Paving the way for affordable and equitable liposomal amphotericin B access worldwide

Abstract

Amphotericin B has long been crucial for treating many serious infectious diseases, such as invasive fungal infections and visceral leishmaniasis, particularly for patients who are immunocompromised, including those with advanced HIV infection. The conventional amphotericin B deoxycholate formulation has largely been replaced in high-income countries with liposomal amphotericin B (LAmB), which has many advantages, including lower rates of adverse events, such as nephrotoxicity and anaemia. Despite an evident need for LAmB in low-income and middle-income countries, where mortality from invasive fungal infections is still substantial, many low-income and middle-income countries still often use the amphotericin B deoxycholate formulation because of a small number of generic formulations and the high price of the originator LAmB. The pricing of LAmB is also highly variable between countries. Overcoming supply barriers through the availability of additional quality-assured, generic formulations of LAmB at accessible prices would substantially facilitate equitable access and have a substantial effect on mortality attributable to deadly fungal infections.

Figure

Price and demand analysis (A) Quantities of the three different amphotericin B formulations purchased between 2017 and 2021 in HICs and LMICs. Our analysis is based on IQVIA MIDAS data of monthly volume sales for January, 2017, to December, 2021, reflecting estimates of real-world activity. (B) Price of liposomal amphotericin B (AmBisome) in selected high-income (red) and middle-income (blue) countries. The price of AmBisome was obtained from the Pharmaceutical Services Programme of the Ministry of Health (Malaysia), Kyoto Encyclopedia of Genes and Genomes (Japan), ViDAL.fr (France), HCI Compendium (Switzerland), Drugs.com (USA), British National Formulary (UK), Medicine Price Registry (South Africa), Ministry of Health (Brazil), and RxMediaPharma (Türkiye). Prices are shown in US$, converted from the local currency at exchange rates of November, 2023. Liposomal amphotericin B is not registered in Malaysia; the price stated relates to an import with special approval from the Malaysian Ministry of Health. HICs=high-income countries. LMICs=low-income and middle-income countries.