NICE HTA Timeline

Timeline

• wk0

Development starts

We invite relevant stakeholders 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.

Find out more about consultee submissions

Organisations can apply to become a consultee or commentator at any point of the process.

• wk0

Request for evidence

We ask the intervention technology company to produce a submission of all relevant evidence – published and unpublished – for the appraisal.

They have 8 weeks to produce the company submission.

Find out more about evidence submissions

• wk0

Information added to the NICE website

We add the remit, scope and a list of stakeholders 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.

• wk3

Request for clinical, commissioning and patient experts

We ask the stakeholders to send in their nominations. The NICE team and the chair of the appraisal committee selects experts from those nominated.

Experts can submit statements and attend the appraisal committee meeting to present their views.

• wk4

Expert invitations

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.

• wk8

Deadline for evidence submissions

• wk9

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-effectiveness of the technology. This is called the ERG report.

• wk10

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 working days to respond.

• wk12

Deadline for receipt of the expert statements

• wk16

Evidence report (ERG) received by NICE

• wk16

ERG report sent to company for information

• wk20

Draft technical report sent to stakeholders for technical engagement

Consultees and commentators and experts can share their views on the technical report.

The technical report is produced by the technical team at NICE. It is based on initial consideration of:

the company submission

Progress: 0%

the ERG report

Progress: 0%

consultee and commentator and expert statements

Progress: 0%

discussions with the company or experts about the appraisal.

Progress: 0%

• Stakeholders have 20 working days to submit comments.

• wk28

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

Progress: 0%

the company submission

Progress: 0%

written submissions from non-company consultees

Progress: 0%

personal statements from patient, clinical and commissioning experts

Progress: 0%

the final scope of the appraisal and the list of stakeholders

Progress: 0%

technical report

Progress: 0%

comments received during technical engagement.

Progress: 0%

• We don’t send the papers to any members of the public who have registered to attend the meeting.

Find out more about the committee and how you can attend a meeting.

• wk30

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 decides whether to produce final recommendations, known as a final appraisal document (FAD) or draft recommendations known as an appraisal consultation document (ACD).

The FAD is the final draft of the guidance and not open to comment (see week 35).

If an ACD is needed we send the document out for comment (see week 33).

We only produce an ACD when the recommendations from the appraisal committee don’t recommend use of the technology, or limit the use of the technology beyond the specifications in the marketing authorisation.

Part 1 of this meeting is open to members of the public and press.

Register to attend a meeting

For non-cancer topics, the committee meeting cannot go ahead until the Committee for Medicinal Products for Human Use (CHMP) opinion is published.