[Ip-health] EMBARGOED FOR TODAY 3 PM CET - Clinton Health Access Initiative, UNITAID, and DFID Announce Lower Prices for HIV/AIDS Medicines in Developing Countries

unitaid unitaid at who.int
Tue May 17 05:30:57 PDT 2011


EMBARGOED FOR 17 MAY 2011, 3 PM CET/9 AM EST

 <http://www.unitaid.eu>     <http://www.clintonfoundation.org/chai>    

Clinton Health Access Initiative, UNITAID, and DFID Announce Lower
Prices for HIV/AIDS Medicines in Developing Countries
Partnership to Reduce ARV Prices will Yield Savings of at Least $600
Million Over 3 Years
Boston, MA; Geneva; and London, 17 May 2011 - Today, the Clinton Health
Access Initiative (CHAI), UNITAID, and the UK's Department for
International Development (DFID) announced further price reductions on
key antiretroviral (ARV) drug regimens used to treat HIV/AIDS in the
developing world. This announcement represents the latest in a series of
price reductions on 'next-generation' ARVs that have been accomplished
through the collaborative efforts of the three organizations. Since
2008, this partnership has achieved price reductions that will generate
global savings of at least $600 million over the next three years,
making HIV treatment more widely accessible. With new research published
last week proving that treating people with AIDS immediately not only
keeps them alive but is also an effective tool to prevent transmission,
making ARVs more affordable can save countless lives. 
"With more than nine million people worldwide in need of HIV/AIDS
treatment, we must see rapid action to increase people's access to
treatment," said President William J. Clinton. "Over 70 countries and
70% of the HIV-infected population have access to the prices my
Foundation negotiated; so these new price reductions, which have been
agreed to by a wide range of suppliers, will provide millions of people
with increased access to better, cheaper and more convenient first and
second-line drug regimens.  We have helped almost four million people
gain access to life-saving medicine, and I'm proud that we can now reach
millions more. " 
The new price ceilings on a range of adult and paediatric ARVs announced
today will be available to most of the over 70 countries in CHAI's
Procurement Consortium. The most significant price reductions were
registered on tenofovir (TDF)- and efavirenz (EFV)-based products. The
World Health Organization (WHO) now recommends TDF as one of the
preferred first-line treatment options, but TDF-based regimens have
historically been prohibitively expensive for developing countries. In
2008, low-income countries paid an average annual cost of $400 per
patient per year for a once-daily regimen including TDF and EFV, nearly
three times the cost of another leading twice-daily regimen. That same
TDF-based regimen is now available at an annual per patient cost of less
than $159, a reduction of 14% from the CHAI ceiling price announced last
year and a reduction of 60% from the average price paid in 2008. 
Price reductions were also secured on key second-line ARVs. A
WHO-recommended second-line regimen is now available at less than $410
per year, down sharply from 2008 when low-income countries paid an
average of $800-$1,200 per patient per year for the most popular
second-line regimens. These gains were due largely to the recent
introduction of a critical new product -atazanavir/ritonavir (ATV/r) -
although price reductions have also been secured on other prominent
second-line drugs.
With many countries shifting increasingly towards TDF- and ATV/r-based
regimens, the price reductions achieved on these emerging products since
2008 are expected to result in over $600 million in cost savings over
the next three years, even assuming no additional patient scale-up. If
patient scale-up continues at its recent pace, the cost savings could
exceed $1 billion over this period.  
These price reductions were made possible through complementary efforts
to build demand for new products, which stimulated market competition
and led to volume-based discounts, while partnering with suppliers to
achieve cost reductions through more efficient manufacturing processes
and sourcing of raw materials. By supporting the purchase of new ARV
formulations for developing countries, UNITAID has played a critical
role in driving demand-side price reductions. Meanwhile, DFID's support
of CHAI's work with suppliers, along with substantial contributions by
the Bill and Melinda Gates Foundation, has driven supply-side cost
reductions. 
"The British Government's support to the Clinton Health Access
Initiative is helping to provide life-saving HIV treatment in countries
that have been devastated by the epidemic," said The UK's International
Development Secretary Andrew Mitchell. "This partnership is leading the
way in providing value for money by working with the private sector to
drive down the cost of lifesaving drugs. It ensures that more people
receive the care they desperately need with UK support alone helping an
extra 500,000 poor people access the treatment they need over the next
three years."
"UNITAID's aim is to catalyse, create or fix markets for medicines,"
said Philippe Douste-Blazy, Chair of UNITAID's Executive Board. "By
stimulating greater availability of better medicines and price
reductions, UNITAID's partnership with CHAI will facilitate the work of
the Global Fund, PEPFAR and countries themselves, and ultimately improve
aid effectiveness by making the money go further." 
UNITAID has partnered with CHAI as the implementing partner to play a
