Sei sulla pagina 1di 3

Hepatitis Medicines Now Added to WHO Model List of Essential Medicines

Every two years, the WHO Model Essential Medicines List is revised by a committee comprised of experts from the
research, medical, academic and pharmaceutical fields.
The Model EML offer guidance on which medicines should be prioritized based on a public health and clinical
perspectives, based on their efficacy, safety and cost-effectiveness. This years revision and addition of large
number of new drugs, even when new drugs are expensive, highlighted the importance of promoting equal access
to essential medicines.

When countries revise their own national EML based on the WHO Model EML this opens up the opportunity to
increase access to these new medicines through financing via government and donor resources. In case of hepatitis,
MDR-TB and cancer significant number of new medicines were added to Model EML

for treatment hepatitis B, entecavir and tenofovir for the treatment of hepatitis B, and fir hepatitis C:
and the addition of six oral direct-acting antiviral medicines including daclatasvir, ledipasvir +
sofosbuvir, ombitasvir + paritaprevir + ritonavir with or without dasabuvir, simeprevir, and
sofosbuvir,

See also WHO press release and executive summary and fact sheets at the end

WHO moves to improve access to lifesaving medicines for hepatitis


C, drug-resistant TB and cancers
News release
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 globally.
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 that direction.
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 global standard.
TB remains one of the worlds 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.

Related links
Essential Medicines List 2015
Essential Medicines List Children 2015
Executive summary
Hepatitis C WHO fact sheet
Cancer WHO fact sheet
TB WHO fact sheet

Media contact
Daniela Bagozzi, WHO
Telephone: +41 79 6037281
E-mail: bagozzid@who.int

Potrebbero piacerti anche