number of people with diabetes, increased pharmaceutical spending also comprised $23.2 billion for diabetes care, and without diabetes, people with dia …


OLICY P EALTH H OCUS ON F
Spring 2003 New Medicines New Hope

Diabetes and Pharmaceutical Spending: New Treatments, New Solutions
Overview
ith rising health care costs gaining more attention, some have pointed to increased spending on prescription drugs as part of the problem Yet this perspective overlooks the real reasons that spending on pharmaceuticals has grown in recent years, as well as the value that new medicines provide to patients and the economy by treating diseases more effectively and helping curb overall health care spending Spending on pharmaceuticals represents just 10 of overall health care spending Yet for some of the most serious diseases and conditions, this spending has risen considerably over the past 10 years This paper examines one increasingly prevalent disease–diabetes–and focuses on why spending on pharmaceuticals to treat it has grown and continues to rise Several clear reasons emerge: the number of people diagnosed with diabetes over the last decade has risen by 50 and continues to rise; five new classes of medicines have emerged to treat type 2 diabetes and are being adopted by physicians as key tools in the fight against this disease; current
standards of diabetes care increasingly emphasize drug therapy in addition to diet and exercise strategies; and disease management strategies have emphasized use of pharmaceuticals to treat diabetes because they can yield better health outcomes and lower overall cost This paper is the first in a continuing series by the Pharmaceutical Research and Manufacturers of America PhRMA on the expanding use of medicines in healthcare and the clinical and economic impact of this trend on treating disease

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The Cost of Treating Diabetes Has Risen Dramatically–and Continues to Grow
In 1992, Americans spent 6643 million on oral diabetes drugs and 6465 million on insulins, for a total of 13 billion in spending on diabetes medicines Over the next 10 years, spending on medicines to treat diabetes increased to 73 billion19 billion on insulins and 54 billion on oral diabetes drugs In addition to the dramatic increase in the number of people with diabetes, increased pharmaceutical spending also is due to
Pharmaceutical Research and Manufacturers of America 1100 Fifteenth Street, NW, Washington, DC 20005 New Medicines New Hope wwwphrmaorg

Diabetic patients make up 6 of our population but consume
15 of our healthcare dollar The main cost of diabetes is in the treatment of its complications and not in the day-to-day treatment of the disease itself The millions of dollars we spend on treatment for patients once they develop heart disease, stroke and kidney failure could be significantly decreased if we instead helped patients manage their diabetes with pharmaceuticals These new medicines provide powerful tools to prevent complications down the road and can help save the health care system money in the long run As someone once said, if you think that it is expensive to treat diabetes, try not treating it Richard O Dolinar, MD Member of the Legislative and Regulatory Committee American Association of Clinical Endocrinologists Practicing physician

What is Diabetes?
Diabetes is a group of chronic diseases characterized by elevated levels of blood sugar, or glucose, due to problems in the way the body produces and uses insulin Diabetes has two major forms: Type 1 diabetes is an autoimmune disease in which the body attacks and ultimately destroys the insulin-producing cells of the pancreas3 Insulin is a hormone that transports glucose from the blood to storage in tissues such as
the liver and muscles If the bodys natural supply of insulin is cut off, blood sugar levels rise The disease can develop at any age, although onset is most common during childhood Type 1 diabetes accounts for 5 to 10 percent of all diagnosed cases of diabetes Type 2 diabetes is a complex disorder in which the body is unable to produce enough insulin or properly use its own insulin to control blood sugar levels Type 2 diabetes is the most common form of diabetes, representing 90 to 95 percent of all cases of diagnosed diabetes4 This form of diabetes generally develops during adulthood, and is often associated with obesity and hypertension The primary goal of treating both type 1 and type 2 diabetes is controlling blood sugar so that levels do not go too high or too low Good control of blood sugar levels slows the progression of the disease and reduces the occurrence of complications Without adequate treatment, diabetes leads to many serious and often fatal health conditions, in large part through vascular disorders leading to organ failure For example, 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 stroke5 Large clinical studies have shown that early and aggressive treatment of diabetes may delay or even prevent many of the complications associated with diabetes, leading to improved quality of life and reduced expenditures in patients with type 2 diabetes6 In patients with type 2 diabetes, co-existing conditions such as hypertension and abnormal lipid levels must also be treated, further adding to the cost of treatment

