bell_oct202011

Malaria RDTs Expanding the Use of RDTs for Febrile Illness: Developing the Agenda for Economic and Financial Analysis David Bell FIND

WHO Malaria RDT Product Testing Rounds 1, 2 & 3 results Rnd 1 (2008-9) 41 products Rnd 2 (2009-10) 29 products Rnd 3 (2010-11) 50 products (Rnd 4 (2011-12) 46 products) P. falciparum 2000 para/uL 200 para/uL

WHO Malaria RDT Product Testing Rounds 1, 2 & 3 results

P. vivax

2000 para/uL 200 para/uL

Product testing: Improvement in RDT quality in 2008-2010 23 re-submitted products • Increase in PDS for Pf @ 200 parasites/µl; – Mean: 61.3 to 74.7 – Median: 63.1 to 83.8 • Increase in PDS for Pv @ 200 parasites/µl; – Mean: 31.1 to 60.7 – Median: 30.0 to 62.9

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RDT Market: Quantitative Data from (17) Manufacturers ie. under-estimate

TOTAL NUMBER OF RDTS MANUFACTURED PER YEAR

120,000,000 100,000,000

104'185'536

71,274,649

80,000,000 52,715,765 60,000,000 40,000,000

38,338,224 24,002,673

20,000,000 0 2007

2008

2009

2010

2011 (Projection based on data from Jan to June)

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Evolution of parasite based diagnosis in malaria in Senegal public health services 2007-2009.

200000

Number of patients tested (microscopy and/or RDTs)

180000

Number of malaria cases confirmed (microscopy and/or RDTs)

160000

Number of patients treated with ACTs

Adherence to RDT results attained

120000 100000 80000 60000 40000

A

20000

B

2007

2008

2009

Dec

Nov

Oct

Sep

Aug

Jul

Jun

May

Apr

Mar

Feb

Jan

Dec

Nov

Oct

Sep

Aug

Jul

Jun

May

Apr

Mar

Feb

Jan

Dec

Nov

Oct

Sep

Aug

Jul

Jun

May

Apr

Mar

Feb

0

Jan

Cases

140000

Safety Is it safe to with-hold ACT from RDT-negative febrile children in high-prevalence P. falciparum areas?

Yeboah-Antwi K, et al. PLoS Med 2010. Zambia (ICT Malaria Pf)

Intervention: Control:

976 children 2094 children

AL 27.5% AL 99.1%

Mortality 2 (non-malarial) Mortality 1 (malaria)

Faucher JF, et al. Malar J 2010. Benin (Paracheck)

677 children with fever - 281 RDT negative , no antimalarials (~61% ABs) 3 episodes of malaria noted in 14 days follow-up. No mortality.

D'Acremont V,. Clin Infect Dis 2010. Tanzania (ParaHit f)

1000 children with fever, 601 RDT negative , no antimalarials (~61% ABs) 3 episodes of parasitaemia noted later. 2 died (non-malarial causes).

2+ large unpublished studies elsewhere with similar results

Relative RDT performance:

Yeboah Faucher D Acremont

Implications • Wide choice of RDTs that can have good performance • Performance is very variable between products of similar design– some form of QC is needed • RDTs are safe in children when of a reasonable standard (at or near minimum WHO procurement criteria) in high transmission situations (would be expected to be safer in adults)

Elements of Public-private structures Private Sector

Public Sector Importation Procurement standards

Importer Wholesaler Batch testing

Procurement standards.

Regulation Quality control

Distribution

Training, Certification

Provider

Results

Training standards, management guidelines

Thank you Acknowledgements: • • • •

WHO/GMP TDR US CDC FIND