These are the main stages
In April 2018 we implemented a new STA proccess. View the new process here.
Topics are referred to us by Ministers following the topic selection process.
We invite relevant stakeholders (known as consultees and commentators) to take part in the appraisal.
All non-company consultees have 8 weeks to submit a statement on the potential clinical and cost effectiveness of a treatment.
Organisations can apply to become a consultee or commentator at any point of the process.
Request for evidence
We ask the intervention technology company to produce a report of all relevant evidence - published and unpublished - for the appraisal.
They have 8 weeks to produce the report.
Key information added to the NICE website
We add the remit, scope and a list of consultees and commentators to the website.
The remit is the brief for the appraisal. The scope sets out what the technology appraisal will cover and the questions that need to be addressed.
Request for clinical, commissioning and patient experts
We ask the consultees and commentators to send in their nominations. The NICE team and the chair of the Appraisal Committee
selectsexperts from those nominated.
Experts can submit statements and attend the appraisal committee meeting to present their views.
Deadline for evidence submissions
Evidence review begins
An independent academic centre (called the Evidence Review Group) critiques the company's evidence submission and prepares a report on the clinical and
cost effectivenessof the technology. This is called the ERG report.
We invite the selected clinical, commissioning and patient experts to attend the appraisal committee. We ask them to submit a statement on the technology and how it should be used in the NHS in England.
Request for clarification sent to company
If the evidence submission is incomplete, we consult with the Evidence Review Group and send a letter of clarification to the company.
The company has 10 days to respond.
Evidence report (ERG) received by NICE
ERG report sent to company for information
Deadline for receipt of the expert statements
Key documents sent to the appraisal committee
The appraisal committee is an independent advisory committee that makes the recommendations.
We send attendees:
- the ERG report and any comments
- the company submission
- written submissions from non-company consultees
- personal statements from patient, clinical and commissioning experts
- a pre-meeting briefing written by NICE's technical lead for the appraisal
- the final scope of the appraisal and the list of consultees and commentators.
We don’t send the papers to any members of the public who have registered to attend the meeting.
Appraisal committee meet to consider the evidence
We hold an appraisal committee meeting to consider the committee papers and hear from nominated clinical, patient and NHS commissioning experts.
The committee will decide to develop an appraisal consultation document (ACD) or final appraisal document (FAD).
The ACD contains the draft recommendations from the Appraisal Committee. The FAD is the final draft of the guidance and includes the committee's final recommendations.
We produce an ACD when the recommendations from the Appraisal Committee don’t recommend
useof the technology,or limit the use of the technology beyond the specifications in the marketing authorisation.
If an ACD isn’t needed we move straight to developing the final appraisal document (FAD) (see week 29).
Part 1 of this meeting is open to members of the public and press.
topicsthe committee meeting cannot go ahead until the CHMP opinion is published.
Appraisal consultation document (ACD) and supporting documents sent out for comment
Consultee and commentators have 20 working days to submit comments on the draft recommendations.
Public consultation on the ACD
The ACD and supporting documents are published on the website for comment. The consultation is open for 15 working days.
Anyone can submit comments during
Final appraisal document (FAD) sent out to consultees and commentators (if no ACD produced)
Consultees have 15 days to appeal.
Final appraisal document (FAD) published on website (if no ACD produced)
Consultation on the ACD ends
Appraisal committee meet to develop the FAD
The Appraisal Committee considers the comments received on the ACD, then makes its final recommendations on how the technology should be used in the NHS in England. This is the FAD.
Part 1 of the meeting is open to members of the public and press.
Guidance issued (if no ACD produced)
If no ACD was produced, and no appeals have been received, the topic is published.
This is the earliest possible point that final guidance can be issued.
FAD and supporting documents sent to consultees and commentators
Consultees have 15 working days to appeal against the final recommendations in the FAD.
We publish the FAD and supporting documents on the website for information.
Close of appeal period
If no appeals have been received, the guidance is prepared for publication. If appeals have been received, the appeals
Technology appraisal published
If there are no appeals the final recommendations are issued as NICE guidance.
The technology appraisal is published on the NICE website and incorporated into NICE Pathways. Registered stakeholders are notified by email.
When the guidance is published we give a date for it to be reviewed. This is when we consult with relevant organisations about whether the guidance needs to be updated.