Transcript Malaria medicines and diagnostics

Malaria medicines
and diagnostics
WHO/UNICEF TBS
Access to medicines
19 November 2009 - Geneva
Silvia Schwarte
Global Malaria Programme
Outline
 WHO Guidelines and Prequalification
 Malaria diagnosis
 Artemisinin market situation
 Resistance and oral artemisinin-based monotherapies
2 |
WHO/UNICEF TBS | 19 November 2009
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)
3 |
* not for wide-scale public sector use in Africa
WHO/UNICEF TBS | 19 November 2009
Co-blisters
Fixed-dose combinations
4 |
WHO/UNICEF TBS | 19 November 2009
Malaria Rapid Diagnostic Tests (RDTs):
International Quality Assurance Systems
Lot testing
2007
Product testing
2008
Dossier review and
manufacturer inspections
2009
Pre-qualification
2010
5 |
WHO/UNICEF TBS | 19 November 2009
WHO/FIND RDT performance testing
6 |
WHO/UNICEF TBS | 19 November 2009
WHO/FIND RDT performance testing
7 |
WHO/UNICEF TBS | 19 November 2009
ACTs: policy adoption, deployment,
past procurement and 2009/10 forecast
180
160
200
160
80
70
140
130
60
120
97
100
82.7
80
50
40
30
60
40
20
31.3
20
0.5
0.6
2.1
10
5
0
0
2001
2002
2003
2004
2005
ACT procured
Number of countries deploying
8 |
?
90
WHO/UNICEF TBS | 19 November 2009
2006
2007
2008
2009
2010
Number of countries: ACT 1st line
Cumulative number of countries
6-24 months from
policy adoption to
ACT deployment
200
AMFm
ACT treatment courses (Mio)
Forecast
Complex ACT Supply Chain Management
Example of artemether-lumefantrine
Extractors
Growers
Extraction
(1 month)
Seedling, nursery, plantation, growth and harvest (7 months)
Manufacturers
API suppliers
Co-formulation, tabletting, packaging
and shipping (4 months)
9 |
Derivatisation
(2 months)
WHO/UNICEF TBS | 19 November 2009
Artemisinin price evolution (2002-2009)
Artemisinin indicatice spot price Price ($/kg)
1200
1100
1000
$/kg
800
750
700
600
400
200
240
300
260
290
170
0
2002
2003
2004
Global
shortage
2005
2006
Years
2007
2008
2009
Relative
over-supply
Data kindly provided by Jacques PILLOY / ARTEPAL (AEDES/OTECI)
10 |
WHO/UNICEF TBS | 19 November 2009
Cost of
production
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
11 |
WHO/UNICEF TBS | 19 November 2009
Artemisinin resistance
12 |
WHO/UNICEF TBS | 19 November 2009
Oral artemisinin-based monotherapy
Slow progress
Manufacturers of oral artemisinin-based
monotherapies:
Pharmaceutical
manufacturers
National Drug
Regulatory Authorities:
National Drug
Regulatory
Authorities
44/78 (56%) in line with WHO recommendations
24/73withdrew
(33%) withdrew their products
24/73 (33%)
their products
(15%) intendto
to comply
with WHO ban
11/73 (15%) 11/73
intend
comply
with WHO ban
Number of countries
30
25
20
15
70
60
50
40
20
10
10
Ja
n.0
6
r.0
6
Ju
l.0
Oc 6
t.0
6
Ja
n.0
7
Ap
r.0
7
Ju
l.0
Oc 7
t.0
7
Ja
n.0
8
Ap
r.0
8
Ju
l.0
8
Oc
t.0
8
Ja
n.0
9
Ap
r.0
9
Ju
l.0
Oc 9
t.0
9
0
5
0
2006
2005
No intention disclosed
13 |
Risk of development
of resistance
30
Ap
Number of companies
45/78 (58%)
in line with
(last updated 14.10.2009)
WHO recommendations
2006
2007
Intiontion to comply
2008
2009
Withdrawn monotherapies
Last updated on 17.11.2009
WHO/UNICEF TBS | 19 November 2009
2007
2008
Number of countries still allowing monotherapies
2009
Thank you
14 |
WHO/UNICEF TBS | 19 November 2009