Favourable opinion for reimbursement in “the initial treatment of severe malaria in adults and children”.
Clinical Benefit
Substantial
The Committee deems that the clinical benefit of ARTESUNATE AMIVAS (artesunate) is substantial in the MA indication.
Clinical Added Value
moderate
Considering:
the partially met medical need in the initial treatment of severe malaria in adults and children;
the effect size of artesunate in terms of reduction in hospital mortality compared to quinine, in patients with a severe form of falciparum malaria, which was statistically significant in:
the ITT population of the SEAQUAMAT trial (1,259 adults and 202 children < 15 years from Asia): 14.7% (107/730) versus 22.4% (164/731), i.e. an HR = 0.60, CI95% = [0.45; 0.79], p = 0.0002;
the ITT population of the AQUAMAT trial (5,425 children < 15 years from Africa): 8.5% (230/2,712) versus 10.9% (297/2,713), i.e. an OR = 0.75; CI95% = [0.63; 0.90], p = 0.0022;
a safety profile that is satisfactory but marked by cases of anaemia, haemoglobinuria and blackwater fever in clinical trials. The important potential risk (risk management plan) is reproductive toxicity (particularly during the first trimester of pregnancy);
but:
the transposability of the results limited to the falciparum species isolated in clinical trials only; but which remains the species of particular concern since it causes potentially serious or even fatal forms;
the lack of evidence of an impact on reduction in the incidence of neurological sequelae (SEAQUAMAT and AQUAMAT trials);
the Committee deems that ARTESUNATE AMIVAS (artesunate)provides a moderate clinical added value (CAV III) compared to IV quinine in the initial treatment of severe malaria in adults and children.
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