“This agreement is significant in that it helps address immediate treatment needs in some countries for one of the world’s most neglected diseases.
But it can not be seen as a global solution as it only covers a small proportion of patients worldwide.
We have doubts about whether this is a sustainable solution: more needs to be done to ensure treatment is affordable and available worldwide in the long-term, and that means encouraging competition from similar products to bring down the price of treatment”
Dr. Koert RITMEIJER
Health Advisor, Médecins Sans Frontières (MSF)
Context
The US pharmaceutical company Gilead Sciences has announced that it has signed an agreement with the World Health Organization (WHO) on a donation of AmBisome for the treatment 50,000 patients with visceral leishmaniasis (VL) in as eligible countries in South Asia and East Africa for a period of five years, starting in 2012.
Liposomal amphotericin B (L-AmB), which Gilead markets under the brand name AmBisome, is indicated for treatment of visceral leishmaniasis, a neglected parasitic tropical disease, and for the treatment of fungal infections, including for severe AIDS-related opportunistic infections such as cryptococcal meningitis. WHO considers L-AmB as the preferred option for elimination of visceral leishmaniasis in the Indian subcontinent,[1] and has recently included it in its latest treatment guidelines for cryptococcal meningitis.
But L-Amb is also marketed in both wealthy and middle-income countries, for lucrative indications such as for immuno-suppressed cancer or transplant patients.
The Gilead donation has a limited scope as it will only serve the needs of a small proportion of patients with visceral leishmaniasis. There are between 250,000 and 300,000 new cases every year, but only an average of 10,000 patients will benefit from the donation annually. In addition, the donation does not apply to AIDS-related fungal infections.
Gilead has not yet disclosed which countries will be eligible. It is unlikely that the donation applies to India, the country with by far the highest burden of visceral leishmaniasis.
MSF has asked Gilead to further bring down the price of AmBisome for visceral leishmaniasis in developing countries. Gilead offers AmBisome for visceral leishmaniasis at US$ 18 per vial for the public sector and for not-for-profit organisations such as MSF. Because several vials are needed, that comes in at around $200 per treatment course. A study has shown that if the price of AmBisome was reduced to under $10 per vial in India, then using the drug would become the most cost-effective strategy to treat the disease[2].
There are also questions surrounding the sustainability of donations, and particularly long-term sustainable access to affordable liposomal amphotericin B in light of this donation. As demand increases over time, it will not be possible to rely on a donation for worldwide supply. AmBisome is so far the only version of L-AmB to have been validated by a stringent drug regulatory authority, but generic manufacturers are currently working on competing versions.
[1] Control of the leishmaniases. Report of a meeting of the WHO Expert Committee on the Control of Leishmaniases, Geneva, 22–26 March 2010, WHO Technical Report Series, 2010
[2] Cost-Effectiveness Analysis of Combination Therapies for Visceral Leishmaniasis in the Indian Subcontinent, Meheus, F. et al, PLoS NTD, September 2010