Time to launch Process Outcome
 
Horizon scanning
Continuous CHS(b) scan horizon, track interventions in development "Vignette" of each intervention
Selection step
2-6 years DH review all interventions close to final clinical trials(c), apply criteria to decide which likely to require appraisal Provisional list of interventions to be appraised
  Consult ABPI/ABHI, NHS, patient groups as appropriate Amend schedule in light of comments
  Sponsoring company discusses research requirements with secretariat(d) to inform design of clinical trials Agreed design of trials (where appropriate)
1-5 years CHS update vignettes as needed  
12 months Final review against selection criteria Formal notice of decision to appraise
     
Appraisal stage
4-6 months Company submits data package to NICE Patient group(s) submit comments  
  Secretariat write critique; company have chance to offer further comments  
2-3 months Appraisal group(e) review all evidence, decide draft recommendations and information to patients  
4-6 weeks Drafts to company/patient groups/health departments for final comment  
  Appraisal group review comments, finalise all drafts NICE issues clinical guidance and patient information (with rationale)

 

Notes to the table
a
 As the process would operate at maturity (initially, notice periods will be very much shorter). There will be slight differences, eg over timescales, between the different types of intervention (medicines, devices, etc).
b
 The Centre for Horizon Scanning of the University of Birmingham, in collaboration with the National Prescribing Centre and the regional Drug Information Pharmacists Group.
c
 Phase 3 trials for medicines, clinical trials to demonstrate safety for devices (where required under the EC directives).
d
 The dedicated secretariat to the appraisal process (part of the NICE secretariat).