For the first time, WHO committee recommends action on high-priced essential medicines

For the first time, a World Health Organization committee has recommended the global agency form a working group to explore policies for contending with the high prices of medicines that are considered essential, but unaffordable in many low and middle-income countries.

The suggestion was made in the latest report about treatments to be added to the WHO list of essential medicines. The list, which is updated every two years, contains the most effective, safe and cost‐effective drugs for treating high-priority illnesses and running a functioning health care system. For this reason, the list is influential because many countries consult the list for determining reimbursement.

In explaining its thinking, the committee noted several medicines — especially several for treating cancer — were not recommended due to concerns over affordability. Among them were treatments for multiple myeloma, breast cancer and non-small cell lung cancer. For example, the committee cited checkpoint inhibitors — such as Keytruda, a Merck (MRK) drug — which were called “prohibitively expensive.”

“The issue of treatment costs and appropriate use of these medicines is further complicated by the need for diagnostic testing to identify patients most likely to benefit, uncertainties about the optimal duration of treatment, the significant disease burden and the likely large eligible patient population,” the committee wrote about this class of cancer medicines.

And so, the committee proposed that a working group should explore when certain medicines become affordable in relation to the ability to pay; pinpoint prices representing “fair value” for expected benefits; identify moves that policy makers and others can take to lower prices and create universal access; and develop a strategy to monitor price and availability trends of essential, but unaffordable medicines.

The decision reflects increasing worries over the rising cost of prescription medicines in a growing number of countries, including such wealthy nations as the U.S. Several cash-strapped governments have responded by exploring licenses that would allow public or private entities to sidestep patents, but such moves have regularly — and vociferously — been opposed by the pharmaceutical industry.

The issue of greater affordability and access, meanwhile, has hampered the global campaign to successfully distribute Covid-19 vaccines, despite efforts by the WHO, public health experts and patients advocates. One advocate praised the recommendation to create a working group, but also predicted the move will face opposition from the pharmaceutical industry.

“The list has been very conservative when it comes to newer products that don’t have low-cost generic or biosimilar alternatives,” Jamie Love of Knowledge Ecology International noted in a blog post. “The fact that this excludes many important drugs was made explicit in the new report. The encouraging news is that the WHO is now proposing a significant review of policies to address the effective but expensive category of drug, including policy interventions that can make products more affordable.”

At the same time, the committee reversed an earlier position and recommended adding long-lasting insulin analogs, which are genetically modified versions of human insulin, on the essential medicines list. The committee noted there are small differences in clinical outcomes, but long-acting analog insulin causes fewer incidents of hypoglycemia, or low levels of sugar in the blood, than human insulin.

While long-acting analog insulin remains more expensive, prices differ considerably among countries. To some extent, this reflects cost containment steps taken by some governments to increase affordability and access, such as negotiating prices with manufacturers, which is causing prices to fall. Prices are also decreasing for analog insulin no longer under patent protection.

“Too many people who need insulin encounter financial hardship in accessing it or go without it and lose their lives,” Tedros Adhanom Ghebreyesus, WHO Director-General, said in a statement. “Including insulin analogues in the Essential Medicines List, coupled with efforts to ensure affordable access to all insulin products and expand use of biosimilars, is a vital step towards ensuring everyone who needs this life-saving product can access it.”

However, Doctors Without Borders suggested the WHO become more aggressive. The medical relief and advocacy group noted that the prevalence of diabetes has nearly doubled over the past 30 years and is now rising faster in low- and middle-income countries than in high-income countries. And it is estimated that by 2045 the number of people with diabetes will rise globally by 51%, with the largest increase — 143% — predicted in Africa.

“It is preposterous that this medicine discovered 100 years ago still remains inaccessible to half of the people who need it. The WHO and governments must demand pharmaceutical corporations open their books to show why prices for various types of insulins remain so high, especially the analogue insulins just added to the WHO essential medicines list,” said Candice Sehoma, advocacy officer in South Africa.

“Unless the price of all types of insulin and the medical supplies required to inject and monitor this treatment comes down, governments will continue to struggle to manage this controllable disease and people with diabetes will keep dying.”