Inclusion on the list of medicines reimbursed by National Health Insurance (B/1 pre-filled syringe) and approved for hospital use (B/1 and B/10 pre-filled syringes).
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Clinical Benefit
Substantial
The actual clinical benefit of this vaccine is major in the populations recommended by the Haut Conseil de la santé publique.
Clinical Added Value
major
The pneumococcal vaccine PREVENAR 13 is to replace PREVENAR (7-valent). In this situation, PREVENAR 13 retains the class I improvement in actual benefit (IAB) (major advance in treatment) allocated in 2002 to PREVENAR (7-valent) by the Transparency Committee for prevention of invasive infection caused by Streptococcus pneumoniae (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) in the treatment of children for whom immunisation is recommended by the Haut Conseil de la santé publique. The Committee emphasises that the efficacy of this prevention strategy is conditional on achieving the highest possible immunisation coverage and on changes in pneumococcal serotype epidemiology. The Committee would like to receive any new data relating to the conditions for inclusion, in particular any updated epidemiological data.
no clinical added value
For the prevention of acute otitis media and pneumo nia without microbiological confirmation of the diagnosis, PREVENAR 13 retains the lack of improvement in actual clinical benefit (IAB class V) allocated to PREVENAR (7-valent) in 2009 for the treatment of children who the Haut Conseil de la santé publique 10 recommends should be immunised. The Committee emphasises that the efficacy of this prevention strategy is conditional on achieving the highest possible immunisation coverage and on changes in pneumococcal serotype epidemiology. The Committee would like to receive any new data relating to the conditions for inclusion, in particular any updated epidemiological data.
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