JAMA: Human Insulin for Type 2 Diabetes: An Effective, Less-Expensive Option

Affordability of insulin has become a major issue for patients with diabetes in the United States. The price of insulin, particularly insulin analogues, has increased substantially over the past 2 decades. Pharmacy prices for 1 vial of glargine or detemir (long-acting insulin analogues) or 1 vial of lispro or aspart (short-acting insulin analogues) now exceed $170. Prefilled pen injectors are even more expensive. Insurance may cover some of the cost, but the burden is increasingly shifting to patients in the form of higher premiums and copayments. As a result, insulin analogues are not feasible for many uninsured or underinsured patients.

Kasia Lipska, MD, Irl Hirsch, MD, Matthew Riddle, MD

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Journal of Diabetes Science and Technology: If PBMs Guard Access to Drugs, Then Quis Custodiet Ipsos Custodies? (Who Will Guard the Guardians?)

Insulin prices in the United States have risen dramatically in recent years, yet pharmacies cannot provide a stable price for a given insulin due to factors that are not widely understood.

This commentary discusses the complex and obscure factors that drive today’s insulin prices with a discussion of the other players, besides the insulin manufacturer, who benefit from higher prices. An open discussion is critical regarding this drug and others that are essential to the lives of millions of people with diabetes. We’ll also explore whether the market introduction of biosimilar insulin will impact insulin prices.

Alan W. Carter, PharmD, Lutz Heinemann, PhD

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JAMA: The High Cost of Prescription Drugs in the United States: Origins and Prospects for Reform

IMPORTANCE The increasing cost of prescription drugs in the United States has become a source of concern for patients, prescribers, payers, and policy makers.

OBJECTIVES To review the origins and effects of high drug prices in the US market and to consider policy options that could contain the cost of prescription drugs.

EVIDENCE We reviewed the peer-reviewed medical and health policy literature from January 2005 to July 2016 for articles addressing the sources of drug prices in the United States, the justifications and consequences of high prices, and possible solutions.

FINDINGS Per capita prescription drug spending in the United States exceeds that in all other countries, largely driven by brand-name drug prices that have been increasing in recent years at rates far beyond the consumer price index.

In 2013, per capita spending on prescription drugs was $858 compared with an average of $400 for 19 other industrialized nations. In the United States, prescription medications now comprise an estimated 17% of overall personal health care services.

 

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Diabetes Obesity and Metabolism: Interchangeability Among Reference Insulin Analogues and Their Biosimilars: Regulatory Framework, Study Design and Clinical Implications

Biosimilars are regulated differently from small‐molecule generic, chemically derived medicines. The complexity of biological products means that small changes in manufacturing or formulation may result in changes in efficacy and safety of the final product. In the face of this complexity, the regulatory landscape for biosimilars continues to evolve, and global harmonization regarding requirements is currently lacking. It is essential that clinicians and patients are reassured that biosimilars are equally safe and effective as their reference product, and this is particularly important when interchangeability, defined as ‘changing one medicine for another one which is expected to achieve the same clinical effect in a given clinical setting in any one patient’, is considered. Although the automatic substitution (i.e. substitution without input from the prescribing healthcare provider) of biosimilars for reference products is currently not permitted by the majority of countries, this may change in the future. In order to demonstrate interchangeability between reference products and a biosimilar, more stringent and specific studies of the safety and efficacy of biosimilars are likely to be needed; however, guidance on the design of and the need for any such studies is currently limited. The present article provides an overview of the current regulatory framework around the demonstration of interchangeability with biosimilars, with a specific focus on biosimilar insulin analogues, and details experiences with other biosimilar products. In addition, designs for studies to evaluate interchangeability with a biosimilar insulin analogue product are proposed and a discussion about the implications of interchangeability in clinical practice is included.

H.A. Dowlat, M.K, Kuhlmann, H Khatami, F.J. Ampudia-Blasco

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Diabetes Spectrum: Insulin in America: A Right or a Privilege?

By: Irl B. Hirsch, University of Washington School of Medicine

Even as a medical student, I was interested in the history of insulin. As an endocrine fellow, I read The Discovery of Insulin by Michael Bliss. It is a book anyone interested in diabetes should read, as life before insulin is difficult to appreciate by today’s standard of care, at least in the United States. Amazing stories of what people did to obtain insulin are plentiful, perhaps none more dramatic than Eva Saxl’s story, with her husband making insulin in Shanghai, China, for the more than 200 Jews who escaped Nazi persecution during World War II.

But in the United States, access to insulin had never been a problem. As a medication required for survival by 10% of those with diabetes, it was always available, although for decades quite crude by today’s standards. The insulin patent from the University of Toronto was sold for $1 with the understanding that cheap insulin would become available. Through the years, insulin remained affordable. Even with the introduction of human insulin in 1982 ($14 per vial) and then insulin analogs in 1996 ($24 per vial), the increases in insulin pricing did not seem to be a concern. At least in the United States, the vast majority of patients requiring insulin had access to all of the insulin analogs as they were developed.

