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New HTA Decisions in France
June 2020
Drug name
CORTIMENT® (budesonide)
Ferring SAS
Decision date
Therapeutic area
Digestive tract conditions
Therapeutic sub area
Inflammatory bowel disease
Official notice date
Reimbursement %
Decision (SMR)
Decision (ASMR)
No improvement (V)
CORTIMENT® is indicated as induction therapy for remission in adult patients with mild-to-moderate active ulcerative colitis (UC) for whom 5-ASA therapy is not sufficient.
Decision Type
Reassessment of ASMR
The committee considered the actual benefit of CORTIMENT® to be 'low' in the indication of the Marketing Authorisation. Given: - the demonstration of superiority of CORTIMENT® compared to placebo on a strict clinical and endoscopic remission criterion, but with a modest amount of effect; - the absence of comparative data to another active drug, while this was possible: 5-ASA and especially systemic action corticosteroid; it was concluded that CORTIMENT® does not provide any improvement in the medical service rendered (ASMR V) in the management strategy for ulcerative colitis. The committee proposed 15% reimbursement.