On November 1, 2023, CMS held a Medicare Drug Price Negotiation Patient-Focused Listening Session for the selected drug Entresto. Nine participants were selected to speak, including 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
Entresto is manufactured by Novartis and indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure and for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients.

Entresto 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 $2.9 billion; a total of 587,000 Medicare Part D enrollees used Enbrel during this time.

Key Takeaways from Entresto Patient-Focused Listening Session

Participants emphasized personal stories about how Entresto has been transformative, allowing them to spend more time with family and enjoy their lives.
Participants raised concerns over changes PBMs will make to formularies and utilization management (e.g., dropping medications from formularies, moving to different tiers, etc.)
Multiple speakers highlighted that Entresto is already affordable; its lack of affordability can be due to patient liability in the coverage gap.

Additional Participant [1] Points

Disease Burden
Heart failure is a health crisis affecting 6M Americans. It’s a leading cause of death and has 1M new cases annually. – Scott Leezer, Patient Advocate – Mended Hearts Inc.
Heart failure has transformed my loved one, who went from being a refusing-to-retire 82-year-old to an 85-year-old who loses his breath tying his shoes. He has avoided hospitalization and is still alive, but those clinical measures mean nothing to him since he can’t catch his breath and deals with the related frustration and anxiety. Having multiple chronic conditions is common with heart failure. Forty percent of Medicare beneficiaries with heart failure have five or more non-cardiac comorbidities, so providers have to consider contraindications and patient needs. Polypharmacy is a real issue – my loved one takes 25+ pills a day. – Candace DeMatteis, Patient Advocate, Partnership to Fight Chronic Disease
Heart failure makes everyday activities difficult. People who have heart failure that is not well managed are often swept into the revolving door of hospital readmissions, raising costs for Medicare. –John Clymer, Patient Advocate, Executive Director, National Forum for Heart Disease & Stroke

