INDIANAPOLIS, March 1, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced price reductions of 70% for its most commonly prescribed insulins and an expansion of its Insulin Value Program that caps patient out-of-pocket costs at $35 or less per month. Lilly is taking these actions to make it easier to access Lilly insulin and help Americans who may have difficulty navigating a complex healthcare system that may keep them from getting affordable insulin.

Today, Lilly is reducing the list price of insulins by:

• Cutting the list price of its non-branded insulin, Insulin Lispro Injection 100 units/mL, to $25 a vial. Effective May 1, 2023, it will be the lowest list-priced mealtime insulin available, and less than the price of a Humalog^® vial in 1999.
• Cutting the list price of Humalog^® (insulin lispro injection) 100 units/mL¹, Lilly's most commonly prescribed insulin, and Humulin^® (insulin human) injection 100 units/mL² by 70%, effective in Q4 2023.
• Launching Rezvoglar^TM (insulin glargine-aglr) injection, a basal insulin that is biosimilar to, and interchangeable with, Lantus^® (insulin glargine) injection, for $92 per five pack of KwikPens^®, a 78% discount to Lantus, effective April 1, 2023.

"While the current healthcare system provides access to insulin for most people with diabetes, it still does not provide affordable insulin for everyone and that needs to change," said David A. Ricks, Lilly's Chair and CEO. "The aggressive price cuts we're announcing today should make a real difference for Americans with diabetes. Because these price cuts will take time for the insurance and pharmacy system to implement, we are taking the additional step to immediately cap out-of-pocket costs for patients who use Lilly insulin and are not covered by the recent Medicare Part D cap."

In addition to reducing the list price of its insulins, Lilly is making it easier for more people with diabetes to get Lilly insulins:   

• Effective immediately, Lilly will automatically cap out-of-pocket costs at $35 at participating retail pharmacies for people with commercial insurance using Lilly insulin.³
• People who don't have insurance can continue to go to InsulinAffordability.com and immediately download the Lilly Insulin Value Program savings card to receive Lilly insulins for $35 per month.

"We are driving for change in repricing older insulins, but we know that 7 out of 10 Americans don't use Lilly insulin. We are calling on policymakers, employers and others to join us in making insulin more affordable," continued Ricks. "For the past century, Lilly has focused on inventing new and improved insulins and other medicines that address the impact of diabetes and improve patient outcomes. Our work to discover new and better treatments is far from over. We won't stop until all people with diabetes are in control of their disease and can get the insulin they need."

Today's announcement builds on years of efforts by Lilly to close the gaps in the U.S. healthcare system that keep some people with diabetes from accessing affordable insulin. In recent years, Lilly has introduced multiple insulin affordability solutions that have made a real impact, including launching low-list-price, non-branded insulins in 2019, implementing the Lilly Insulin Value Program in 2020 and committing all of our insulins to the Medicare Part D Senior Savings Model in 2021. Because of these efforts, the average out-of-pocket cost for Lilly insulins has dropped to $21.80 over the last five years.

In the coming weeks, Lilly will launch a nationwide public awareness campaign to help ensure all Lilly insulin users understand how to access the company's industry-leading affordability solutions. For more information, go to Lilly.com/insulin.

PURPOSE and SAFETY SUMMARY

Important Facts About Humalog^® (HU-ma-log) and Insulin Lispro Injection

• Humalog is also known as insulin lispro injection.
• Humalog and Insulin Lispro Injection are fast-acting insulins. They are used to control high blood sugar in adults and children with diabetes. They are available only with a prescription.
• Humalog comes in two strengths: U-100 (100 units per milliliter) and U-200 (200 units per milliliter). The Humalog U-200 prefilled pen contains 2 times as much insulin per 1 milliliter as standard (U-100) insulin. The dose window on the pen shows your insulin dose.
• It is not known if Humalog or Insulin Lispro Injection are safe and effective for children with type 2 diabetes or for children younger than 3 years of age with type 1 diabetes. There were no studies done with these insulins in these groups of children. If your doctor decides to give your child one of these insulins, he or she may give you special instructions.

