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Malaria medicines and
diagnostics
WHO/UNICEF TBS Access to medicines
19 November 2009 - Geneva
Silvia Schwarte Global Malaria Programme
WHO/UNICEF TBS | 19 November 2009 2 |
OutlineOutline
WHO Guidelines and Prequalification
Malaria diagnosis
Artemisinin market situation
Resistance and oral artemisinin-based monotherapies
WHO/UNICEF TBS | 19 November 2009 3 |
WHO Guidelines for the Treatment of Malaria
WHO Guidelines for the Treatment of Malaria
Malaria diagnosis - Prompt parasitological confirmation by microscopy or alternatively by RDTs is recommended in all patients suspected of malaria before treatment is started. - Treatment solely on the basis of clinical suspicion should only be considered when a parasitological diagnosis is not accessible.
Malaria treatment: - artemether – lumefantrine (AL) - artesunate – amodiaquine (AS+AQ) - artesunate + mefloquine (AS+MQ)* - artesunate + sulfadoxine-pyrimethamine (AS+SP) - dihydroartemisinin–piperaquine (DHA-PPQ)
*not for wide-scale public sector use in Africa
Update
WHO/UNICEF TBS | 19 November 2009 4 |
Co
-bli
ster
sF
ixe
d-d
os
e c
om
bin
atio
ns
WHO/UNICEF TBS | 19 November 2009 5 |
Product testing
2008
Pre-qualification
2010
Lot testing
2007
Malaria Rapid Diagnostic Tests (RDTs):International Quality Assurance Systems Malaria Rapid Diagnostic Tests (RDTs):
International Quality Assurance Systems
Dossier review and manufacturer
inspections 2009
WHO/UNICEF TBS | 19 November 2009 6 |
WHO/FIND RDT performance testing
WHO/FIND RDT performance testing
WHO/UNICEF TBS | 19 November 2009 7 |
WHO/FIND RDT performance testing
WHO/FIND RDT performance testing
WHO/UNICEF TBS | 19 November 2009 8 |
ACTs: policy adoption, deployment,
past procurement and 2009/10 forecast
ACTs: policy adoption, deployment,
past procurement and 2009/10 forecast
0.5 0.6 2.1 5
31.3
82.7
97
130
160
200
0
20
40
60
80
100
120
140
160
180
200
2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
0
10
20
30
40
50
60
70
80
90
ACT procured Number of countries: ACT 1st lineNumber of countries deploying
AC
T t
reatm
en
t cou
rses
(Mio
)
Cum
ula
tive n
um
ber
of
countr
ies
Forecast
6-24 months from
policy adoption to
ACT deployment
6-24 months from
policy adoption to
ACT deployment
?
AM
Fm
WHO/UNICEF TBS | 19 November 2009 9 |
Complex ACT Supply Chain Management
Example of artemether-lumefantrine
Complex ACT Supply Chain Management
Example of artemether-lumefantrine
Seedling, nursery, plantation, growth and harvest (7 months) Seedling, nursery, plantation, growth and harvest (7 months)
Extraction (1 month) Extraction (1 month)
Derivatisation
(2 months)
Derivatisation
(2 months)
Co-formulation, tabletting, packaging and shipping (4 months)
Co-formulation, tabletting, packaging and shipping (4 months)
Growers
Manufacturers
Extractors
API suppliers
WHO/UNICEF TBS | 19 November 2009 10 |
Artemisinin price evolution (2002-2009)
Artemisinin price evolution (2002-2009)
Artemisinin indicatice spot price Price ($/kg)
240300
750
1100
700
170260 290
0
200
400
600
800
1000
1200
2002 2003 2004 2005 2006 2007 2008 2009
Years
$/k
g
Data kindly provided by Jacques PILLOY / ARTEPAL (AEDES/OTECI)
Global shortage
Relative over-supply
Cost of production
WHO/UNICEF TBS | 19 November 2009 11 |
Artemisinin market situationAssured Artemisinin Supply System (A2S2)Artemisinin market situation
Assured Artemisinin Supply System (A2S2)
Confirmed artemisinin production gap Variable market forecasts, low available stocks or raw material, low profit and low incentives for growers resulting in low plantings, low extraction efficiency
May 2009: UNITAID approves A2S2 Project Loan facility for artemisinin extractors and API suppliers
Urgent action required to meet 2010-2012 forecasts High approval rates GF R7/R8, ongoing R9 and upcoming AMFm launch
WHO/UNICEF TBS | 19 November 2009 12 |
Artemisinin resistance
WHO/UNICEF TBS | 19 November 2009 13 |
Oral artemisinin-based monotherapy Slow progress
Oral artemisinin-based monotherapy Slow progress
National Drug Regulatory Authorities:44/78 (56%) in line with WHO recommendations
(last updated 14.10.2009)
0
10
20
30
40
50
60
70
Num
ber o
f cou
ntrie
s
Number of countries still allowing monotherapies
Risk of development of resistance
National Drug Regulatory Authorities 45/78 (58%) in line with WHO recommendations
2006 2007 2008 2009
Manufacturers of oral artemisinin-based monotherapies: 24/73 (33%) withdrew their products
11/73 (15%) intend to comply with WHO ban
0
5
10
15
20
25
30
2005 2006 2007 2008 2009
Numb
er of
comp
anies
No intention disclosed Intiontion to comply Withdrawn monotherapies
Pharmaceutical manufacturers24/73 (33%) withdrew their products
11/73 (15%) intend to comply with WHO ban
Last updated on 17.11.2009
WHO/UNICEF TBS | 19 November 2009 14 |
Thank you
