Table 2.

Overview of miltefosine access issues by region

Region	Year first marketed/approved	Access issues	Supply and delivery
Asia27 75 108	2002	Large minimum quantities to be eligible for the preferential price (one batch or min 200 000 caps) Long lead time or delivery time and frequent stock-outs Difficulties in forecasting demand Tender system for national procurement: lack of details in the process for the manufacturer, programmes faced with lack of response Low affordability for the government and NGO sector	Through national VL control programme
Africa106	NA*	The reluctance of the manufacturer to register the drug in endemic countries Governments and end user/patients’ affordability Limited evidence on its effectiveness in the continent The dysfunctional or weak supply system	Usually brought in the country by NGOs or WHO
Europe31 78	2004	Only registered in Germany and very expensive (to buy directly from the manufacturer) Can be accessed through the name-based patient compassionate programme Liquid formulation for canine leishmaniasis is registered in most countries and widely used to treat pet dogs109	To be ordered directly from the company
North America31 86 97	2014	High cost and likely not covered by health insurance Governments' and end users' affordability	Available through CDC as an off-label treatment for PAM private market (producer price)*
Latin America53 110	2005	Registration has expired in many countries, no renewal sought by the company High cost and limited availability outside research use in most of the countries in the region	Through MoH in coordination with PAHO

*Impavido is available in the USA since Knight Therapeutics provided licensing agreement to Profounda in 2015 (www.impavido.com).

CDC, Centres for Disease Control and Prevention; MoH, Ministry of Health; NGOs, non-governmental organisations; PAHO, Pan American Health Organization; PAM, primary amoebic meningoencephalitis; VL, visceral leishmaniasis.