Selection of malaria treatments

1
Selection of malaria treatments diagnostics

• Presentation by Rémy ProhomRBM Partnership
  Secretariat, Malaria Medicines Supplies
  Services
• Anglophone PSM Workshop, Nairobi Kenya,
  20-24February 2006

2
Treatments
Selection 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

4
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_ at cost
  price for public health sector
• Partners advocacy to strengthen production and
  bring more manufacturers in the loop

5
Combination therapies recommended by WHO
Response to increasing resistance

WHO Technical Consultation on Antimalarial
Combination Therapy April 2001
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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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Novartis Pharma AG
Artemether/Lumefantrine
Model Model Description Unitsbox 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
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ArtesunateAmodiaquine

• 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.

9
ArtesunateAmodiaquine

• 3 Manufacturers currently selected
• CIPLA
• IPCA
• SANOFI AVENTIS

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ArtesunateAmodiaquine
Average prices for ASAQ
33 0.50
66 0.85
1212 1.51
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CIPLA
ArtesunateAmodiaquine
Model Model Description units/ box
Falcimon kit Artesunate 50 mgAmodiaquine 153mg (base) tablets (33) in co-blister, combined treatment for children from 1 to 7 years old (10-20 kg), individually packed. 1
Falcimon kit Artesunate 50 mgAmodiaquine 153mg (base) tablets (66) in co-blister, combined treatment for children from 7 to 13 years old (21-40 kg), individually packed. 1
Falcimon kit Artesunate 50 mgAmodiaquine 153mg (base) tablets (1212) in co-blister, combined treatment for patients over 13 years old (over 40kg), individually packed. 1
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IPCA PHARMACEUTICALS
ArtesunateAmodiaquine
Model Description units/ box
Artesunate 50 mgAmodiaquine 153mg (base) tablets (33) in co-blister, combined treatment for children from 1 to 7 years old (10-20 kg) 10 and 100
Artesunate 50 mgAmodiaquine 153mg (base) tablets (66) in co-blister, combined treatment for children from 7 to 13 years old (21-40 kg) 10 and 100
Artesunate 50 mgAmodiaquine 153mg (base) tablets (1212) in co-blister, combined treatment for patients over 13 years old (over 40kg) 10 and 100
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SANOFI-AVENTIS
ArtesunateAmodiaquine
Model Model Description units/box
Arsucam Artesunate 50 mgAmodiaquine 153mg (base) tablets (33) in co-blister, combined treatment for children from 1 to 6 years old (10-20 kg) 25
Arsucam Artesunate 50 mgAmodiaquine 153mg (base) tablets (66) in co-blister, combined treatment for children from 7 to 13 years old (21-40 kg) 25
Arsucam adult Artesunate 50 mgAmodiaquine 153mg (base) tablets (1212) in co-blister, combined treatment for patients over 13 years old (over 40kg) 25
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ArtesunateSulfadoxine/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).

15
GUILIN
ArtesunateSulfadoxine/Pyrimethamine
Model Model Description units/box Unit price
Artecospe for children Artesunate 50mg Sulfadoxine/Pyrimethamine 500/25mg tablets (62) 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 (63) in co-blister, combined treatment for patients over 14 years old and body weight over 40kg, individually packed. 1 1.41
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ArtesunateMefloquine

• 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.

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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 Tests
Selection of malaria treatments diagnostics
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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.

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Quality assurance
Quality assurance system to sustain the
reliability of RDTs
ManufacturerGood manufacturing practices/control
LaboratoryNat/RegionalBatch control
District/remote areassensitivity check
Final userTraining supervision
Transport stockMonitoring temperature control
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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 (ISO134852003 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 [phone]
• E-mail prohomr_at_who.int