1. WHO/Roll Back Malaria – 3 May 2004 1 Forecast of ACT needs based on current and expected changes in antimalarial treatment policies Procurement, Quality and Sourcing Project: Prequalification of Antimalaria Drug Products Procurement, Quality and Sourcing Project: Prequalification of Antimalaria Drug Products Presented by Dr A. Bosman Access to Prompt and Effective Treatment Malaria Policy and Strategy Team Roll Back Malaria Department

2. 2 Response to increasing resistance of P.falciparum to antimalarial drugs WHO Informal Consultation on “ Use of Antimalarial Drugs” (November 2000, Geneva): The potential value of drug combinations, notably those including an artemisinin derivative (ACT), to improve efficacy, delay development of drug- resistance and prolong the useful therapeutic life of antimalarial drugs was widely accepted. Recommended that combinations that do not contain an artemisinin derivative could be a preferred option for reasons of cost and accessibility in some countries

3. 3 Untried and Untested ? TOTAL= 435 (Courtesy of Prof N.White)

4. 4 Combination therapies recommended by WHO Artesunate + amodiaquine Artemether/lumefantrine Artesunate + SP Artesunate + mefloquine FDC MDT WHO Technical Consultation on “Antimalarial Combination Therapy” – April 2001 ACTs Amodiaquine + SP

5. WHO/Roll Back Malaria – 3 May 2004 5 Malaria endemic countries which are experiencing resistance to currently used antimalarial monotherapies (chloroquine, sulfadoxine/pyrimethamine or amodiaquine) should change treatment policies to the highly effective Artemisinin-based Combination Therapies WHO recommends ACTs WHO/RBM Position Statement - November 2003

6. WHO/Roll Back Malaria – 3 May 2004 6 Limitations of AQ+SP: 1.Restricted to few countries in West Africa due to drug resistance; 2.Unlikely to delay resistance because widely used as monotherapies; 3.Combined use endangers their potential as partner drugs for ACTs; 4.Risk of compromising efficacy of SP - only option for IPT in pregnancy; 5.Resources for policy change and implementation should be directed to the most effective and durable treatment policy. Amodiaquine + Sulfadoxine/Pyrimethamine, limited to countries of West Africa, as interim policy for countries unable to move immediately to ACTs Role of Combination Therapy (CT) WHO/RBM Position Statement - November 2003

7. 7 35 countries adopted ACTs ContinentCountriesOptionsLevel AFRICA 16: 1 st -line 3: 2 nd -line Burundi, Cameroon, Eq. Guinea, Gabon, Ghana, Liberia, South Sudan, Sao Tomé & Principe, Zanzibar ART + AQ1 st -line Benin, Comoros, Kenya, South Africa, Tanzania, Zambia CoA1 st -line Côte d'Ivoire, Mozambique, Senegal CoA2 nd -line North Sudan ART + SP1 st -line ASIA 9: 1 st -line 2: 2 nd -line Cambodia, Laos, Myanmar, Thailand ART + MEF1 st -line Bangladesh, Bhutan CoA1 st -line Indonesia ART + AQ1 st -line India (5 Provinces) ART + SP1 st -line Viet Nam CV-81 st -line Papa New Guinea ART + SP2 nd -line Philippines CoA2 nd -line SOUTH AMERICA 5: 1 st -line Ecuador, Peru ART + SP1 st -line Bolivia, Peru ART + MEF1 st -line Guyana, Surinam CoA1 st -line

8. 8 Trends in malaria treatment policy CQ+SP SP/AQ AQ+SP ACT Malawi S.Africa Kenya Botswana Tanzania Ethiopia Zimbabwe Uganda S.Africa Rwanda DRC Burundi Zambia Eritrea Zanzibar Cameroon <1993199819992000200120022003 Burundi Mozambique 2004 Comores Gabon Philippines Côte d'Ivoire Senegal PNG Viet Nam Cambodia Thailand Laos Myanmar Peru Bolivia Surinam 1 st -line: Colombia

9. 9 Adoption of ACTs in 1 st -quarter 2004 Africa Benin, Eq. Guinea, Ghana, Kenya, Liberia, Sao Tome, N Sudan, S Sudan, Tanzania Asia Bangladesh, Bhutan, India South America Ecuador, Guyana Promoting factors: drug resistance + international pressure + commitment of GFATM resources

10. 10 30 countries: 1 st -line Countries' choices of ACTs: the current situation 5 countries: 2 nd -line 20 more countries are currently considering policy change to ACTs 10 4 4 1 4 1 ART+AQ ART+MEF ART+SP CoA ART+SP CV8

11. 11 WHO Technical Consultation on Forecasting of Artemisinin-based Combination Treatment (ACT) Requirements for Malaria WHO/HQ Geneva, Switzerland, 23-24 February 2004 Country estimations of ACT requirements Global forecast of ACT requirements

12. 12 Global forecasts of ACTs for the transition period 2004 -2005 Recent change to ACTs – consumption data not applicable for new medicines. Market forces (demand & supply) will intervene soon to provide real-time data to manufacturers and funding agencies 1.Focus on countries introducing 1 st -line ACTs in 2003 - 2005 2.Morbidity-based method using WHO’s most recent estimates of country malaria incidence (all age groups) 3.No adjustment for treatment based on fever 4.Upper and lower limits (= 60% if distribution limited to public sector only) Global forecasts of ACTs for the transition period 2004 -2005 Recent change to ACTs – consumption data not applicable for new medicines. Market forces (demand & supply) will intervene soon to provide real-time data to manufacturers and funding agencies 1.Focus on countries introducing 1 st -line ACTs in 2003 - 2005 2.Morbidity-based method using WHO’s most recent estimates of country malaria incidence (all age groups) 3.No adjustment for treatment based on fever 4.Upper and lower limits (= 60% if distribution limited to public sector only) Global forecasts of ACTs WHO Technical Consultation on Forecasting of ACT Requirements for Malaria

13. 13 219,305,163 50,012,796 Upper 131,583098 2005 30,007,678 2004 Lower These are conservative estimates based on country needs, and current processes of policy change Based on the following assumptions: 1.country-wide deployment, 2.implementation 9 months after adoption of the new policy, and 3.funding available Forecasts for procurement only by the public sector Based on total morbidity estimates (for both public and private sectors) Global forecasts of ACTs

14. 14 ACT forecast for Africa 152,796,350 30,802,367 91,677,810 2005 18,481,420 2004 Upper Lower Forecasts for procurement only by the public sector Based on total morbidity estimates (for both public and private sectors)

15. 15 Scale up required for end 2005 0 50 100 150 200 Number of Treatments (millions) 20042005 Year Minimum Maximum Current ACT production capacity Global forecasts of ACTs and production capacity

16. 16 GFATM - the largest financial supporter of ACTs in countries A total of about US$ 41 million has been committed over the full 5-year life of GFATM Board-approved proposals from endemic countries for the purchase of ACTs in three proposal rounds. In addition funds for chloroquine, SP or amodiaquine can be reprogrammed to ACTs if needed GFATM funding of ACTs Total annual number of ACT treatments (eq. adult doses) funded by GFATM

17. 17 The costs of estimated global ACT requirements far exceeds the current level of ACT financing by the GFATM. An enhancement of the financial resources for purchasing ACTs is, therefore, urgently required to both encourage endemic countries to adopt these effective treatment policies and to stimulate the market. Malaria is a highly treatable disease, and very effective treatment is available in the form of ACTs. WHO calls on all RBM partners to unite in a global coalition to enable countries accelerate access to ACTs and make these life- saving medicines affordable to the people in need. Momentum is high to ensure access to effective antimalarial treatment

18. 18