A Closer Look At Diabetes

Diabetes A CLOSER LOOK

The number of Americans diagnosed with diabetes jumped 49 percent from 1990 to 2000.

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JOINT PROJECT BETWEEN T H E A M E R I C A N D I A B E T E S A S S O C I AT I O N A N D T H E N AT I O N A L P H A R M AC E U T I C A L C O U N C I L

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t is estimated that 17 million Americans suffer from diabetes, a group of chronic diseases characterized by defects in the way the body produces and uses insulin leading to elevated levels of blood sugar 1,2 (glucose). The number of Americans diagnosed with diabetes jumped 49 percent from 1990 to 2000, and approximately one million new cases are diagnosed each 1,2 year. This may reflect improved methods of diagnosis, an increase in obesity, an aging population, and growth among demographic groups for which diabetes is increasingly becoming a problem. The Centers for Disease Control and Prevention (CDC) conservatively estimate that diabetes in the U.S. will increase 165 percent by 2050.

There are two major types of diabetes. Type 1 is an autoimmune disease in which the body attacks and ultimately destroys the insulin-producing cells of the pancreas. With the body’s natural supply of insulin cut off, blood sugar levels rise. The disease can develop at any age, although onset is most common at puberty. Type 1 diabetes accounts for five to ten percent of all 1 diagnosed cases of diabetes. Type 2 diabetes is a metabolic disorder in which the body is unable to properly use insulin to control blood sugar levels, and in some cases, to make enough insulin. Type 2 diabetes is the most common form of diabetes, representing 90 to 95 percent of all cases 1 of diagnosed diabetes. Other forms of diabetes account for 1 one to five percent of all diagnosed cases. Undiagnosed and untreated diabetes can lead to many serious and often fatal health conditions. Diabetes is the main cause of kidney failure, new cases of blindness, and lower limb amputations, and is a major risk factor for heart disease and stroke. In 1999, over 114,000 people with 1 diabetes underwent dialysis or kidney transplantation. Nearly two-thirds of people with diabetes die of heart 3 disease or stroke. Each year, 82,000 people lose a foot or leg to diabetes, and it is the most frequent cause of lower 4 limb amputations. The risk of having a leg amputated is 15 to 40 times greater for a person with diabetes than for a person without diabetes. Since 1980, the number of deaths 5 related to diabetes has increased 40 percent. Unfortunately, the amount of money available for diabetes research and education programs has not matched the 2 increase in disease prevalence and death.

According to the American Diabetes Association, the total annual economic cost of diabetes in 1997 was estimated to be $98 billion. Of this figure, $44 billion was due to direct medical and treatment costs and $54 billion was due to 6 indirect costs attributed to disability and death. In 1997, the per capita costs of health care for people with diabetes amounted to $10,071, compared to $2,699 for people 3 without diabetes. However, proper treatment can significantly reduce the costs associated with diabetesrelated illness. One analysis of intensive treatment of type 2 diabetes found that stabilizing blood sugar at normal levels would raise life expectancy by 1.4 years and reduce the incidence of blindness by 72 percent, end-stage kidney disease by 87 percent, and lower extremity amputation by 7 67 percent. Treatment guidelines for type 1 and type 2 diabetes differ, although proper nutrition and exercise are a fundamental part of treating each condition. Because people with type 1 diabetes cannot produce any insulin, they must inject it daily. First-line treatment of type 2 diabetes usually calls for adjusting diet and exercise and reducing weight. Often a short trial of weight reduction and exercise is recommended 6 before the initiation of drug therapy in type 2 diabetes. In July 1995, the American Diabetes Association convened a panel of experts to develop a consensus statement on drug treatment of high blood sugar in type 2 diabetes. The panel recommended that if progress was not apparent within a three-month period after initiation of diet and exercise changes, then the use of a prescription medicine is 6 appropriate. The array of diabetes drugs available makes a number of therapy combinations possible. Evidence is mounting that combinations of drugs often have complementary effects and can control glucose levels better than a single form of 8,9,10 therapy over time. No single therapy currently available appears to be superior when used alone, and patients not responding to a single form of therapy often experience better outcomes when a second type is added, rather than 11 substituted. One recent study reports that the percentage of patients who were able to maintain target glucose levels on a single-therapy regimen dropped to 50 percent after three years, and to approximately 25 percent after nine years. Given the lessening effect of single therapies over time, the majority of patients require multiple therapies to maintain adequate control of blood sugar levels in the long 10 term. Carefully selected combination therapies may also have beneficial effects on complications associated with diabetes or other medical conditions. Eventually, many type 2 diabetes patients require insulin therapy, either alone or 12 with prescription therapies.

THE INCREASING PREVALENCE

OF

DIABETES

Over the last two decades, the incidence of diagnosed diabetes has increased. Additionally, 5.9 million people are believed to 1 have undiagnosed diabetes. The disease is more common among older people and non-whites. The number of people diagnosed with diabetes, particularly type 2 diabetes, is increasing for several reasons: • Improvements in screening and changes in the diagnostic criteria; 2 • Increasing rates of obesity and sedentary lifestyle; 13 • Growth in populations that have high rates of type 2 diabetes; and 14 • Recognition that type 2 diabetes is an increasing problem in children and adolescents.

