Malaria treatment policies: the challenge, strategies and the options SOTA, Nairobi, Kenya

1. Malaria treatment policies: the challenge, strategies and the options SOTA, Nairobi, Kenya 12th 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] Access Rational Use Equitable access to reduce mortality and morbidity Emphasis on community management Reduces development of resistance Emphasis on regulation and controlled 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. effectivenesse.g. SP • Parasite clearance=80% • Availability=90% • Affordability=100% • Compliance=100% (single dose/DOT)

9. Efficacy vs. effectivenesse.g. SP

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

11. Efficacy vs. effectivenesse.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 protocolsOther 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