Accelerating global adoption of the best severe malaria treatment
Three year old Saudat was at death’s doorstep last year when she was brought into Murtala Mohammed Specialist Hospital in Kano State, Nigeria. She had severe malaria, which is nearly always deadly if untreated.
Like Saudat, countless children are brought into the hospital every year with severe malaria, often unconscious, convulsing and with high fever. Saudat was given injectable artesunate, a new treatment recently introduced into Kano State that can save lives more quickly than existing treatments. Within 48 hours, Saudat had regained consciousness and was on the road to recovery.
In December 2012, the UNITAID Executive Board approved an investment of up to US$34 million to accelerate the global adoption of injectable artesunate and prepare healthcare workers to quickly integrate this drug into their standard of care. This grant will be implemented by the Medicines for Malaria Venture (MMV), the Clinton Health Access Initiative (CHAI) and the Malaria Consortium.
Challenge and market shortcomings:
Out of 219 million estimated annual malaria cases, approximately eight million are severe. Typically, children diagnosed in hospitals with severe malaria are given intravenous (IV) quinine. It is a cumbersome process: the IV drip needs to be changed every eight hours and treatment can last seven days. With a shortage of health workers in endemic countries, the need for such intense monitoring puts a high burden on the health care system and increases the risk for patients.
Clinical trials results published in 2010 showed that injectable artesunate is 22.5% more efficacious than quinine in reducing mortality in children. Artesunate can be administered rapidly through IV injection over 3-5 minutes or as an injection. Only two doses are administered on the first day of treatment, and the drug is given once daily thereafter. Despite being recommended by the WHO since 2011, several market shortcomings have limited the use of injectable artesunate. Inadequate advocacy, education and training have lead to poor acceptance by patients and healthcare providers. Injectable artesunate costs three times more than injectable quinine, due to the low volume manufactured and the lack of competition. Currently, there is only one WHO prequalified supplier of injectable artesunate.
MMV and UNITAID will create a market for injectable artesunate and introduce it as an alternative to quinine for the treatment of severe malaria. MMV will also encourage the market entry of a second supplier of injectable artesunate through negotiation in order to increase competition. To ensure that children are given a chance to reach hospital for treatment of severe malaria, this grant will also support the market entry of rectal artesunate. A community health worker or a mother can administer these suppositories; in effect, ‘buying time’ while the child is transported to hospital. Currently, no rectal artesunate product has been WHO-prequalified or approved by a stringent regulatory authority, despite being recommended by the WHO for the pre-referral treatment of severe malaria. This project will provide technical support to manufacturers of artesunate suppositories so that they can attain regulatory approval of the product.