Pharma wrap: WHO pushes for affordable insulin, to encourage pre-qualification of generics

November 18
06:56 2019

Last week, the World Health Organisation (WHO) announced that it would start a pilot programme to pre-qualify human insulin, to increase treatment for diabetes in low and middle-income countries (LMICs).

This pre-qualification means — WHO will test the insulin product to check whether they are meet requirements for safety and efficacy, before approving it for use.

WHO also said they would encourage generics to drive down the cost of insulin.

Despite ample supply, insulin prices are currently a barrier against treatment in LMICs, according to WHO.

Three manufacturers — Eli Lilly, Novo Nordisk and Sanofi — control most of the global market for insulin, setting prices that are prohibitive for many people and countries.

Over 420 million people live with diabetes. Of these, 80 percent are living in LMICs. Diabetes is the seventh leading cause of death and a major cause of costly and debilitating complications such as heart attacks, stroke, kidney failure, blindness and lower limb amputations.

Affordable insulin

WHO’s announcement is significant as the cost of insulin treatment has been rising and is becoming increasingly unaffordable for most people in LMICs. Even in developed countries such as the US, things are not that rosy when it comes to insulin prices.

A study published in the Journal of American Medical Association shows that one in four patients are rationing use of insulin because of increased prices, resulting in higher morbidity and in some cases, death. There were extreme cases of people using insulins meant for dogs, as they cannot afford it.

In India, insulin prices, despite being controlled by the government by adding them on the National List of Essential Medicines (NLEM), are steadily rising. A study of online e-pharmacy Netmeds, show that cost of basal insulin — the type of insulin that regulates glucose levels between meals has gone up by 20 percent in 2018. The pens and cartridge, devices costs are also seeing price increases.

It costs around 36 US cents per day, or nearly Rs 1,000 per month, for diabetes patient on human insulin in LMICs countries, assuming an insulin dosage of 40 IU per day.

Data collected by WHO in 2016-2019, from 24 countries across four continents, shows that human insulin was available only in 61 percent of health facilities and analogue insulins in 13 percent. The data showed that a month’s supply of insulin would cost a worker in Accra, Ghana, the equivalent of 5.5 days of pay per month, or 22 percent of his/her earnings.

HIV drugs and vaccines template

When anti-retroviral drugs to treat HIV infected patients were first produced, the cost per patient per year was $ 10,000. However, once WHO opened pre-qualification for generic HIV products, the price came down to $ 300 per year.

Now, over 80 percent of the patients in the world are relying on WHO pre-qualified generic antiretroviral medicines.

Even in vaccines, WHO pre-qualification had helped LMICs get affordable yet quality vaccines.

The move is expected to potentially help Indian companies like Biocon, Wockhardt and Strides Pharma Science, which has plans to produce insulins.

Biocon has already announced to supply human insulin (rh-Insulin) at less than 10 US cents per day in LMICs, procured by the governments directly. This is almost 70 percent cheaper than the existing prices.

Insulin pre-qualification is one of a number of steps WHO will take in the coming year to address the diabetes burden. Plans are underway to update diabetes treatment guidelines, devise price reduction strategies for analogues and improve delivery systems and access to diagnostics.Get access to India’s fastest growing financial subscriptions service Moneycontrol Pro for as little as Rs 599 for first year. Use the code “GETPRO”. Moneycontrol Pro offers you all the information you need for wealth creation including actionable investment ideas, independent research and insights & analysis For more information, check out the Moneycontrol website or mobile app.

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