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New HTA Decisions in France
December 2019
Drug name
RAGWIZAX® (Standardized allergenic extract of ambrosia with sagebrush leaf (Ambrosia artemisiifolia))
Company
SA ALK-Abello
Decision date
23/10/2019
Therapeutic area
Respiratory conditions
Therapeutic sub area
Respiratory conditions: general and other
Official notice date
08/11/2019
Reimbursement %
Decision (SMR)
Weak
Decision (ASMR)
No improvement (V)
Indication
RAGWIZAX is indicated for the management of adults with allergic rhinitis triggered by ragweed pollen which is insufficiently controlled by symptomatic drugs.
Decision Type
New technology assessment
Summary
The committee considered the actual benefit of RAGWIZAX® to be 'low' in the indication of the Marketing Authorisation. Taking into account: - the quality of the demonstration (comparative, randomised, double-blind studies) but also the inclusion of patients who had not necessarily failed symptomatic treatments; - the small amount of effect of RAGWIZAX® demonstrated compared to placebo on a composite score taking into account the severity of symptoms and the consumption of symptomatic treatments (primary endpoint); - the risk of severe anaphylactic reactions; - lack of efficacy data in terms of quality of life in a condition that has a strong impact on this. It was concluded that RAGWIZAX® does not provide any improvement in the medical service rendered (ASMR V) in the management of adults with allergic rhinitis triggered by ragweed pollen which is insufficiently controlled by symptomatic drugs.