient Advocate/Founder of stopafib.org
    • Please do not allow utilization management schemes to get in the way of doctors and their patients. – Seth, Patient/Health Care Professional
    • CMS needs to closely monitor utilization management practices from PBMs. Prior authorization, step therapy, and non-medical switching prioritizes profits over patient health. CMS must consider how drug pricing could affect patient access. – Joe, Patient
    • PBMs don’t pass discounts to patients. There’s a fear that while Medicare will negotiate reduced costs, PBMs will move the drug tiers or remove the negotiated drugs from the formulary. – Charles, Patient
    • Formulary issues need to be rectified so drugs aren’t relegated to non-preferred tiers. – Scott, Patient/Patient Advocate –Mended Hearts
    • Some plans require failure on Xarelto before getting on Eliquis; you’d have to have a stroke to be able to access it. There’s no real reason to be denied this life-saving drug. – David, Patient
    • Switching people off of Eliquis for non-medical reasons is alarming; there needs to be safeguards in place from the dangerous potential impacts of price negotiation. – Sue Peschin, President & CEO, Alliance for Aging Research
    • CMS is urged to ensure beneficiaries have access to appropriate, evidence-based treatments. It is imperative CMS be guarded against utilization management; price ceilings could reduce access if there are formulary changes – anticoagulant therapies are not interchangeable. – John Clymer, Executive Director, National Forum for Heart Disease & Stroke Prevention
    • Eliquis is an excellent drug but it’s not the problem – it’s the drug plans. Negotiation is great, but there is a need to change how plans work as well – certain rural pharmacies are never preferred which affects patient access. –Gina, Patient/Health Care Worker 
  • Consequences of Negotiation
    • Negotiation as it stands will impede the innovation of new drugs. – Seth, Patient/Health Care Professional
    • Five of the ten selected drugs are used to treat heart patients. This dynamic could impede the development of new, innovative drugs. Please consider the new Part D reimbursement structure will have on breakthrough drugs like Eliquis. – Scott, Patient/Patient Advocate – Mended Hearts
    • Every patient is unique and depends on medical miracles being developed in this country. Policy should not be about us, without us. Unrestricted access to medications is critical to length and quality of life, and there is concern that patients will have issues accessing therapies subject to negotiation. CMS should ensure the negotiation process and policies lead to continuous innovation in therapies. – Elizabeth Helms, Patient Advocate – Founder & Director Chronic Care Policy Alliance
    • It is imperative that the negotiation program does not exacerbate access challenges for communities of color. – John Clymer, Executive Director, National Forum for Heart Disease & Stroke Prevention

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

ADVI will continue monitoring developments and the next steps. This is a delayed release. ADVI Instant content is distributed in real-time for retainer clients. Get in touch to learn more about how we can support your commercialization, market access, and policy needs.

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Brenna Raines

Senior Director