Consideration of diabetes medicines as part of the revisions to 2019 WHO Model List of Essential Medicines for adults (EML): Long-acting insulin analogues (Insulin glargine; Insulin detemir; Insulin degludec (and biosimilars))

Human insulin has been included on the EML since the first list in 1977. In 1985, the WHO Expert Committee on the Selection and Use of Essential Medicines approved the inclusion of isophane neutral protamine Hagedorn (NPH) insulin.

Since 1996, different insulin analogues, altered form of human insulins, have been introduced on markets worldwide. Over the last years additional comparative evidence on biosimilars and reference medications in terms of efficacy and safety became available.

In 2017, at the 21st meeting of the Expert Committee of the WHO EML, an application for the inclusion of long-acting analogues to the EML was rejected due to the limited magnitude of the benefits of analogues over human insulin in terms of reduced glycated haemoglobin and reduced hypoglycaemia as compared to the large difference in price between analogues and human insulin.

Since that time, additional evidence has become available encompassing both effectiveness and increasing affordability of analogues.