who antipalu pres 06

8/8/2019 Who Antipalu Pres 06

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Selection of malaria treatments

& diagnostics

Presentation by Rmy Prohom

RBM Partnership Secretariat, Malaria Medicines & Supplies Services

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


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TreatmentsSelection of malaria treatments & diagnostics


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Artemisin-based combination therapieshave proven to be the most effective.

ISSUE:

API of artemisinin cannot be produced yetby synthesis

ACTs manufacturing rely then on agriculturalraw material production


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Combination therapies recommended by WHO

WHO Technical Consultation on Antimalarial Combination Therapy April 2001

Artesunate + amodiaquine

Artemether/Lumefantrine

Artesunate + SP

Artesunate + mefloquine

FD

C

ACTs

Response to increasing resistance


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Treatment of acute uncomplicatedmalaria due to Plasmodium falciparumor mixed infections including P.

falciparum in areas with significantmultidrug resistance.


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Model Model DescriptionUnitsbox

UnitPrice

Coartem (30X24)Artemether 20 mg + Lumefantrine120 mg, tablets (6x4) treatment forpatients over 35 kg

30 $2.4

Coartem (30X18) Artemether 20 mg + Lumefantrine120 mg, tablets (6x3) treatment forpatients from 25 to 34 kg

30 $1.9

Coartem (30X12) Artemether 20 mg + Lumefantrine

120 mg, tablets (6x2) treatment forpatients from 15 to 24 kg

30 $1.4

Coartem (30X6) Artemether 20 mg +Lumefantrine120 mg, tablets (6) treatment forpatients from 5 to 14 kg.

30 $0.9


Novartis Pharma AG


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Treatment of acute uncomplicatedmalaria due to Plasmodium falciparumor mixed infections including

P. falciparum in areas with significantdrug resistance to Chloroquine orSulfadoxine-Pyrimethamine.

Artesunate+Amodiaquine


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3 Manufacturers currently selected:

CIPLA

IPCA

SANOFI AVENTIS



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Average prices for AS+AQ:

3+3 $0.50

6+6 $0.85

12+12 $1.51



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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


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

1


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

1



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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)

10and 100

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

10and 100

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

for patients over 13 years old (over 40kg)

10and 100



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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 treatmentfor 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, combinedtreatment for patients over 13 years old (over

40kg)

25


SANOFI-AVENTIS


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Until now both independent drug WHO GMPapproved were purchased separately and giventogether to the patient;

A co-blister formulation has just been GMPapproved and is available on the market,but at a much higher price.

Artesunate+Mefloquine


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Lead time delivery

Address a request to the manufacturer(or procurement agent) for each and every orderfor 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 beplanned much ahead.


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Remember aboutACTs

Short shelf life (24 months)

Increased costs

Longer lead time for deliveries

Challenging implementation


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Rapid Diagnostic TestsSelection of malaria treatments & diagnostics


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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 ofRDTs


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Quality assurance

Quality assurance systemto sustain the reliability of RDTs

Transport & stockMonitoring & temperature

control

ManufacturerGood manufacturing

practices/control

LaboratoryNat/RegionalBatch control

District/remoteareas

sensitivity check

Final userTraining &

supervision


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Procurement issues

Real-time temperature stability data on the product, andaccelerated 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 ofsupply)

Evidence of Good Manufacturing Practice /ISO certification(ISO13485:2003 is specific for quality management systems formedical devices)

/


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Procurement issues

Availability of product support

Provision of sample products for assessment and testingfor ease of use

Agreement for replacement of products which fail agreedquality control procedures (see above)

Box sizes appropriate to the rate of use of tests in the intendedarea, to minimize storage time in poor conditions and reducethe need to split boxes.


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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: [email protected]

who antipalu pres 06

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