Levodopa With Carbidopa Monohydrate, Intestinal Gel

ICER from revised base case calculated during evaluation; considered likely to be an under-estimate and highly uncertain because the model included costs associated with DBS but no effects of DBS were attributed

Populationpatients with advanced Parkinson disease with severe disabling motor fluctuations not adequately controlled by oral therapy

• uncertain clinical benefit, unacceptably high and uncertain cost effectiveness ratio, significant administration safety concerns with PEG tube (high risk of aspiration pneumonia, sudden cessation could precipitate neuroleptic malignant syndrome), uncertainty regarding clinical importance of trial results, highly uncertain utilisation estimates, invasive nature of PEG procedure may limit use, carer utilities inappropriately incorporated in base case, safety and quality of life issues with PEG administration not incorporated into economic evaluation, multiple unaddressed issues from previous submission

Label narrower than PBS population — PBAC restricts to hospital-based Movement Disorder Clinic initiation/continuation; TGA label has no setting restriction.