Important Facts about Humalog^® Mix50/50™, Humalog^® Mix75/25™, and Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25

• Humalog Mix50/50 and Humalog Mix75/25 are known as insulin lispro protamine and insulin lispro injectable suspension.
• Humalog Mix50/50, Humalog Mix75/25, and Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 are mixed U-100 insulins. This means they contain a mix of fast-acting and intermediate-acting insulins. They are used to control high blood sugar in people with diabetes. They are available only with a prescription.
• It is not known if Humalog Mix50/50, Humalog Mix75/25, or Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 are safe and effective for children younger than 18 years of age. There were no studies done with these insulins in children younger than 18. If your doctor decides to give your child one of these insulins, he or she may give you special instructions.

All Humalog and Insulin Lispro Injection products contain insulin lispro. Humalog Mix50/50, Humalog Mix75/25, and Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 contain insulin lispro protamine mixed with insulin lispro.

Warnings

Do not take Humalog, Insulin Lispro Injection, Humalog Mix50/50, Humalog Mix75/25, or Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 if you have:

• symptoms of low blood sugar (hypoglycemia)
• an allergy to insulin lispro products or any of their ingredients.

Do not reuse needles or share your insulin injection supplies with other people. This includes your: 

• prefilled pen for use by a single patient
• cartridges
• reusable pen that works with Lilly 3mL cartridges
• needles
• syringes

You or the other person can get a serious infection. This can happen even if you change the needle. 

Do not change the type of insulin you take or your dose, unless your doctor tells you to. This could cause low or high blood sugar, which could be serious. 

Do not use a syringe to remove Humalog from your prefilled pen. This can cause you to take too much insulin. Taking too much insulin can lead to severe low blood sugar. This may result in seizures or death.

Humalog, Insulin Lispro Injection, Humalog Mix50/50, Humalog Mix75/25, and Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 may cause serious side effects. Some of these can lead to death. The possible serious side effects are:

• Low blood sugar. This can cause:

If you are at risk of having severely low blood sugar, your doctor may prescribe a glucagon emergency kit. These are used when your blood sugar becomes too low and you are unable to take sugar by mouth. Glucagon helps your body release sugar into your bloodstream.

• Severe allergic reaction.
  Get emergency help right away if you have:

• Low potassium in your blood. This can lead to severe breathing problems, irregular heartbeat, and death.
• Heart failure. Taking diabetes pills called thiazolidinediones (thIE-uh-zOH-li-dEEn-dIE-OHns), or "TZDs," with insulin lispro products may cause heart failure in some people. This includes people who do not have any heart problems. If you have heart failure, it may get worse if you take TZDs with these insulin lispro products. Tell your doctor if you have any new symptoms of heart failure, or if they get worse. Some symptoms of heart failure include: shortness of breath, swelling of ankles and feet, and sudden weight gain. Your doctor may need to change or stop treatment with TZDs and your insulin lispro product.
• High blood sugar and ketoacidosis. You can have these serious problems when your insulin pump or infusion set stops working. They can also happen if your insulin is no longer effective. For these reasons, always keep extra insulin injection supplies with you.

Common side effects

The most common side effects of Humalog, Insulin Lispro Injection, Humalog Mix50/50, Humalog Mix75/25, and Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 are:

These are not all of the possible side effects. Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before using

Talk with your doctor about low blood sugar and how to manage it. Also tell your doctor:

• about all of the medicines you take, including over-the-counter medicines, vitamins, and herbal supplements.
• about any other prescription medicines you take, especially ones called TZDs.
• about all of your medical conditions, including if you have heart failure or other heart, liver, or kidney problems.
• if you are pregnant, breastfeeding, or plan to become pregnant or breastfeed.

How to take

Read the Instructions for Use that come with your Humalog, Insulin Lispro Injection, Humalog Mix50/50, Humalog Mix75/25, or Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25. Be sure to take your insulin lispro product and check your blood sugar levels exactly as your doctor tells you to. Your doctor may tell you to change your dose because of illness, increased stress, or changes in your weight, diet, or physical activity level. He or she may also tell you to change the amount or time of your dose because of other medicines or different types of insulin you take.

Before injecting your insulin lispro product

You can inject your insulin dose yourself, or you can have a trained caregiver inject it for you. Make sure you or your caregiver:

• Check the insulin label before each injection. This will help you make sure that you are taking the correct insulin.
• Use a new needle for each injection. You can get a serious infection or the wrong dose of insulin if you re-use needles.
• Change (rotate) where you inject your insulin with each dose. This can reduce your chance of getting pits, lumps, or thickened skin where you inject your insulin. Do not inject your insulin into the exact same spot or where the skin has pits or lumps. Avoid injecting into thickened, tender, bruised, scaly, hard, scarred, or damaged skin.

