SMC | SCOTTISH MEDICINES CONSORTIUMABOUT USMEDICINES ADVICEHOW WE DECIDEMAKING A SUBMISSIONPACE SMC | Scottish Medicines Consortium. We are the national source of advice on the clinical and cost-effectiveness of all new medicines for NHSScotland. Our aim is to ensure that people in Scotland have timely access to medicines that provide most benefit based on best available

evidence.

TIMELINES & SUBMISSION SCHEDULING The usual assessment timeline is 18 weeks, i.e. from scheduling of a submission to publication of advice. A longer timeline, e.g. 22 - 26 weeks, is required for submissions for: end of life / orphan medicines that require a Patient and Clinician Engagement (PACE) meeting. medicines with a complex patient access scheme (PAS), and. DARATUMUMAB (DARZALEX) following a full submission considered under the orphan assessment process: daratumumab (Darzalex®) is accepted for restricted use within NHSScotland. Indication under review: In combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. DUPILUMAB (DUPIXENT) dupilumab (Dupixent®) is accepted for restricted use within NHSScotland. Indication under review: the treatment of moderate-to-severe atopic dermatitis in adolescents (≥12 to