Selection of malaria treatments& diagnostics

Presentation by Rémy ProhomRBM Partnership Secretariat, Malaria Medicines & Supplies Services

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

TreatmentsSelection 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

• 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

Practical solutions

Combination therapies recommended by WHO

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

• Artesunate + amodiaquine

• Artemether/Lumefantrine

• Artesunate + SP

• Artesunate + mefloquine

FDC

ACTs

Response to increasing resistance

Artemether/Lumefantrine

Treatment of acute uncomplicated malaria due to Plasmodium falciparum or mixed infections including P. falciparum in areas with significant multidrug resistance.

Model Model Description Units

box Unit

Price

Coartem® (30X24) Artemether 20 mg + Lumefantrine 120 mg, tablets (6x4) treatment for patients over 35 kg

30 $2.4

Coartem® (30X18) Artemether 20 mg + Lumefantrine 120 mg, tablets (6x3) treatment for patients from 25 to 34 kg

30 $1.9

Coartem® (30X12) Artemether 20 mg + Lumefantrine 120 mg, tablets (6x2) treatment for patients from 15 to 24 kg

30 $1.4

Coartem® (30X6) Artemether 20 mg +Lumefantrine 120 mg, tablets (6) treatment for patients from 5 to 14 kg.

30 $0.9

Artemether/Lumefantrine

Novartis Pharma AG

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

Model Model Descriptionunits/box

Falcimon kit Artesunate 50 mg+Amodiaquine 153mg (base) tablets (3+3) in co-blister, combined

treatment for children from 1 to 7 years old (10-20 kg), individually packed.

1

Falcimon kit Artesunate 50 mg+Amodiaquine 153mg (base) tablets (6+6) in co-blister, combined

treatment for children from 7 to 13 years old (21-40 kg), individually packed.

1

Falcimon kit Artesunate 50 mg+Amodiaquine 153mg (base) tablets (12+12) in co-blister, combined

treatment for patients over 13 years old (over 40kg), individually packed.

1

Artesunate+Amodiaquine

IPCA PHARMACEUTICALS

Model Descriptionunits/box

Artesunate 50 mg+Amodiaquine 153mg (base) tablets (3+3) in co-blister, combined treatment

for children from 1 to 7 years old (10-20 kg)

10 and 100

Artesunate 50 mg+Amodiaquine 153mg (base) tablets (6+6) in co-blister, combined treatment for children from 7 to 13 years old (21-40 kg)

10 and 100

Artesunate 50 mg+Amodiaquine 153mg (base) tablets (12+12) in co-blister, combined treatment

for patients over 13 years old (over 40kg)

10 and 100

Artesunate+Amodiaquine

Model Model Description units/box

Arsucam® Artesunate 50 mg+Amodiaquine 153mg (base) tablets (3+3) in co-blister, combined treatment

for children from 1 to 6 years old (10-20 kg)

25

Arsucam® Artesunate 50 mg+Amodiaquine 153mg (base) tablets (6+6) in co-blister, combined treatment for children from 7 to 13 years old (21-40 kg)

25

Arsucam®adult

Artesunate 50 mg+Amodiaquine 153mg (base) tablets (12+12) in co-blister, combined

treatment for patients over 13 years old (over 40kg)

25

Artesunate+Amodiaquine

SANOFI-AVENTIS

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

Model Model Description units/boxUnit

price

Artecospe for children

Artesunate 50mg + 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.

1 $0.79

Artecospe for adults

Artesunate 100mg + 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.

1 $1.41

Artesunate+Sulfadoxine/Pyrimethamine

GUILIN

• 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.

Artesunate+Mefloquine

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 TestsSelection of malaria treatments & diagnostics

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 purchaseare likely to be of greater importance.

Choice of RDTs

Quality assurance

Quality assurance system to sustain the reliability of RDTs

Transport & stockMonitoring & temperature

control

ManufacturerGood manufacturing

practices/control

LaboratoryNat/RegionalBatch control

District/remote areas

sensitivity check

Final userTraining & supervision

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