Favourable opinion for reimbursement in the “symptomatic treatment of adult patients with overactive bladder (OAB) syndrome”.
Clinical Benefit
Low
The clinical benefit of OBGEMSA (vibegron) is low in the MA indication.
Clinical Added Value
no clinical added value
Considering:
the low efficacy observed compared to placebo in a double-blind phase 3 study (EMPOWUR study - NCT03492281, RVT-901-3003) conducted in 1,518 adults with symptoms of overactive bladder (OAB) syndrome after 12 weeks of treatment, for change from baseline in average daily number of micturitions, with an estimated mean difference in favour of vibegron of -0.5 95% CI [-0.8; -0.2]; p < 0.001, and for change from baseline in average daily number of urge urinary incontinence episodes, with an estimated mean difference in favour of vibegron of -0.6 95% CI [-0.9; -0.3]; p < 0.001,
a safety profile of vibegron that appears to be globally favourable and different from the problematic profile of anticholinergic drugs,
the limitations of the assessment (quality of life data in favour of vibegron but with a modest effect size, in the short term and versus placebo, absence of assessment versus anticholinergic drugs in treatment-naive patients, absence of direct comparison versus the therapeutic alternatives),
indirect comparison results that do not enable the superiority or non-inferiority of vibegron to be established versus anticholinergic drugs or the treatments to be ranked in relation to one another, the Committee deems that OBGEMSA (vibegron) 75 mg film-coated tablets provides no clinical added value (CAV V, non-existent) in the symptomatic treatment of adult patients with overactive bladder (OAB) syndrome.,
the Committee deems that OBGEMSA (vibegron) 75 mg film-coated tablets provides no clinical added value (CAV V, non-existent) in the symptomatic treatment of adult patients with overactive bladder (OAB) syndrome.
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