8 MAY 2015 | GENEVA –
WHO today published the new edition of its Model List of
Essential Medicines which includes ground-breaking new treatments for
hepatitis C, a variety of cancers (including breast cancer and
leukaemia) and multi-drug resistant tuberculosis (TB), among others. The
move opens the way to improve access to innovative medicines that show
clear clinical benefits and could have enormous public health impact
“When new effective medicines emerge to safely treat serious
and widespread diseases, it is vital to ensure that everyone who needs
them can obtain them,” said WHO Director-General, Dr Margaret Chan.
“Placing them on the WHO Essential Medicines List is a first step in
Increasingly, governments and institutions around the world
are using the WHO list to guide the development of their own essential
medicines lists, because they know that every medicine listed has been
vetted for efficacy, safety and quality, and that there has been a
comparative cost-effectiveness evaluation with other alternatives in the
same class of medicines.
The list is updated every two years by an Expert Committee,
made up of recognized specialists from academia, research and the
medical and pharmaceutical professions. This year, the Committee
underscored the urgent need to take action to promote equitable access
and use of several new highly effective medicines, some of which are
currently too costly even for high-income countries.
New medicines to treat Hepatitis C
These included new medicines to treat hepatitis C, which
affects about 150 million people globally, killing approximately half a
million people each year, when chronic infection develops into liver
cirrhosis or liver cancer. The disease is present in high- and
lower-income countries alike, with higher concentrations in several
middle- and low-income countries.
Until recently, treatment for the disease presented minimal
therapeutic benefits and serious side effects. Five new medicines –
direct acting oral antivirals – have recently come on the market
transforming chronic hepatitis C from a barely manageable to a curable
condition, the new medicines have few side effects and high tolerance in
patients. All 5 products, including sofosbuvir and daclatasvir, were
included in the List. But high prices currently make them unaffordable
and thus inaccessible to most people who need them.
“Treatments for hepatitis C are evolving rapidly, with several
new, highly effective and safe medicines on the market and many in the
development pipeline,” said Dr Marie-Paule Kieny, WHO Assistant
Director-General for Health Systems and Innovation. “While some efforts
have been made to reduce their price for low-income countries, without
uniform strategies to make these medicines more affordable globally the
potential for public health gains will be reduced considerably.”
Cancers figure among the leading causes of illness and death
worldwide, with approximately 14 million new cases and 8.2 million
cancer-related deaths in 2012. The number of new cases is expected to
rise by about 70% over the next 2 decades. New breakthroughs have been
made in cancer treatment in the last years, which prompted WHO to revise
the full cancer segment of the Essential Medicines List this year: 52
products were reviewed and 30 treatments confirmed, with 16 new
medicines included in the List.
“Some of these medicines produce relevant survival benefits
for cancers with high incidence, such as trastuzumab for breast cancer,”
explained Dr Kees De Joncheere, WHO Director of Essential Medicines.
“Other treatment regimens for rare cancers such as leukemia and
lymphoma, which can cure up to 90% of patients, were added to set a
TB remains one of the world’s most deadly infectious diseases.
In 2013, 9 million people fell ill with TB and 1.5 million died from
the disease. Over 95% of TB deaths occur in low- and middle-income
countries. After about 45 years of scarce innovation for TB medicines, 5
new products were included in the EML. Four of these, including
bedaquiline and delamanid, target multi-drug-resistant TB.
The Committee also recommended supporting off-label uses in
cases where there is clear evidence of major health benefits, though no
licensed indication, such as for many medicines for children.
“The Essential Medicines List includes medicines on the basis
of safety and efficacy evidence, not on the basis of approved
indications within national jurisdictions or availability of licensed
alternatives,” added Dr De Joncheere. “For example, when it reviewed the
application to include ranibizumab, to treat severe eye diseases such
as macular degeneration, the Committee looked at the evidence base and
the price difference with bevacizumab – the medicine currently listed.
The Committee agreed to maintain bevacizumab as the preferred medicine,
rejecting the ranibizumab application. ”
“It is important to understand that the Essential Medicines
List is the starting block and not the finishing line,” concluded Dr
Kieny. “Its purpose is to provide guidance for the prioritization of
medicines from a clinical and public health perspective.The hard work
begins with efforts to ensure that those medicines are actually
available to patients.”
Note to Editors
The meeting of the 20th Expert Committee on the
Selection and Use of Essential Medicines was held from 20 to 24 April
2015 at WHO Headquarters. The Expert Committee considered 77
applications for medicines to be added to the 18th WHO Model List of Essential Medicines (EML) and the 4th
WHO Model List of Essential Medicines for Children (EMLc). WHO
technical departments were involved and consulted with regard to
applications relating to their disease areas.
Essential Medicines List 2015
Press Release Source: http://www.who.int/mediacentre/news/releases/2015/new-essential-medicines-list/en/
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