co-careldopa-levodopa (Duodopa)

following a 2nd resubmission assessed under the orphan process

co-careldopa (Duodopa®) intestinal gel is accepted for restricted use within NHS Scotland.

Indication under review: treatment of advanced levodopa-responsive Parkinson's disease with severe motor fluctuations and hyper-/dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results.

SMC restriction: for use in patients not eligible for deep brain stimulation.

In a phase III, 12-week study, co-careldopa intestinal gel significantly reduced ‘off’ time compared with oral levodopa plus a dopa decarboxylase inhibitor.
 
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of co-careldopa intestinal gel. This advice is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.

This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.