the emergence of important new medicines to treat the diseases and a growing recognition of their value in controlling diabetes and its costs1 Although spending on medicines to treat diabetes has increased, it remains a small part of the total cost of diabetes care and of increased costs for diabetes care over time Since 1992, the direct cost of diabetes care has more than doubled–from 452 billion in 1992 to 918 billion in 2002 [Figure 1] Direct medical expenditures comprised 232 billion for diabetes care, 246 billion for chronic complications attributable to diabetes, and 441 billion for excess prevalence of general medical conditions Indirect expenditures resulting from lost workdays, restricted activity days, mortality, and permanent
disability due to diabetes totaled 398 billion In addition, when adjusting for differences in age, sex, and race/ethnicity between the population with and without diabetes, people with diabetes had medical expenditures that were 24 times higher than expenditures that would be incurred by the same group in the absence of diabetes2 If diabetes prevalence rates remained constant over time, the projected increase in the number of people with diabetes
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Diabetes and Pharmaceutical Spending: New Treatments, New Solutions

would cost an estimated 156 billion by 2010 and 192 billion by 2020

Figure 1: Retail Spending on Diabetes Medications and Direct Medical Care Costs Attributable to Diabetes, 1992 and 2002
100 90 80 Dollars in Billions 70 60 50 40 30 20 10 0
13 73 452

Rx Drugs Direct Medical Care Costs

918

1992

2002

Sources: Rx Drug Spending Data: IMS Health, based on custom analysis of Retail and Provider Perspective TM, 3/2003; 1992 Medical Care Cost Data: American Diabetes Association: Direct and Indirect Costs of Diabetes in the United States in 1992 Alexandria, VA: ADA, 1993; 2002 Medical Care Data: American Diabetes Association, Economic Costs of Diabetes in the US in 2002;
Diabetes Care 26 March 2003: 3

Why Has Spending on Diabetes Drugs Increased?
Some are asking why spending on medicines is increasing Examining this question in the context of specific diseases, such as diabetes, rather than simply citing national-level spending figures, helps answer this question

The Prevalence and Diagnosis of Diabetes Has Increased
The number of Americans diagnosed with diabetes jumped 49 from 1990 to 20007 About 17 million Americans now suffer from this disease–an estimated 111 million have been diagnosed, and an estimated 59 million people or one-third are unaware that they have the disease8 According to the American Diabetes Association, the prevalence of diabetes increases with age and is higher

among certain racial and ethnic minority populations The growth, aging, and increasing racial and ethnic diversity of the US population portends a substantial increase in the size of the population with diabetes9 Although rates of diabetes are similar for men and women, the rates for non-Hispanic blacks and Mexican-Americans are higher than those for nonHispanic whites For example, Type 2 diabetes among African Americans aged 40 to 74 has doubled in just 12 years,
from 89 to 182 More than 10 of all Mexican Americans aged 20 or older have diabetes This percentage more than doubles–to 24–among Mexican Americans aged 45 to 74 Approximately 50 of Arizonas Pima Indians between the ages of 30 and 64 have diabetes10 The increase in prevalence of diabetes is a big contributor to increased prescription medicine costs and even more important to total health care costs because the annual healthcare costs of treating a person with diabetes is more than 24 times that of treating a person without diabetes 13,243 versus 5,64211 Moreover,
Focus on Health Policy Spring 2003

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this increase is likely to continue because the Centers for Disease Control and Prevention CDC conservatively estimates that diabetes in the US will increase 165 by 205012

