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Table 1 SMC and NICE criteria for consideration as an end-of-life or rare condition

From: Cancer drug funding decisions in Scotland: impact of new end-of-life, orphan and ultra-orphan processes

NICE End-of-Life criteria SMC End-of-Life and Rarity criteria
the treatment is indicated for patients with a short life expectancy, normally less than 24 months; EoL: medicine to treat a condition at a stage that usually leads to death within 3 years.
and  
the treatment offers an extension to life, normally of at least an additional 3 months;  
and or
for small patient populations normally not exceeding a cumulative total of 7000 for all licensed indications in England (ie 1 in 7700)* Orphan: medicine to treat a condition affecting fewer than 2500 people in a population of 5 million) (ie 1 in 2000).
  or
  Ultra-orphan: medicine to treat a condition with a prevalence of 1 in 50,000 or less.
  1. Sources: NICE [3] SMC [7]
  2. * this criterion was removed in April 2016