Review of Access to New Medicines
An independent review to assess the impact of the new approach introduced in 2014 by Scottish Medicines Consortium (SMC).
Appendix 2: Task & Finish Group Definitions for end-of-life, orphan and ultra-orphan medicines
Task and Finish Group Definitions
End-of-Life Medicine:
"A medicine used to treat a condition at a stage that usually leads to death within 3 years with currently available treatments."
Orphan Medicine:
"A medicine with European Medicines Agency ( EMA) designated orphan status ( i.e. conditions affecting fewer than 2,500 people in a population of 5 million) or a medicine to treat an equivalent size of population irrespective of whether it has designated orphan status."
Ultra-Orphan Medicine:
"A medicine used to treat a condition with a prevalence of 1 in 50,000 or less (or around 100 people in Scotland)".
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