More, and Better, Medications are Now Available to Treat Diabetes
Before the discovery of insulin in 1921, everyone with type 1 diabetes died within 6 months to 2 years after diagnosis13 In 1921, Canadian researchers isolated a substance from a dogs pancreas, which they called insulin The first insulin used to treat people with diabetes was made from crudely purified pancreas glands from pigs and cattle Over the
years, insulin preparations steadily improved In 1982, human insulin produced in a laboratory through recombinant DNA technology entered the market Human insulin has largely taken the place of the earlier insulin Human insulin is available in several different forms, each for a specific use according to the needs of the patient Historically, regular insulin, which was the fastest-acting insulin available until recently, had to be given 30-45 minutes before a meal to allow insulin action to begin Further, regular insulin persisted in the bloodstream for several hours, increasing the risk of low blood sugar for many patients This action profile of regular insulin sometimes meant that if a person took the insulin too close to a meal, he or she would

be likely to have high blood sugar hyperglycemia an hour or two after eating, and low blood sugar hypoglycemia 3 to 6 hours after eating Hypoglycemia can cause a person to become nervous, shaky, confused, and dizzy Judgment can be impaired if blood sugar becomes too low, and a person can faint Seizures, coma, and possible neurological damage are also possible with hypoglycemia In 1996, the US Food and Drug Administration FDA approved the
first rapid-acting insulin analog, and a second such insulin was recently approved Rapid-action insulins work more like the bodys own insulin because of their quick action and ability to decrease blood sugar levels after meals The rapidacting insulins are designed to be taken just before, or immediately after, a meal Rapid-acting insulins begin working almost immediately–within 10 to 15 minutes–to help the body metabolize sugars in carbohydrates It peaks from 1 to 3 hours after injection, and essentially is gone from the body in roughly 4 hours This quick action means that the insulin is less likely to cause low blood sugar problems hours later In 2001, a long-acting analog of insulin with activity up to 24 hours was introduced This long-acting insulin is intended to provide a baseline amount of insulin throughout the day Until 1995, only one category of oral medicines was available to patients with type 2 diabetes This category of drugs, the sulfonylureas SU, was a major advance

The Accelerating Pace of Discovery in Diabetes Drug Treatments
1995-Present: FDA approves 5 new classes of oral drugs that allow for customized treatment and vastly improved control of blood glucose
levels 1995: oral biguanides; alpha-glucosidase inhibitors 1996: first rapid-acting insulin analog 1997: thiazolidinediones; meglitinides 2000: D-phenylalanine derivatives

1921: isolation of insulin from dog pancreas, allowing first-ever treatment of type 1 diabetes

1982: recombinant DNA technology used to produce human insulin

1920

1930

1940

1950

1960

1970

1980

1990

2000

1954: first oral drugs sulfonylureas become available to treat type 2 diabetes

1984: second generation oral drugs sulfonylureas become available to treat type 2 diabetes

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Diabetes and Pharmaceutical Spending: New Treatments, New Solutions

in treatment for type 2 diabetes because it was the first oral medicine that could be used to treat the disease Available in the United States since 1954, SU drugs stimulate the pancreas of a patient with type 2 diabetes to produce more insulin and remains an important part of diabetes treatment today14 Second generation SU drugs with fewer side effects have been developed and are used as monotherapy or as part of combination therapy with other types of diabetes pills and/or insulin Since 1995, five new classes of medicines have been introduced to treat
diabetes These new classes biguanides, alpha-glucosidase inhibitors, thiazolidinediones, meglitinides, and D-phenylalanine derivatives allow physicians to customize treatments and help individuals better manage and control their disease Keeping blood sugar levels as close to normal as possible is important in both type 1 and type 2 diabetes because, by preventing or slowing the progression of devastating complications, such as eye, kidney, and nerve damage, they result in improved clinical outcomes Having a variety of medications that treat diabetes in different ways gives individuals greater opportunities to control their disease and achieve better outcomes, including better quality of life Biguanides, approved by the FDA in 1995 for use in the United States, lower blood sugar levels by keeping the liver from making too much glucose, increasing glucose removal from the bloodstream by enhancing the sensitivity of muscle cells to insulin, and decreasing intestinal absorption of glucose Unlike the SU drugs, the biguanides do not directly increase insulin levels; therefore they cannot cause hypoglycemia Nor do these medicines promote obesity, high blood pressure, and abnormal blood
lipid levels, all of which are often observed in patients with insulin resistance Also, because biguanides have a different mechanism of action than SU drugs, medicines of this type can be used in combination with SUs to better control a persons blood sugar levels, and thus avoid or delay the progression of diabetes and its complications Alpha-glucosidase inhibitors, approved by the FDA in 1995, help to control blood sugar levels by

