Lilly and U.S. government agree to expand access to obesity medicines to millions of Americans

Rhea-AI Summary

Eli Lilly (NYSE: LLY) agreed with the U.S. government to expand access to its obesity medicines, capping out-of-pocket costs for Medicare beneficiaries at $50 per month for Zepbound (tirzepatide) and orforglipron (if FDA-approved) starting as early as April 1, 2026. The deal allows Medicaid expansion by states, adds self-pay access via LillyDirect, and prices Zepbound multi-dose pens at $299–$449 and orforglipron at $149–$399. Lilly commits > $50 billion to U.S. manufacturing and receives three years of tariff relief plus protection from future pricing mandates.

Positive

• Medicare cap of $50/month for Zepbound and orforglipron
• Zepbound priced at $299–$449 for multi-dose pens
• Orforglipron priced at $149–$399 for retail doses
• Lilly commits > $50 billion in U.S. manufacturing investment
• Three-year tariff relief and protection from pricing mandates

Negative

• Agreement applies to government programs and self-pay, not commercial channel
• Access to orforglipron depends on FDA approval, not guaranteed
• Medicare pricing starts April 1, 2026, delaying near-term access

Insights

Pharmaceutical access strategist

Lilly's deal to cap patient costs and broaden government coverage materially increases access and alters pricing dynamics for its obesity portfolio.

Lilly will make Zepbound and orforglipron available to Medicare beneficiaries at no more than $50 per month starting as early as April 1, 2026 if approved by the FDA, and states may expand access via Medicaid; the company also offers tiered self-pay prices through LillyDirect and maintains a $35 insulin cap.

The business mechanism ties broader public coverage to explicit out‑of‑pocket caps and a LillyDirect self‑pay channel, which should increase patient uptake while preserving the commercial channel outside the agreement; risks include dependency on FDA approvals, the limited scope (no commercial‑channel price obligations), and the company's reciprocal concessions such as three years of tariff relief and protection from future pricing mandates.

Watch for the FDA approval milestones for orforglipron and Zepbound, implementation timing around April 1, 2026, and any state Medicaid adoption decisions within the next 6–18 months; these items will determine the near‑term scale of access and measurable budget impact.

 Medicare beneficiaries with obesity or overweight will have access to Zepbound and orforglipron, if approved, at $50 a month 

INDIANAPOLIS, Nov. 6, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced an agreement with the U.S. government to expand access to its obesity medicines and reduce patient costs. The agreement builds on Lilly's longstanding commitment to finding solutions with policymakers that improve access to life-changing medicines. In 2020, Lilly partnered with the Trump Administration on a pilot program that paved the way for Lilly to be the first company to cap out-of-pocket insulin costs at $35 per month. Lilly will now improve access to nearly 40 million Americans living with obesity on government insurance programs and millions more who pay out-of-pocket. Unlocking access to these medicines can be game-changing for Americans with obesity – a risk factor driving more than 200 associated diseases, including heart disease, strokes and certain types of cancers.

"Today marks a pivotal moment in U.S. health care policy and a defining milestone for Lilly, made possible through collaboration with the Trump Administration. As we expand access to obesity treatments for more Americans and advance one of the most innovative obesity pipelines, we remain focused on improving outcomes, strengthening the U.S. healthcare system, and contributing to the health of our nation for generations to come," said David A. Ricks, Lilly chair and CEO. "This agreement adds to our established commitment to affordability – from being the first company to cap insulin prices at $35 to launching LillyDirect, the end-to-end digital healthcare experience."

What are the Details of the Lilly and Trump Administration Agreement?

• Starting as early as April 1, 2026, Medicare beneficiaries will pay no more than $50 per month for Zepbound (tirzepatide), available in a multi-dose pen, and for orforglipron, Lilly's convenient once-daily obesity pill, provided both receive approval from the U.S. Food and Drug Administration (FDA). States will also have the ability to expand access to Zepbound and orforglipron through Medicaid.
  • Lilly applied for the Commissioner's National Priority Voucher for orforglipron, potentially accelerating U.S. FDA approval.
    
    
• Upon FDA approval, self-pay patients living with obesity will be able to access these medicines through LillyDirect's self-pay pharmacy channel.
  • Zepbound multi-dose pen will be available at the lowest dose at $299, with additional doses up to $449 representing a $50 discount to current direct-to-patient prices; priced similar to what is available in Europe. When patients refill their multi-dose pen prescription on the LillyDirect digital health platform, they will pay no more than $449. Orforglipron will be available with the lowest dose starting at $149 with additional doses up to $399.
    
    
• The scope of the agreement does not include pricing obligations in the commercial channel. 
  
  
• Emgality (galcanezumab-gnlm), Trulicity (dulaglutide) and Mounjaro (tirzepatide) will be added to LillyDirect and made available for self-pay patients with pricing 50-60% off their current list prices.
  
