Access to Artemisinin-Based Antimalarial Products

1. Access to Artemisinin-Based Antimalarial Products Dr Clive O Ondari Essential Drugs and Medicines Policy Dept & Roll Back Malaria (RBM) Department World Health Organization

2. Access Framework 1. Rational 3. Sustainable selection financing ACCESS 4. Reliable 2. Affordable health and systems supply prices

3. What is RBM? • RBM = Roll Back Malaria • Initiated as a WHO/Cabinet project in 1998 • Started UN Agencies movement – UNICEF, UNDP, WB (founding partners) • Initiated Global Movement "doing things differently": Regional Dev. Bank; major partners: USAID, DfID, NGOs, private sector • Regional Initiatives (OAU →African Union) • Country movement: MOH (Nat. Malaria Control Programmes) + country-level partners: NGOs, community-based organizations, large private-sector employers (estates, mining and petroleum companies, etc.)

4. What is RBM? • WHY? • mechanism for coordinated international approach to fighting malaria • HOW? • an assembly of expertise, infrastructure, funding • working together – globally, regionally, nationally • raising awareness • GOAL? • burden of malaria reduced by 50% - 2010 • Strategies: • Protecting most vulnerable groups (pregnant women, <5's) • Preventing measures: insecticide-treated bednets (ITNs), in-door residual spraying (IRS) • Right medicines, right place, right time • Addressing emergencies and epidemics

5. What environment are we working in? • Quality of antimalarial medicines has been declining • Efficacy of (affordable) antimalarial medicines has been declining and high cost of replacement treatment options • >50% of population does not have regular access to most vital essential medicines • 60 - 90% of the population seek initial treatment from unqualified sources, i.e. street vendors, kiosks (private informal sector) • Supply of medicines is often inefficient and unreliable • Use of ineffective medicines leads to inadequate treatment and leads to drug resistance

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

7. Pilot Project on Quality of Antimalarial Products • Project Design: • Country selection criteria: “spot light countries” in AFRO and EMRO • Evaluation of most widely used antimalarials in these regions • Samples from various levels of distribution chain (household, peripheral health unit, district, private sector pharmacy, district hospital, teaching/referral hospital and gvt. medical stores • Quality testing of samples in central QC laboratory (CENQAM), South Africa • Evaluation of results and publication

8. Failure rates (%) - Content

9. Failure Rates (%) - Dissolution

10. FDC MDT Selection of antimalarials Moving towards ACTs • Artemether/lumefantrine • Artesunate + amodiaquine ACTs • Artesunate + SP • Artesunate + mefloquine • Amodiaquine + SP

11. What is required to include ACTs in the WHO Model List? • Submission to the Expert Committee on Essential Drugs by: • RBM Department • Pharmaceutical Manufacturers • Review by the relevant WHO Department(s) and Expert Committee(s) - comparison with other drugs on: • efficacy • safety • cost-effectiveness • public health relevance

12. Introducing ACTS - Scheme of Events Private Sector Public Sector Registration Selection Wholesaler CMS Procurement Retailer Facilities Wide Availability

13. Cost implications of combination therapy (ACT) Average cost per adult treatment (US$)

14. What has been done? • Development of monographs for: • artemether (tabs, caps, inj); • artemisinin (caps); • artemotil (arteether) (inj); • artenimol (DHA) (tabs); • artesunate (tabs) + mefloquine, proguanil • Antimalarial drug quality survey in 7 African countries • Training (DRA and manufacturers) in GMP and QA: focus on antimalarials • Clinical screening of traditional medicines for antimalarial activity (TRM support) • Development of treatment guidelines for malaria • Development of Malaria Medicines and Supplies Service (MMSS)

15. 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 Global Forecasts/Estimates Forecasts for procurement Adult treatments Total Morbidity estimates 2004 30,007,678 50,012,796 2005 - 2006 131,583098 219,305,163

16. GFATM grants for ACTs

17. Challenges – Access to ACTs • Only one fixed dose combination (FDC) 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!

18. Pre-qualification of ACT Manufacturers and Products • Objectives: • accelerate access to, and use of, assured quality ACTs • ensure adequate and effective treatment reaches greater numbers of people in need • support implementation of ACTs in ways that respond to specific needs of individual countries • support drug regulatory agencies in regulating ACTs • Progress: • Limited: Coartem® and 1 Artesunate 50mg tab. prequalified

19. Malaria Medicines and Supplies Services (MMSS) • What it MMSS? • Mechanism for assisting countries to scale-up access to medicines and other products • What will MMSS do? • Link NMCP with suppliers and other products • How will MMSS operate? • Creating procurement platform: depository of information on: • sources and prices • prequalified suppliers and products • national quantification of requirements → global estimates • mechanism for providing support to national programmes and producers)