Access to Artemisinin-based Antimalarial Medicines Dr Clive Ondari Medicines Policy and Standard and Roll Back Malaria (RBM) Department TBS 2005

Scope of the presentation What environment are we working in? An overview of the problem of antimalarial drug resistance Changing of antimalarial treatment policies The challenges in optimisation of Access to antimalarial medicines Where are we going?

Partnering to tackle malaria - RBM RBM = Roll Back Malaria UN Agencies Movement – UNICEF, UNDP, WB (founding partners) – initiated 1998 Global Movement – doing things differently: Regional Dev. Bank, Major Dev. Partners: USAID, DfID), Private Sector, NGOs Regional Cooperation Initiatives (OAU/AU) MOH (National Malaria Control Programmes) + Country-level Partners: NGOs, community-based organizations, large private-sector employers (estates, mining and petroleum companies, etc.) Focuses on "right medicine, right place at the right time

Situation analysis: the challenges Quality of antimalarial drugs has been declining. The efficacy of (affordable) antimalarial drugs has been declining (drug resistance) and high cost of replacement options. 60-90% of the population seek initial treatment from non- public sector, i.e. street vendors, kiosks. Supply of drugs is often inefficient and unreliable.

Failure rates (%) – Content (2003)

Failure Rates (%) – Dissolution (2003)

Malaria distribution and reported case of resistance or treatment failure

Factors leading to development of resistance Lack of guidelines/poor drug treatment policies Irrational prescribing Irrational drug use Drug concentration “tail” – poor formulations Liberalized, uncontrolled drug market leading to poor quality products circulating in international and domestic markets

Selection: Artemisinin-based Combination Therapies (ACTs) FDC Artemether/lumefantrine MDT Artesunate + amodiaquine ACTs Artesunate + SP Artesunate + mefloquine Amodiaquine + SP

Access to ACTs - 2001 Only one fixed dose combination available: artemether-lumefantrine (Coartem®), patented and single-source All other ACTs: multi-source products, available as individual products to be co-administered (preferably in course-of-therapy blister packs). Market not primed: few manufacturers, limited experience with manufacturing and packaging of artemisinin derivatives (highly hygroscopic), API linked to natural plant production – shortages? Relatively new products on the international market – limited country experience in regulation and procurement In Jan. 2005 GFATM will support ONLY prequalified medicines!

Cost implications of moving to ACTs Average cost per adult treatment (US$) (2002)

Global Forecasts/Estimates for procurement Total Morbidity estimates 2004 30,007,678 50,012,796 2005 - 2006 131,583098 219,305,163 These are conservative (cautious) estimates of the countries that have changed, that are changing, and that are expected to change, and which will be deploying ACTs in 2004 and 2005

GFATM grants for ACTs

Summary: Interventions to address limited Access Selection: 1st WHO Malaria Treatment Guidelines (2005) Quality issues: Prequalification Objectives: To accelerate sustained access to, and use of, good quality ACTs To support drug regulatory agencies in regulating ACTs Progress: Limited – Coartem and 1 Artesunate 50mg tab. prequalified Supply issues: Malaria Medicines Supplies Service Linking national programmes with suppliers Forecasting demand and supply (ACT – long supply chain) Financing: working closely with GFATM and development partners (esp. regional development banks)