ACT IMPLEMENTATION IN THE AFRICAN REGION: An Update

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ACT IMPLEMENTATION IN THE AFRICAN REGION An
Update

• Thomas SUKWA
• Malaria Drug Policy
• WHO/AFRO

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Outline of Presentation

• Definitions
• Rationale for ACT Policies
• Recommended ACTs for Africa
• Evidence that ACT works
• Current Status of Treatment Policies
• Challenges
• WHO Support for Deployment of ACTs
• Conclusion.

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Definitions

• Antimalarial combination therapy (CT) is the
  simultaneous use of two or more blood
  schizonticidal drugs with different biochemical
  targets in the parasites and independent modes of
  action
• Fixed-combinations medicinal products
• Free-combinations (co-administered in separate
  tablets or capsules)
• Artemisinin-based combination therapy (ACT) is
  antimalarial combination therapy with an
  artemisinin derivative as one component of the
  combination

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Definitions contd.

• Within this definition, the following therapies
  are not considered antimalarial combination
  therapy
• use of an antimalarial drug with a
  non-antimalarial drug that enhances its action
  (e.g. chloroquine plus chlorpheniramine)
• use of a blood schizonticidal drug with a tissue
  schizonticidal or gametocytocidal drug (e.g.
  chloroquine plus primaquine)
• combinations in which neither of the individual
  components has significant schizonticidal effect
  (e.g. sulphadoxine-pyrimethamine,
  chlorproguanildapsone, atovaquoneproguanil)

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Rationale for ACT

• Widely established resistance to chloroquine and
  sulfadoxine-pyrimethamine
• Theoretical basis of CT are
• - protect individual drug against occurrence
  of resistance
• - to decrease rate of decline in efficacy
• - interrupt spread of resistant strains
• - decrease transmission in a region
• The degree of protection will depend on the
  frequency of genes resistant to the drugs in the
  combination already present in the parasite
  population and number of mutations to confer
  resistance.

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Why Artemisinins?

• Short half-life hence good for combination
• Rapid substantial reduction of the parasite
  biomass
• Rapid resolution of clinical symptoms
• Effective action against multi-drug resistant P.
  falciparum
• Reduction of gametocyte carriage
• No documented parasite resistance yet
• Few reported adverse effects.

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Adoption of Combination Therapy

• Technical Consultation on Antimalarial
  Combination Therapy Geneva, April 2001
• Reviewed current evidence on antimalarial drug
  combination therapies in different
  epidemiological settings
• Selected combinations for short-term use,
  particularly in Africa based on efficacy, safety,
  potential for wide-scale use, cost-effectiveness
  and potential to delay resistance.

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Combinations Recommended

• Artemether-Lumefantrine (Coartem)
• Artesunate (3 days) Amodiaquine
• Artesunate (3 days) SP
• 4. Artesunate (3 days) Mefloquine
• 5. Amodiaquine SP

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Combinations NOT Recommended

• Chloroquine based combinations (e.g CQ SP CQ
  Artesunate)
• Artesunate (single dose) SP
• 3. Chloproguanil-Dapsone (LapDap)

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EVIDENCE THAT ACT WORKS
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(No Transcript)
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Cambodia

• Number of confirmed malaria cases reduced by 33
  between 1999 and 2001 ( from 64,679 to 50,284)
• Number of recorded malaria deaths reduced by 54
  between 1999 and 2001 (from 891 to 412)

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Malaria Mortality RateThailand, 1949-1999
MR per 100,000
Year
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Malaria Notifications in KwaZulu Natal before
(2000) and after (2001 2002) effective residual
spraying w DDT and deployment of
artemether-lumefantrine
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CURRENT STATUS OF TREATMENT POLICIES
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Trends in malaria treatment policy
1st-line
Burundi
Comores
Ben Cam Ken Tan STP
S.Africa
Gabon
ACT
Zambia

