Health Care and the Growing Burdens of Diabetic Care - By E.J. Leavitt

Health Care and the Growing Burdens of Diabetic Care

Introduction:

In recent news, there have been reports of sharp criticisms against Mylan, Inc. in regards to the heavily increased prices of their EpiPen over the last eight years. The EpiPen is an auto-injector syringe that is pre-loaded with epinephrine to stem anaphylactic reactions, which often result from bee sting, nut, and other allergies. Many families and children require a form of epinephrine auto injector to be held nearby in case of emergencies, and are generally prescribed EpiPens for that purpose. Mylan has allegedly increased the price of their EpiPen from $100 for a pack of two syringes to about $608 per pack (Mole 2016). Undoubtedly, these prices provide an extremely heavy financial burden for families and individuals who need the product for times of need. However, despite the controversy and struggle surrounding Mylan and the EpiPen, it is merely a small example of the burdening cost of treating a common condition (i.e. severe allergies) and that big changes are very much needed. There are other life-saving medical products that have also been subject to worrisome price-hikes, such as one product in particular that treats a pervasive disease: insulin.

            Insulin is a hormone that is secreted by beta cells within the pancreas when blood glucose levels increase. Once released from the beta cells, the hormone molecules attach to insulin receptors that initiate pathways to absorb and metabolize glucose and process the energy that can be harvested from it. Without the proper release of insulin, blood sugar levels can rise until the affected individual becomes hyperglycemic. If left untreated, serious consequences may occur such as a coma or death. In fact, more than 4.2 million individuals in the U.S. are hospitalized for diabetes-related hyperglycemia (Leventan 2000). Therefore, it is a required, life-saving, and life-maintaining drug for Type I diabetics whose bodies have rid of their pancreatic beta cells and their ability to produce insulin, and also for Type II diabetics whose bodies have become resistant to insulin and need extra amounts of it to maintain glucose levels (American Diabetes Association, 2013).

The use of extracted insulin as a drug began after its discovery in 1921 when Sir Frederick Grant Banting and Charles Herbert Best performed experiments on diabetic dogs, extracting and administering purified bovine insulin with the aid of John MacLeod and James Collip (Banting and Macleod won a Nobel Prize in Physiology or Medicine during the following year (Discovery, 2016). Since then, the drug has undergone several improvements in extraction and purification techniques, and is a staple for diabetic treatment. Because of the need that diabetics nationwide have for insulin, there is also a secure market for the production and sale of exogenous insulin.

Rising Cost of Insulin:

Various forms of insulin are sold by several companies, but the pricing of insulin has been a growing controversial topic. In a study published in the Journal of the American Medical Association, researchers found that between 2002 and 2013 the mean price of insulin increased from $4.34 to $12.92, which nearly represents a 300% rise in costs (Hua et al. 2016). This translates to a change from $231 in 2002 to $736 in 2013 per individual in mean yearly expenses. These costs escalate further when they are added to other diabetes-related medical expenses (e.g. hospital visits, syringes, pumps, etc.; Silverman 2016).

It is noted in the JAMA study that the rate by which the insulin prices have increased far surpass that of oral medications. However, what is causing the insulin prices to rise, even after all of the years that it has been medically known? A general pricing trend with new drugs is that the developers of a medication earn a patent, which gives them sole protection to raise prices for several year, serving as a prize for developing a new drug. After the patent expires, generic forms of the same drug can be made by other companies. These generic products can then be sold at a lower price, which in turn competes with the original producers, leading them to also lower their prices.

Although many medications drop in price after a generic form is introduced to the market, insulin has not followed that trend, even though it has been available as a medication (in various forms) for nearly 100 years. One reason that a generic form of insulin has not come to the market – according to Dr. Lutz Heinemann, Ph.D. of Science & Co. – is that gradually improved insulin products have been patented and released to consumers. As insulin medications have been improved, the newer products have been deemed to be more effective and safer than their predecessors (Lutz 2016). It has been questioned whether these incrementally improved insulin products are worth the higher prices, but they continue to be approved, closing the door for the entry of generic insulin.

There are additional factors that contribute to insulin’s inability to be introduced in generic form or to drop in price. For example, the lack of transparency between countries concerning the price of insulin has made it difficult to compare prices and form a competitive global market. A detail that compounds this problem is that pharmacies and health care providers do not necessarily charge the “official price” of an insulin product, as there generally is not one given for them (Lutz 2016). Therefore, there is more price obscurity and less pressure for companies to lower prices.

Nevertheless, there is a recent development that may indirectly lower the price of insulin. Biosimilars, which are approved versions of already existing drugs that have lost their former patent protection, have been in development in the insulin industry. A biosimilar insulin (BioIns) is expected to be released in the European market, and eventually to the American market if it is approved (Lutz 2016). When biosimilar drugs are released, the prices of similar drugs usually drop. However, whether or not a BioIns will cause a drop in insulin prices is still in question.

