UNITAID and the Clinton HIV/AIDS Initiative Announce New Price Reductions for Key AIDS Medicines

Price of most affordable generic second-line drug regimen reduced to $590 annually, from more than $700 in 2008

Tenofovir-based, one-pill, once-daily first-line regimen now available for $210 annually, down 30 percent from 2008

Over 300,000 patients living with HIV now benefiting from UNITAID & Clinton Foundation partnership

Geneva, Switzerland and New York, NY – UNITAID and the Clinton HIV/AIDS Initiative (CHAI), a project of the William J. Clinton Foundation, today announced new agreements with generic manufacturers that significantly reduce the price of key pediatric and second-line antiretroviral medicines (ARVs) used in the treatment of HIV/AIDS. These medicines are currently supplied to 42 beneficiary countries through two projects funded by UNITAID and implemented by CHAI. Beyond the scope of the UNITAID projects, the reduced prices will be available to over 70 developing countries that are members of the CHAI Procurement Consortium, and will also be extended to Global Fund recipients participating in the Global Fund’s new Voluntary Pooled Procurement scheme.

“The innovative partnership with UNITAID aims to improve market dynamics to better serve patients while continuing to meet the needs of manufacturers,” said Anil Soni, CEO of CHAI. “Developing countries have been hard-hit by today’s global economic crisis, and the health of patients living with HIV will depend on the global community’s ability both to sustain funding for treatment programs and to maximize the value of the funds available.”

“These price reductions, made possible by UNITAID's predictable funding, will help save thousands of lives in a number of countries," said Dr Jorge Bermudez, Executive Secretary of UNITAID. "Our partnership with CHAI will continue to explore innovative mechanisms to expand access to newer and better medicines and rapidly deliver them to the people who most need them."

The new agreements will further lower the cost of the most affordable generic second-line ARV regimen (tenofovir (TDF), lamivudine (3TC) and lopinavir/ritonavir (LPV/r)) by 17 percent, compared to prices announced by UNITAID and CHAI in April 2008. The new price for this leading regimen is 18 percent and 39 percent lower, respectively, than the average market prices in low and middle-income countries . The deals announced today also include agreements with 3 generic suppliers to offer heat-stable LPV/r, a member of the protease inhibitor drug class that represents the mainstay of second-line therapy, at a price of $470 per patient per year. The introduction of generic versions of atazanavir (ATV) and heat-stable ritonavir (RTV) is expected to create a further reduction in the cost of second-line treatment.

In addition to agreements covering products that will be offered through the UNITAID Pediatric and Second Line HIV/AIDS Projects, CHAI also negotiated lower pricing for a key “next-generation” first-line treatment, a once-daily pill that combines the drugs tenofovir, lamivudine and efavirenz (EFV). This product offers greater convenience, an improved resistance profile and fewer side effects in comparison to the regimens used most commonly in developing countries. The new price for this treatment—$210 per patient per year—is 30 percent lower than the prices announced by UNITAID and CHAI in 2008 and represents a 37 percent reduction relative to today’s average market pricing among low-income countries. These price reductions were made possible by the UNITAID Second-Line Project, which has increased and aggregated demand for tenofovir by supplying other tenofovir-based products for use in second-line treatment and also on an exceptional basis for first-line use in three countries. While the focus of this UNITAID project is on second-line price reductions, the increased tenofovir volumes have translated into a cumulative price reduction since 2007 of 62 percent for once-daily first-line HIV/AIDS treatment in low-income countries, further broadening the market impact of UNITAID support.

In total, the agreements announced today cover 41 adult and pediatric formulations. The new prices represent an average reduction of 16 percent compared to the lowest indicative pricing in the 2008 report of ARV prices from Médecins Sans Frontières. Relative to prevailing market rates, as monitored by the World Health Organization, the prices represent average reductions of 13 percent in low-income countries and 35 percent in middle-income countries. Cumulatively, since the 2006 launch of their partnership, CHAI and UNITAID have reduced prices by an average of 64 percent for leading pediatric regimens and 43 percent for leading adult ARV regimens in low-income countries. These reductions are projected to yield annual savings of more than $100 million in global spending on pediatric and second-line ARVs after the conclusion of the UNITAID-funded projects.

CHAI will procure drugs at the prices announced today using UNITAID funds. The price reductions will also benefit countries that are not directly supported by UNITAID, through CHAI’s Procurement Consortium, which currently includes over 70 developing countries in Africa, Asia, Eastern Europe, Latin America and the Caribbean.

