1. Selection of malaria treatments& diagnostics Presentation by Rémy ProhomRBM Partnership Secretariat, Malaria Medicines & Supplies Services Anglophone PSM Workshop, Nairobi Kenya, 20-24February 2006

2. Treatments Selection of malaria treatments & diagnostics

3. ISSUE: • API of artemisinin cannot be produced yet by synthesis • ACTs manufacturing rely then on agricultural raw material production Artemisin-based combination therapies have proven to be the most effective.

4. Practical solutions • Joint tender WHO-UNICEF to manufacturers of ACTs • Long Term Agreement to ensure low and stable price with selected manufacturers • WHO-UNICEF-IAPSO can order Coartem@ at cost price for public health sector • Partners advocacy to strengthen production and bring more manufacturers in the loop

5. FDC • Artemether/Lumefantrine • Artesunate + amodiaquine ACTs • Artesunate + SP • Artesunate + mefloquine Combination therapies recommended by WHO Response to increasing resistance WHO Technical Consultation on “Antimalarial Combination Therapy” – April 2001

6. Artemether/Lumefantrine Treatment of acute uncomplicated malaria due to Plasmodium falciparum or mixed infections including P. falciparum in areas with significant multidrug resistance.

7. Novartis Pharma AG Artemether/Lumefantrine

8. Artesunate+Amodiaquine Treatment of acute uncomplicated malaria due to Plasmodium falciparum or mixed infections including P. falciparum in areas with significant drug resistance to Chloroquine or Sulfadoxine-Pyrimethamine.

9. Artesunate+Amodiaquine 3 Manufacturers currently selected: • CIPLA • IPCA • SANOFI AVENTIS

10. Artesunate+Amodiaquine Average prices for AS+AQ:

11. CIPLA Artesunate+Amodiaquine

12. IPCA PHARMACEUTICALS Artesunate+Amodiaquine

13. SANOFI-AVENTIS Artesunate+Amodiaquine

14. Artesunate+Sulfadoxine/Pyrimethamine Treatment of acute uncomplicated malaria due to Plasmodium falciparum in areas where resistance to Sulfadoxine-Pyrimethamine is low (i.e. where the 28-day cure exceeds 80%).

15. GUILIN Artesunate+Sulfadoxine/Pyrimethamine

16. Artesunate+Mefloquine • Until now both independent drug WHO GMP approved were purchased separately and given together to the patient; • A co-blister formulation has just been GMP approved and is available on the market, but at a much higher price.

17. Lead time delivery • Address a request to the manufacturer (or procurement agent) for each and every order for any ACT and get a written answer on the delivery time for your specific order. • Lead time may vary depending of many factors (production site, quantities, packaging, volume and destination) and therefore should be planned much ahead.

18. Remember about ACTs… • Short shelf life (24 months) • Increased costs • Longer lead time for deliveries • Challenging implementation

19. Rapid Diagnostic Tests Selection of malaria treatments & diagnostics

20. Choice of RDTs Considerations for choosing an RDT include: • Plasmodium species to be detected (P. falciparum only, or panspecific) • Shelf -life and temperature stability in intended conditions of storage and use • Ease of use, including format of the test (e.g. cassette, dipstick, card) • Requirement for post-treatment testing of patients • Cost (including transport, training, and quality control) • Sensitivity Good quality assurance processes after purchase are likely to be of greater importance.

21. Quality assurance Quality assurance system to sustain the reliability of RDTs ManufacturerGood manufacturing practices/control LaboratoryNat/RegionalBatch control District/remote areassensitivity check Final userTraining & supervision Transport & stockMonitoring & temperature control

22. Procurement issues • Real-time temperature stability data on the product, and accelerated data on the purchased lot • Evidence of successful operational use, or good quality field data on the product • Long-term viability of manufacturer (to ensure continuity of supply) • Evidence of Good Manufacturing Practice /ISO certification (ISO13485:2003 is specific for quality management systems for medical devices) …/…

23. Procurement issues • Availability of product support • Provision of sample products for assessment and testing for ease of use • Agreement for replacement of products which fail agreed quality control procedures (see above) • Box sizes appropriate to the rate of use of tests in the intended area, to minimize storage time in poor conditions and reduce the need to split boxes.

24. How to contact us… Malaria Medicines & Supply Services (MMSS) Roll Back Malaria Partnership Secretariat Website: http://rbm.who.int/mmss/ Mr Remy Prohom Technical Officer ACTs and RDTs related issues Tel: +41 (0)22 791 2679 E-mail: prohomr@who.int