When you are ready to inject

• If you are taking Humalog or Insulin Lispro Injection, inject it under your skin within 15 minutes before or right after you eat a meal.
• If you are taking Humalog Mix50/50, Humalog Mix75/25, or Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25, inject it under your skin within 15 minutes before you eat a meal.

Staying safe while taking your insulin lispro product

To stay safe while taking your insulin, be sure to never inject Humalog U-200, Humalog Mix50/50, Humalog Mix75/25, or Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 in your vein, muscle, or with an insulin pump. Also be sure not to:

• mix Humalog U-200, Humalog Mix50/50, Humalog Mix75/25, or Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 with other insulins or liquids.
• drive or use heavy machinery until you know how your insulin lispro product affects you.
• drink alcohol or use other medicines that contain alcohol when taking your insulin lispro product.

Learn more

For more information, call 1-800-545-5979 or go to www.humalog.com or www.lillyinsulinlispro.com.

This summary provides basic information about Humalog, Insulin Lispro Injection, Humalog Mix50/50, Humalog Mix75/25, and Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25. It does not include all information known about these medicines. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other health care provider about your insulin lispro product and how to take it. Your doctor is the best person to help you decide if these medicines are right for you.

Humalog^®, Humalog^® Mix50/50^TM, and Humalog^® Mix75/25^TM are trademarks and registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

HI BOI SP U100 75/25 CON BS 10JAN2020

INDICATION AND SAFETY SUMMARY for Humulin^®

Humulin^® (HUE-mu-lin) R U-500 (500 units/mL) is for adults and children who need more than 200 units of insulin in a day to control high blood sugar for their diabetes mellitus. It is more concentrated than Humulin R U-100. It has 5 times as much insulin in each mL as Humulin R U-100 (100 units/mL).

It is not known if Humulin R U-500 is safe and effective when used with other insulins or when used in an insulin pump.

Warnings: Humulin R U-500 may cause serious side effects, including:

• Severe low blood sugar, which can lead to seizures, unconsciousness, and death.
• Severe allergic reactions. Get medical help right away if you develop a rash over your whole body, have trouble breathing, have a fast heartbeat, or are sweating.
• Swelling of your hands and feet. Tell your doctor if you are short of breath, have swelling in your ankles, or have gained weight suddenly.
• Heart failure when taking a medication from a class of drugs called thiazolidinediones (TZDs) with Humulin R U-500. This may occur in some people even if they have not had heart problems before.
• Low potassium in your blood (hypokalemia). This can lead to severe breathing problems, irregular heartbeat, and death.

Do not share your Humulin R U-500 KwikPen^® or U-500 syringe with anyone. Even if you have changed the needle, you or the other person can get a serious infection.

When using the Humulin R U-500 KwikPen: The Humulin R U-500 KwikPen is made to dial and deliver the correct dose of Humulin R U-500 insulin. Do not remove Humulin R U-500 from the KwikPen to inject with any syringe. This could cause severe overdose and may lead to death.

When using the Humulin R U-500 vial: There is a special syringe to measure Humulin R U-500 called the "U-500 insulin syringe." Only use the U-500 insulin syringe to inject Humulin R U-500. If you do not use the right syringe, you may take the wrong dose of Humulin R U-500. This could cause severe overdose and may lead to death.

Do NOT perform dose conversion when using the Humulin R U-500 KwikPen or U-500 insulin syringe.

Do not use Humulin R U-500 in an insulin pump or inject it into your vein.

Do not take this medicine if you have low blood sugar.

Do not change the insulin you use without talking to your doctor. Changing insulin may lead to low or high blood sugar.

Do not drive or use heavy machinery until you know how Humulin R U-500 affects you. Do not drink alcohol while using Humulin R U-500.

Common side effects

The most common side effects of Humulin R U-500 include:

• Low blood sugar (hypoglycemia). Talk to your doctor about low blood sugar symptoms and treatment. Symptoms may be different for each person.
• Allergic reactions, such as redness and swelling at the site where you inject.
• Skin thickening or pits at the injection site (lipodystrophy).
• Itching and rash.

