Malaria medicines and diagnostics WHO/UNICEF TBS

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 |

Outline

WHO Guidelines and Prequalification

Malaria diagnosisArtemisinin market situationResistance and oral artemisinin-based

monotherapies


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


Co-

blis

ters

Fixe

d-do

se c

ombi

natio

ns


Product testing2008

Pre-qualification

2010

Lot testing2007

Malaria Rapid Diagnostic Tests (RDTs):International Quality Assurance Systems

Dossier review and manufacturer

inspections 2009


WHO/FIND RDT performance testing


WHO/FIND RDT performance testing


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

020406080

100120140160180200

2001 2002 2003 2004 2005 2006 2007 2008 2009 20100

10

20

30

40

50

60

70

80

90

ACT procured Number of countries: ACT 1st lineNumber of countries deploying

ACT

trea

tmen

t co

urse

s (M

io)

Cum

ulat

ive

num

ber o

f co

untri

es

Forecast6-24 months

from policy adoption

to ACT deployment

?

AMFm


Complex ACT Supply Chain Management

Example of artemether-lumefantrine

Seedling, nursery, plantation, growth and harvest (7 months)

Extraction (1 month)

Derivatisation

(2 months)

Co-formulation, tabletting, packaging and shipping (4 months)

Growers

Manufacturers

Extractors

API suppliers


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

$/kg

Data kindly provided by Jacques PILLOY / ARTEPAL (AEDES/OTECI)

Global shortage

Relative over-supply

Cost of production


Artemisinin market situationAssured 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


Artemisinin resistance


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

Numbe

r of c

ompa

nies

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


Thank you

Malaria medicines and diagnostics WHO/UNICEF TBS

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