Small exceptions to price hikes have occurred that demonstrated some effectiveness in maintaining lower prices. There is a form of insulin called Lantus that is a longer-acting formulation of insulin relative to other products. It is marked by Sanofi, and in 2015 the company reportedly experienced some pushback from insurers that caused Lantus’ unit cost to fall by nearly 14% (Silverman 2016). Many patients are able to have their insurers pay for a portion or the whole cost of their insulin medications, so if insurance companies largely backlash against insulin manufacturers by request and by refusing to cover their products, then some companies may concede to lower product prices.

Effect of Costs for Individuals

Medical costs related to diabetes dramatically affect the lives of those with the disease compared to those who do not have diabetes. Financially, the average diabetic pays much more in medical costs compared to those without diabetes. In a data analysis performed by Xiaohui Zhuo et al., the lifetime medical expenditures of an average individual were estimated across several age categories. The team found that those diagnosed with diabetes at age 40 will spend about $124,600 to $211,400 more than non-diabetic individuals throughout the rest of their lifetime on medical costs (Zhuo et al. 2014). This estimate of excess expenditures decreases as the individual is diagnosed later in life, and increases if one is diagnosed early in life (which is often the case for type I diabetics).

Effects of Costs Nationwide:

            Diabetes incurs a dramatic cost and effect on the economy nationwide. Over 22.3 million U.S. individuals have diabetes, and the American Diabetic Association (ADA) estimated that overall health care expenditures in 2012 amounted to approximately $1.3 trillion nationwide. Of this estimate, the cost of diabetes accounts for about 23% of that amount at $306 billion. Total medical expenditures are not the only factor of diabetes that affects the nation. There are also lost work hours and productivity that come as a consequence of individuals having diabetes. Additional health care resources are also consumed – the ADA found that about a third of the days in nursing and residential facilities are filled by diabetics, and half of those days are related to diabetic conditions (2013).

            Nationally, the overall expenditure on insulin is small relative to all of the other medical costs incurred by diabetic patients and the national economy. It has been estimated by the ADA that costs to insulin and other diabetic medications account for about 28% of the total national health expenditure on diabetes (2013). However, if insulin prices are reduced, this could lead to positive results for individuals and across the nation. For instance, it has been found that less than 50% of type II diabetics achieve the recommended glycemic goals given by their caregivers (Garcia-Perez et al. 2013). It is likely that some of the individuals in this group would be encouraged to achieve their goals if the price of insulin was lowered. If a significant portion of these individuals were able to maintain and care for their diabetic conditions with the aid of lowered prices, then further medical expenses resulting from poor maintenance could be avoided.

Conclusion:

            There is much at stake and much that can be done regarding the price and availability of insulin and diabetic treatments. However, while the problems at hand are relatively complex, creative policies can be made in hand with good communication to lower the prices of insulin medications nationwide. The availability of generic insulin, the development of BioIns, and the regulation of prices by legislation and by insurers can all contribute to more affordable care for diabetics. Hopefully significant changes and improvements can be sought and made in the next several years to come.

References:

American Diabetes Association. 2013. Economic costs of diabetes in the U.S. in 2012. Diabetes Care 36: 1033-1046.

Garcia-Perez, L. E., Alvarez, M., Dilla, T., Gil-Guillen, V., and Orozco-Beltran, D. 2013. Adherence to therapies in patients with type 2 diabetes. Diabetes Therapy 4: 175-194

Heinemann, Lutz. 2016. Biosimilar insulin and costs: what can we expect? Journal of Diabetes   Science and Technology 10: 457-462

Hua, X., Carvalho, N., Tew, M., Huang, E. S., Herman, W. H., and Clarke, P. 2016. Expenditures and prices of antihyperglycemic medications in the United States: 2002-2013. Journal of the American Medical Association 315: 1400-1402.

Mole, Beth. EpiPen maker CEO to seething lawmakers: We’re doing the world a favor. (2016, September 22). Retrieved September 22, 2016, from http://arstechnica.com/science/2016/09/epipen-maker-ceo-to-seething-lawmakers-were-doing-the-world-a-favor/

Levetan, Claresa. 2000. Controlling hyperglycemia in the hospital: a matter of life and death. Clinical Diabetes 18(1). Retrieved September 22, 2016 from http://journal.diabetes.org/clinicaldiabetes/v18n12000/Pg17.htm

Silverman, Ed. 2016. What’s behind skyrocketing insulin prices? PBS Newshour. Retrieved September 23, 2016 from http://www.pbs.org/newshour/rundown/whats-behind-skyrocketing-insulin-prices/ 

The Discovery of Insulin. 2009. Nobelprize.org. Retrieved September 22, 2016 from https://www.nobelprize.org/educational/medicine/insulin/discovery-insulin.html

Type 2. 2016. American Diabetes Association. Retrieved September 22, 2016 from http://www.diabetes.org/diabetes-basics/type-2/

Zhuo, X., Zhang, P., Barker, L., Albright, A., Thompson, T. J., and Gregg, E. 2014. The lifetime cost of diabetes and its implications for diabetes prevention. Diabetes Care 37:2557-2564