Levodopa with carbidopa monohydrate, intestinal gel
PBAC's latest decision on Levodopa with carbidopa monohydrate, intestinal gel: Not recommended (2009). Considered for initial treatment commenced in a hospital based Movement Disorder Clinic for patients with advanced Parkinson disease with severe disabling motor fluctuations not adequately controlled by oral therapy; continuation of treatment with Duodopa intestinal gel commenced in a hospital based specialised Movement Disorder clinic.
PBAC outcome
Not recommended
2009
ICER (AUD/QALY)
$105k/QALY
Range: $75k/QALY–$105k/QALY
Submissions
1
first 2009
Submissions
1
2009 → 2009
Eligible population
patients with advanced Parkinson disease with severe disabling motor fluctuations not adequately controlled by oral therapy
standard medical management, which also includes deep brain stimulation (DBS)
Economic model
CUA
ICER note
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
Why PBAC said no
Reasons cited in the latest PSD: 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