Reason for request

Extension of the indication

-


Clinical Benefit

Substantial

Substantial AB


Clinical Added Value

moderate

Given the efficacy of VOTUBIA (everolimus) in reducing renal angiomyolipoma volume associated with tuberous sclerosis complex in adult patients, VOTUBIA provides a substantial improvement in actual benefit (IAB III) in the treatment of patients not requiring immediate surgery (nephrectomy or embolisation).


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See also