TBS 2005

Access to Artemisinin-based Antimalarial Medicines

Dr Clive Ondari Medicines Policy and Standard and Roll Back Malaria (RBM) Department

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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?

Department of Medicines Policy and Standards

TBS 2005

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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 Department of Medicines Policy and Standards

TBS 2005

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Situation analysis: the challenges

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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.

Department of Medicines Policy and Standards

TBS 2005

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100 80 60 40 20 0 G ab on

Failure rates (%) – Content (2003)

G ha na M al i Ke ny a M oz am bi qu e Zi m ba bw e Su da n

Department of Medicines Policy and Standards

TBS 2005

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Chloroquine Syrup Chloroquine Tablets Sulphadoxine/Pyrimetha mine Tablets

Failure Rates (%) – Dissolution (2003)

100 80 60 40 20 0

G ab on G ha na M al i

Chloroquine Tablet s

K en ya M oz am bi qu e

SP Tablet s

Zi m ba bw e Department of Medicines Policy and Standards

TBS 2005

6 Su da n

Malaria distribution and reported case of resistance or treatment failure

Department of Medicines Policy and Standards

TBS 2005

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Factors leading to development of resistance

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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 Department of Medicines Policy and Standards

TBS 2005

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Selection: Artemisinin-based Combination Therapies (ACTs) FDC MDT

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Artemether/lumefantrine Artesunate + amodiaquine Artesunate + SP Artesunate + mefloquine Amodiaquine + SP Department of Medicines Policy and Standards

TBS 2005

9 ACTs

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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!

Department of Medicines Policy and Standards

TBS 2005

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Cost implications of moving to ACTs 6 1 0 5 4 3 2 CQ SP AS/AQ AS/SP AT/LM AS/MF Department of Medicines Policy and Standards

TBS 2005

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Global Forecasts/Estimates Forecasts for procurement Total Morbidity estimates 2004 2005 - 2006

30,007,678 131,583098 50,012,796 219,305,163

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 Department of Medicines Policy and Standards

TBS 2005

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GFATM grants for ACTs 200 150 100 50 0 2.4

Round 1 5.2

Round 2 6.07

Round 3 Award Cummulative Department of Medicines Policy and Standards

TBS 2005

13 200 Round 4

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Summary: Interventions to address limited Access Selection: 1 st WHO Malaria Treatment Guidelines (2005) Quality issues: Prequalification

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Objectives: To accelerate sustained access to, and use of, good quality ACTs

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To support drug regulatory agencies in regulating ACTs Progress: Limited – Coartem and 1 Artesunate 50mg tab. prequalified Supply issues:

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Malaria Medicines Supplies Service

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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) Department of Medicines Policy and Standards

TBS 2005

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Thank you!