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HE TOTAL ANNUAL ECONOMIC COST OF DIABETES IN 1997 WAS ESTIMATED TO BE $98 BILLION.

DIABETES

AND

HEART DISEASE

Heart disease is the leading cause of death in the United States, claiming the lives of nearly 460,000 Americans each 15 year. Patients with diabetes often suffer from heart disease as well, and the presence of diabetes greatly increases the 16 risks associated with heart disease: 4

• Nearly two-thirds of people with diabetes die of heart disease or stroke. 17 • People with diabetes have the same cardiovascular risk as if they have already had a heart attack. 1 • Adults with diabetes have heart disease rates two to four times higher than adults without diabetes. • Women with diabetes have three to seven times the risk of heart disease and heart attack than women who do not have 18 diabetes.

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TABILIZING BLOOD SUGAR AT NORMAL LEVELS WOULD RAISE LIFE EXPECTANCY BY 1.4 YEARS AND REDUCE THE INCIDENCE OF BLINDNESS BY 72 PERCENT, END-STAGE KIDNEY DISEASE BY PERCENT, AND LOWER EXTREMITY AMPUTATION BY 67 PERCENT.

METHODOLOGY This study separately analyzed prescription drug spending growth for two large national claims databases, one representing managed care plan enrollees and the other representing those covered by large employer-provided health benefit plans. The study defined and assessed several factors affecting the price per day of therapy and the volume of therapy — the number of days of therapy received and the number of patients receiving drug therapy. The analysis also examined the effects of price and volume changes for established drugs on the market during the entire period of analysis and for new drugs that were first marketed during this period.

FACTORS INFLUENCING DRUG SPENDING FOR DIABETES 1994-1997

Spending on pharmaceuticals was analyzed for individuals who received health benefit coverage from large employers in 1994 and 1997. The sample included individuals who were diagnosed with diabetes. Overall, spending on drugs for treating diabetes was 94 percent higher in 1997 than in 1994. Factors affecting the volume of drugs used outweighed factors affecting the price of drugs in influencing spending growth by more than three to one.

Price Factors

Volume Factors

Factors Influencing Growth in Rx Expenditures: Total Growth in Expenditures Growth Due to Volume Factors

% Positive Impact +94 +73

Changes in the Number of Prescriptions per Person for Established Drugs

-36

Changes in the Number of Prescriptions per Person for New Entrants

+66

Changes in Days of Therapy for Established Drugs

+9

Changes in Days of Therapy for New Entrants

+4

Patients per 1000 Health Plan Enrollees

+30

Growth Due to Price Factors Inflation

+21 +11

Changes in Mix of Established Drugs Price of New Entrants

% Negative Impact

-13 +23

Thirty percent of the overall spending growth could be attributed to an increase in the number of patients treated for diabetes. Educational outreach and disease management programs that encourage screening and diagnosis of people with unrecognized diabetes may have influenced such substantial growth. The underlying prevalence of diabetes may also have risen. Source: MEDSTAT’s Marketscan database

Approximately 5.9 million people are believed to have undiagnosed diabetes. SPENDING PER CAPITA FOR DIABETES MEDICATIONS The addition of three new drug classes between 1995 and 1997 had a marked effect on diabetes spending per patient. Per capita spending on all related medications together was 52 percent higher in 1997 than in 1994, representing an increase from $138 in 1994 to $210 in 1997. During this period, spending on drugs in the sulfonylurea class fell from $90 to $75 per capita, whereas spending on insulin rose slightly from $91 to $95 per capita. In 1997, per capita spending was $70 and $67 for two of the new antidiabetic drug classes, biguanides and TZDs.

Source: MEDSTAT’s Marketscan database

DIABETES

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MINORITIES 1

• The prevalence of diabetes among African-Americans is almost twice that of non-Hispanic whites. • One Native American tribe in Arizona has the highest rate of diabetes in the world. About 50 percent of these adults 3 between the ages of 30 and 64 have diabetes. 1 • The prevalence of type 2 diabetes is twice as high in Hispanics than non-Hispanic whites. • African-Americans with diabetes are 2.6 to 5.6 times more likely to suffer from kidney disease than other people with 3 diabetes. More than 4,000 new cases of end-stage kidney disease are diagnosed among this group each year. Among Mexican-Americans, the rate of diabetic end stage kidney disease is four to six times higher than in other diabetes 3 patients. • Among Native Americans, the rate of diabetic end-stage kidney disease is six times higher than in other diabetes 3 patients. Lower limb amputation rates among Native Americans are three to four times higher than the general 3 population and are 1.5 to 2.5 times higher among African-Americans than the general population.

