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 lispro mix 75/25, or insulin lispro mix50/50?  

• 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 lispro mix 75/25, or insulin lispro mix50/50, 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 lispro mix 75/25, or insulin lispro mix 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.
• If you 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.  

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(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>

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SOURCE Eli Lilly and Company