Catalyse the market for adult second-line medicines
Since its launch in 2007, UNITAID’s intervention in the adult second-line HIV medicines market has been highly successful in terms of overall public health impact and a sustainable, positive influence on the market. Implemented by the Clinton Health Access Initiative (CHAI), this project has created a generic market for second-line antiretrovirals (ARVs) by increasing the number of suppliers and spurring dramatic price reductions.
Challenge and Market Shortcoming
HIV/AIDS is a life-long disease. People on ARVs eventually will need newer and more potent drug combinations when they develop resistance or side effects. Every year an estimated 2-3% of people on life-sustaining ARVs need to make a switch to these “second-line” drugs.
An underdeveloped market for these medicines contributed to low access before 2006. Formulations adapted for low-resource settings were not available and prices were too high for patients. Complicated treatment guidelines and numerous possible regimens further fractured an already small market into several smaller pieces. This meant that few people who became resistant to their first-line medicines in developing countries were transitioned onto life-saving second-line medicines. The end result was often death.
CHAI used a series of interventions to increase the number of suppliers and bring second-line prices down. Interventions included pooled procurement to consolidate demand and price negotiations. UNITAID funding offered a reliable and timely payment stream to suppliers. Click here for an example of a supplier letter [PDF, 577 KB] to select manufacturers to supply antiretrovirals for this project.
Five years later, these interventions led to the creation of a healthy market for second-line HIV medicines. By 2011, 12 new quality-assured generic manufacturers of second-line HIV medicines have entered the market, fostering healthy generic competition. Today, the leading second-line regimen (TDF+3TC & LPV/r) costs about US$ 527 per patient per year as opposed to US$ 1500 per year in 2006.
Another key development has been UNITAID’s introduction of better adapted formulations and a lower pill burden. Prior to 2006, all second-line antiretrovirals in low-income countries required refrigeration. In 2010, atazanavir and heat stable ritonavir singles were launched in 11 countries. These heat-stable formulations allow for simpler delivery and storage of drugs, helping patients adhere to their drugs and giving caregivers the confidence needed to switch patients from first- to second-line treatment. By 2010 there were two manufacturers producing six heat-stable fixed-dose combinations for second-line treatment.
In November 2011, WHO Prequalification and the Food and Drug Administration approved the first heat-stable atazanavir/ritonavir (ATV/r) fixed-dose combination. This should reduce the cost of the leading second-line regimen to less than US$ 400 per patient per year. This landmark decision offers the first real alternative to lopinavir/ritonavir (LPV/r), another preferred second-line treatment that UNITAID has achieved significant price reductions for. ATV/r should cost up to 60% less than the current LPV/r. Five beneficiary countries ordered this new formulation during the December 2011 order cycle.
This project now provides positive benefits - lower prices and improved quality – to purchasers outside of UNITAID-funded countries. CHAI’s Procurement Consortium allows over 70 member countries to access lower prices and better quality second-line products. This means more people treated with less money, as governments and donors can continue to treat patients who need to switch from first-line antiretrovirals. Global cost savings for this project amount to at least US$ 600 million over the next three years.
A time-limited project that ended in December 2011, 15 out of 25 countries have transitioned to alternative funding sources. This includes five countries that transitioned out in the first half of 2011: Benin, Chad, Kenya, Mali, and Togo. The remaining 10 countries all transitioned out of the Project in 2011: Burundi, Cameroon, Democratic Republic of Congo, Haiti, India, Mozambique, Nigeria, Uganda, Zambia, and Zimbabwe.
UNITAID granted a no-cost extension of US$ 8,100,000 to cover all second-line emergency orders in 2012.