  
• Lilly will also continue to offer insulin at no more than $35 per month out-of-pocket, whether a person has commercial insurance or no insurance.

"The U.S. health care system has evolved in a way that's unfair to American patients and taxpayers who disproportionately pay a higher share of the costs for developing breakthrough medicines compared to other countries," Ricks added. "Lilly is in a unique position to work with the U.S. government to rebalance the global system, expand access and lower costs for Americans while also protecting our company's ability to both innovate and enhance manufacturing capacity to meet the significant demand for our life-saving medicines."

Today's announcement also reflects Lilly's commitment to strengthening U.S. life sciences through significant investments in manufacturing and research and development. As part of its industry-leading commitment to U.S.-based innovation and scientific progress, the company is investing more than $50 billion in U.S. manufacturing to boost domestic production in key therapeutic areas. 

As part of the agreement, Lilly is addressing all four of the Administration's priorities, including launching new medicines with a more balanced pricing approach across developed nations. In return, Lilly will receive three years of tariff relief and will not be subject to future pricing mandates.

About orforglipron 
Orforglipron (or-for-GLIP-ron) is an investigational, once-daily small molecule (non-peptide) oral glucagon-like peptide-1 receptor agonist that can be taken any time of the day without restrictions on food and water intake.¹ Orforglipron was discovered by Chugai Pharmaceutical Co., Ltd. and licensed by Lilly in 2018. Chugai and Lilly published the preclinical pharmacology data of this molecule together.² Lilly is running Phase 3 studies on orforglipron for the treatment of type 2 diabetes and for weight management in adults with obesity or overweight with at least one weight-related medical problem. It is also being studied as a potential treatment for obstructive sleep apnea, hypertension and osteoarthritis pain in adults with obesity.

INDICATIONS AND SAFETY SUMMARY WITH WARNINGS
Zepbound^® (ZEHP-bownd) is an injectable prescription medicine that may help adults with:

• obesity, or some adults with overweight who also have weight-related medical problems to lose excess body weight and keep the weight off.
• moderate-to-severe obstructive sleep apnea (OSA) and obesity to improve their OSA.

It should be used with a reduced-calorie diet and increased physical activity.

Zepbound contains tirzepatide and should not be used with other tirzepatide-containing products or any GLP-1 receptor agonist medicines. It is not known if Zepbound is safe and effective for use in children.

Warnings - Zepbound may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.

• Do not use Zepbound if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).
• Do not use Zepbound if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• Do not use Zepbound if you have had a serious allergic reaction to tirzepatide or any of the ingredients in Zepbound.                  

Zepbound may cause serious side effects, including:

Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Zepbound. Tell your healthcare provider if you have stomach problems that are severe or will not go away.

Dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration.

Gallbladder problems. Gallbladder problems have happened in some people who use Zepbound. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), or clay-colored stools.

Inflammation of the pancreas (pancreatitis). Stop using Zepbound and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.

Serious allergic reactions. Stop using Zepbound and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, or very rapid heartbeat.

Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Zepbound with medicines that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, mood changes, hunger, weakness or feeling jittery.

Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Zepbound.

Depression or thoughts of suicide. You should pay attention to changes in your mood, behaviors, feelings or thoughts. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you.

Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Zepbound may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking Zepbound before you are scheduled to have surgery or other procedures.

Common side effects
The most common side effects of Zepbound include nausea, diarrhea, vomiting, constipation, stomach (abdominal) pain, indigestion, injection site reactions, feeling tired, allergic reactions, belching, hair loss, and heartburn. These are not all the possible side effects of Zepbound. Talk to your healthcare provider about any side effect that bothers you or doesn't go away.

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 Zepbound

• Your healthcare provider should show you how to use Zepbound before you use it for the first time.
• Talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea.
• If you take birth control pills by mouth, talk to your healthcare provider before you use Zepbound. Birth control pills may not work as well while using Zepbound. Your healthcare provider may recommend another type of birth control for 4 weeks after you start Zepbound and for 4 weeks after each increase in your dose of Zepbound.

Review these questions with your healthcare provider:

❑ Do you have other medical conditions, including problems with your pancreas, or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food?
❑ Do you take diabetes medicines, such as insulin or sulfonylureas?
❑ Do you have a history of diabetic retinopathy?
❑ Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)?
❑ Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements?
❑ Are you pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed? Zepbound may harm your unborn baby. Tell your healthcare provider if you become pregnant while using Zepbound. Zepbound may pass into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using Zepbound.

• Pregnancy Exposure Registry: There will be a pregnancy exposure registry for women who have taken Zepbound during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may contact Lilly at 1-800-LillyRx (1-800-545-5979).

