Single Technology Appraisal (STA)

A Single Technology Appraisal (STA) conducted by the National Institute for Health and Care Excellence (NICE) in the UK is a process where a new technology is compared with the standard of care for a specific indication. Here, the new technology may be assessed against one or more comparator interventions, though these comparators are not evaluated against each other. The assessment may also address distinct sub-populations if the new technology is applicable at different points in the care pathway or if the comparator interventions vary among these sub-populations.

Key aspects of the STA process include:

– Components of the STA Process:

– Scoping: Defining the appraisal’s scope, including identifying relevant comparators and sub-populations.

– Submission: The technology sponsor submits detailed evidence supporting the new technology.

– Evidence Assessment: An independent academic group, the Evidence Review Group (ERG), assesses the submitted evidence.

– Appraisal Meetings: Typically, two meetings are held to discuss the evidence and form recommendations.

– Final Appraisal Determination: A final determination is made based on the evidence and discussions.

– Communication: The final determination is communicated to relevant stakeholders.

– Appeal: There is a provision for an appeal if requested by the technology sponsor.

– Assessment and Review:

– The ERG independently reviews the evidence submission from the technology sponsor.

– Inputs are also sought from independent clinical experts and patients’ representatives to ensure a comprehensive evaluation.

– Timeline: The STA process typically spans 48 weeks from scoping to the final determination.

– Common Usage: STAs are most frequently employed for new pharmaceuticals at the time of marketing authorization, ensuring timely and efficient assessment of new treatments.

Process Overview:

  1. Scoping: Initial phase to define the technology, comparators, and relevant sub-populations.
  2. Submission: Detailed dossier submission by the technology sponsor.
  3. Evidence Assessment: Independent review and critique of the submitted evidence by the ERG.
  4. Appraisal Meetings: Discussions to evaluate the evidence and draft recommendations.
  5. Final Determination:Decision-making and formulation of final recommendations.
  6. Communication: Dissemination of the final recommendations to stakeholders.
  7. Appeal Process: Opportunity for the technology sponsor to appeal the decision if needed.

Detailed guidance on the STA process is available in the 2018 process guide revision from NICE, which provides comprehensive instructions and criteria for conducting technology appraisals .