Express Scripts to add Zepbound to National
Preferred Formulary
INDIANAPOLIS, Dec. 5, 2023
/PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced
that Zepbound™ (tirzepatide) injection is now available.
Zepbound is indicated for adults with obesity (with a BMI of 30
kg/m2 or greater), or those who are overweight (with a
BMI of 27 kg/m2 or greater) and also have weight-related
medical problems such as hypertension, dyslipidemia, type 2
diabetes mellitus, obstructive sleep apnea or cardiovascular
disease, to lose weight and keep it off. It should be used with a
reduced-calorie diet and increased physical activity. Zepbound
should not be used with other tirzepatide-containing products or
any GLP-1 (glucagon-like peptide-1) receptor agonist
medicines, and it has not been studied in patients with a history
of pancreatitis, or with severe gastrointestinal disease, including
severe gastroparesis.
Following the U.S. Food and Drug Administration (FDA) approval
on Nov. 8, 2023, people living with
obesity can now access Zepbound in six doses (2.5 mg, 5 mg, 7.5 mg,
10 mg, 12.5 mg, 15 mg) through a prescription that can be filled at
retail and mail-order pharmacies.
"Today opens another chapter for adults living with obesity who
have been looking for a new treatment option like Zepbound," said
Rhonda Pacheco, group vice
president, Lilly Diabetes and Obesity, U.S. "The availability of
Zepbound in U.S. pharmacies is the first step, but we have to work
hand-in-hand with employers, government and healthcare industry
partners to remove barriers and make Zepbound available to those
who need it. We are excited to see growing coverage in the
marketplace, giving millions of Americans access to Zepbound."
Effective Dec. 1, 2023, Zepbound
was added to the National Preferred Formulary for Express Scripts
and Cigna Healthcare, and effective Dec. 15,
2023, it will be added to Cigna Healthcare's commercial
formularies. Lilly's commercial savings card program is now
available at U.S. pharmacies to help adults who need Zepbound
access it.
- People who are commercially insured with coverage for Zepbound
may be eligible to pay as low as $25
for a 1-month or 3-month prescription.
- People who are commercially insured without coverage for
Zepbound may be eligible to pay as low as $550 for a 1-month prescription of Zepbound,
approximately 50% lower than the list price.
To learn more about Zepbound and eligibility for the savings
card program, please visit www.Zepbound.Lilly.com. Terms and
conditions apply.
Lilly continues to invest in the expansion of its global
manufacturing footprint to address the expected demand for
innovative new treatments, like Zepbound, and help ensure the safe
and reliable supply of its medicines.
About Zepbound™ (tirzepatide)
injection1
Zepbound™ (tirzepatide) injection is FDA-approved as an adjunct to
a reduced-calorie diet and increased physical activity for chronic
weight management in adults with obesity (BMI ≥ 30
kg/m2), or overweight (BMI ≥ 27 kg/m2) with
at least one weight-related comorbid condition. Zepbound is the
first and only FDA-approved obesity treatment that activates both
GIP (glucose-dependent insulinotropic polypeptide) and GLP-1
(glucagon-like peptide-1) hormone receptors.
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 trademarks 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 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/newsroom or
follow us
on Facebook, Instagram, Twitter and LinkedIn.
P-LLY
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 Zepbound (tirzepatide) as a
potential treatment for adults with obesity or overweight and the
timeline for additional regulatory submissions, future readouts,
supply and commercialization of Zepbound, presentations, and other
milestones relating to Zepbound 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 planned or ongoing
studies will be completed as planned, that future study results
will be consistent with the results to date, that Zepbound will
receive additional regulatory approvals, or that Zepbound will be
commercially successful or that we will meet anticipated timelines
for its commercialization. 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.
References
- Zepbound. Prescribing Information. Lilly USA,
LLC.
PP-ZP-US-0409 12/2023 ©Lilly USA, LLC 2023. All
rights reserved.
Refer
to:
|
Jessica
Thompson; thompson_jessica@lilly.com, 317-499-2042
(Media)
|
|
Joe Fletcher;
jfletcher@lilly.com, 317-296-2884 (Investors)
|
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SOURCE Eli Lilly and Company