Insights,

by Brenna Raines, MHA

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

On November 2, 2023, CMS held a Medicare Drug Price Negotiation Patient-Focused Listening Session for the selected drug Farxiga. Five participants were selected to speak, including patients and patient advocates. 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

Farxiga is manufactured by AstraZeneca and indicated to reduce the risk of sustained eGFR decline, end stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progress; to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure; to reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors; and as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Farxiga 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 $3.3 billion; a total of 799,000 Medicare Part D enrollees used Farxiga during this time.

Key Takeaways from Farxiga Patient-Focused Listening Session

  • Participants highlighted Farxiga’s multiple indications and how the multiple indications are related to improved adherence.
  • Participants shared concerns over changes PBMs will make to formularies and utilization management because of negotiated prices (e.g., dropping medications from formularies, moving to different tiers, etc.).
  • Participants expressed concerns about the future of innovation in the cardiovascular sector and for drugs with multiple indications.

Additional Participant[1] Points

  • Disease Burden
    • I celebrated my 21st anniversary of having open heart surgery. At the time of my surgery, my cardiologist gave me four years. – Harry, Patient
    • People with the conditions treated by Farxiga have a higher risk of hospitalizations and mortality, and a reduced ability to engage in daily activities. – John Clymer, Patient Advocate, Executive Director, National Forum for Heart Disease & Stroke Prevention
    • The percentage of people with heart failure will rise by 46% by 2030. One-third of patients with heart failure die within one year of hospitalization. – Scott Leezer, Patient Advocate, Mended Hearts Inc.
    • Heart failure is the leading diagnosis for Medicare hospitalizations and readmissions. Chronic kidney disease goes undiagnosed until it’s severe for 90% of those affected. – Candace DeMatteis, Patient Advocate, Policy Director, Partnership to Fight Chronic Disease
  • Farxiga Benefit
    • A gentleman yesterday said, “You’re getting along better than you have in a long time.” It worked for me, but everybody’s different. – Harry, Patient
    • The current prescription abandonment for Farxiga is low and adherence is high. – John Clymer, Patient Advocate, Executive Director, National Forum for Heart Disease & Stroke Prevention
    • Clinical trials found a marked decline in mortalities, hospitalizations, and urgent care visits. – Scott Leezer, Patient Advocate, Mended Hearts Inc.
    • Farxiga is an example of innovation. It can improve adherence by covering more indications. – Candace DeMatteis, Patient Advocate, Policy Director, Partnership to Fight Chronic Disease
  • Unique Patient Considerations & The Need for Options
    • More than three-quarters of people with type 2 diabetes or heart failure or CKD live with three or more chronic conditions. – Candace DeMatteis, Patient Advocate, Policy Director, Partnership to Fight Chronic Disease
    • African Americans are four times more likely to develop ESKD than whites. Hispanic and American Indians are twice as likely to develop ESKD. – Candace DeMatteis, Patient Advocate, Policy Director, Partnership to Fight Chronic Disease
  • Cost Concerns
    • I use mail service to keep costs low. Last year I paid $1,958.15. $436 was rolled over to this year, where I’ve paid $893.34 so far. I’m affording it but not liking it. It’s exorbitant. – Harry, Patient
  • PBM & Plan Concerns
    • 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
  • Considerations and Concerns Regarding Negotiation
    • With five of the 10 drugs chosen for negotiation being in the cardiovascular space, we are worried about this impact on future research and development. The [clinical] benchmark set for drugs is notably high, and incentives may decrease for developing chronic condition drugs. – Scott Leezer, Patient Advocate, Mended Hearts Inc.
    • How will CMS weigh the benefits across multiple chronic conditions? The benefits are greater than [the sum of its parts]. CMS’ reactions could impact decisions to pursue multiple indications. – Candace DeMatteis, Patient Advocate, Policy Director, Partnership to Fight Chronic Disease
    • Had the IRA slowed innovation for me, I would have spent my life as a burden. When a solution goes undiscovered, it hurts the whole country, with lost productivity and lost lives. – 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.

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.

Interested in getting in touch with Brenna?

Brenna Raines, MHA

Senior Director