major role in creating a market for emerging first- and second-line
ARVs. Conceived with the intent to fund time-limited catalytic
interventions to enable greater access to medicines among patients in
developing countries, UNITAID has invested more than $200 million in
funding for second-line drugs and TDF since 2006. By focusing its
resources within these emerging markets, UNITAID generated sufficient
demand to trigger major price reductions and accelerated the
introduction of important new products.  
Supply-side efforts have also played a critical role in lowering ARV
prices. Support from DFID and the Bill and Melinda Gates Foundation has
enabled CHAI to collaborate with suppliers to identify and capture
manufacturing efficiency improvements, while also driving uptake of
these products and stimulating market competition. This approach has
resulted in particularly significant cost reductions on TDF, EFV, and
second-line products over the past few years, as considerable
improvements in the manufacturing process and sourcing of raw materials
were realized. These technical efficiencies are responsible for nearly
40% of the projected $600 million in total cost savings over the next
three years. 
CHAI ceiling prices for these and other products can be found at:
http://www.clintonfoundation.org/files/chai_arv_ceilingPriceList_201105_
english.pdf 
Future Trends
Demand for TDF-based first-line regimens is projected to grow rapidly,
from almost 1 million patients in 2010, representing 18% of the adult
first-line market, to an estimated 4.2 million patients in 2013, or 53%
of the total first-line market. The cost differential between TDF and
zidovudine (AZT)-based regimens has already declined significantly, and
this trend is expected to continue. When purchased as two separate
pills, a once-daily TDF-based regimen is now available at an annual cost
of less than $159 (the regimen is also available as a single pill for
less than $169 annually), which is within 20% of the price of a
twice-daily AZT-based regimen. CHAI expects the price of once-daily
TDF-based regimens to fall below the price of twice-daily AZT-based
options over the coming few years as demand for TDF grows. 
The price of a three-pill once-daily second-line regimen - TDF +
lamivudine (3TC) + atazanavir (ATV) + ritonavir (RTV) - is currently
available to many countries at less than $410 per year when sourced
individually from separate suppliers. A co-packaged version of this
regimen, with all three pills in the same packaging, is available at
less than $395; approval for this product is pending with the WHO and US
FDA and is expected this year. Governments are already accessing these
lower prices. Deliveries of ATV and heat-stable RTV are now occurring in
ten countries through the UNITAID program. Additionally, orders are
pending for the co-packaged second-line treatment, which is awaiting
final approval by the WHO or US FDA, expected this year.  
While both ATV/r and lopinavir/ritonavir (LPV/r) are recommended by the
WHO for second-line treatment, demand for LPV/r is still much greater
than for ATV/r. CHAI expects and encourages a rapid switch to ATV/r
given its lower cost and greater convenience of once-daily dosing.
Further significant price reductions on ATV/r are expected as demand
grows. In light of concerns amongst the international community that
resource limitations may constrain treatment scale-up, aggressive uptake
of ATV/r could enable more patients to be treated - and potentially
result in better treatment outcomes. ATV/r is, in fact, one of the
components of the current preferred first-line regimens in the US
Department of Health and Human Services treatment guidelines.
Approach
Since 2005, CHAI has conducted annual price negotiations with several
suppliers of key ARVs on an explicit cost-plus basis whereby suppliers
provide costing information and agree to reduce prices if CHAI and/or
the supplier can identify opportunities for further cost reductions.
Through a series of collaborations, suppliers and CHAI have identified
lower-priced suppliers of raw materials and novel approaches for
improving the manufacture of key drugs.  
For example, in 2005, CHAI identified a new, lower-priced source of
magnesium tert-butoxide (MTB), a key raw material and cost driver in the
production of TDF.  Regulatory approvals from the US FDA and WHO for
this alternative source have contributed to a lower cost for the TDF
active pharmaceutical ingredient (API), resulting in savings of
approximately $15 per patient taking TDF, per year. CHAI also helped
suppliers identify new routes of synthesis for TDF, pioneering new and
improved ways of synthesizing the API. CHAI recently published results
of the improved synthesis and several suppliers have incorporated
elements of this new process, or improvements they have discovered as a
result of this work, to further reduce their cost. 
CHAI, UNITAID and DFID are grateful to key suppliers of ARVs and raw
materials, including Aptuit Laurus, Aurobindo Pharma, Cipla, Emcure,
Hetero, Mahidhara, Matrix (a subsidiary of Mylan), Ranbaxy, and Strides
Arcolab for their contributions in advancing access through price
reductions and the development of new improved products. Their
willingness to engage in the ARV marketplace in developing countries,
coupled with their leadership and foresight in recognizing the value of
these changes to the benefit of both patients and industry has been a
key driver for improving access.  

