1. Malaria treatment policies: the challenge, strategies and the options SOTA, Nairobi, Kenya 12 th June 2002

2. Global Malaria Control Strategy Early diagnosis and effective treatment of malaria illness

3. Some factors preventing effective case management Failure to recognize malaria Failure to recognize signs of severe malaria Use of inappropriate or inadequate courses of treatment Poor adherence to tx guidelines at health facility level Poor adherence at the household level Poor availability and access to drugs Use of poor quality drugs Use of ineffective drugs due to drug resistance

4. Challenges to antimalarial drug policy Widespread resistance to common antimalarials e.g. chloroquine Mounting resistance to replacement therapies e.g. sulphadoxine-pyrimethamine (SP) New therapies are more expensive and have more complicated treatment regimens Availability of poor quality or substandard drugs Home treatment; private sector more difficult to control

5. Challenges to antimalarial drug policy [2] Equitable access to reduce mortality and morbidity Emphasis on community management Reduces development of resistance Emphasis on regulation and controlled use AccessRational Use

6. Changing national treatment policies Need a rational approach for decision making for: When to change national first line treatment –AFRO guidelines: ›15-25% drug resistance alert phase ›≥ 25% drug resistance is action phase “Evidence” for changing policy ~Drug resistance and monitoring ~Attitudes and practices ~Behaviors

7. Efficacy vs. effectiveness Program effectiveness: Drug efficacy Drug use determinants ~Availability ~Affordability ~Acceptability ~Compliance –Frequency and total number of doses –Adverse effects and acceptability –Ability of users and mothers to follow directions

8. Efficacy vs. effectiveness e.g. SP Parasite clearance=80% Availability=90% Affordability=100% Compliance=100% (single dose/DOT)

9. Efficacy vs. effectiveness e.g. SP

10. Efficacy vs. effectiveness e.g. Artesunate/SP Parasite clearance=99% Availability=50% Affordability=50% Compliance=50%

11. Efficacy vs. effectiveness e.g. Artesunate/SP

12. Changing national treatment protocols: Factors to consider Efficacy and safety Adverse effects Compliance (ease of use, acceptability, formulation) Cost Ability to curb resistance development Ability to reduce transmission (gametocytocidal) Useful therapeutic life Use in young children and pregnant women

13. Changing national treatment protocols: Other factors to consider Biological vs. clinical diagnosis Quality Rational use Reduce availability/demand of undesired product Role of regulation ~Regulate undesirable drugs ~Decrease availability

14. Changing national treatment protocols Other factors to consider Financial burden for change ~Direct cost: more expensive drugs ~Indirect cost: retraining of HW, new STGs etc. Capacity of health system to implement policy Provision for Intermittent Preventive Therapy (IPT) for pregnant women Home management Engage the private sector (franchising, subsidies, social marketing, incentives)

15. Options for replacement therapies Continue using SP until it is no longer effective (potential of compromising the use of other antifolates under development) Amodiaquine monotherapy (cross-resistance with CQ) Mefloquine, Malarone etc. but, not without problems Combination therapy but not without consideration to issues

16. Artemisinin based combination therapy Advantages of ACT: High efficacy and rapid clearance of parasites Experience in SE Asia shown to slow down the development of resistance Artemisinin reduces gametocyte carriage thus reduces malaria transmission

17. Issues concerning use of ACT Limited experience in Africa Lack of safety data in pregnant women Higher cost Need for better diagnosis Compliance, packaging Issues of misuse due to role in severe malaria All monotherapies must be replaced with CT Public vs Private sector Which combinations?

18. Cost comparison of adult tx courses of available new combinations in relation to selected monotherapies

19. Cost Incremental cost of AQ+AS rather than AQ+SP: US$1.10 per patient Tanzania: 16 million cases annually Increased cost of US$17.6 million (annually) Total annual government expenditure on health: US$ 5.5 per capita (malaria: US$ 0.42 per capita)

20. Lessons learned Need for documentation of lessons learned and a framework for a rational approach to drug policies and implementation Examples: ~Malawi: Difficulties in implementation ~Kenya: SP deregulation ~Zambia: Cost of combination therapy ~Uganda: CQ + SP (pre-packaging etc.)

21. Malaria Action Coalition USAID mechanism for focusing funds towards an integrated work plan Goal: The attainment of the Abuja goals for the treatment of malaria and the control of malaria during pregnancy Partners: WHO/CDC/MNH/RPM Plus Funds channeled to partners through field support and “core” funds to provide support to address these programmatic challenges of antimalarial drug policy development and implementation