ADVI Instant: IRA Implementation: CMS Patient-Focused Listening Session on Jardiance
On November 8, 2023, CMS held a Medicare Drug Price Negotiation Patient-Focused Listening Session for the selected drug Jardiance. Ten 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.
Jardiance is a sodium-glucose co-transporter 2 (SGLT2) inhibitor manufactured by Boehringer Ingelheim and Eli Lilly and Company. It is indicated:
- To reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure.
- To reduce the risk of sustained decline in eGFR, end-stage kidney disease, cardiovascular death, and hospitalization in adults with chronic kidney disease at risk of progression.
- To reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease.
- As an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus.
Jardiance 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 $7.1 billion; a total of 1.6 million Medicare Part D enrollees used Jardiance during this time.
Key Takeaways from Jardiance Patient-Focused Listening Session
- Jardiance is a standard of care pharmaceutical treatment for heart failure that provides clinical benefit and value by preventing health care resource utilization.
- However, patients need to afford their medication to avoid ending up in the hospital and, in turn, cause the healthcare system more money.
- There needs to be an adequate balance between the cost of the drug and saving both the government and patients money; participants highlighted the role Jardiance plays as one of the pillars* of heart failure therapy.
Additional Participant Points
- Disease Burden
- Heart failure is a leading cause of death in US. Mortality is high, with one in three patients who have heart failure dying within one year of hospitalization, and 40 to 50 percent dying within five years of diagnosis. –Scott Leezer, Patient Advocate, Mended Hearts
- Diabetes is a serious disease. Many diabetics need several medications. Many of them have issues with administering medications. – Dr. Lubnah Mirzah, Healthcare Practitioner
- The heart failure population accounted for 41% of inpatient admissions, and hospital stays cost more than medications. – John Clymer, Patient Advocate, Executive Director, National Forum for Heart Disease & Stroke Prevention
- Jardiance Benefit
- More than a year after a second ventricular tachycardia attack, I was still experiencing low energy levels. At my six-month appointment, I was prescribed Jardiance. Seven weeks later I had nearly a complete energy return. –George, Patient
- Jardiance has shown evidence of effectively treating patients with heart conditions. Its inclusion in the clinical arsenal has been helpful. –Scott Leezer, Patient Advocate, Mended Hearts
- Jardiance has a low rate of issues and improves blood sugar and blood pressure, aids in weight reduction, and reduces the rate of heart and kidney failure. – Dr. Lubnah Mirzah, Healthcare Practitioner
- Jardiance received initial approval for treating diabetes and has received additional approval for treating heart failure and chronic kidney disease. Research has shown even more improvements to patients’ lives due to Jardiance. –Candace DeMatteis, Patient Advocate, Partnership to Fight Chronic Disease
- I have seen a lot of diabetic patients. Jardiance lowers mortality greatly and rarely has serious side effects – it is generally well tolerated. – Bich-May Nguyen, Healthcare Practitioner, Patient Advocate, Board of Doctors for America
- Unique Patient Considerations & The Need for Options
- My husband and I were on Jardiance for diabetes. I no longer use Jardiance due to side effects but that illustrates the diversity of needs. Older medications often have more side effects while newer medications are more effective and have fewer side effects. Access to new, better meds is critical for patient health. – Liz, Patient, Patient Advocate, Founder & Director, Chronic Care Policy Alliance
- Cardiac Rhythm Management conditions are highest among minorities. I recommend CMS work with Office of Minority Health. – John Clymer, Patient Advocate, Executive Director, National Forum for Heart Disease & Stroke Prevention
- Cost Concerns
- The highest reason for non-compliance is cost – these patients end up back in the hospital. I understand that drug companies have high costs, but ensuring this population has access to care is the right thing to do, despite costs. – Letty Laura, Healthcare Practitioner
- High drug prices in diabetes medications are a health equity issue; we must address pricing issues. I am glad drug makers are negotiating because taxpayers have already helped subsidize these drugs. – Bich-May Nguyen, Healthcare Practitioner, Patient Advocate, Board of Doctors for America
- Out of pocket costs are what affect patients. – John Clymer, Patient Advocate, Executive Director, National Forum for Heart Disease & Stroke Prevention
- Jardiance has helped many patients but has been out of reach for many Medicare patients, and the price has been too high for many patients. CMS should look at long term benefits of reducing hospital admissions rather than short term benefits of cutting the cost of the medicine. Long-term costs will go down with Jardiance by lowering overall health costs. – Dr. Lubnah Mirzah, Healthcare Practitioner
- PBM & Plan Concerns
- Mended Hearts supports the aims of the IRA, but the new law is concerning. Without safeguarding access or formulary tiering issues, Jardiance may be inaccessible by becoming non-preferred. Five of the ten selected drugs treat heart conditions; we urge CMS to address these issues. –Scott Leezer, Patient Advocate, Mended Hearts
- I urge CMS to guard against unintended consequences such as PBMs moving to higher priced price tiers. I support the implementation of evidence-based care that aligns incentives. – John Clymer, Patient Advocate, Executive Director, National Forum for Heart Disease & Stroke Prevention
- Considerations and Concerns Regarding Negotiation
- I encourage CMS to ensure access to the right drug at the right time. These often-interconnected conditions hurt patients, and Jardiance slows disease progression and is a treatment recommended in guidelines. – John Clymer, Patient Advocate, Executive Director, National Forum for Heart Disease & Stroke Prevention
- $39.2 billion was spent on heart failure care in 2010, and the biggest proportion was spent on hospital stays, which drugs can help reduce or prevent. From the guidelines on heart failure management, there are four pillars of care for heart therapy* (known as “quad therapy”). Three of the four drugs in quad therapy are selected drugs. –Letty Laura, Healthcare Practitioner
- CMS is focusing on the drug price without addressing the needs Jardiance has met for patients. –Candace DeMatteis, Patient Advocate, Partnership to Fight Chronic Disease
- I am afraid heart patents will not receive adequate care due to the IRA. Jardiance is one of the four pillars* of heart failure therapy. I implore CMS to make sure the drug remains available to all and that there is an adequate balance between government cost containment and pharmaceutical profit. –Rhonda, Patient, Patient Advocate, CEO, Better Outcomes Optimal Scientific Therapies
- I applaud efforts to lower prices but ask CMS to take into account for issues of access to drugs due to negotiation. – Liz, Patient, Patient Advocate, Founder & Director, Chronic Care Policy Alliance
 Note: Participants were asked to not share their last names for confidentiality purposes; some patient advocates identified full names, titles, and organizations.
*The four pillars of heart therapy are beta blockers, angiotensin receptor-neprilysin inhibitors (ARNIs), mineralcorticoid receptor antagonists (MRAs), and sodium-glucose co-transporter 2 inhibitors (SGLT2i). Jardiance is an SGLT2i.
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