These are not all the possible side effects of Humulin R U-500.

Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before using

Tell your doctor if you are pregnant or plan to become pregnant. Also tell your doctor about:

• Any allergies you have. Your doctor can check if the medicine has ingredients that may cause a reaction.
• Any medical conditions, including problems with your liver, kidney, or heart.
• All the medicines you take, especially a class of drugs called thiazolidinediones, or TZDs. Be sure to include the over-the-counter medicines, vitamins, and herbal supplements you take.

How to take

• Read the instructions that come with your Humulin R U-500 carefully. Take it exactly the way your doctor tells you.
• Know how much Humulin R U-500 you are supposed to take. Do not change your dose unless your doctor tells you to.
• Check the label of your insulin each time you use it. This will help you make sure you are using the right one.
• Test your blood sugar before you take Humulin R U-500. Do not take it if your blood sugar is too low.
• Do not mix Humulin R U-500 with any other insulin.
• Always use a new needle when injecting Humulin R U-500. This will help you avoid infection.
• Inject Humulin R U-500 under your skin. Change (rotate) where you inject your insulin with each dose. Do not inject your insulin into the exact same spot. Avoid injecting your insulin into areas where the skin has pits or lumps, or is thickened, tender, bruised, scaly, hard, scarred, or damaged. This will help reduce your chance of getting pits, lumps, or thickened skin where you inject your insulin.

Learn more

Humulin R U-500 is a prescription medicine. For more information, call 1-800-545-5979 or go to humulin.com.

This summary provides basic information about Humulin R U-500 but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about Humulin R U-500 and how to take it. Your doctor is the best person to help you decide if Humulin R U-500 is right for you.

HM CON BS 02FEB2023

Humulin^® and KwikPen^® are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

INDICATION AND SAFETY SUMMARY for REZVOGLAR^TM

REZVOGLAR^TM (REHZ-voh-glahr) is a long-acting man-made insulin only available with a prescription used to control high blood sugar in adults and children with diabetes mellitus.

REZVOGLAR is not for use to treat diabetic ketoacidosis.

Warnings - Do not take REZVOGLAR if you have:

• symptoms of low blood sugar (hypoglycemia)
• an allergy to REZVOGLAR or any of its ingredients

Do not reuse needles or share your REZVOGLAR^TM KwikPen^® with other people. You or the other person can get a serious infection. This can happen even if you change the needle.

Do not change the insulin you use or your dose, unless your doctor tells you to. This could cause low or high blood sugar, which could be serious.

REZVOGLAR may cause serious side effects. Some of these can lead to death. The possible serious side effects of REZVOGLAR are:

• Low blood sugar. This can lead to:

• Severe allergic reaction. 
  Get emergency help right away if you have:

• Low potassium in your blood (hypokalemia). This can lead to severe breathing problems, irregular heartbeat, and death.
• Heart failure. Taking diabetes pills called thiazolidinediones /thIE-uh-zOH-li-dEEn-dIE-OHns/ (TZDs) with REZVOGLAR may cause heart failure in some people. This includes people who do not have any heart problems. If you have heart failure, it may get worse if you take TZDs with REZVOGLAR. Tell your doctor if you have any new symptoms of heart failure, or if they get worse. These are: shortness of breath, swelling of the ankles or feet, and sudden weight gain. Your doctor may need to change or stop treatment with TZDs and REZVOGLAR.

Common side effects

The most common side effects of REZVOGLAR are:

These are not all of the possible side effects. Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

Before using

Talk with your doctor about low blood sugar and how to manage it. Tell your doctor:

• about all of the medicines you take, including over-the-counter medicines, vitamins, and herbal supplements.
• about any other prescription medicines you take, especially ones called TZDs.
• about all of your medical conditions, including if you have heart failure or other heart, liver, or kidney problems. If you have heart failure, it may get worse while you take TZDs with REZVOGLAR.
• if you are pregnant, breastfeeding, or plan to become pregnant. It is not known if REZVOGLAR may harm your unborn or breastfeeding baby.

How to take

The REZVOGLAR KwikPen is a disposable insulin delivery device for use by a single patient to inject REZVOGLAR. Read the Instructions for Use that come with your REZVOGLAR single-patient-use prefilled KwikPen. These instructions provide details on how to prepare and inject a dose of REZVOGLAR, and how to throw away used REZVOGLAR prefilled pens and needles.

