Sharply increased demand for artemether-lumefantrine, an artemisinin-based combination therapy (ACT) used to treat malaria, is likely to result in a shortage from now until at least March 2005. ACTs are currently the most effective medicines available to treat falciparum malaria -- the deadliest form of the disease.
Since 2001, the World Health Organization (WHO) has recommended that countries where malaria is resistant to conventional treatments such as chloroquine should switch to ACTs. WHO currently recommends four ACTs: artemether-lumefantrine, artesunate-mefloquine, artesunate-amodiaquine, and artesunate-sulfadoxine/pyrimethamine.
Forty countries (20 of them in Africa) have officially adopted these medicines for the treatment of malaria since 2001. Eighteen countries adopted them in 2004 alone. Fourteen countries have opted for artemether-lumefantrine as their first-line malaria treatment.
WHO concluded an agreement in 2001 with Novartis Pharma AG, under which Novartis provides its co-formulated artemether-lumefantrine product (Coartem®) to WHO at cost for supply to the public sector of malaria endemic developing countries.
Coartem® is currently the only ACT that has been prequalified by WHO. This means that WHO has arranged for the product dossier and the manufacturing process to be evaluated, and that as a result of this evaluation, the drug was found to be acceptable in principle for procurement by UN agencies.
Orders for artemether-lumefantrine have increased rapidly since 2001, when WHO requested 220 000 treatment courses for the public sector. In 2004, demand of ten million treatment courses was forecast. For 2005, WHO projects demand for 60 million treatment courses.
Novartis has informed WHO that due to insufficient supply of the key ingredient artemether from its Chinese suppliers, there is currently a shortage of the drug. As a result, WHO will not be able to procure the quantities of artemether-lumefantrine required by countries during the coming months.
Artemether is derived from artemisinin, a raw material extracted from the plant Artemisia annua. Cultivation of Artemisia annua requires a minimum of six months. The extraction, processing and manufacturing of the final product require an additional three to five months. The recent surge in demand for artemisinin has created temporary pressure on availability in the market. The shortage is likely to persist until at least March 2005. Countries and NGOs are placing orders for 4.5 million treatment courses of artemether-lumefantrine for that time period. At present it is uncertain how many of those courses can be delivered.
WHO is recommending that all countries facing shortages increase procurement of their second-line antimalarial treatment, which is generally quinine. Quinine is made from the bark of the Cinchona tree and used to be the mainstay of malaria treatment. Unlike chloroquine, quinine is still effective against falciparum malaria, but it is difficult to use because treatment takes longer.
WHO will offer technical assistance to any country facing interrupted supply of artemether-lumefantrine. It will also provide each country that has placed an order for artemether-lumefantrine with details of expected quantities available, and delivery schedules.
WHO has engaged in stepped up malaria prevention, working with partners towards rapid deployment of free or highly subsidized insecticide-treated mosquito nets to those most vulnerable to death or serious harm from malaria -- young children and pregnant women.
As a result of the supply shortage, WHO will establish a system to prioritize between requests for Coartem®, based on a number of specific criteria (in addition to the existing eligibility criteria).
WHO will issue an update on the artemether-lumefantrine supply situation by the end of November 2004.