Selection of malaria treatments

& diagnostics
Presentation by Rémy Prohom
RBM Partnership Secretariat, Malaria Medicines & Supplies Services

Anglophone PSM Workshop, Nairobi Kenya, 20-24February 2006

 Treatments
Selection of malaria treatments & diagnostics
 Artemisin-based combination therapies
have proven to be the most effective.

ISSUE:

• API of artemisinin cannot be produced yet

by synthesis
• ACTs manufacturing rely then on agricultural
raw material production
 Practical solutions

• Joint tender WHO-UNICEF to manufacturers

of ACTs

• Long Term Agreement to ensure low and

stable price with selected manufacturers

• WHO-UNICEF-IAPSO can order Coartem@

at cost price for public health sector

• Partners advocacy to strengthen production

and bring more manufacturers in the loop
 Response to increasing resistance

Combination therapies recommended by WHO

FDC
• Artemether/Lumefantrine
• Artesunate + amodiaquine
ACTs
• Artesunate + SP

• Artesunate + mefloquine

WHO Technical Consultation on “Antimalarial Combination Therapy” – April 2001

 Artemether/Lumefantrine

Treatment of acute uncomplicated

malaria due to Plasmodium falciparum
or mixed infections including P.
falciparum in areas with significant
multidrug resistance.
 Artemether/Lumefantrine

Novartis Pharma AG

Units Unit
Model Model Description
box Price
Coartem® (30X24) Artemether 20 mg + Lumefantrine 30 $2.4
120 mg, tablets (6x4) treatment for
patients over 35 kg
Coartem® (30X18) Artemether 20 mg + Lumefantrine 30 $1.9
120 mg, tablets (6x3) treatment for
patients from 25 to 34 kg
Coartem® (30X12) Artemether 20 mg + Lumefantrine 30 $1.4
120 mg, tablets (6x2) treatment for
patients from 15 to 24 kg
Coartem® (30X6) Artemether 20 mg +Lumefantrine 30 $0.9
120 mg, tablets (6) treatment for
patients from 5 to 14 kg.
 Artesunate+Amodiaquine

Treatment of acute uncomplicated

malaria due to Plasmodium falciparum
or mixed infections including
P. falciparum in areas with significant
drug resistance to Chloroquine or
Sulfadoxine-Pyrimethamine.
 Artesunate+Amodiaquine

3 Manufacturers currently selected:

– CIPLA
– IPCA
– SANOFI AVENTIS
 Artesunate+Amodiaquine

Average prices for AS+AQ:

3+3 $0.50

6+6 $0.85

12+12 $1.51
 Artesunate+Amodiaquine

CIPLA

units/
Model Model Description
box
Falcimon kit Artesunate 50 mg+Amodiaquine 153mg (base) 1
tablets (3+3) in co-blister, combined
treatment for children from 1 to 7 years old
(10-20 kg), individually packed.
Falcimon kit Artesunate 50 mg+Amodiaquine 153mg (base) 1
tablets (6+6) in co-blister, combined
treatment for children from 7 to 13 years old
(21-40 kg), individually packed.
Falcimon kit Artesunate 50 mg+Amodiaquine 153mg (base) 1
tablets (12+12) in co-blister, combined
treatment for patients over 13 years old
(over 40kg), individually packed.
 Artesunate+Amodiaquine

IPCA PHARMACEUTICALS

units/
Model Description
box
Artesunate 50 mg+Amodiaquine 153mg (base) 10
tablets (3+3) in co-blister, combined treatment and 100
for children from 1 to 7 years old (10-20 kg)

Artesunate 50 mg+Amodiaquine 153mg (base) 10

tablets (6+6) in co-blister, combined treatment and 100
for children from 7 to 13 years old (21-40 kg)

Artesunate 50 mg+Amodiaquine 153mg (base) 10

tablets (12+12) in co-blister, combined treatment and 100
for patients over 13 years old (over 40kg)
 Artesunate+Amodiaquine