blocking the enzyme that digests starches into carbohydrates in the small intestine Slowing starch digestion makes it easier to avoid high levels of blood sugar after a meal These medicines can be used in combination with SUs to better control a persons blood sugar levels–the ultimate treatment goal in diabetes Thiazolidinediones, approved by the FDA in 1997, reduce the resistance to the actions of insulin in the muscle and other cells of patients with type 2 diabetes Making a persons cells more sensitive to insulin enables these cells to remove sugar from the blood more efficiently and to use it as a source of energy in cell function15 These medicines can be used in combination with SUs or biguanides because they work through a different mechanism
of action Meglitinides, the first of which was approved by the FDA in 1997, and D-phenylalanine derivatives, the first of which was approved by the FDA in 2000, are sometimes classified together as glitinides or non-SU secretagogues They act in a manner similar to the SU medicines in that they help the pancreas make more insulin in response to a meal However, unlike the SU medicines, they act very quickly and their peak insulin production effects occur about 1 hour after the pill is taken Thus the persons insulin levels peak with his or her blood glucose levels after a meal Medicines in these classes are structurally different than the SU medicines, so they can be taken by patients who are allergic to sulfa medicines They can also taken with a biguanide medicine to improve control of blood sugar levels Because these classes of medications have different mechanisms of action and side effects, combination therapy using more than one type of medicine to treat the condition can prevent patients from becoming hypoglycemic, as well as prevent the long-term effects of diabetes, such as cardiovascular problems, blindness, amputations, and kidney failure To facilitate this strategy, one
diabetes medication already available combines an SU with a biguanide

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Evolving Standards of Medical Care Emphasize Earlier and More Aggressive Treatment
Research has revealed much about the basic science and underlying mechanisms of diabetes, including the role of the liver and pancreas in glucose metabolism, issues of insulin resistance, and the effect of diabetes on multiple body systems As a result, medical standards for diagnosing, treating, and monitoring diabetes have changed significantly, with a resulting increase in spending for diabetes and related medications For example, in the late 1990s, the level of fasting blood glucose used for diagnosing diabetes was lowered from 140 mg/dl to 126 mg/dl because studies showed that patients with the higher fasting blood sugar levels were already developing the complications of diabetes when they were diagnosed16 Diagnosing patients earlier and providing them with appropriate medications can help regulate blood sugar levels and prevent or delay these complications The concept of early and aggressive action clearly applies to treatment as well as diagnosis During the 1990s, several key studies
demonstrated that lowering blood glucose levels in patients with diabetes significantly reduced the incidence of microvascular complications, such as eye disease and kidney failure For example, in the UK Prospective Diabetes Study UKPDS, whose results were published in 1998, the rate of microvascular complications were decreased by 25 in patients with type 2 diabetes who were treated intensively with a sulfonylurea, metformin, or insulin compared with patients on conventional diet therapy17,18 As this study concluded, Until recently, many patients have fallen short of these treatment goals because of a variety of factors, including lack of adherence and understanding of both patients and physicians New therapeutic options are now available, and aggressive intervention may prevent or delay the onset of microvascular and macrovascular complications, including coronary heart disease, stroke, and peripheral vascular disease among others19 Although the intensive management of diabetes, which is neces6
Diabetes and Pharmaceutical Spending: New Treatments, New Solutions

