Distributed
through LillyDirect®'s self-pay channel, Zepbound
single-dose vials are at least 50% less than the list price
of all other incretin medicines for obesity
INDIANAPOLIS, Aug. 27,
2024 /PRNewswire/ -- Eli Lilly and Company (NYSE:
LLY) today announced Zepbound® (tirzepatide) 2.5 mg and
5 mg single-dose vials are available for self-pay for patients
with an on-label prescription, significantly expanding the supply
of Zepbound in response to high demand. The single-dose vials are
priced at a 50% or greater discount compared to the list price of
all other incretin (GLP-1) medicines for obesity. This new
option helps millions of adults with obesity access the medicine
they need, including those not eligible for the Zepbound savings
card program, those without employer coverage, and those who need
to self-pay outside of insurance.
"We are excited to share that the Zepbound single-dose vials are
now here, further delivering on our promise to increase supply of
Zepbound in the U.S.," said Patrik
Jonsson, executive vice president, and president of Lilly
Cardiometabolic Health and Lilly USA. "These new vials not only help us meet
the high demand for our obesity medicine, but also broaden access
for patients seeking a safe and effective treatment option. In a
clinical study, the 5 mg maintenance dose helped patients achieve
an average of 15% weight loss after 72 weeks of treatment and has
been a powerful tool for millions of people with obesity looking to
lose weight and keep it off."
Lilly has created a new self-pay pharmacy component of
LillyDirect where patients with a valid, on-label prescription from
the health care provider of their choice can purchase the vials.
Distributing the vials via this channel ensures patients and
providers can trust they are receiving genuine Lilly medicine,
building on the company's efforts to help protect the public
from the dangers posed by the proliferation of counterfeit, fake,
unsafe or untested knock-offs of Lilly's medications. Lilly has
also taken a vocal stance against the use of obesity medicine for
cosmetic weight loss; a multi-step verification process will help
ensure the vials are dispensed only to patients who have a valid,
on-label electronic prescription from their health care provider.
Patients can also purchase ancillary supplies, like syringes and
needles, and will have access to important patient-friendly
instructional materials on correctly administering the medicine via
needle and syringe.
"People living with obesity have long been denied access to the
essential treatment and care needed to manage this serious chronic
disease," said James Zervos, chief
operating officer, Obesity Action Coalition. "Expanding coverage
and affordability of treatments is vital to people living with
obesity. We commend Lilly for their leadership in offering an
innovative solution that brings us closer to making equitable care
a reality. Now, it's time for policymakers, employers and insurers
to work with pharmaceutical companies to ensure no one is left
behind in receiving the care they deserve and need."
A four-week supply of the 2.5 mg Zepbound single-dose vial is
$399 ($99.75 per vial), and a four-week supply of the 5
mg dose is $549 ($137.25 per vial) – less than half the list price
of other incretin medicines for obesity and in line with the
Zepbound savings program for non-covered individuals. The self-pay
channel enables a transparent price by removing third-party supply
chain entities and allowing patients to access savings directly
outside of insurance.
"Despite obesity being recognized as a serious chronic illness
with long-term consequences, it's often misclassified as a
lifestyle choice, resulting in many employers and the federal
government excluding medications like Zepbound from insurance
coverage," said Jonsson. "Outdated policies and lack of coverage
for obesity medications create an urgent need for more innovative
solutions. Bringing Zepbound single-dose vials to patients will
help more people living with obesity manage this chronic condition.
We will also continue to advocate for a system that better aligns
with the science."
In a clinical study, tirzepatide 5 mg, along with a reduced
calorie diet and increased physical activity, achieved an average
of 15% weight loss over 72 weeks compared to 3.1% for placebo.
Zepbound is the first and only obesity treatment of its kind that
activates both GIP (glucose-dependent insulinotropic polypeptide)
and GLP-1 (glucagon-like peptide-1) hormone receptors. Zepbound
tackles an underlying cause of excess weight. It reduces appetite
and how much you eat. Zepbound is indicated for adults with
obesity, or those who are overweight and also have weight-related
medical problems, to lose weight and keep it off. Zepbound should
be used with a reduced-calorie diet and increased physical
activity. It should not be used in children under 18 years of age
or with other tirzepatide-containing products or any GLP-1 receptor
agonist medicines. Zepbound has not been studied in patients with a
history of pancreatitis, or with severe gastrointestinal disease,
including severe gastroparesis, and it is unknown if patients with
a history of pancreatitis are at higher risk for developing
pancreatitis on Zepbound.
Zepbound is also available in 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5
mg, or 15 mg per 0.5 ml doses in a single-dose pen (autoinjector).
The recommended maintenance dosages are 5 mg, 10 mg, or 15 mg
injected subcutaneously once weekly.
To learn more about the Zepbound single-dose vial, please visit
Zepbound.lilly.com.
To learn more about LillyDirect, please visit:
LillyDirect.lilly.com.
INDICATION AND SAFETY SUMMARY WITH
WARNINGS
Zepbound® (ZEHP-bownd) is an
injectable prescription medicine that may help adults with obesity,
or with excess weight (overweight) who also have weight-related
medical problems, lose weight and keep it off. 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 when
taken with other prescription, over-the-counter, or herbal weight
loss products. It is not known if Zepbound can be used in people
who have had pancreatitis. It is not known if Zepbound is safe and
effective for use in children under 18 years of age.
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.
Kidney problems (kidney failure). 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.
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 healthcare provider 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.
- Tell your healthcare provider if you are taking medicines to
treat diabetes including insulin or sulfonylureas which could
increase your risk of low blood sugar. Talk to your healthcare
provider about low blood sugar levels and how to manage
them.
- 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 kidneys, 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?
❑ 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. It
is not known if Zepbound passes 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.
- Zepbound is injected under the skin (subcutaneously) of your
stomach (abdomen), thigh, or upper arm.
- 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,
seek medical advice promptly, or contact a Poison Center expert
right away at 1-800-222-1222.
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 CBS 08NOV2023
Zepbound® and its delivery device base are registered
trademarks owned or licensed by Eli Lilly and Company, its
subsidiaries, or affiliates.
LillyDirect® is a registered trademark owned or
licensed by Eli Lilly and Company, its subsidiaries, or
affiliates.
* The in-person and telehealth providers listed on the
LillyDirect site are independent. Treatment decisions and
prescribing practices are made based on the independent medical
judgment of the provider's care team. They may prescribe medication
or another course of treatment.
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 more than 51 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/news, or follow
us on Facebook, Instagram and LinkedIn. P-LLY
PP-ZP-US-0986 08/2024 ©Lilly USA, LLC 2024. All rights reserved.
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), including statements about the supply and access of Zepbound
(tirzepatide) as a treatment for adults with obesity or overweight
and reflects Lilly's current belief and expectations. However, as
with any pharmaceutical product, there are substantial risks and
uncertainties in the process of drug research, development, and
commercialization. Among other things, there can be no guarantee
that future study results will be consistent with the results to
date, that Zepbound will receive additional regulatory approvals,
that Zepbound will be commercially successful, or that Lilly will
execute its strategy as planned. For further discussion of these
and other risks and uncertainties, see Lilly's most recent 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.
Refer to: Brooke Frost;
brooke.frost@lilly.com; 317-432-9145 (Media)
Joe Fletcher;
jfletcher@lilly.com; 317-296-2884 (Investors)
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