WHO Insulin Prequalification Program to Expand Access


As the price of insulin has skyrocketed, patients with diabetes are struggling to pay for their medication.

The price of insulin has increased significantly over the past 20 years.1 Currently, the price of 100 units of short-acting insulin for adults without insurance is approximately $18.1 However, 100 units will only last the average person about 2 days, and patients will generally also require other types of insulin (eg intermediate, long-acting) to control their diabetes.

Unfortunately, due to the high cost of insulin some patients have turned to rationing their medication, which can lead to serious complications including uncontrolled blood glucose, ketoacidosis, and even death.1 Colorado passed the first bill in the nation to cap insulin co-pays at $100 per month, and other states are trying to follow this model.2 Since insulin is a biologic, additional studies are required prior to an approval of a biosimilar product.The World Health Organization (WHO) is now trying to tackle the cost issue on a global basis with the first insulin prequalification program to increase treatment for diabetes in low- and middle-income countries.3  

WHO Insulin Prequalification Program

The WHO announced their insulin prequalification pilot program November 13, 2019, right before World Diabetes Day, to address diabetes and the growing global public health issue.3 Approximately 65 million people with type 2 diabetes need insulin, and only about half are able to access the medication, primarily due to high prices.3  Over 420 million individuals globally are living with diabetes, which is the seventh leading cause of death.3 All patients with type 1 diabetes require insulin to survive. Approximately 90% of insulin sold is manufactured by 3 companies, which limits competition and therefore results in high costs to patients.1 Insulin was discovered as a treatment for diabetes almost 100 years ago, and it has been on WHO’s List of Essential Medicines since the first List was published in 1977.3 “WHO’s prequalification initiative for insulin is a vital step towards ensuring everyone who needs this life-saving product can access it,” Dr. Tedros Adhanom Ghebreyesus, WHO Director General, said.3

     According to data collected by WHO between 2016-2019 from 24 countries on 4 continents, human insulin was available only in 61% of the health facilities and analogue insulins in 13%.3 Additionally, a month’s supply of insulin would cost a worker in Accra, Ghana the equivalent of 5.5 days of pay per month.3 “Prequalifying products from additional companies will hopefully help to level the playing field and ensure a steadier supply of quality insulin in all countries,” said Dr. Mariângela Simão, Assistant Director General for Medicines and Health products.3  The program will help to ensure that countries have more choices for insulin products at affordable prices. In addition to the prequalification program, WHO is taking other measures to address diabetes and public health. These goals include updating diabetes treatment guidelines, creating price reduction strategies, and promoting lifestyle modifications (eg diet and exercise) to reduce the risk of developing type 2 diabetes.3


1. Fralick M, Kesselheim AS. The U.S. insulin crisis-rationing a lifesaving medication discovered in the 1920s. N Engl J Med. 2019;381:1793-1795. Doi: 10.1056/NEJMp1909402. 
2. Colorado General Assembly. HB19-1216 Reduce Insulin Prices. https://leg.colorado.gov/bills/hb19-1216. Accessed January 6, 2020.
3. WHO launches first-ever insulin prequalification programme to expand access to life-saving treatment for diabetes [news release]. WHO’s website.  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. Published November 13, 2019.  Accessed January 6, 2020.

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