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New HTA Decisions in France
December 2019
Drug name
CORTIMENT® (budesonide)
Company
Ferring SAS
Decision date
23/10/2019
Therapeutic area
Digestive tract conditions
Therapeutic sub area
Inflammatory bowel disease
Official notice date
18/11/2019
Reimbursement %
15
Decision (SMR)
Weak
Decision (ASMR)
No improvement (V)
Indication
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
Summary
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.