ESPE Yearbook of Paediatric Endocrinology

Diabetes Care 2018;41:1125–1131. DOI: 10.2337/dc18-er09a)

• Many people currently in need of insulin are unable to access it.

• Unaffordable price of insulin is a major barrier.

• These authors analyse the causes of unsatisfactory access to insulin from a U.S. and global perspective.

This article identifies the various components of a global framework that regulates insulin affordability: the private sector, the government and a plural sector that includes NGOs, academia, research organisations and patient groups. Presently, the private sector has, by far, the greatest influence on insulin cost. One of the reasons is that 99% of the value and 96% of the volume of the insulin market are controlled by only 3 pharmaceutical companies (Novo Nordisk, Eli Lilly and Sanofi), which contributes to keeping insulin prices high.

The article discusses 2 important points. First, the emergence of biosimilar insulins, which would be expected to increase competition and consequently improve affordability (1). However, those benefits remain to be seen. It is true that an increasing number of smaller pharmaceutical companies are now manufacturing biosimilar insulins (defined as human or analog insulins that are almost identical to a reference product or comparator). However, with a few exceptions, biosimilar insulins have not been successfully evaluated according to the stringent criteria of agencies such as the FDA (USA), PMDA (Japan) or the EMA (Europe). The WHO is presently working on a prequalification process that could contribute to increasing penetration of insulin in more countries. Secondly, they discuss whether the use of analog insulins, which remain more expensive than human insulins, should be promoted in low resource settings. Indeed, there is a concern that high use of analog insulins could contribute to keeping the overall cost of insulin high. The authors feel that the marginal improvement in metabolic control offered by insulin analogs does not justify their higher price. Whether other potential advantages of analog insulins compared to human insulin (such as convenience and decreased risk of hypoglycemia in settings where glucagon is mostly unavailable) is worth the high price remains to be evaluated (2–3).

As health professionals, our primary goal should be to ensure that patients get universal access to at least human insulin.

References: 1. McCall C. Biosimilars for insulin: a cost-saving alternative? Lancet 2018 392; 463-464.

2. Beran D, Hemmingsen B, Yudkin JS. Analogue insulin as an essential medicine: the need for more evidence and lower prices. Lancet Diabetes Endocrinol 2018; 7: 338.

3. Beran D, Laing RO, Kaplan W, Knox R, Sharma A, Wirtz VJ, Frye J, Ewen M. A perspective on global access to insulin: a descriptive study of the market, trade flows and prices. Diabet Med 2019; 1–8.