Former US President Bill Clinton announced today that the Clinton HIV/AIDS Initiative has secured new and substantial reductions in the price of second-line antiretroviral drugs for low and middle-income countries, and also a price of $339 a year for a triple combination, tenofovir-based once daily pill for first-line treatment.
The Clinton HIV/AIDS Initiative has been charged by UNITAID with achieving lower prices for second-line and paediatric antiretroviral drugs, chiefly by working with generic manufacturers to identify cost-saving improvements in the productions process. UNITAID is funded by airline passenger levies and other contributions from around 30 countries including France, Chile, Norway and the United Kingdom, and is expected to raise €200 million this year to provide drugs and diagnostics for treatment of HIV, tuberculosis and malaria.
Today’s price reduction offers all come from two Indian generic drug companies, Cipla and Matrix, who will receive a guaranteed volume of orders that will allow them to scale up production, leading in turn to economies of scale.
A big reduction in price for tenofovir is one of the key features of the announcement. The generic manufacturers are now guaranteeing a ceiling price of $149 a year for tenofovir, compared with an originator `access` price of $207 in low-income countries and $360 in lower middle-income countries.
A tenofovir/3TC combination tablet will cost only slightly more ($179 a year), while a tenofovir/emtricitabine combination tablet will cost $225 a year, compared to an access price of $319 in low income countries and $552 in lower middle-income countries. Emtricitabine, or FTC, appears to be interchangeable with 3TC; the two compounds are very similar in chemical structure, and WHO has said that developing countries only need to keep one of the two drugs in stock.
A triple combination tablet containing tenofovir, 3TC and efavirenz – a first line combination recommended by WHO for resource-limited settings, and the standard of care in Europe and the United States – will cost $339 in both low income and lower middle-income countries, less than the price charged by the Gilead access programme for tenofovir alone.
Tenofovir is now preferred to d4T (stavudine) in first-line treatment because of the lower rate of side-effects associated with the drug, but uptake in developing countries has been slow because of lack of registration and the high price of the drug compared to AZT-based combinations. Tenofovir will remain more expensive than AZT, but the new price reductions close the gap substantially.
Lopinavir/ritonavir, marketed by Abbott as Aluvia or Kaletra in low and middle-income countries, will be offered by generic manufacturers at a ceiling price of $695 a year – higher than the price offered by Abbott to sub-Saharan Africa and some other least developed countries, but still substantially cheaper than the $1000 price tag recently announced for lower middle-income countries by Abbott.
Other important reductions include cheaper AZT/3TC combination tablets, down to $129 a year, compared with an average of $180 paid by low income countries during the past year, according to the World Health Organization’s Global Price Reporting Mechanism.
The WHO price reporting mechanism reflects what countries actually paid after procurement negotiations – some countries get better prices because they pay on time and place regular orders, not because they placed the largest orders, according to research into prices paid by Global Fund grantees carried out by Brenda Waning of Boston University School of Public Health.
Abacavir, a second-line nucleoside analogue, will be available at $331 a year, compared to an average price of $750-$800 paid recently, while another second-line nucleoside analogue, didanosine, falls from an average of $1096 in lower middle-income countries to $248 a year.
The prices will be available to 66 countries that currently buy their antiretrovirals through the Clinton HIV/AIDS Initiative procurement consortium, and the second-line drug prices will be available for 27 countries that will receive drugs financed by UNITAID in 2007-2008.
“All of the products included in today’s announcement have either been approved by or submitted to a stringent regulatory authority such as the WHO or US FDA, or will be submitted to these authorities in the next few months,” the Clinton HIV/AIDS Initiative said in a press statement.