Statement by Boehringer Ingelheim on selection of Jardiance® (empagliflozin) by the Centers for Medicare and Medicaid Services (CMS) Drug Price Negotiation Program

Boehringer Ingelheim prioritizes innovative solutions to ensure our medications are accessible and affordable for all patients, with a focus on improving their quality of life and saving or extending their lives. 

Today, the Centers for Medicare and Medicaid Services (CMS) announced that Jardiance® (empagliflozin) is among the group of ten drugs included in its “Drug Price Negotiation Program” within the Inflation Reduction Act (IRA). The law is often mischaracterized in news reports and public statements as focusing on the highest-priced drugs, when in reality CMS has selected medicines with the overall highest Medicare spending. We believe that CMS selected Jardiance based on the spend associated with improving health of the millions of patients who rely on the proven outcomes of Jardiance – not based on the already heavily discounted price for the government.

Almost 60% of U.S. adults aged 65 years and older – more than 33.5 million Americans - have at least one cardio-renal-metabolic condition, driving significant disease burden, mortality and total overall healthcare spend.   

Jardiance is the number one prescribed SGLT2 inhibitor with 59 million prescriptions. To date, we estimate that the use of Jardiance has extended the lives of treated patients by more than 461,000 patient-life years. Peer-reviewed, published economic assessments using real-world data consistently demonstrate that Jardiance lowers total cost of care.  

We have continued to invest significantly in research and development that has extended the impact of Jardiance in order to expand its use with additional patient populations. This investment in additional research and development in products like Jardiance is at risk due to the flawed price-controlling measures of the IRA. Jardiance indications made possible by our continued R&D include:

• First approval by the FDA in 2014 for use in adults with type 2 diabetes,
• Subsequent approvals to reduce the risk of cardiovascular death in adults with type 2 diabetes and known cardiovascular disease, and to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure,
• June 2023 FDA approval making Jardiance the first and only SGLT2 inhibitor approved to treat type 2 diabetes in children 10 and older, and
• Recent approval in the European Union for the treatment of adults with chronic kidney disease (CKD), with evaluation currently underway by the FDA for this use.

We remain concerned about the detrimental effects the IRA will have on the future of biopharmaceutical innovation. But we share the goal of ensuring the medicines we produce are affordable and available to patients and we are committed to engaging in open and transparent conversations with CMS. We look forward to sharing detailed information with CMS on the value of Jardiance and to reinforce the need to invest in scientific medical innovation for the patients we serve.

What is JARDIANCE?

JARDIANCE is a prescription medicine used to:

• reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure, when the heart cannot pump enough blood to the rest of your body
• reduce the risk of cardiovascular death in adults with type 2 diabetes who also have known cardiovascular disease
• lower blood sugar along with diet and exercise in adults and children who are 10 years of age and older with type 2 diabetes

JARDIANCE is not for people with type 1 diabetes. It may increase their risk of diabetic ketoacidosis (increased ketones in the blood or urine).

JARDIANCE is not for use to lower blood sugar in adults with type 2 diabetes who have severe kidney problems, because it may not work.

IMPORTANT SAFETY INFORMATION

• Do not take JARDIANCE if you are allergic to empagliflozin or any of the ingredients in JARDIANCE.

• Do not take JARDIANCE if you are on dialysis.

JARDIANCE can cause serious side effects, including:

• Ketoacidosis (increased ketones in your blood or urine). Ketoacidosis is a serious condition which needs to be treated in the hospital. Ketoacidosis may lead to death. Ketoacidosis occurs in people with type 1 diabetes and can also occur in people with type 2 diabetes taking JARDIANCE, even if blood sugar is less than 250 mg/dL. Ketoacidosis has also happened in people with diabetes who were sick or who had surgery during treatment with JARDIANCE. Stop taking JARDIANCE and call your healthcare provider right away or go to the nearest hospital emergency room if you get any of the following symptoms, and if possible, check for ketones in your urine: nausea, vomiting, stomach-area (abdominal) pain, tiredness, or trouble breathing.
   
