NICE process and methods

5 Notifications to the programme

5 Notifications to the programme

5.1 Sources and timing of notifications to the programme

Clinicians and healthcare professionals are the main notifiers to the interventional procedures programme. However, anyone may notify NICE about a procedure for consideration.

Non‑clinical NHS staff wanting to notify NICE about a procedure are encouraged to discuss it with a clinician first because completion of the notification form is improved by clinical knowledge of the procedure.

Medical technology companies may notify NICE about procedures they believe might be within the remit of the programme but, before doing so, they should contact the NICE Office for Market Access (at oma@nice.org.uk), to ensure they are directed to the appropriate NICE team.

Professional organisations, the Medicines and Healthcare products Regulatory Agency (MHRA), the National Institute for Health Research Health Technology Assessment (NIHR HTA) Programme and other organisations may also notify NICE about interventional procedures that are being done in the NHS outside a formal research setting, or about those that clinicians are considering doing. The NIHR Horizon Scanning Research & Intelligence Centre notifies NICE of procedures likely to be used for the first time in the NHS outside a formal research setting within the next year.

Members of the interventional procedures team may identify new procedures, usually when investigating notified procedures. The team sometimes approaches professional organisations to invite them to notify procedures that have been identified in this way. Notifications to the programme are made using the notification form on NICE's website.

It is appropriate to notify NICE about an interventional procedure if:

  • it is novel, with an unknown or uncertain efficacy and/or safety profile, or

  • it is a variation of an established procedure that may have a different efficacy and/or safety profile from that of the established procedure.

Anyone can contact the interventional procedures programme team for advice on whether it is appropriate for a procedure to be notified.

Sometimes practitioners make minor alterations to established procedures and these do not merit notification, for example, a small change in the length or site of an incision to improve access in an operation.

Interventional procedures involving robotics are generally considered a minor modification of their non‑robotic equivalent, and are therefore outside of the remit unless the procedure differs substantially because of the robotic element.

Clinicians doing a well‑established procedure for the first time should not notify it to the programme.

While guidance is in development, clinicians wishing to carry out the procedure, and their trusts, should ensure that special arrangements are in place for consent, governance, audit and research.

5.2 Surveillance

The MHRA has the statutory function of monitoring serious device‑related adverse events and is responsible for overseeing the application of European medical device directives. If the MHRA gets reports of serious concerns about the safety of a procedure or device, it can notify the procedure to NICE. This will prompt NICE to consider assessing the procedure or, if interventional procedures guidance has already been published, updating this guidance.

5.3 Outcome of notifications to the programme

If a procedure falls within the remit of the interventional procedures programme, it is assessed (see section 5).

Details of all interventional procedures notified to the programme are available on NICE's website. The following information is given about each procedure within the programme's remit:

  • the name of the procedure

  • a procedure description

  • a description of current established practice, including other procedures used for the same purpose

  • the disease area

  • the clinical specialty or specialties of clinicians who might do the procedure

  • links to relevant documents produced by NICE (overview, consultation document, guidance, table of consultation comments including NICE's responses, External Assessment Centre report for certain procedures, and information for the public)

  • links to relevant documents produced by other agencies, like the MHRA

  • links to related NICE technology appraisal guidance and NICE guidelines

  • notices about changes of status to a piece of interventional procedures guidance (for example, if the guidance has been withdrawn or replaced through incorporation into a NICE guideline).

The status of the procedure is shown as 1 of 2 main categories:

  • 'guidance issued' – guidance has been published and is available on NICE's website

  • 'in progress' – the procedure is being assessed by the programme.

If a procedure notified to the programme appears to fall within the remit of the programme in all respects except that it is not yet being used in the NHS or independent healthcare sector, or there is no evidence base with which to assess it, the programme monitors it and assesses it at a future date if circumstances change. Such procedures are listed on NICE's website, along with the reason why they are not yet being assessed.

If a procedure does not fall within the remit of the programme, it is not assessed. Notified procedures that are not within the programme's remit and the reasons for this are also listed on NICE's website.

Whether the procedure is within the remit of the programme or not, NICE informs the notifier of the procedure of the outcome of their notification.

If guidance production is paused or stopped before publication, published documents relating to NICE's assessment of the procedure remain on the website for a maximum of 6 months. After 6 months, if NICE is not going to publish guidance, the documents are removed.