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

On November 7, 2023, CMS held a Medicare Drug Price Negotiation Patient-Focused Listening Session for the selected drug Januvia. Five 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. 

Background

Januvia is a dipeptidyl peptidase-4 (DPP-4) inhibitor manufactured by Merck. It is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. 

Januvia 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 $4.1 billion; a total of 869,000 Medicare Part D enrollees used Januvia during this time. 

Key Takeaways from Januvia Patient-Focused Listening Session

• Participants discussed both the cost of Januvia and the cost of drugs overall, specifically mentioning rebates and federal funding of drug development. 
• Participants highlighted the widespread prevalence of type 2 diabetes, the comorbidities and health disparities among the patient population, and the importance of disease management. 

Additional Participant[1] Points

• Disease Burden
  • Thirty-seven million Americans, about one in ten, have diabetes. Ninety-five percent of these Americans have type 2 diabetes. Type 2 diabetes mostly develops in people aged forty-five or older – those who are quickly approaching Medicare age. Recently, more children, teens, and young adults are developing it. Maintaining normal blood sugar levels is critical to controlling complications of diabetes, like chronic kidney disease, nerve damage, oral health, and mental health. – Elizabeth Helms, Patient/Patient Advocate, Founder and Director, Chronic Care Policy Alliance 
  • One in three Medicare beneficiaries has been diagnosed with diabetes. Forty-three percent of Black beneficiaries and 46% of Hispanic beneficiaries have diabetes. Compared with white beneficiaries, Black beneficiaries suffer twice the death rate, four times the risk of hospitalization for uncontrolled diabetes, and three times the risk of developing ESRD. – Candace DeMatteis, Patient Advocate, Policy Director, Partnership to Fight Chronic Disease 
• Januvia Benefit
  • The value of Januvia is limited. It does not do much for patient outcomes compared to other classes of diabetes drugs. – Bich-May Nguyen, MD, Healthcare Prescriber, Board Member, Doctors for America 
  • Januvia is taken once daily with or without food. It is easy to take with few contraindications and is well tolerated. It is important in addressing unmet needs in people with type 2 diabetes. – Candace DeMatteis, Patient Advocate, Policy Director, Partnership to Fight Chronic Disease 
• Unique Patient Considerations & The Need for Options
  • I watched my grandmother give herself insulin shots – she had two strokes. She would have appreciated having pills instead of insulin. – Bich-May Nguyen, MD, Healthcare Prescriber, Board Member, Doctors for America 
  • For individuals who develop insulin resistance, older medications do not work. New medications work more effectively and have different approaches. Access to new, better, and more effective treatments is important, as patients require regular monitoring and ongoing treatment to maintain normal blood sugar levels. Making patients the center of the conversation is very critical. – Elizabeth Helms, Patient/Patient Advocate, Founder and Director, Chronic Care Policy Alliance 
• Cost Concerns
  • A 30-day supply of Januvia costs between $545 and $946. There are no generics available, even though Januvia received FDA approval in 2006. Drug companies often try to suppress competition like generics and biosimilars. Of the drugs approved from 2010-2019, all received NIH funding; however, drug companies still charge Americans high prices. According to a RAND report, drug prices are 256% higher in the U.S. than in other countries. Januvia is not worth the price. – Bich-May Nguyen, MD, Healthcare Prescriber, Board Member, Doctors for America 
  • I am living with a rare blood cancer and type 2 diabetes.Every month, my treatment for blood cancer is $16,000 and I have a $600 copay for Januvia. I have worked multiple jobs simultaneously to afford my medications. My doctors have warned me that this is impacting my health. I cannot retire because my drugs are too expensive. Lower drug prices would help me to rest more often and move from working full-time to part-time. – Steven, Patient 
  • Januvia costs Medicare less than $400 per beneficiary before rebates.– Candace DeMatteis, Patient Advocate, Policy Director, Partnership to Fight Chronic Disease 
• PBM & Plan Concerns
  • Medicare benefits from substantial rebates on diabetes medications. According to a GAO report, beneficiaries paid more than Part D plans for 79 of 100 drugs due to rebates; diabetes drugs accounted for 42% of those rebates. Plans did not use the rebates to lower beneficiaries’ out-of-pocket costs. Access barriers are likely [after negotiation] as plans gain revenue and favor more highly rebated products without passing on savings to patients. – Candace DeMatteis, Patient Advocate, Policy Director, Partnership to Fight Chronic Disease 
• Considerations and Concerns Regarding Negotiation 
  • I am personally grateful for the passage of the Inflation Reduction Act. Many Americans like me need drug negotiations. Drugs do not work if people cannot afford them.-Steven, Patient 
  • When a solution goes undiscovered, it does not just harm the people in need, but it hurts the whole country-John Czwartacki, Patient Advocate, Founder, Survivors for Solutions 
  • How will CMS weight the potential effects of such a dominant focus on diabetes in the first round of drugs? Even small policy changes can have profound consequences. The indications of three medications on the list have diabetes comorbidities, two medications are insulins, and three are indicated for diabetes [Jardiance, Januvia, and Farxiga]-Candance DeMatteis, Patient Advocate, Policy Director, Partnership to Fight Chronic Disease 

[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, MHA
Vice President, Market Access and Policy Strategy