Edmund J. Pezalla, MD, MPH

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Drug developers and manufacturers often refer to the unmet need of patients when they introduce new products, but what is unmet need and how do we assess it? One way to address this issue is to refer to public health agency reports on causes of mortality and morbidity. Another is to ask what benefits a treatment can confer on patients and others.

 in the U.S., according to the CDC. However, this does not tell the whole story.

Diabetes contributes significantly to cardiovascular disease and stroke (the first and fourth leading causes of death) and to disability due to kidney and neurologic disease and blindness, as well as vascular insufficiency and amputation.

There can also be unmet needs for people with rare disorders or uncommon severe versions of common disorders. Diabetes is a case in point. Many type 2 diabetes patients do reasonably well when they are prescribed and take their medications to control glucose, blood pressure, and lipids. Many patients with type 1 do well with continuous insulin infusions or multiple injections.

However, there are still other patients who suffer the long-term consequences of diabetes. This unmet need is the result of system, scientific and personal issues.

 include the high rate of underdiagnosis (

which we have discussed in this column before

), and the failure to prescribe or follow up on necessary medications. Other system issues go beyond healthcare provision to public health and socioeconomic concerns that impact diet, physical activity and mental health. The 

, such as difficulty paying for healthcare and problems implementing life style changes or adhering to medication are also important, and must be accommodated and supported if we are to make further improvements in diabetes outcomes.

 are another matter. The science-based approach to diabetes follows several broad arcs that are dependent on developments in science and engineering:

1. Basic research has been responsible for the discovery of insulin, and the complex interplay of hormones and external signals that are involved in glucose, fat and related metabolism;

2. Development of specific medications for controlling glucose, blood pressure and lipids has contributed significantly to improved longevity and reduced morbidity for people with diabetes. Drug discovery is dependent on science and also on a bit of luck; and

3. Creation of devices such as pumps and monitors has grown along with developments in computing and materials science. Science tends to move at its own pace and is not linear.

Insulin was first injected into a patient with diabetes in 1922 but sulfonylurea based medications were not discovered until 1942. Metformin was first described in 1922. Two other biguanide medications were developed but with drawn from the market. Metformin was not approved until 1972.

Recently, one pharmaceutical company ended the 

 for a new basal insulin based on insulin lispro instead of insulin glargine. Peglispro was unique in that it targeted impacted liver glucose metabolism and transport more than muscle glucose activity. This property, which could have proved valuable through reduction in hypoglycemic episodes, eventually proved the undoing of the drug because it led to increasing fat deposits in the liver.

This illustrates both the complexity of glucose metabolism, but also the difficulty in developing drugs with new mechanisms of action or new, and perhaps desirable, properties.

Over the past several years a handful of new drugs, many in the same class, have been approved for use in diabetes (see graph). The most recent additions have been in the SGLT-2 inhibitor class, which not only have a novel mechanism of action (glucose wasting in the kidney) but which are 

 in the treatment of diabetic patients with advanced heart disease.

Although the pipeline is not large, we continue to have progress in meeting needs of patients with diabetes. Over time, we can hope to see new drugs that are easier to use, have fewer side effects, and help to reduce complications over time.

In the meantime, screening, diagnosis, appropriate prescribing, and patient adherence to medication, diet and activity regimens will continue to help many patients with diabetes live a long and healthy life.

Edmund Pezalla, MD, MPH, is vice president and national medical director for pharmaceutical policy and strategy, Aetna. 

Articles

Although the diabetes pipeline is not large, we continue to have progress in meeting the unmet needs of patients with diabetes.

Put drug development to work for diabetic patients

An immediate issue, and one of tremendous importance, is the under diagnosis of diabetes. A recent estimate from the National Diabetes Statistics Report puts the number of undiagnosed diabetics in the U.S. at 

People who are unaware they have diabetes are at risk for progression to the serious complications of high blood sugar such as cardiovascular and renal disease. There are few publications on the causes of under diagnosis. However, we can postulate that they fall into three general groupings:

2) Failure to obtain screening for diabetes;

3) Inaction on the part of patients who screen positive but do not follow up, or do not understand that they have diabetes.

Access to care, as measured by those with insurance coverage, has clearly improved with the implementation of insurance exchanges and Medicaid expansion under the Affordable Care Act. However, it is not yet clear how many people are actually seeing primary care and other physicians for check ups and screenings.

