selection of malaria treatments & diagnostics presentation by rémy prohom rbm partnership...
TRANSCRIPT
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Selection of malaria treatments& diagnostics
Presentation by Rémy ProhomRBM 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 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
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• 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
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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
FDC
ACTs
Response to increasing resistance
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Artemether/Lumefantrine
Treatment of acute uncomplicated malaria due to Plasmodium falciparum or mixed infections including P. falciparum in areas with significant multidrug resistance.
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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
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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
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3 Manufacturers currently selected:
– CIPLA– IPCA– SANOFI AVENTIS
Artesunate+Amodiaquine
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Average prices for AS+AQ:
3+3 $0.50
6+6 $0.85
12+12 $1.51
Artesunate+Amodiaquine
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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
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
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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)
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
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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 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
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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
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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
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• 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
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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.
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Remember about ACTs…
• 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 of RDTs
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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
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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)
…/…
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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.
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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]