sary to achieve tighter blood glucose control, is associated with higher up front costs, the investment has been shown
to be effective in reducing morbidity and mortality, as well as minimizing later expenditures for the most costly long-term complications20 In addition to controlling blood sugar levels, ways to reduce the risk of type 2 diabetes complications include controlling cholesterol level and blood pressure through diet and/or medication, smoking cessation, maintaining an appropriate weight, and exercising regularly Diet and exercise also have been shown to reduce the risk of developing type 2 diabetes in people with impaired glucose tolerance An oral medicine from the biguanide class has been found to help reduce the risk of developing type 2 diabetes21 Science has also improved our methods for monitoring diabetes in patients, allowing for adjustment of medications when necessary For example, a blood test developed in the 1970s measures the percentage of a patients hemoglobin that has glucose attached to it glycosylated hemoglobin or HbA1c This test has been shown to track a persons long-term blood sugar levels and, more importantly, the potential risk of developing diabetes complications Thus, the HbA1c level is very useful in assessing the adequacy of a patients treatment program and as
a tool for adjusting medication dosages The goal for a person with diabetes is to have an HbA1c level of less than 657 Any level about 7 indicates that changes in the patients treatment should be considered These changes can include increasing the dosage of medicines, changing medicine, or adding additional medicines in addition to revisiting the weight, diet and exercise components of the patients treatment plan

Treating Co-existing Illnesses is a Growing Component of Diabetes Care
Researchers and physicians have come to appreciate the importance of controlling other chronic conditions, principally high blood pressure and high lipid levels, that often occur in tandem with diabetes as an integral

Institute of Medicine Report Supports Early, Aggressive Diabetes Treatment
The health consequences of not treating diabetes early are grave According to the American Diabetes Association, 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 On January 7, 2003, the Institute of Medicine IOM issued
a report urging the Department of Health and Human Services and other public and private stakeholders to focus on 20 priority areas to improve health-care quality and delivery for all Americans22 One of the 20 priority areas identified by the IOM was appropriate treatment of diabetes According to the IOM report, the aim is to prevent the progression of diabetes through vigilant, systematic management of patients who are newly diagnosed or at a stage in their disease prior to the development of major complications23 According to the IOM report, outcomes from the Diabetes Control and Complications Trial confirmed that lowering blood glucose levels slows or prevents complications arising from type 1 diabetes Individuals in the group receiving intensive therapy with three or more insulin injections per day or who used an insulin pump, and who monitored their blood glucose levels four or more times a day, experienced approximately a 60 reduction in risk for eye disease, kidney disease, and neurological disease as compared with standard treatment group The lifetime benefit of such intensive therapy could result in approximately 8 years of additional sight, 6 years free from end-stage
renal disease, and 6 years deferral of lower-extremity amputation relative to conventional therapy24

should significantly decrease risk for both microvascular and macrovascular complications26 Of course, medicines also are available to treat a variety of diabetes complications when they occur, such as neuropathy diabetic nerve disease, kidney disease, and erectile dysfunction

Cost Management and Outreach Strategies Increase Short-term Costs But Yield Better Results for Patients and Lower Overall Costs
Disease management has played an important role in early diabetes treatment, and these programs continue to gain in popularity as providers try to contain health care costs27 For example, a comprehensive disease management program for approximately 7,000 diabetes patients in seven managed care organizations produced savings of 50 per diabetic member per month 123 [Figure 2] Although pharmaceutical costs increased under the program, total health care spending declined The largest decrease in costs for people with diabetes was attributable to the reduction in inpatient hospitalizations and bed days Hospital admissions per 1,000 diabetic member years decreased by 18 and bed days fell
by 2128 Thus, cost management strategies may contribute to increased spending on medicines for patients with diabetes, but they result in decreased overall healthcare spending A second aspect of this issue is that despite advances in pharmaceutical and clinical care for diabetes, one-third of people in the US with the disease are not currently diagnosed, and 58 of those who are diagnosed are not receiving adequate treatment Increased outreach to diagnose people with diabetes would likely result in significantly increased spending on prescription medicines However, it would also clearly improve the quality of their healthcare and of their lives while reducing longterm spending in other components of the healthcare system People with diabetes who are untreated or undertreated are at risk for more rapid disease progression, and their overall healthcare costs are higher than
Focus on Health Policy Spring 2003

component of diabetes management25 These conditions are frequently managed with medications Home glucose monitoring and newer drugs for type 2 diabetes and associated conditions are now allowing many patients to achieve and maintain acceptable blood sugar levels, blood pressure,
and lipid levels, which