As the years passed, the cost of insulin continued to increase.

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JAMA: Expenditures and Prices of Antihyperglycemic Medications in the United States: 2002-2013

A recent study demonstrated widespread substitution of analog for human insulin and rising out-of-pocket costs in privately insured people with type 2 diabetes in the United States. Medicaid reimbursements have increased for both human insulin and more costly analog insulins. Although studies have described per-person changes in excess medical spending of US adults with diabetes on prescription medications, they have not reported trends in expenditures for different classes of antihyperglycemic medications that simultaneously consider changes in use and price.

DISCUSSION Based on a nationally representative survey, the mean price of insulin increased from $4.34 per milliliter in 2002 to $12.92 in 2013.

The estimated expenditure per patient for insulin in the United States in 2013 was greater than all other antihyperglycemic medications combined.

Another factor contributing to the rise in expenditures on insulin was increased treatment intensity.

Xinyang Hua, MSc; Natalie Carvalho, PhD; Michelle Tew, MPH; et al

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The Lancet Diabetes & Endocrinology: Constraints and challenges in access to insulin: a global perspective

Substantial attention has been given to the issue of access to medicines for communicable diseases; however, access to essential medicines for diabetes, especially insulin, has had insufficient focus. Although insulin was discovered in 1921, the drug is unattainable to many globally, and this Review aims to highlight the range and complexity of factors that contribute to this unattainability. Manufacturers’ selling prices of various insulin formulations and presentations, duties, taxes, mark-ups, and other supply chain costs affect the price of insulin and hence the drug’s affordability to health systems and individuals. Unlike drugs for HIV and AIDS, the production of generic or biosimilar insulin has not had an effect on the overall market. Other factors contributing to poor availability of insulin include its quantification at the national level, in-country distribution, and determination of needs at lower levels of the health system. Although insulin is essential for the survival of people with type 1 diabetes and is needed for improved management of diabetes for some people with type 2 diabetes, very little has been done globally to address the issue of access, despite the UN’s political commitment to address non-communicable diseases and ensure universal access to drugs for these disorders.

David Beran, PhD, Margaret Ewen, Richard Laing, MD

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The Lancet: Evolution of insulin patents and market exclusivities in the USA

The cost of management of complications from diabetes in the USA amounted to US$263 billion (about £171 billion) in 2013, up from $92 billion (about £60 billion) in 2002. More than half of the growth in the costs of diabetes care can be attributed to prescription drugs such as insulin, the price of which has increased at alarming rates for both patients and insurers.

Using state Medicaid data, we recently noted that inflation-adjusted expenditures have increased on a per-unit basis for all commercially available insulin since 1991.

Jing Luo, Aaron S Kesselheim

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JAMA: Trends in Medicaid Reimbursements for Insulin From 1991 Through 2014

Importance  Insulin is a vital medicine for patients with diabetes mellitus.

Newer, more expensive insulin products and the lack of generic insulins in the United States have increased costs for patients and insurers.

Objective  To examine Medicaid payment trends for insulin products. Cost information is available for all 50 states and has been recorded since the 1990s.

Results  Since 1991, Medicaid reimbursement per unit (1 mL) of insulin dispensed has risen steadily. In the 1990s, Medicaid reimbursed pharmacies between $2.36 and $4.43 per unit. By 2014, reimbursement for short-acting insulins increased to $9.64 per unit; intermediate, $9.22; premixed, $14.79; and long-acting, $19.78. Medicaid reimbursement for rapid-acting insulin analogs rose to $19.81 per unit. The rate of increase in reimbursement was higher for insulins with patent protection ($0.20 per quarter) than without ($0.05 per quarter) (P < .001).Total Medicaid reimbursements peaked at $407.4 million dollars in quarter 2 of 2014. Total volume peaked at 29.9 million units in quarter 4 of 2005 and was 21.2 million units in quarter 2 of 2014.

Jing Luo, MD; Jerry Avorn, MD; Aaron S. Kesselheim, MD, JD, MPH

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JAMA: Costs Associated With Using Different Insulin Preparations

In 2012, an estimated 29 million individuals, or 9.3% of the US population, had diabetes, with 30.8% of these patients using insulin. For patients with type 2 diabetes, many options for insulin therapy are available, challenging clinicians to find appropriate insulin regimens that best fit with their patients’ lifestyles.

However, the affordability of insulin is becoming an important factor in decision making, and clinicians should be aware of the lower-cost options that may be available for their patients.

Tracy Tylee, MD; Irl B. Hirsch, MD

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