BACKGROUND

HIV/AIDS is a life-long condition and people on antiretroviral treatment often become resistant to first-line therapy over time. Medicines used in second-line treatment cost much more than drugs used in first-line combinations. While competition among generic manufacturers has helped bring the price of first-line ARVs down by more than 99 percent since 2000, newer second-line medicines have remained much more expensive. This is due to a range of factors—including the complexity of production for these newer drugs, patent barriers, and lower demand volume—which has discouraged suppliers from entering the second-line market niche and investing in cost reduction. But the need for second-line treatment is now growing rapidly. According to WHO estimates, three percent of patients on first-line ARVs need to switch to second-line regimens annually.

Over the last three years, the collaboration between UNITAID and CHAI has helped to increase access to ARVs among children and second-line patients by making drugs more widely available and improving market dynamics. The partnership currently provides ARVs to over 300,000 patients in 42 countries, including nearly 200,000 children.

The pediatrics project has helped to nearly triple the number of children on ARV treatment globally—a dramatic improvement over the historically low rates of pediatric coverage. In addition, 16 new pediatric and second-line formulations have been launched since the inception of the UNITAID-CHAI projects in 2006. The new formulations include first-line pediatric fixed-dose combination pills (FDCs) now used in over 30 countries, which combine three drugs into one dispersible tablet and replace individual solutions that require refrigeration. The UNITAID-CHAI collaboration has also helped encourage 4 new suppliers to enter the pediatric and second-line ARV markets. The average number of suppliers per product has doubled for pediatric products and tripled for second-line products. 18 pediatric and second-line products also now have WHO or FDA-approved generic versions previously not available at the start of the CHAI-UNITAID projects.

By the end of 2008, UNITAID had committed more than US$ 300 million for orders of pediatric and second-line HIV/AIDS drugs and diagnostics. For 2009, the UNITAID Board approved an additional US$ 140 million for these programs, which are implemented by CHAI.

Today’s announcement represents the fourth major price reduction achieved by UNITAID and CHAI since they began their partnership in September 2006.

For this most recent reduction, CHAI issued an open invitation in December 2008 to 18 manufacturers for proposals to supply pediatric and second-line drugs in 2009. In responding to the invitation, suppliers had the option of submitting a traditional price bid or, alternatively, negotiating pricing with CHAI on a “cost-plus” basis and collaborating with CHAI to lower production costs, in part by securing lower prices for key raw materials and by addressing major chemistry challenges. CHAI will facilitate a new process of competitive bidding and supplier selection at the end of 2009, and further price reductions are anticipated.

Products supplied under the UNITAID projects have either already been approved by the World Health Organization and/or U.S. FDA or another stringent regulatory authority or have been submitted for review to these authorities, based on tests by research labs that have been audited by the WHO and/or FDA. Products purchased will also be subject to regular quality control testing.

The public disclosure of these prices, in addition to tools like the WHO Global Price Reporting Mechanism (GPRM) are intended to assist national purchasers in future negotiations with manufacturers to achieve more equitable prices (see www.who.int/hiv/amds/price/hdd/).

Market prices have been calculated from ARV transaction data in the WHO Global Price Reporting Mechanism, which includes purchases of both branded and generic products.

See answers to frequently asked questions regarding this announcement.

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UNITAID
UNITAID was established to provide additional funding to support existing efforts in the fight against HIV/AIDS, malaria and tuberculosis. The additional funding comes primarily from a solidarity contribution on airline tickets. Through implementing partners, UNITAID channels its funds to purchasing tests and medicines of assured quality and ensuring fast delivery to the patients who most need them - those in low- and middle-income countries. Launched in September 2006, UNITAID was founded by the governments of Brazil, Chile, France, Norway and the United Kingdom. Today it is supported by 29 countries and the Bill and Melinda Gates Foundation.

Clinton HIV/AIDS Initiative
Since 2002, the Clinton HIV/AIDS Initiative (CHAI), a project of the William J. Clinton Foundation, has assisted countries in implementing large-scale, integrated care, treatment and prevention programs. CHAI works side-by-side with more than 20 countries in Africa, Asia, Eastern Europe, and Latin America and the Caribbean to build systems that will deliver HIV/AIDS treatment and healthcare by providing governments with technical assistance, leveraging human and financial resources, and facilitating the sharing of best practices across nationwide projects. CHAI also brokers agreements to lower prices of essential medicines and diagnostics, which are now accessible to more than 70 countries, representing more than 90 percent of people living with HIV/AIDS in the developing world. Learn more at www.clintonfoundation.org.

See CHAI’s 2009 price list.

Contacts:

UNITAID: Daniela Bagozzi, Communication
Tel: +41 22 791 45 44
Mob: +41 79 475 54 90
bagozzid@who.int

To learn more about the work of the Clinton HIV/AIDS Initiative and the William J. Clinton Foundation, please visit www.clintonfoundation.org
Contact: press@clintonfoundation.org