How to take

• Read the Instructions for Use that come with Zepbound.
• Use Zepbound exactly as your healthcare provider says.
• Use Zepbound with a reduced-calorie diet and increased physical activity.
• Inject Zepbound under the skin (subcutaneously) of your stomach (abdomen), thigh, or have another person inject in the back of the upper arm. Do not inject ZEPBOUND into a muscle (intramuscularly) or vein (intravenously).
• Use Zepbound 1 time each week, at any time of the day.
• Change (rotate) your injection site with each weekly injection. Do not use the same site for each injection.
• If you take too much Zepbound, call your healthcare provider, call the Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

Zepbound injection is approved as a 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg per 0.5 mL in single-dose pen or single-dose vial.

Learn more
Zepbound is a prescription medicine. For more information, call 1-800-LillyRx (1-800-545-5979) [or go to www.zepbound.lilly.com].

This summary provides basic information about Zepbound 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 healthcare provider. Be sure to talk to your healthcare provider about Zepbound and how to take it. Your healthcare provider is the best person to help you decide if Zepbound is right for you.

ZP CON BS 25SEP2025
Zepbound® and its delivery device base are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

1. Ma X, Liu R, Pratt EJ, Benson CT, Bhattachar SN, Sloop KW. Effect of Food Consumption on the Pharmacokinetics, Safety, and Tolerability of Once-Daily Orally Administered Orforglipron (LY3502970), a Non-peptide GLP-1 Receptor Agonist. Diabetes Ther. 2024 Apr;15(4):819-832. doi: 10.1007/s13300-024-01554-1. Epub 2024 Feb 24. PMID: 38402332; PMCID: PMC10951152.
2. T. Kawai, B. Sun, H. Yoshino, D. Feng, Y. Suzuki, M. Fukazawa, S. Nagao, D.B. Wainscott, A.D. Showalter, B.A. Droz, T.S. Kobilka, M.P. Coghlan, F.S. Willard, Y. Kawabe, B.K. Kobilka, & K.W. Sloop, Structural basis for GLP-1 receptor activation by LY3502970, an orally active nonpeptide agonist, Proc. Natl. Acad. Sci. U.S.A. 117 (47) 29959-29967, https://doi.org/10.1073/pnas.2014879117(2020).

About Lilly
Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of 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/news, or follow us on Facebook, Instagram, and LinkedIn. P-LLY

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, among other items, Lilly's agreement with the U.S. government designed to expand access to obesity medicines for U.S. patients, planned access, pricing, treatment presentation, and supply for Lilly products and product candidates resulting from the agreement, manufacturing investments and commitments, expected tariff and product pricing impacts, and potential regulatory review timelines for Lilly product candidates and devices and reflects Lilly's current beliefs and expectations. However, there can be no assurance that our voluntary agreement with the U.S. government and related plans and initiatives will achieve Lilly's objectives or that Lilly will execute its strategy as planned. Risks and uncertainties include the impact of the voluntary agreement with the U.S. government on Lilly's business, operations and financial condition and results; risks related to the ability to realize the anticipated benefits of the voluntary agreement with the U.S. government, including the possibility that patient access and other expected benefits will not be realized or will not be realized within expected time periods; the uncertainties inherent in pharmaceutical research, development, and regulatory reviews and dispositions; the uncertainties inherent in business and financial planning, including, without limitation, risks related to Lilly's business and prospects, manufacturing expansion and capabilities, adverse developments in Lilly's markets, or adverse developments in the U.S. or global capital markets, credit markets, regulatory environment or economies generally; risks and uncertainties related to issued or future executive orders or other new, or changes in, laws or regulations; and competitive developments. 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.

Trademarks and Trade Names
All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are references in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

Refer to:	Anne Gill; anne.gill@lilly.com;  317-999-7402 (Media)
	Michael Czapar; czapar_michael_c@lilly.com; 317-617-0983 (Investors)

View original content to download multimedia:https://www.prnewswire.com/news-releases/lilly-and-us-government-agree-to-expand-access-to-obesity-medicines-to-millions-of-americans-302607652.html

SOURCE Eli Lilly and Company

FAQ

What will Medicare beneficiaries pay for Zepbound and orforglipron under the Lilly agreement (LLY)?

Medicare beneficiaries will pay no more than $50 per month for Zepbound and orforglipron, if both drugs receive FDA approval.

When does the Lilly (LLY) Medicare price cap for obesity medicines take effect?

The price cap can begin as early as April 1, 2026, subject to FDA approval where required.

How much will Zepbound and orforglipron cost through LillyDirect for self-pay patients?

Zepbound multi-dose pens will be priced at $299–$449 and orforglipron at $149–$399 through LillyDirect's self-pay channel.

Does the Lilly agreement (LLY) change commercial insurance pricing for its drugs?

No; the agreement's pricing scope excludes obligations in the commercial channel.

What manufacturing or policy concessions does Lilly (LLY) receive in the agreement?

Lilly will receive three years of tariff relief and protection from future pricing mandates in return for expanded access commitments.

Will orforglipron be available to Medicaid and state programs under the Lilly agreement?

States will have the ability to expand access to Zepbound and orforglipron through Medicaid under the agreement.