Access to medicines: antimalarials Dr Maryse Dugué Malaria Medicines and Supplies Service.

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

Artesunate + amodiaquine

• Artemether/lumefantrine

• Artesunate + SP

• Artesunate + mefloquine

FDC

ACTs

WHO recommandation: Artemisinin-based Combination Therapies

(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

In April 2003, tripartite meeting to discuss possible solutions and actions until a sufficient number of products are pre-qualifiedWHO/UNICEF cooperation on selection and procurement.

Procurement of ACT'sWHO/UNICEF Interim solution

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, shelf-life 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

2001 2002 2003 2004 2005

0

10

20

30

40

50

60

No countries w ACT 1st line No countries implementing ACT

Cumulative No. of countries adopting ACT as 1st-line Rx

Cu

mu

lati

ve N

o. o

f co

un

trie

s a

do

pti

ng

AC

T a

s 1s

t-lin

e R

x

Cumulative No. of countries

implementing ACT

66 countries have adopted ACTsContinent

Countries Drug Line

AFRICA

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

ASIA

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

SOUTH

AMERICA

Ecuador, Peru AS + SP 1st

Bolivia, Peru, Venezuela AS + MQ

1st

Brazil, Guyana, Suriname AL 1st

39 are deploying ACTsUpdated

September 2006

AQ=amodiaquine; AL=artemether/lumefantrine; AS=artesunate; DP=dihydroartemisinin/piperaquine; MQ=mefloquine; SP=sulfadoxine/pyrimethamine;

75% deploying

72% deploying

56% deploying

Procurement of ACTs (2001–2006)

0

10

20

30

40

50

60

70

Millions of treatment courses

2001 2003 2005Year

2006 as of 31.08.2006

20042002

0.5 0.6 2.15

31.3

65

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

150

110

2.10.5 0.65

31.3

0

20

40

60

80

100

120

140

160

2001 2002 2003 2004 2005 2006 2007

0

10

20

30

40

50

60

70

ACT procured No countries w ACT 1st line No countries implementing

ACT forecast

Mill

ion

s o

f tr

eatm

ent

cou

rses

Cu

mu

lati

ve N

o. o

f co

un

trie

s a

do

pti

ng

AC

T a

s 1s

t-lin

e R

x

Cumulative No. of countries adopting ACT as 1st-line Rx

Cumulative No. of countriesimplementing ACT

150

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!