About Clinton Health Access Initiative

The Clinton Health Access Initiative (CHAI), founded in 2002 by
President Bill Clinton, is dedicated to improving access to health care
for all individuals. Residents of developing countries often cannot
afford and do not have access to systems that provide basic health care,
including medicines for diseases that are preventable, treatable or
curable. This is where CHAI intervenes - by partnering with governments
and working with other NGOs to provide solutions to the biggest
challenges impeding effective health care in developing countries. CHAI
began by bringing care and treatment to people living with HIV/AIDS
through access to medicines, and has expanded its work to include high
quality treatment for malaria, accelerating the roll out of new
vaccines, and lowering infant mortality. To learn more about CHAI,
please visit www.clintonfoundation.org/chai

For press enquiries, please contact Jove Oliver,
press at clintonhealthaccess.org
<../AppData/Local/Microsoft/Windows/Temporary Internet
Files/Content.Outlook/SN9GC4WB/press at clintonhealthaccess.org>  

About UNITAID

UNITAID is a global health initiative established to provide
sustainable, predictable and additional funding to impact on markets to
reduce prices and increase the availability and supply of
quality-assured treatments for HIV/AIDS, malaria and tuberculosis.
UNITAID was launched in 2006 by the Governments of Brazil, Chile,
France, Norway and the United Kingdom as an innovative financing
mechanism to provide additional funding for global health. About 70% of
UNITAID's funds come from a small solidarity contribution on airline
tickets. Today, UNITAID is supported by 28 countries and the Bill and
Melinda Gates Foundation. Through implementing partners, UNITAID
finances the purchase of quality-assured drugs and diagnostics for
patients in poor countries, using its market power to expand supply,
promote development of new and better products, cut delivery lead times
and reduce prices.  UNITAID currently supports partner programmes in 94
countries worldwide - we are addressing HIV/AIDS in 51 countries;
malaria in 29; and tuberculosis in 72 countries. Since late 2006 UNITAID
has committed US$ 1.3 billion to the diagnosis and treatment of these
three diseases, representing a total of approximately 47 million patient
treatments supplied. For more information on UNITAID, please visit
www.unitaid.eu. 

For press enquiries, please contact Daniela Bagozzi, bagozzid at who.int
<../AppData/Local/Microsoft/Windows/Temporary Internet
Files/Content.Outlook/SN9GC4WB/bagozzid at who.int> ; Mob. +41794755490

About DFID

DFID, the Department for International Development: leading the UK
government's fight against world poverty. Since its creation, DFID has
helped more than 250 million people lift themselves from poverty and
helped 40 million more children to go to primary school. But there is
still much to do. 1.4 billion people still live on less than US$ 1.25 a
day. Problems faced by poor countries affect all of us. Britain's
fastest growing export markets are in poor countries. Weak government
and social exclusion can cause conflict, threatening peace and security
around the world. All countries of the world face dangerous climate
change together. DFID works with national and international partners to
eliminate global poverty and its causes, as part of the UN 'Millennium
Development Goals.' DFID also responds to overseas emergencies. 

For press enquiries, please contact the DFID press office on +44 (0) 207
023 0600.

 <<UTD-CHAI-DFID_17May2011.pdf>> 


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