On November 2, 2023, CMS held a Medicare Drug Price Negotiation Patient-Focused Listening Session for the selected drugs NovoLog, NovoLog FlexPen, NovoLog PenFill, Fiasp, Fiasp FlexTouch, and Fiasp PenFill. Fifteen 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

NovoLog and Fiasp are rapid-acting human insulin analogs, manufactured by Novo Nordisk and indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.

NovoLog and Fiasp were selected for Medicare drug price negotiation for the Initial Price Applicability Year 2026 based on their total Part D gross covered prescription drug costs from June 2022 – May 2023 of $2.6 billion; a total of 777,000 Medicare Part D enrollees used NovoLog and Fiasp during this time.

Key Takeaways from Novolog and Fiasp Patient-Focused Listening Session

Participants shared experiences rationing insulin or purchasing insulin from friends or family. Participants discussed how their choice of insulin products is tied to their insurance plan.
Many participants expressed frustration at the lack of affordability for Fiasp, NovoLog, and other insulin products. Several participants noted that there are no unbranded alternatives for these insulin products and described a discrepancy between the manufacturing cost of insulin and the cost paid at the pharmacy counter.
Participants commented on the coupling of NovoLog and Fiasp products, expressing concern that this may be viewed as saying the two products were interchangeable.

Additional Participant[1] Points

Disease Burden
3 million Americans have diabetes. Diabetes can lead to vision and limb loss, eye disease, chronic kidney disease, nerve damage, and other problems with oral and mental health. – Elizabeth Helms, Patient Advocate, Founder and Director, Chronic Care Policy Alliance
Diabetes can be fatal without lifelong insulin therapy. – Aaron Turner-Phifer, Patient Advocate, Director, Health Policy, JDRF
With human insulin, I had to adhere to a strict insulin and food schedule. – Kate Pidwerbecki, Patient and Patient Advocate, Operations Manager, T1International
When I was diagnosed, my blood sugar was over eight hundred and I weighed around thirty-five pounds at age five. – Emmabella, Patient
I have suffered complications, macular degeneration, infertility, amputations, blackouts, and seizures. – Kevin, Patient
A person with an A1c of 9% or higher has the same life expectancy as a person with stage 3 colon cancer. – Zoe, Patient
NovoLog and Fiasp Benefit
Short-acting analog insulins are some of the most effective ways to control diabetes. – Shaina Kasper, Patient Advocate, Policy & Advocacy Director, T1International
I am no longer tied to schedules. My A1c has improved, and my hyperglycemia episodes have decreased. I can take Fiasp before my meal or 20 minutes after starting my meal. While on human insulin, I had to take insulin before meals, and when eating out, sometimes meals would not arrive when expected which often resulted in hypoglycemia. – Gina, Patient
NovoLog worked better for me than Humalog. – Arden, Patient
When NovoLog was available, I was able to live a more normal life and return to focus on school instead of staying alive. – Kate Pidwerbecki, Patient, Operations Manager, T1International
NovoLog was my new lifeline. – Emmabella, Patient
Unique Patient Considerations & The Need for Options
My insurance covered Humalog when I was first diagnosed, then kept switching between that and NovoLog. The drugs had different effects on me. – Arden, Patient
Human insulin would reduce my ability to manage my life. – Kate Pidwerbecki, Patient, Operations Manager, T1International
Racial healthcare gaps continue to be present in diabetes care. People of color are more likely to experience lapses in insurance and ration costs. – Kate Pidwerbecki, Patient, Operations Manager, T1International
Choice leads to better glycemic control, reducing the incidence of diabetes complications. – Aaron Turner-Phifer, Patient Advocate, Director, Health Policy, JDRF
Three-quarters of beneficiaries with diabetes live with at least two other chronic conditions. – Candace DeMatteis, Patient Advocate, Policy Director, Partnership to Fight Chronic Disease
Cost Concerns
There has been so much fanfare about the $35 copay cap, but we know many in our community who have been unable to access the promised price cuts. Manufacturers promised to lower list prices but that does not cover all types [of insulin]. Without insurance, it would still be $500 a month. – Shaina Kasper, Patient Advocate, Policy & Advocacy Director, T1International