Be sure to check your blood sugar levels and use REZVOGLAR exactly as your doctor tells you to. Your doctor may tell you to change your dose because of illness, increased stress, or changes in your weight, diet, or level of physical activity or exercise. He or she may also tell you to change your dose because of other medicines you take.

The dose indicator on your pen shows your dose of REZVOGLAR. Do not make any dose changes unless your healthcare provider tells you to. Do not use a syringe to remove REZVOGLAR from your KwikPen disposable prefilled pen. DO not re-use needles. Always use a new needle for each injection. Re-use of needles increases your risk of having blocked needles, which may cause you to get the wrong dose of REZVOGLAR. Using a needle for each injection lowers your risk of getting infection. If your needle is blocked, follow the instructions in Step 3 of the Instructions for Use.

Before injecting your REZVOGLAR

You can inject REZVOGLAR yourself, or you can have a trained caregiver inject it for you. Make sure you or your caregiver:

• Check your insulin label each time you give your injection. This will help you make sure that you are using the correct insulin.
• Use a new needle for each injection. You can get a serious infection or the wrong dose of insulin if you re-use needles.

When you are ready to inject

• Take REZVOGLAR once a day, at the same time each day.
• Change (rotate) where you inject your insulin with each dose. This can help reduce your chance of getting pits, lumps, or thickened skin where you inject your insulin. Do not inject your insulin into the exact same spot or where the skin has pits or lumps. Avoid injecting into thickened, tender, bruised, scaly, hard, scarred, or damaged skin.

Staying safe while taking your REZVOGLAR

To stay safe while taking REZVOGLAR, be sure you only use REZVOGLAR that is clear and colorless and does not have any particles.

Be sure you do not:

• mix REZVOGLAR with any other type of insulin or solution.
• drive or use heavy machinery until you know how REZVOGLAR affects you.
• drink alcohol or use other medicines that contain alcohol when taking REZVOGLAR.
• use REZVOGLAR in an insulin pump or inject REZVOGLAR into your vein (intravenously).

Learn more

REZVOGLAR is a prescription medicine. For more information, call 1-800-545-5979 or go to REZVOGLAR.com.

This summary provides basic information about REZVOGLAR but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other health care provider about REZVOGLAR and how to take it. Your doctor is the best person to help you decide if REZVOGLAR is right for you.

RV CON BS 17NOV2022

REZVOGLAR^TM is a trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

About Lilly

Lilly unites caring with discovery to create medicines that make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help more than 47 million people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges, redefining diabetes care, treating obesity and curtailing its most devastating long-term effects, advancing the fight against Alzheimer's disease, providing solutions to some of the most debilitating immune system disorders, and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/newsroom or follow us on Facebook, Instagram and LinkedIn. P-LLY

Humalog^®, Humulin^®, KwikPen^® are registered trademarks and REZVOGLAR^TM is a trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

Lilly Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about our efforts to lower insulin prices and expand the $35 insulin cap and reflects Lilly's current beliefs and expectations. However, there can be no assurance that these efforts will achieve Lilly's objectives or that Lilly will execute its strategy as planned. For further discussion of risks and uncertainties relevant to Lilly's business that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.  

Lantus^® is a registered trademark of sanofi-aventis U.S. LLC.

Footnotes

1. Includes Humalog U-100 (10mL and 3mL vials, cartridges, and KwikPen and Junior KwikPen), Humalog Mix 50/50 (10mL vial and KwikPen), and Humalog Mix 75/25 (10mL vial and KwikPen). It does not include the Tempo Pen^®.
2. Includes Humulin N U-100 (10mL and 3mL vials, and KwikPen), Humulin R U-100 (10mL and 3mL vials), and Humulin 70/30 (10mL and 3mL vials, and KwikPen).
3. Terms and conditions apply. At the majority of retail pharmacies. Government restrictions exclude people enrolled in federal government insurance programs from Lilly's $35 solutions. But federal law provides that Medicare Part D beneficiaries also pay no more than $35 per month for insulin.

PP-DB-US-0850 02/2023 ©Lilly USA, LLC 2023. All rights reserved.