8 October 2018 - Following the Scottish Government's announcement around a new pathway in June 2018, a new approach to the assessment of ultra-orphan medicines is being introduced.

To be considered as an ultra-orphan medicine all criteria listed should be met:

• The condition has a prevalence of 1 in 50,000 or less in Scotland,
  
• The medicine has an EMA orphan designation for the condition and this is maintained at time of marketing authorisation,
  
• The condition is chronic and severely disabling and
  
• The condition requires highly specialised management.
  

Submissions for medicines that are validated as ultra-orphan according to this definition will be assessed by SMC and will then be available to prescribers for a period of at least three years while further clinical effectiveness data are gathered. After this period SMC will re-assess the data and make a final decision on routine use of the medicine in NHSScotland.

Read SMC press release