7

Figure 2: Overall Savings of 50 Per Diabetic Per Month in Disease Management Program for 7,000 Diabetic Patients in 7 Managed Care Organizations
450 400 350 300 250 200 150 100 50 0 Total Inpatient Outpatient Physician RX Drugs Other

Baseline Before Start of Disease Management Program Follow-Up After Start of Disease Management Program

Source: RJ Rubin, KA Dietrich, and AD Hawk, Clinical and Economic Impact of Implementing a Comprehensive Diabetes Management Program in Managed Care, Journal of Clinical Endocrinology and Metabolism 83 1998: 8, 26352642

those who receive adequate treatment29 A random sample of 733 patients with diabetes showed that more than half 58 had HbA1c of greater than 7 Another study of 3,017 type 2 diabetes patients showed that each percentage point of HbA1c over 6 increased medical care costs for these patients, by 4, 10, 20, and 3030

Experimental pharmaceutical treatments for diabetes that work through new mechanisms of actions also are being developed In fact, 24 new medicines are in development for diabetes today31 Some of the new experimental pharmaceutical treatments include: a compound that mimics the effects of a
natural cohormone by working along with insulin to control blood glucose levels; a protein to promote increased insulin secretion when blood glucose levels are high, but not when they are normal; inhaled forms of insulin that would not require injections; a compound that may modify the metabolism of fat cells and thus help treat diabetes-related obesity; dual-acting sensitizers that increase muscle cell uptake of blood sugar and inhibit the livers production of blood sugars, as well as reduce blood lipid levels; and drugs that are designed to lessen diabetic nerve disease and complications involving small blood vessels, such as those in the eye or kidney

Future Options for Treating Diabetes
The ultimate cure for diabetes would be to give someone with diabetes a new pancreas either a biological transplant from a donor or derived from a patients own stem cells or a mechanical device that would mimic the pancreas normal release of insulin in response to rising blood sugar levels Both of these options are being pursued and researchers have recently made some promising advances in transplanting pancreatic cells, but widespread availability of either option is not on the immediate
horizon

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Diabetes and Pharmaceutical Spending: New Treatments, New Solutions

Conclusion
In sum, we have increased spending on pharmaceuticals to treat diabetes because new medicines offer a real solution to a serious disease Without the emergence of these new treatments, as well as new technologies to diagnose and monitor diabetes, the disease and its related complications would take a far higher toll on the health of Americans As the number of people with diabetes continues to climb, and as physicians increasingly recognize the important role of pharmaceuticals in treating the disease, these trends can be expected to continue

Recent experiences in disease management point to the role that new medicines will play in meeting the growing challenge of diabetes The dollars we spend on more aggressive diagnosis, monitoring, and treatment return better outcomes and lower overall costs Increased investment in new medicines for diabetes is a positive trend that gives people with diabetes longer, better lives and enables us as a society to focus on other important health care needs rather than paying for more kidney transplants, amputations, and services for the blind

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Policy Spring 2003

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Notes
1

16

IMS Health, based on custom analysis of Retail and Provider PerspectiveTM data, 3/2003 1992 data include sales through chain, independent, and food stores, mass merchandisers, non-federal hospitals, clinics, long-term care, federal facilities, and HMO staff model 2002 data include, in addition to above, sales through mail service, home health care, and miscellaneous channels American Diabetes Association, Economic Costs of Diabetes in the US in 2002, Diabetes Care 26 March 2003: 3
3 2

