Transcript Access to medicines: antimalarials

Access to medicines:
antimalarials
Dr Maryse Dugué
Malaria Medicines and Supplies
Service
Situation analysis: the
challenges
• Quality of antimalarial drugs has been declining.
• "Disease of the South": not much investment in the
North, or export-only productions
• The efficacy of (affordable) antimalarial drugs has been
declining (drug resistance) and high cost of replacement
options.
• 60-90% of the population seek initial treatment from
non- public sector, i.e. street vendors, kiosks.
• Supply of drugs is often inefficient and unreliable.
• Pharmacovigilance very weak in most affected countries
Factors leading to development
of resistance
• Lack of guidelines/poor drug treatment policies
• Irrational prescribing
• Irrational drug use
• Drug concentration “tail” – poor formulations
• Liberalized, uncontrolled drug market leading to poor
quality products circulating in international and domestic
markets
Malaria distribution and reported case of
resistance or treatment failure
WHO recommandation: Artemisininbased Combination Therapies
(ACTs)
FDC
•
Artemether/lumefantrine
Artesunate + amodiaquine
•
Artesunate + SP
•
Artesunate + mefloquine
ACTs
Still many challenges!
• Relatively high price of ACTs (average of
UNICEF/WHO price $1.21/treatment):
critical aspects of external financial
support
• Slow process of changing drug policy at
country level
• Artemisinin monotherapies have to be
banned!
• Only one ACT prequalified yet
Procurement of ACT's
WHO/UNICEF Interim solution
In April 2003, tripartite meeting to discuss
possible solutions and actions until a
sufficient number of products are prequalified
WHO/UNICEF cooperation on selection and
procurement.
WHO/UNICEF joint tender 2003,
2004, 2005, 2006
Evaluation based on the UNICEF product quality
questionnaire (similar to WHO's)
Criteria included GMP certification, registration
information (countries), API, stability reports, shelflife and storage conditions
Quality assurance based on a review of the
documentation submitted jointly by UNICEF
Pharmaceutical Team and WHO (EDM and
Procurement with assistance from QSM when
necessary)
Availability of ACTs
There is NO SHORTAGE of recommended
ACTs
There are GOOD QUALITY manufacturers
for all the recommended combinations
12–18 month lag time between
ACT adoption &
implementation
Cumulative No.
of countries adopting
ACT as 1st-line Rx
50
Cumulative
No. of countries
implementing ACT
40
30
20
10
0
2001
2002
No countries w ACT 1st line
2003
2004
2005
No countries implementing ACT
Cumulative No. of countries
adopting ACT as 1st-line Rx
60
66 countries have adopted ACTs
Updated
September 2006
Continen
t
AFRICA
ASIA
Countries
Drug Line
Burundi, Cameroon, Congo, Côte d'Ivoire, Democratic Republic of Congo, Eq.
Guinea, Gabon, Ghana, Guinea, Liberia, Madagascar, Mauritania, Senegal,
Sao Tomé & Principe (ST&P), Sierra Leone, Sudan (S), Zanzibar
AS +
AQ
1st
Angola, Benin, Burkina Faso, Central African Republic, Comoros, Ethiopia,
Gambia, Guinea Bissau, Kenya, Mali, Namibia, Niger, Nigeria, Rwanda,
Uganda, S. Africa, Tanzania, Tchad, Togo, Zambia, Zimbabwe
AL
1st
Côte d'Ivoire, Djibouti, Gabon, Mozambique, Sudan (N), ST&P, Zanzibar
AL
2nd
Mozambique, Djibouti, Somalia, South Africa (Mpumalanga), Sudan (N)
AS + SP
1st
Cambodia, Malaysia, Myanmar, Thailand
AS +
MQ
1st
Bangladesh, Bhutan, Laos, Saudi Arabia
AL
1st
Indonesia
AS +
AQ
1st
Afghanistan, India (5 Provinces), Iran, Tajikistan, Yemen
AS + SP
1st
Viet Nam
DP
1st
Papua New Guinea
AS + SP
2nd
Iran, Philippines, Solomon Islands
AL
2nd
Ecuador, Peru
AS + SP
SOUTH AL=artemether/lumefantrine; AS=artesunate; DP=dihydroartemisinin/piperaquine; MQ=mefloquine;
AQ=amodiaquine;
SP=sulfadoxine/pyrimethamine;
1st
st
Procurement of ACTs
(2001–2006)
Millions of treatment courses
65
70
60
50
40
31.3
30
20
10
0.5
0.6
2.1
2002
2003
5
0
2001
Year
2004
2005
2006
as of
31.08.2006
After a slow start,
orders are picking up
Treatments delivered from the
1st of January
to the 30th of June 2005
Treatments delivered from the
1st of January
to the 30th of June 2006
AS+AQ
3,239,830
7,585,652
AL
1,250,080
37,311,150
2007 ACT forecast
ACT forecast
160
150
150
60
120
110
50
100
40
80
60
40
Cumulative No.
of countries adopting
ACT as 1st-line Rx
Cumulative
No. of countries
implementing ACT
30
20
31.3
10
20
0.5
0.6
2.1
5
0
0
2001
2002
ACT procured
2003
2004
2005
No countries w ACT 1st line
2006
2007
No countries implementing
Cumulative No. of countries
adopting ACT as 1st-line Rx
Millions of treatment courses
140
70
What will influence
access/demand/market size
• FDCs/new combinations
manufacturers/research
• Price
manufacturers/procurement/competition
• Paediatric formulations
manufacturers/research
• Private sector market penetration (up to 80%)
manufacturers/donors/countries
• Global subsidy
donors
What else will influence ACCESS?
Timely procurement, logistics and
distribution systems!