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Malaria medicines and diagnostics WHO/UNICEF TBS

Malaria medicines and diagnostics WHO/UNICEF TBS Access to medicines 19 November 2009 - Geneva Silvia Schwarte Global Malaria Programme. Outline. WHO Guidelines and Prequalification Malaria diagnosis

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Malaria medicines and diagnostics WHO/UNICEF TBS

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  1. Malaria medicines and diagnostics WHO/UNICEF TBS Access to medicines 19 November 2009 - Geneva Silvia Schwarte Global Malaria Programme

  2. Outline • WHO Guidelines and Prequalification • Malaria diagnosis • Artemisinin market situation • Resistance and oral artemisinin-based monotherapies

  3. WHO Guidelines for the Treatment of Malaria Malaria diagnosis - Prompt parasitological confirmation by microscopy or alternatively by RDTs is recommended in all patients suspected of malaria before treatment is started. - Treatment solely on the basis of clinical suspicion should only be considered when a parasitological diagnosis is not accessible. Malaria treatment:- artemether – lumefantrine (AL) - artesunate – amodiaquine (AS+AQ) - artesunate + mefloquine(AS+MQ)* - artesunate + sulfadoxine-pyrimethamine (AS+SP) - dihydroartemisinin–piperaquine (DHA-PPQ) Update * not for wide-scale public sector use in Africa

  4. Co-blisters Fixed-dose combinations

  5. Malaria Rapid Diagnostic Tests (RDTs):International Quality Assurance Systems Lot testing 2007 Product testing 2008 Dossier review and manufacturer inspections 2009 Pre-qualification 2010

  6. WHO/FIND RDT performance testing

  7. WHO/FIND RDT performance testing

  8. ACTs: policy adoption, deployment,past procurement and 2009/10 forecast Forecast ACT treatment courses (Mio) 6-24 months from policy adoptionto ACT deployment ? Cumulative number of countries AMFm

  9. Complex ACT Supply Chain ManagementExample of artemether-lumefantrine Extractors Growers Extraction (1 month) Seedling, nursery, plantation, growth and harvest (7 months) Derivatisation (2 months) Manufacturers API suppliers Co-formulation, tabletting, packaging and shipping (4 months)

  10. Artemisinin price evolution (2002-2009) Cost of production Relative over-supply Global shortage Data kindly provided by Jacques PILLOY / ARTEPAL (AEDES/OTECI)

  11. Artemisinin market situationAssured Artemisinin Supply System (A2S2) • Confirmed artemisinin production gap Variable market forecasts, low available stocks or raw material, low profit and low incentives for growers resulting in low plantings, low extraction efficiency • May 2009: UNITAID approves A2S2 Project Loan facility for artemisinin extractors and API suppliers • Urgent action required to meet 2010-2012 forecasts High approval rates GF R7/R8, ongoing R9 and upcoming AMFm launch

  12. Artemisinin resistance

  13. Oral artemisinin-based monotherapy Slow progress Pharmaceutical manufacturers 24/73 (33%) withdrew their products 11/73 (15%) intend to comply with WHO ban National Drug Regulatory Authorities45/78 (58%) in line with WHO recommendations 2006 2007 2009 2008 Last updated on 17.11.2009

  14. Thank you

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