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

2. 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?

3. 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

4. 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.

5. Failure rates (%) – Content (2003)

6. Failure Rates (%) – Dissolution (2003)

7. Malaria distribution and reported case of resistance or treatment failure

8. 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

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

10. Access to ACTs
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 GFATM will support ONLY prequalified medicines!

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

12. Global Forecasts/Estimates
for procurement
Total Morbidity estimates
2004
30,007,678
50,012,796
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

13. GFATM grants for ACTs

14. 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)