Analysis Compares Cost-Effectiveness of Premixed Insulin Analogs to Long-Acting Insulin Analogs in the Long-Term Treatment of Type 2 Diabetes in the U.S.

SAN DIEGO and INDIANAPOLIS, June 24, 2011 /PRNewswire/ –Eli Lilly and Company
(NYSE: LLY) today announced results from an analysis designed to evaluate the
cost-effectiveness of insulin lispro mix 75/25 and insulin lispro mix 50/50
versus long-acting insulin analog (LAIA).

The analysis indicated that for patients with type 2 diabetes who do not
experience frequent hypoglycemia, insulin lispro premixed insulin analogs are
likely to be cost-effective when compared to LAIA in the long-term treatment of
type 2 diabetes. The results were presented today at the Association’s 71st
Scientific Sessions in San Diego, CA. The study also will be featured at the
President’s Poster Session, a showcase featuring 100 outstanding posters
selected by the Scientific Sessions Meeting Planning Committee.

The analysis further quantified a recent meta-analysis conducted by the Agency
for Healthcare Research and Quality (AHRQ), which assessed the relative
effectiveness and safety of premixed analog insulin and LAIA, finding that
premixed insulin analogs may provide tighter glycemic control than long-acting
alternatives.

A validated diabetes model was used to compare the cost effectiveness of insulin
lispro premixed insulin analogs versus LAIA from a U.S. healthcare payer
perspective.

Insulin lispro premixed insulin analogs were associated with improvements in
both life expectancy (+0.07 and +0.09 years, respectively) and quality-adjusted
life expectancy (+0.07 quality-adjusted life years [QALYs] and +0.08 QALYs,
respectively) when compared with LAIA. These clinical benefits were accompanied
by increases in direct lifetime costs of $1,724 and $1,720 relative to LAIA,
yielding incremental cost-effectiveness ratios of $28,580 and $23,150 per QALY
gained for the premixed insulin analogs versus LAIA, respectively.

To calculate the costs, the base case analysis was run over a time horizon of 35
years to capture all relevant long-term complications and associated costs and
assess their impact on life expectancy and quality-adjusted life expectancy.
Future cost and clinical outcomes were discounted at 3 percent annually.

Sensitivity analyses were performed to investigate the effect of time horizon,
discounting, minor hypoglycemia rates, diabetes complication costs, insulin
costs and method of quality-adjusted life expectancy estimation on outcomes.

Study limitations included variability in the quality of the reported data on
hypoglycemia rates from the studies used for the meta-analysis. Additionally,
the meta-analysis represented data from short-term clinical trials, which was
extrapolated to make long-term projections.

“We know that 28 percent of people with type 2 diabetes use insulin to manage
their diabetes, and once insulin treatment begins, it could be a life-long part
of their disease management,” said Dana Hardin, MD, a clinical research
physician at Lilly. “These study findings are encouraging because, while not all
patients are candidates for premixed insulin, those who are may have another
viable and cost-effective treatment option.”

Diabetes affects more than 25 million people in the U.S.(1) and is the fifth
leading cause of death by disease. In 2007, the most recent year for which data
is available, costs for diabetes were approximately $174 billion dollars.(2)

Indication

Who should use insulin lispro premixed insulin analogs?

Insulin lispro premixed insulin analogs are used to treat people with diabetes
for the control of high blood sugar.

Important Safety Information for insulin lispro, insulin lispro mix 75/25, and
insulin lispro mix 50/50

Who should not take Insulin lispro,insulin lispromix 75/25, orinsulin
lispromix50/50?

— Do not take these insulins if your blood sugar is too low (hypoglycemia)
or if you are allergic to insulin lispro or any of the ingredients in
these insulins.

What is the most important information I should know about insulin lispro,
insulin lispro mix 75/25, and insulin lispro mix 50/50?

— Do not change the insulin you use without talking to your healthcare
provider. Doses of oral antidiabetic medicines may also need to change
if your insulin is changed.
— Test your blood sugar levels as your healthcare provider instructs.
— When used in a pump, do not mix Insulin lispro with any other insulin or
liquid. Never use Insulin lispro mix 75/25 or Insulin lispro mix 50/50
in a pump.

Before using Insulin lispro,insulin lispromix 75/25, orinsulin
lispromix50/50,what should I tell my healthcare providers?

Tell your healthcare providers:

— About all of your medical conditions, including liver or kidney
problems.
— If you are pregnant or breastfeeding.
— About all the medicines you take, including prescription and
non-prescription medicines, vitamins, and herbal supplements.

How should I use insulin lispro,insulin lispromix 75/25, orinsulin lispromix
50/50?