Insurance has helped assuage the cost of staying alive even though insurance coverage is expensive. Having to keep insurance coverage via employment has kept me from pursuing professional opportunities without health insurance. – Stacy, Patient
At age 26, I started rationing NovoLog. My insulin cost $2,400 even with platinum insurance. I dug through trash cans looking for a few drops. No one told me it would cost more than my entire monthly paycheck. I called Novo Nordisk begging for help, but I did not qualify for the patient assistance program. Someone is going to leave the pharmacy counter without their insulin because they cannot afford it. – Kristin, Patient, T1International
When I lost health insurance, I started viewing my meals based on the cost of insulin. – Arden, Patient
Most days, affording my illness has been harder than living with it. When I aged out of Medicaid, I rationed my insulin. I found unauthorized insulin. My nursing school friend snuck insulin out of the hospital for me. I restricted carbs and skipped doses. I was disqualified from enrolling in any patient assistance programs – many insurances ask us to pay 50% of the list price. – Lacy, Patient
On a teacher’s salary, I was unable to pay out-of-pocket for NovoLog. My parents started giving me insulin for my birthday and as holiday gifts. The out-of-pocket cost for insulin can be $1,600 a month or more. – Zoe, Patient
My father and I consume $4,000 of insulin between the two of us each month. At least once a month, I meet someone in a parking lot to give them insulin. – Kevin, Patient
One-fourth of diabetics ration insulin. – Stacy, Patient
PBM & Plan Concerns
I pay less than $35 a month because it is so heavily rebated through negotiations by my PBM. – Shaina Kasper, Patient Advocate, Policy & Advocacy Director, T1International
Formularies change mid-year which requires a new script and another meeting with a doctor. – Stacy, Patient
In March 2023, my insurance switched, and my new insurer decided they were not going to cover NovoLog. NovoLog has always worked but I needed to pay $3,000 out-of-pocket. I borrowed additional vials of insulin during this time from other type 1 diabetics. – Emmabella, Patient
My insurance has dictated my treatment. I have been called non-compliant in the past, but it was because I could not afford my insulin. – Lacy, Patient
The fact that I am at the mercy of insurance companies, manufacturers, and wholesalers is a frightening reality. – Kate Pidwerbecki, Patient, Operations Manager, T1International
We would like CMS to clarify how Part D sponsors will cover these products without ensuring each product is excluded from formularies. – Aaron Turner-Phifer, Patient Advocate, Director, Health Policy, JDRF
Considerations and Concerns Regarding Negotiation
Negotiation will save the government money and will save lives. – Shaina Kasper, Patient Advocate, Policy & Advocacy Director, T1International
CMS cannot look at net price or average sales price and they cannot look at therapeutic alternatives, because all the prices are artificially inflated. They need to look at the manufacturing cost, which is between $3 and $6 per vial of insulin. – Kristin, Patient, T1International
It is important that we have access to the latest innovations, so insulin continues to improve. – Gina, Patient
The coupling of these products cannot lead to reduced access. – Aaron Turner-Phifer, Patient Advocate, Director, Health Policy, JDRF
The coupling decision may perpetuate misunderstandings that the products are interchangeable. These are different drugs with separate FDA approvals, prescribed for different reasons. This raises concerns about what CMS will consider as a therapeutic alternative. Clinical standards distinguish between rapid and fast rapid insulins; it is like the difference between dial-up and broadband. – Candace DeMatteis, Patient Advocate, Partnership to Fight Chronic Disease
There are billions of dollars of profit for companies like Novo Nordisk who price gouge these medicines while we ration and die. Do more to protect us. – Kevin, Patient

[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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