ACT Scale up: The Global Picture

Transcription

1 ACT Scale up: The Global Picture Luke Rooney November 8 th 2012

2 The key to artemisnin combination therapy (ACTs) scale up has been in the last 10 years Active ingredient identified as artemisinin and extraction process developed Lumefantrine developed and used in combination with artemether Artemether-lumefantrine first ACT to gain regulatory approval Global Fund and WHO actively facilitate switch to ACTs AMFm phase I begins to provide subsidized ACTs in the private sector Anti-malarial qualities of artemisia officially noted by Chinese scientists First suggestion of using artemisinin in combination with longer acting drug Rights to sell artemetherlumefantrine outside China sold to Novartis WHO recommends the use of ACTs in the treatment of malaria Additional manufacturers gain WHO pre-qualification for ACTs Source: Artemisia annua, Artemisinin, ACTs & Malaria Control in Africa Tradition, Science and Public Policy Dana G. Dalrymple 2

3 The vast majority of countries now recommend an ACT as the first line treatment in the public sector There was a concerted effort to move away from sub-optimal treatments to ACTs The majority of countries now have ACTs as first-line treatment Cumulative number of countries in Africa adopting ACTs AL ASAQ AS-SP AL / ASAQ Unknown Preferred Treatment Note: Some countries have multiple recommended treatments and may or may not indicate one as preferred Source: World Malaria Report

4 There are now 6 available ACTs with quality assured 1 suppliers - 2 of these represent 98% of ACT demand in the public sector Overview of timeline to launch ACT Share of Global Market (2012) 1 Formulations Co-b FDC Disp. Quality-Assured Suppliers 1 AL 77.5% AS-AQ 19.6% AS-MQ % AS-SP 1.8% DHA-PQP 0.9% AS-PY 0% SRA or WHO PQ approved product available 1) CHAI ACT forecast Note: Quality-Assured is defined according to the Global Fund s Quality Assurance Policy (i.e. is either WHO Prequalified, approved by another stringent regulatory authority, or is recommended by the Global Fund s ERP) 4

5 The AMFm has been key to ACT scale-up over the last 3 years with Indian manufacturers representing 61% of the supply AMFm Orders (M) ASAQ Co-b ASAQ FDC 33.7 DHA-PPQ Madagascar 3.0 Cambodia Tanzania 32.5 Niger 4.7 Guilin 10.0 Sigma-Tau Sanofi-Aventis 33.7 Quality Chemicals 3.7 Uganda 43.7 Ghana 46.1 Novartis 66.5 AL Kenya 48.5 Ipca 69.5 Nigeria Cipla % Ajanta 47.0 Drug Country Manufacturer Note: Only includes orders uploaded to Global Fund website; Data cleaned to remove repeat approved orders and negative deliveries Source: Global Fund website Data from July 2010 September 30,

6 Over 1 billion ACTs have now been delivered with 60% of the treatments supplied in the last 3 years Global volumes of ACT treatments (M) ,239.3 AMFm phase I provides subsidized ACTs in the private sector WHO recommends the use of ACTs in the treatment of malaria Global Fund and WHO actively facilitate switch to ACTs : Dr. Maryse Dugue, WHO, "ACT market evolution: an overview" February, : WHO WMR - 7 major companies, public sector + AMFm private sector orders from GFATM website : ACT Demand Forecast, UNITAID ACT forecasting consortium July 2012 excluding private premium sector 2012e Total 6

7 There are still future challenges and opportunities in ACT scale-up 1 Artemisinin Tight global supply/demand balance in due to long lead times and uncertain demand 2 Funding Reductions and gaps in donor funding with lack of visibility in the longer term 3 Supply Chain Issues in quantification and lack of coordination of procurement at the country-level 4 Resistance Artemisinin and combination drug resistance cause issues with product choice and scale up 5 Formulation Need to increase the diversity in supply of childfriendly formulations 6 Private sector There is huge demand for anti-malarials in the private sector but the vast majority is not for ACTs 7