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New HTA Decisions in France
December 2019
Drug name
URIVESC® (trospium (chloride))
Company
Mylan Medical SAS
Decision date
23/10/2019
Therapeutic area
Urological conditions
Therapeutic sub area
Lower urinary tract symptoms
Official notice date
04/11/2019
Reimbursement %
30
Decision (SMR)
Moderate
Decision (ASMR)
No improvement (V)
Indication
URIVESC® is indicated for the symptomatic treatment of urge urinary incontinence and/or urinary urgency and urinary frequency that may occur in patients with overactive bladder (e.g. idiopathic or neurological detrusor hyperreflexia).
Decision Type
New technology assessment
Summary
The Committee considered the actual benefit of URIVESC® to be 'moderate' in the indication of the Marketing Authorisation. Considering: - demonstration of the superiority of URIVESC® (trospium chloride LP, 60 mg capsule per day) over placebo in reducing the number of urinations per day and the number of urinary incontinence episodes per day in two comparative and randomised studies; - an effect amount of low clinical relevance to these criteria, established after 12 weeks; - the lack of demonstration of efficacy on urgency or improvement of quality of life; - the lack of comparative clinical data versus the other available anticholinergics (including CERIS® containing trospium chloride, 20 mg tablet twice daily) when this comparison was possible; - an expected tolerance profile for URIVESC® similar to that of CERIS®; it was concluded that URIVESC® does not provide any improvement in the medical service rendered (ASMR V) compared with CERIS®. The committee proposed 30% reimbursement.