To combat globally high prices of insulin, the World Health Organisation (W.H.O) has announced an initiative to allow drug companies to produce biosimilar insulin products. This would be through a prequalification program, which would permit pharmaceutical companies to submit their products to test for quality and safety (W.H.O, 2019). If approved, cheaper versions of insulin can enter global markets at a rate which will allow them to compete with the main brands, driving down prices. The W.H.O are hoping to repeat a previous initiative with HIV medication, in which a prequalification program allowed generic retroviral drugs to be approved and made cheaply available. Unicef have also announced that they would be purchasing W.H.O approved insulins, in order to provide low income countries with treatment.
In the USA, it is estimated that more than 100 million individuals are living with Diabetes or Prediabetes (Centers For Disease Control and Prevention, 2017). Diabetes can be categorised into two main groups, Type 1 (T1DM) and Type 2 (T2DM). Both types differ in their epidemiology, pathophysiology and treatments. They are however, both characterised by hyperglycaemia stemming from destruction or dysfunction of β-cells in the pancreas (Skyler et al., 2016). More specifically, the aetiology of T1DM is the loss of Insulin production following autoimmune destruction of β-cells (Acharjee et al., 2013). This in turn requires insulin to be administered to T1DM patients to ensure that blood glucose concentrations are correctly regulated. T2DM, however, results from both an increased resistance to insulin and a reduction in insulin production, marked by increased levels of glycated haemoglobin (HbA1c) (Web.archive.org, 2019).
Insulin treatments of T2DM
Various insulin treatments exist to control blood glucose in T2DM where insulin is no longer produced naturally. Treatments can be delineated by the time take for the insulin to take effect, when the peak time period of effectiveness is and how long insulin remains active in the body. Therefore, manufacturers produce different treatment options to suit the patient’s requirements. For example, insulin analogues such as Humalog and NovoRapid are genetically altered to produce a faster onset (<15 minutes) and are typically used after a meal. Regular insulin, in products such as Humulin R and Novolin R, have an onset of 30-60 minutes and last for 5-8 hours. Other insulin analogue products such as Lantus and Levemir, are altered to have an onset of an hour and are active for roughly 24 hours.
Factors behind the price increases
Several political, legal and supply chain factors are behind the dramatic increase in insulin prices. Firstly, three companies, Eli Lilly, Novo Nordisk and Sanofi have a dominant global market share of insulin products. Without the competition of rival companies, manufacturers can often sell insulin without the concern of having their prices undercut. Furthermore, there is very little incentive for manufacturers to enter the market with generic insulin products. This is because insulin is classed as a biologic and not a generic medicine, this means producing a biosimilar insulin would come at a great cost and would face many regulatory stages before approval.
Pharmaceutical companies also use loopholes in American patent frameworks, using additional patents to increase their monopoly over drug markets. A typical example is Lantus, despite its original patent expiring in 2015, 70 additional patents have been applied for, with almost all of them coming after the drug’s launch in 2000. This allows pharmaceutical companies to potentially maintain exclusivity of a product with broader patents which would not be accepted under European and Japanese regulatory rules. Manufacturers claim this gives them justification for price increases and puts pressure on doctors to prescribe these products over older treatments.
Acharjee, S., Ghosh, B., Al-Dhubiab, B. and Nair, A. (2013). Understanding Type 1 Diabetes: Etiology and Models. Canadian Journal of Diabetes, 37(4), pp.269-276.
Centers For Disease Control and Prevention (2017). New CDC report: More than 100 million Americans have diabetes or prediabetes. [online] Available at: https://www.cdc.gov/media/releases/2017/p0718-diabetes-report.html [Accessed 18 Nov. 2019].
Skyler, J., Bakris, G., Bonifacio, E., Darsow, T., Eckel, R., Groop, L., Groop, P., Handelsman, Y., Insel, R., Mathieu, C., McElvaine, A., Palmer, J., Pugliese, A., Schatz, D., Sosenko, J., Wilding, J. and Ratner, R. (2016). Differentiation of Diabetes by Pathophysiology, Natural History, and Prognosis. Diabetes, 66(2), pp.241-255.
Web.archive.org. (2019). Causes of Diabetes. [online] Available at: https://web.archive.org/web/20160202083725/http://www.niddk.nih.gov/health-information/health-topics/Diabetes/causes-diabetes/Pages/index.aspx [Accessed 18 Nov. 2019].
W.H.O (2019). WHO launches first-ever insulin prequalification programme to expand access to life-saving treatment for diabetes. [online] Available at: https://www.who.int/news-room/detail/13-11-2019-who-launches-first-ever-insulin-prequalification-programme-to-expand-access-to-life-saving-treatment-for-diabetes [Accessed 19 Nov. 2019].