SANOFI-AVENTIS

Model Model Description units/box

Arsucam® Artesunate 50 mg+Amodiaquine 153mg (base) 25

tablets (3+3) in co-blister, combined treatment
for children from 1 to 6 years old (10-20 kg)
Arsucam® Artesunate 50 mg+Amodiaquine 153mg (base) 25
tablets (6+6) in co-blister, combined treatment
for children from 7 to 13 years old (21-40 kg)
Arsucam® Artesunate 50 mg+Amodiaquine 153mg (base) 25
adult tablets (12+12) in co-blister, combined
treatment for patients over 13 years old (over
40kg)
 Artesunate+
Sulfadoxine/Pyrimethamine

Treatment of acute uncomplicated malaria

due to Plasmodium falciparum in areas
where resistance to Sulfadoxine-
Pyrimethamine is low (i.e. where the 28-day
cure exceeds 80%).
 Artesunate+
Sulfadoxine/Pyrimethamine

GUILIN

Unit
Model Model Description units/box
price
Artecospe Artesunate 50mg + 1 $0.79
for children Sulfadoxine/Pyrimethamine 500/25mg
tablets (6+2) in co-blister, combined
treatment for paediatric patients from 5
months to 13 years old (or under 40 kg),
individually packed.
Artecospe Artesunate 100mg + 1 $1.41
for adults Sulfadoxine/Pyrimethamine 500/25mg
tablets (6+3) in co-blister, combined
treatment for patients over 14 years old
and body weight over 40kg, individually
packed.
 Artesunate+Mefloquine

• Until now both independent drug WHO GMP

approved were purchased separately and given
together to the patient;

• A co-blister formulation has just been GMP

approved and is available on the market,
but at a much higher price.
 Lead time delivery

• Address a request to the manufacturer

(or procurement agent) for each and every order
for any ACT and get a written answer on the
delivery time for your specific order.

• Lead time may vary depending of many factors

(production site, quantities, packaging, volume
and destination) and therefore should be
planned much ahead.
 Remember about ACTs…

• Short shelf life (24 months)

• Increased costs

• Longer lead time for deliveries

• Challenging implementation
 Rapid Diagnostic Tests
Selection of malaria treatments & diagnostics
 Choice of RDTs

Considerations for choosing an RDT include:

• Plasmodium species to be detected (P. falciparum only, or panspecific)

• Shelf -life and temperature stability in intended conditions of storage
and use
• Ease of use, including format of the test (e.g. cassette, dipstick, card)
• Requirement for post-treatment testing of patients
• Cost (including transport, training, and quality control)
• Sensitivity

Good quality assurance processes after purchase

are likely to be of greater importance.
 Quality assurance

Quality assurance system

to sustain the reliability of RDTs

Manufacturer Laboratory District/remote Final user

Good manufacturing Nat/Regional areas Training &
practices/control Batch control sensitivity check supervision

Transport & stock

Monitoring & temperature
control
 Procurement issues

• Real-time temperature stability data on the product, and accelerated data

on the purchased lot

• Evidence of successful operational use, or good quality field data

on the product

• Long-term viability of manufacturer (to ensure continuity of supply)

• Evidence of Good Manufacturing Practice /ISO certification (ISO13485:2003

is specific for quality management systems for medical devices)

…/…
 Procurement issues

• Availability of product support

• Provision of sample products for assessment and testing

for ease of use

• Agreement for replacement of products which fail agreed

quality control procedures (see above)

• Box sizes appropriate to the rate of use of tests in the intended

area, to minimize storage time in poor conditions and reduce
the need to split boxes.
 How to contact us…

Malaria Medicines & Supply Services (MMSS)

Roll Back Malaria Partnership Secretariat
Website: http://rbm.who.int/mmss/

Mr Remy Prohom
Technical Officer
ACTs and RDTs related issues
Tel: +41 (0)22 791 2679
E-mail: prohomr@who.int