Zanzibar
Rwanda
Mozambique
AQSP
Senegal
Uganda
Eritrea
CQSP
Ethiopia
Zimbabwe
Botswana
Malawi
Burundi
SP/AQ
Tanzania
Cameroon
Côte d'Ivoire
S.Africa
Kenya
DRC
lt1993
1998
1999
2000
2001
2002
2003
2004
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CURRENT TREATMENT POLICIES FOR UNCOMPLICATED
MALARIA IN THE AFRICAN REGION (May 2004)
ACT Policy 13
CT Policy 6
SP Policy 3
CQ Policy 20
EMRO Region
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Challenges
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Global Challenges

• Lack of Adequate Funding
• Availability of ACTs
• Long lead times involved in scaling-up production
  of ACTs
• Lack of urgency and political will among
  international and national policy makers,
  donors,NGOs

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ACT forecast for Africa
Upper
Lower
30,802,367
18,481,420
2004
152,796,350
91,677,810
2005
Forecasts for procurement only by the
public sector
Based on total morbidity estimates (for both
public and private sectors)
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Global forecasts of ACTsand production capacity
Minimum
200
Maximum
150
Number of Treatments
(millions)
100
Current ACT production capacity
50
0
2004
2005
Year
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WHO support for deployment of ACTs
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1. Procurement

• Artemether-lumefantrine (Coartem) Agreement
  between WHO and Novartis (May 2001) to make drug
  available to WHO at cost price for supplying
• governments of disease endemic developing
  countries,
• UN Agencies, governmental and non-governmental
  aid organizations working in association with
  such governments
• The MOU shall continue for 10 years
• Inability to place orders does not breach the MOU
  obligations

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2. Availability of the product

• as long as Coartem is commercially produced or
  distributed, Novartis will make it available to
  WHO at cost (ex-Basel) price
• US 2.40 for a blister pack of 24 tablets (4
  tabs/dose)
• US 1.90 for a blister pack of 18 tablets (3
  tabs/dose)
• US 1.40 for a blister pack of 12 tablets (2
  tabs/dose)
• US 0.90 for a blister pack of 6 tablets (1
  tab/dose)
• yearly price reviews (around May every year)
• mutually acceptable independent auditor on
  pricing (on WHO request)

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Course-of-therapy blister packs

• 4 different packs
• 10-14 kg (1-2 yrs)
• 15-24 kg (3-7 yrs)
• 25-34 kg (8-10 yrs)
• 35 kg (11 yrs)

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COARTEM PREFERENTIAL PRICING FOR PUBLIC SECTOR
EXPECTED PRICE CHANGES BY 2005
10.0
0.9
1.4
1.9
2.4
0.54
40.0
1.06
1.59
2.11
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3. Pre-qualification Scheme

• Expression of Interest (EOI) -
  Artemisinin-based antimalarials
• Products selected for Phase I
• Artesunate (oral preparations)
• Dihydroartemisinin (tablets, capsules, granules,
  suppositories)
• Artemether (oral preparations)
• Artemether lumefantrine (oral preparations)
• Artesunate (injection for IV and IM)
• Artemotil (injection forms)
• Dihydroartemisinin piperaquine
• ASMEF, ASAQ, and ASSP

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4. Diagnosis

• Greater role for laboratory diagnostics to
  improve the targeting of expensive treatments -
  microscopy facilities to be strengthened
• Rapid Diagnostic Tests (RDTs) can supplement
  microscopy in situations where the latter is not
  feasible
• Microscopy and RDTs have potential for cost
  saving expensive antimalarial treatment (gt1 USD)
  in areas of low to moderate transmission
• A quality assurance facility has been established
  by WHO in WPRO to assist countries in the
  procurement of RDTs

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5. A Malaria Drug Facility

• Global market estimates and projections for
  antimalaria drugs based on the requirements of
  endemic countries
• Pre-qualify drug manufacturers to ensure quality
  of manufacturing and production
• Negotiate price with manufacturers by pooling
  orders and forecasting market demands
• Improve formulation and packaging needs of
  endemic countries by presenting country needs to
  the pharmaceutical industry, and supporting R D
  in neglected areas
• Procurement and distribution to endemic
  countries
• Malaria Medicines Supply Services (MMSS).

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GFATM funding of ACTs
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
African 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
Total annual number of ACT treatments (eq.
adult doses) funded by GFATM
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CONCLUSION
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Momentum is high to ensure access to effective
antimalarial treatment

• 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.

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The time of poor drugs for poor people is over