Entresto Benefit
Patients on Entresto see benefits in their productivity at work and in their personal lives. They are more efficient and have higher energy. It’s important that these patients stay on their medications, so heart failure doesn’t return, and they don’t have unintended consequences from stopping the medicine. – Raymond, Pediatric Cardiologist
I am a six-time heart failure survivor. In 2019, I struggled to breathe and had swelling throughout my body. I went to the hospital and had to be relocated to the ICU for heart failure – I was 41 years old and a single parent of two. After I was released to go home, I was on a variety of medications and attended follow-up appointments with cardiologists. I made lifestyle changes in terms of eating and exercise. I tried medications and faced side effects, and over a year and a half, I went into heart failure five more times. I was mentally exhausted and frustrated. After a new consultation, I tried out Entresto. A nurse helped me fill out the request for patient assistance and within three months of starting, I noticed fewer issues with swelling and stopped feeling fatigued. The biggest change was not having to make as many calls to my cardiologist’s office. I have been two years heart failure-free. I was able to go with my son as he went off to college, I can be with my grandson, and I will be able to celebrate my 46th –J.P., Patient Medications like Entresto are game changers. 6.2M people are impacted by heart failure and 0.5M Medicare beneficiaries take Entresto, saving the healthcare system tens of millions of dollars. Treatments like Entresto give Americans more time with family and friends, doing things that bring them joy. I don’t know how you put a price on that. Patients need access to the best treatments and pipeline therapies. – Ryan Gogh, Patient Advocate, Executive Director, Partnership to Advance Cardiovascular Health
We have gone from having a few medicines to many, including Entresto. That innovation addresses significant unmet needs. Entresto positively impacts quality of life scores. – Candace DeMatteis, Patient Advocate, Partnership to Fight Chronic Disease
At the time I was diagnosed, my future looked really grim, the average life expectancy was five years. My doctor prescribed Entresto in 2016 and this was key for my treatment. In the seven years since my diagnosis, even though other heart-related things have happened, I have never been hospitalized and am “well compensated” according to my cardiologist because of Entresto. Entresto allows me to enjoy a post-retirement, fulfilling life with family nearby. I truly believe Entresto was transformative; I’m really grateful to the doctor who prescribed it for me. I hope that it remains within reach and affordable to others because I think it is a really helpful medication. – Jennifer, Patient
Unique Patient Considerations & The Need for Options
Over 70% of patients hospitalized for heart failure are Medicare beneficiaries, and the prevalence of heart failure among Medicare beneficiaries is highest among Black and American Indian beneficiaries. We recommend CMS work with the Office of Minority Health to address this, and [stress that] heart failure therapies are not interchangeable. – John Clymer, Patient Advocate, Executive Director, National Forum for Heart Disease & Stroke
Heart disease impacts historically underrepresented communities – those living in rural, Black men and women, and those with lower socioeconomic status. – Ryan Gough, Patient Advocate, Executive Director, Partnership to Advance Cardiovascular Health
If there is one thing I want to be taken away, it is that every patient is unique, and it depends on the medical miracles that continue to be developed every day. Individualized care decisions and treatment flexibility must be preserved throughout the process as they are critical to a patient’s ability to function and how long they will live. – Elizabeth Helms, Patient Advocate – Founder and Director, Chronic Care Policy Alliance
Cost Concerns
Entresto is already demonstrated to be accessible – beneficiaries pay $29 per month. – Scott Leezer, Patient Advocate – Mended Hearts Inc.
Entresto costs Medicare $400 per person per month before rebates – it is the patients’ preferences that are driving spending. – Candace DeMatteis, Patient Advocate, Partnership to Fight Chronic Disease
I have heard a number of patient stories where patients cannot access medicines or can’t stay on medicines because of the cost. Our institution was caring for a 63-year-old who had congenital heart disease. She needed Entresto but after a number of scripts, the insurance maxed out and she couldn’t cover the donut hole. The patient then had decreased heart function and later required surgery for their gastrointestinal tract which was a higher-risk surgery because of their decreased heart function. – Raymond, Healthcare Practitioner – Pediatric Cardiologist
The transition from employer insurance to Medicare was shocking as my medication costs went way up for the same prescription. I don’t have any hurdles in terms of receiving it – it’s still within my budget and it really changes my life and what I’m able to do. My copays remain manageable for me because I have a good retirement system as a former educator. I don’t know if that is true for other people who don’t have the same type of insurance. – Jennifer, Patient
PBM & Plan Concerns
CMS needs to safeguard access and address any formulary issues that may arise. Medications like Entresto could be regulated to non-preferred formularies, and patients could face unchecked utilization management practices. – Scott Leezer, Patient Advocate – Mended Hearts Inc.
How access will be affected by negotiations remains concerning since CMS is not requiring better access to benefit patients. PBMs tend to charge patients the list price when calculating deductibles and coinsurance. – Candace DeMatteis, Patient Advocate, Partnership to Fight Chronic Disease
We ask CMS to guard against potential unintended consequences – price ceilings could result in reduced access if PBMs drop medications from formularies or move to higher out-of-pocket costs. – John Clymer, Patient Advocate, Executive Director, National Forum for Heart Disease & Stroke
CMS should meaningfully monitor utilization management of negotiated medications. Many aspects of the Part D redesign will help with costs but may cause PBMs to make access more difficult. Providers already have difficulty putting patients on therapies and they already say utilization management is out of control. These medications don’t do any good if no one can access them. – Ryan Gogh, Patient Advocate, Executive Director, Partnership to Advance Cardiovascular Health
Considerations and Concerns Regarding Negotiation
This attempt to increase affordability and access is crucially important, and the IRA’s focus on patients is very admirable. I support what CMS is doing and I will tell my patients to look forward to this coming into place. – Raymond, Healthcare Practitioner – Pediatric Cardiologist
We urge CMS to make sure its drug price negotiation program ensures beneficiary access to appropriate evidence-based care – the right treatment, for the right patient, at the right time. – John Clymer, Patient Advocate, Executive Director, National Forum for Heart Disease & Stroke
Our illness is the problem, the cost isn’t the problem – the last thing we need is fewer treatments to fight disease. This exercise is not to lower patient costs but to target therapies that the government doesn’t want to pay for. – John Czwartacki, Patient Advocate, Founder, Survivors for Solutions
Patients want to ensure that the development of life-changing medicine continues and that they have access to it. 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 negotiated protects patients while preserving access to alternatives that work. CMS should ensure that the negotiation process and other policies support ongoing research into products and new indications and should also protect patients who use drugs off-label for other purposes. – Elizabeth Helms, Patient Advocate – Founder and Director, Chronic Care Policy Alliance
We support the ideas behind the negotiation program; the Part D out-of- pocket maximum, prescription payment plan, and expanded LIS all make costs more affordable. We are apprehensive about the ripple effects in the cardiovascular sector, with five of the ten drugs picked being used to treat these patients. This could impact the development of new treatments, especially since the cardiovascular sector has a low success rate in clinical trials. Patients are also treated off-label with Entresto – the negotiation program might limit sponsors from creating clinical trials for additional indications. – Scott Leezer, Patient Advocate – Mended Hearts Inc.

[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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