E-drug: CHAI, UNITAID, and DFID Announce Lower Prices for HIV/AIDS Medicines in Developing Countries
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<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_engl
ish.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
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.
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.
Kirsten Myhr