Normal fasting blood glucose levels in non-diabetics is 70-110mg/dl This measurement is typically taken in the morning before the patient has had anything to eat or drink Diagnosis of diabetes can be made based upon two fasting blood glucose levels greater than 126mg/dl, two random blood glucose levels of greater than 200mg/dl in a patient who has symptoms indicating diabetes, or a positive glucose tolerance test where a patients blood glucose level is greater than 200mg/dl after swallowing a 75 gram dose of glucose
17

American Diabetes Association and the National Pharmaceutical Council, A Closer Look at Diabetes, http://wwwnpcnoworg/issues_productlist/PDF/
DiabetesWebpdf 7 March 2003
4 5 6

UK Prospective Diabetes Study UKPDS Group, Intensive blood-glucose control with sulfonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes, Lancet 352 1998:837-853
18

Ibid Ibid

UK Prospective Diabetes Study UKPDS Group, Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes, British Medical Journal 17 1998:703-713
19 20

Ibid

Terrance Killiea, Long-term consequences of Type 2 Diabetes Mellitus, The American Journal of Managed Care 8 October 2002: 16 suppl
7

American Diabetes Association and the National Pharmaceutical Council, op cit
8 9

The American Association of Clinical Endocrinologists, Medical Guidelines for the Management of Diabetes Mellitus: The AACE System of Intensive Diabetes SelfManagement, 2002 Update, accessed May 12, 2003 at: http://wwwaacecom/clin/guidelines/diabetes_2002pdf
21

American Diabetes Association, wwwdiabetesorg American Diabetes Association, Economic Costs, op cit

National Institute of Diabetes and Digestive and Kidney Diseases, Diabetes Prevention Program, op cit
22

10

National Institute of
Diabetes and Digestive and Kidney Diseases, National Report Says Minorities Hard Hit by Diabetes: National Diabetes Education Program Responds, press release, January 25, 2000
11 12

Institute of Medicine Priority Areas for National Action: Transforming Health Care Quality, 2003 wwwiomedu 1 May 2003
23 24 25

Ibid Ibid

American Diabetes Association, Economic Costs, op cit

American Diabetes Association and the National Pharmaceutical Council, op cit
13

National Institute of Diabetes and Digestive and Kidney Diseases, Diabetes Prevention Program http://www niddknihgov/health/diabetes/summary/dpp/dpphtm 19 March 2003
14

Collins, Francis, M, Current Treatment Approaches to Type 2 Diabetes Mellitus: Success and Shortcomings, The American Journal of Managed Care, 8 October 2002: 16 suppl
26 27

Ibid

Silvio Inzucchi, Oral Antihyperglycemic Therapy for Type 2 Diabetes, Journal of the American Medical Association 287 16 January 2002: 3
15

National Pharmaceutical Council, Disease Management: Balancing Cost and Quality Studies on the Benefits of Disease Management Services for the Treatment of Diabetes, Reston, VA: NPC, October 2001
28

National Institute of Diabetes and Digestive and
Kidney Diseases, Medicines for People with Diabetes, www niddknihgov/health/diabetes/pubs/med/specifichtm 27 February 2003

Robert Rubin, Kimberly Dietrich, and Anne Hawk, Clinical and Economic Impact of Implementing a Comprehensive Diabetes Management Program in Managed Care, Journal of Clinical Endocrinology and Metabolism 83 1998: 2635-2642

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Diabetes and Pharmaceutical Spending: New Treatments, New Solutions

29

L Takiya and S Chawla, Therapeutic Options for the Management of Type 2 Diabetes Mellitus, The American Journal of Managed Care 8 November 2002: 10091023
30 31

Ibid

Pharmaceutical Research and Manufacturers of America, New Medicines in Development wwwphrmaorg/ newmedicines 1 May 2003

Focus on Health Policy Spring 2003

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Pharmaceutical Research and Manufacturers of America 1100 Fifteenth Street, NW Washington, DC 20005 wwwphrmaorg

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