The appraisal looks at the technology and a comparator, which is normally current practice and possibly an alternative technology which could be a surrogate.  As the sponsor you are required to provide the evidence base on which the assessment is made.

The appraisal is in three parts. 

  • Parts A and B outline the clinical case
  • Part C the economic case.  

For part B and C published evidence needs to be identified, analysed, and presented. In addition for part C a de novo economic model needs to be derived which allows known and unknown variables to be addressed. Published meta analyses, where a number of separate studies are pooled, enhance the evidence base demanded in B.   Likewise HTA assessments help in supporting the economic argument.
NICE asks that you have clinical advisors, normally NHS consultants, who can validate key aspects of the submission.

The assessment centre, which will normally be based at a UK university, will review the evidence provided; reject that which it feels is not appropriate and add additional material to produce a comprehensive appraisal. 

The submission is the sponsor’s opportunity to put forward their arguments why the technology should be adopted.