ABOUT

THIS PUBLICATION: "A Closer Look at Diabetes" is a joint publication of the American Diabetes Association and the National Pharmaceutical Council. The mission of the American Diabetes Association is to prevent and cure diabetes, and to improve the lives of all people affected by diabetes. To fulfill this mission, the American Diabetes Association funds research, publishes scientific findings, provides information and other services to people with diabetes, their families, health care professionals and the public and advocates for scientific research and for the rights of people with diabetes. Since 1953, the National Pharmaceutical Council (NPC) has sponsored and conducted scientific, evidence-based analyses of the appropriate use of pharmaceuticals and the clinical and economic value of pharmaceutical innovation. NPC provides educational resources to a variety of health care stakeholders, including patients, clinicians, payers and policy makers. More than 20 research-based pharmaceutical companies are members of the NPC.

FOR MORE INFORMATION ABOUT DIABETES, PLEASE CONTACT: American Diabetes Association 1-800-DIABETES www.diabetes.org National Diabetes Education Program (NDEP)/National Institutes of Health (NIH) 1-800-438-5383 www.ndep.nih.gov American Association of Diabetes Educators 1-800-338-3633 www.aadenet.org National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)/ National Institutes of Health (NIH) 1-800-860-8747 www.niddk.nih.gov Centers for Disease Control and Prevention (CDC), Division of Diabetes Translation 1-877-CDC-DIAB www.cdc.gov/diabetes

1

Centers for Disease Control and Prevention. National Diabetes Fact Sheet: general information and national estimate on diabetes in the United States, 2000. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, 2002.

2

Mokdad AH, Bowman BA, Ford ES, et al. The Continuing Epidemics of Obesity and Diabetes in the United States. JAMA. 2001; 286:1195-1200.

3

Javitt JC, Chiang Y-P. Economic impact of diabetes. Chapter 30 in MI Harris, ed., Diabetes in America, 2nd ed. NIH Pub. No. 95-1468. Rockville, MD: National Institute of Diabetes and Digestive and Kidney Disease, U.S. Department of Health and Human Services. 1995.

4

American Heart Association. (2002) Diabetes Mellitus Statistics. [Online]. Available: http://216.185.112.5/presenter.jhtml?identifier=4551 [3/13/02].

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For more information about NPC or for additional resources, please contact:

Phone: 703-620-6390 Fax: 703-476-0904 www.npcnow.org

Riddle MC. Oral Pharmacologic Management of Type 2 Diabetes. Am Fam Phys. 1999; 60(9):2613-2620.

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Fonseca V, Rosenstock J, Patwardhan R, Salzman A. Effect of Metformin and Rosiglitazone Combination Therapy in Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Trial. JAMA. 2000; 283(13):1695-1702. 11

Purnell JQ, Hirsch IB. New Oral Therapies for Type 2 Diabetes. Am Fam Phys. 1997; 56(7):1835-1842. 12

Edelman SV, Henry RR. Diagnosis and Mangement of Type II Diabetes, 2nd ed. Berkeley, CA: University of California. 1998. 13

Harris MI, Flegal KM, Cowie CC, et al. Prevalence of Diabetes, Impaired Fasting Glucose, and Impaired Glucose Tolerance in U.S. Adults. Diab Care. 1998; 21(4):518-524.

14

American Diabetes Association. Type 2 Diabetes in Children and Adolescents. Diab Care. 2000; 23(3):381.

National Center for Health Statistics. Health, United States, 2001. Hyattsville, Maryland: 2001.

15 American Heart Association. 2001 Heart and Stroke Statistical Update. Dallas, TX: AHA, 2001.

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American Diabetes Association. Clinical practice recommendations 1996. Diab Care. 1996; 19 (Suppl 1):S1-S118. 7

The National Pharmaceutical Council 1894 Preston White Drive Reston, VA 20191-5433

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Eastman RC, Javitt JC, Herman WH, et al. Model of complications of NIDDM. Analysis of the Health Benefits and Cost-Effectiveness of Treating NIDDM with the Goal of Normoglycemia. Diab Care. 1997; 20:735-744. 8

Florence JA, Yeager BF. Treatment of Type 2 Diabetes Mellitus. Am Fam Phys. 1999; 59(10):2835-2844, 28492850.

National Cholesterol Education Program (NCEP). Expert Panel on Detection, Evaluation and Treatment of High Blood Cholesterol in Adults. Executive summary of the third report of the NCEP expert panel on detection, evaluation, and treatment of high blood cholesterol (adult treatment panel III). National Heart, Lung, and Blood Institute, 2001.

17

Haffner SM, et al. Mortality from Coronary Heart Disease in Subjects with Type 2 Diabetes and in Nondiabetic Subjects without Prior Myocardial Infarction. N Eng J Med. 1998; 339(4):229-234.

18

American Heart Association. (2002) Women, Heart Disease and Stroke. [Online]. Available: http://216.185.112.5/presenter.jhtml?identifier=4786 [3/13/02]. 1DST0070402