[Ip-health] Stat: For the first time, WHO committee recommends action on high-priced essential medicines

Thiru Balasubramaniam thiru at keionline.org
Sat Oct 2 08:12:21 PDT 2021


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

By Ed Silverman  Oct. 1, 2021

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

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 effort 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 effort 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.

Related: Lilly cuts the wholesale price on some insulin products, but
impact is likely to be limited

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.”

About the Author

Ed Silverman

Pharmalot Columnist, Senior Writer

Ed covers the pharmaceutical industry.

 ed.silverman at statnews.com

Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International
41 22 791 6727
thiru at keionline.org

More information about the Ip-health mailing list