• Dehydration. JARDIANCE can cause some people to become dehydrated (the loss of body water and salt). Dehydration may cause you to feel dizzy, faint, light-headed, or weak, especially when you stand up. Sudden worsening of kidney function has happened in people who are taking JARDIANCE. You may be at a higher risk of dehydration if you: take medicines to lower your blood pressure, including water pills (diuretics), are on a low salt diet, have kidney problems, or are 65 years of age or older. Talk to your healthcare provider about what you can do to prevent dehydration, including how much fluid you should drink on a daily basis, and if you reduce the amount of food or liquid you drink, if you are sick or cannot eat, or start to lose liquids from your body from vomiting, diarrhea, or being in the sun too long.
   
• Serious urinary tract infections. Serious urinary tract infections can occur in people taking JARDIANCE and may lead to hospitalization. Tell your healthcare provider if you have symptoms of a urinary tract infection, such as a burning feeling when passing urine, a need to urinate often or right away, pain in the lower part of your stomach or pelvis, or blood in the urine. Sometimes people also may have a fever, back pain, nausea, or vomiting.
   
• Low blood sugar (hypoglycemia). In adults, if you take JARDIANCE with another medicine that can cause low blood sugar, such as sulfonylurea or insulin, your risk of low blood sugar is higher. In children 10 years of age and older, the risk for low blood sugar may be higher with JARDIANCE regardless of use with another medicine that can also lower blood sugar. The dose of your sulfonylurea or insulin may need to be lowered. Symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, shaking or feeling jittery.
   
• Necrotizing fasciitis. A rare but serious bacterial infection that causes damage to the tissue under the skin in the area between and around your anus and genitals (perineum). This bacterial infection has happened in women and men who take JARDIANCE, and may lead to hospitalization, multiple surgeries, and death. Seek medical attention immediately if you have a fever or are feeling very weak, tired or uncomfortable (malaise), and you develop any of the following symptoms in the area between and around your anus and genitals: pain or tenderness, swelling, and redness of skin (erythema).
   
• Vaginal yeast infection. Talk to your healthcare provider if you have vaginal odor, white or yellowish vaginal discharge (discharge may be lumpy or look like cottage cheese), and/or vaginal itching.
   
• Yeast infection of the penis. Swelling of an uncircumcised penis may develop that makes it difficult to pull back the skin around the tip of the penis. Talk to your healthcare provider if you have redness, itching or swelling of the penis, rash of the penis, foul smelling discharge from the penis, and/or pain in the skin around the penis.

Talk to your healthcare provider about what to do if you get symptoms of a yeast infection of the vagina or penis. Your healthcare provider may suggest you use an over-the-counter antifungal medicine. Talk to your healthcare provider right away if you use an over-the-counter antifungal medication and your symptoms do not go away.

• Allergic (hypersensitivity) reactions. Symptoms of serious allergic reactions to JARDIANCE may include: swelling of your face, lips, throat and other areas of your skin; difficulty with swallowing or breathing; raised, red areas on your skin (hives). If you have any of these symptoms, stop taking JARDIANCE and contact your healthcare provider or go to the nearest emergency room right away.

The most common side effects of JARDIANCE include urinary tract infections and yeast infections in females.

These are not all the possible side effects of JARDIANCE. For more information, ask your healthcare provider or pharmacist.

Before you take JARDIANCE, tell your healthcare provider about all of your medical conditions, including if you have kidney problems. Also tell your healthcare provider if you have liver problems; have a history of infection of the vagina or penis; have a history of urinary tract infections or problems with urination. Tell your healthcare provider if you are going to have surgery because your healthcare provider may stop JARDIANCE before you have surgery. Talk to your healthcare provider about when to stop taking JARDIANCE if you are having surgery and when to start it again. Also tell your healthcare provider if you are eating less or there is a change in your diet; have or have had problems with your pancreas, including pancreatitis or surgery on your pancreas; drink alcohol very often, or drink a lot of alcohol in the short term (“binge” drinking); have type 1 diabetes as JARDIANCE should not be used to treat people with type 1 diabetes; are pregnant or plan to become pregnant. JARDIANCE may harm your unborn baby. If you become pregnant while taking JARDIANCE, tell your healthcare provider as soon as possible. Tell your healthcare provider if you are breastfeeding or are planning to breastfeed. JARDIANCE may pass into your breast milk and may harm your baby. Do not breastfeed while taking JARDIANCE.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For more information, please see Prescribing Information and Medication Guide.

CL-JAR-100163 06.20.2023