Failure to obtain screening is directly related to access to care, but also to what happens during encounters with the healthcare system. If a patient’s encounters primarily consist of emergency or acute care visits, that patient will not likely receive screening for diabetes, breast cancer, colon cancer or a range of other conditions. Even within the context of a primary care visit it is unclear how many Americans receive appropriate screening.

In a positive step, the U.S. Preventive Services Task Force  has 

 for overweight/obese adults ages 40 to 70. However, the impact of this screening recommendation on the number of undiagnosed persons is currently unknown.

It is also possible that some patients who screen positive do not follow up on the screening. This may be because of a misunderstanding of what the results mean, or fear of what comes next. In any case, this is clearly a failure of our healthcare system and of our efforts to improve health literacy in the U.S.

There are positive steps that we can take to reduce the number of undiagnosed people.

Encourage preventive service visits with healthcare providers.

 Most people with health insurance can receive screenings and other preventive services covered at first dollar with no or low copays.

, especially in those at risk for developing Type 2 diabetes (overweight or obese adults over age 45, those who do not regularly exercise three times per week, or women who have had gestational diabetes).

Increase awareness of the serious problems caused by diabetes

 on the detection and treatment of pre-diabetes.

In conclusion, we need to take a patient centric view of diabetes prevention and treatment that includes increased opportunities for screening and an increased focus on prevention via diet and exercise.

Consequences range from cardiovascular disease to renal disease

Undiagnosed diabetes: A high cost for the health system

Diabetes is a prevalent and costly condition. In this essay I will put it into perspective in terms of contribution to overall health expenditures and to the entire U.S. economy. Considering the amount of money spent on diabetes, there is an opportunity for healthcare providers to assume more responsibility and receive more rewards for the care of people with diabetes.  

recently published an article on projected healthcare expenditures through 2024. Important projections include a further shift toward government payment through Medicare and Medicaid, and an increase in the percentage of Gross Domestic Product (GDP) devoted to healthcare from 

 Total expenditures are expected to top $5.4 trillion.

Although no disease specific projections were included, we can estimate the impact that diabetes will have on overall cost based on the American Diabetes Association Scientific Statement from 2012. In the 2012 report the estimated direct cost of diabetes care was 

If we apply a 4% growth rate (consistent with the 

 report) that $176 billion will have grown to over $197 billion and likely is over $200 billion for 2015. If diabetes expenses grow at the same rate as overall costs, we can expect diabetes healthcare to consume 1.2% of the GDP by 2024. This is equivalent to the percentage of GDP attributed to agriculture and fisheries.

These numbers are big enough to make us pause and think. Spending on healthcare can be good-higher expenditures on cancer care are linked to better outcomes-but in the case of diabetes, more spending likely means worsening outcomes.

More people with significant end organ involvement are suffering complications of therapy such as hypoglycemia. Approximately one-third of nursing home and residential facility days are used by people with diabetes. And diabetic patients use 43 million bed days per year in acute-care hospitals.

There are clearly things we can do to lower costs and improve care. Forty three percent of expenditures attributed to diabetes are for hospital inpatient stays while only 8% of expenditures are for physician office visits and 18% of expenditures are for medications. Surely we can shift the balance away from rescue and problem solving to proactive intervention and preventing or delaying disease progression.

With diabetes becoming a significant portion of the national economy, it should also become a focus for investment. Over 59% of diabetes patients and a much larger portion of diabetic costs are born by Medicare and Medicaid. This should make diabetes a national priority. But, we should not wait for federal action.

Diabetes services, medications and labs are all covered by both commercial and government health plans. Providers, and in particular those providers who are accepting risk through value-based arrangements should be organizing to manage the care of these patients in a patient-centered and evidence-based manner. This is a huge opportunity for providers who must transition from fee-for-service and bed days to population health and outpatient care.

There is a lot of technology available to help people who have diabetes. This ranges from new pharmaceuticals to devices to mobile apps. No one of these items will cure or fix our diabetes problem. However, using a combination of these in a thoughtful way and in the context of basic good medical care can make a difference. The real problem is not lack of funding (we pay plenty for diabetes care) or lack of technology, but lack of organization and focusing on what really matters before the patient progresses to hospitalization.

 Diabetes Health Management topic resource center. Pezalla is vice president and national medical director for pharmaceutical policy and strategy, Aetna. 

Spending on healthcare can be good, but in the case of diabetes, more spending likely means worsening outcomes.

Author | Edmund J. Pezalla, MD, MPH

Articles

Put drug development to work for diabetic patients

Undiagnosed diabetes: A high cost for the health system

Diabetes cost projections raise alarm bells