— These insulins start working faster than other insulins that contain
regular human insulin. You should take Insulin lispro within fifteen
minutes before eating or right after eating a meal. You should take
Insulin lispro mix 75/25 and insulin lispro mix 50/50 within fifteen
minutes before eating.
— Always make sure that you receive the correct type of insulin from the
pharmacy.
— Do not use Insulin lispro if it is cloudy, colored, or has solid
particles or clumps in it.
— Do not use Insulin lispro mix 75/25 or insulin lispro mix 50/50 if they
have solid particles or clumps in them. Insulin lispro mix 75/25 and
insulin lispro mix 50/50 should be mixed carefully before each use and
should be cloudy or milky after mixing.
— Do not mix Insulin lispro with insulin other than NPH when using a
syringe. Do not mix or dilute Insulin lispro when used in a pump.
— Never mix insulin lispro mix 75/25 or insulin lispro mix 50/50 in the
same syringe with other insulin products. Never use insulin lispro mix
75/25 or insulin lispro mix 50/50 in a pump.
— Inject your insulin under your skin (subcutaneously). Never inject into
a vein or muscle. Change (rotate) your injection site with each dose.
Make sure you inject the correct insulin and dose.
— Depending on the type of diabetes you have, you may need to take Insulin
lispro with a longer-acting insulin or with oral antidiabetic
medications.
— Ifyou forget to take your insulin, your blood sugar may go too high
(hyperglycemia), which can lead to serious problems like loss of
consciousness (passing out), coma, or even death.
— Your insulin dose may need to change because of illness, stress, other
medicines you take, change in diet, or change in physical activity or
exercise.

What are the possible side effects of Insulin lispro, insulin lispro mix 75/25,
or insulin lispro mix 50/50?

— Low blood sugar is the most common side effect. There are many causes of
low blood sugar, including taking too much insulin. It is important to
treat it quickly. You can treat mild to moderate low blood sugar by
drinking or eating a quick source of sugar right away. If severe, low
blood sugar can cause unconsciousness (passing out), seizures, and
death. Symptoms may be different for each person. Be sure to talk to
your healthcare provider about low blood sugar symptoms and treatment.
— Severe life-threatening allergic reactions (whole-body reactions) can
happen. Get medical help right away if you develop a rash over your
whole body, have trouble breathing, have a fast heartbeat, or are
sweating.
— Reactions at the injection site (local allergic reaction) such as
redness, swelling, and itching can happen. If you keep having skin
reactions or they are serious, talk to your healthcare provider. Do not
inject insulin into a skin area that is red, swollen, or itchy.
— Skin may thicken or pit at the injection site (lipodystrophy). Do not
inject insulin into skin with these types of changes.
— Other side effects include swelling of your hands and feet, low
potassium in your blood (hypokalemia), and weight gain.
— These are not all of the possible side effects. Ask your healthcare
providers for more information or for medical advice about side effects.

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.

How should I store insulin lispro, insulin lispro mix 75/25, and insulin lispro
mix 50/50?

— Unopened insulin lispro, insulin lispro mix 75/25, and insulin lispro
mix 50/50 should be stored in a refrigerator and can be used until the
expiration date on the carton or label.
— Insulin should be stored away from light and heat. Do not use insulin if
it has been frozen.
— Opened vials should be kept at room temperature or in a refrigerator.
Opened cartridges or prefilled pens should be kept at room temperature.
— Once opened, insulin lispro vials, prefilled pens, and cartridges should
be thrown away after 28 days.
— Once opened, insulin lispro mix 75/25 and insulin lispro mix 50/50 vials
should be thrown away after 28 days. Opened Insulin lispro mix 75/25 and
insulin lispro mix 50/50 prefilled pens should be thrown away after 10
days.

Insulin lispro, insulin lispro mix 75/25, and insulin lispro mix 50/50 are
available by prescription only.

For more information about insulin lispro, insulin lispro mix 75/25 and insulin
lispro mix 50/50, please see the Full Prescribing Information
(http://pi.lilly.com/us/insulin lispro-pen-pi.pdf,http://pi.lilly.com/us/insulin
lispro7525-pi.pdf,http://pi.lilly.com/us/insulin lispro5050-pi.pdf) and Patient
Information (http://pi.lilly.com/us/insulin
lispro-pen-ppi.pdf,http://pi.lilly.com/us/insulin
lispro7525-pen-ppi.pdf,http://pi.lilly.com/us/insulin lispro5050-pen-ppi.pdf).

Please see full user manual that accompanies your pen.

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of pharmaceutical products by applying the latest research from its
own worldwide laboratories and from collaborations with eminent scientific
organizations. Headquartered in Indianapolis, IN, Lilly provides answers –
through medicines and information — for some of the world’s most urgent medical
needs. Additional information about Lilly is available at www.lilly.com.

About Lilly Diabetes

For more than 85 years, Lilly has been a worldwide leader in pioneering
industry-leading solutions to support people living with and treating diabetes.
Lilly introduced the world’s first commercial insulin in 1923, and remains at
the forefront of medical and delivery device innovation to manage diabetes.
Lilly is also committed to providing solutions beyond therapy — practical
tools, education, and support programs to help overcome barriers to success
along the diabetes journey. At Lilly, the journeys of each person living with or
treating diabetes inspire ours. For more information, visit
www.lillydiabetes.com.

Presentation 418-PP

P-LLY

(1) American Diabetes Association. Diabetes Statistics.
http://www.diabetes.org/diabetes-basics/diabetes-statistics/. Accessed June 1,
2011. < Section 1, Paragraph 1, Line 1>
(2) American Diabetes Association. Direct and Indirect Costs of Diabetes in the
United States.

http://www.diabetes.org/how-to-help/action/resources/cost-of-diabetes.html.

Accessed June 1, 2011. < Section 2, Paragraph 4, Line 1>

(Logo: http://photos.prnewswire.com/prnh/20031219/LLYLOGO )

SOURCE Eli Lilly and Company