Guide to the processes of technology appraisal

When NICE publishes guidance, a suggested time for its review is given. This is the length of time after publication when NICE will consult with relevant organisations on a proposal about whether or not the guidance needs to be updated, and if so, how to update the guidance. The length of time between guidance publication and review consideration varies depending on the available evidence for the technology, and knowledge of when ongoing research will be reported.

Guidance may be reviewed before the suggested review time when there is significant new evidence that is likely to change the recommendations. NICE is keen to hear about any new evidence that becomes available before the time of review (please send information to nice@nice.org.uk). NICE will assess the likely impact of the new evidence on the recommendations and will propose an update to the published guidance if needed. The steps involved are shown in figure 11.

NICE develops the review proposal after gathering relevant information and doing a literature search. NICE identifies new indications for the appraised technology, searches for new related technologies, assesses the progress of ongoing trials, and gathers new evidence. NICE also asks companies to provide information about the existing marketing authorisation (or equivalent) or any extensions to the marketing authorisation.

When guidance includes a patient access scheme or commercial access agreement, the (possible) review provides a useful opportunity to review how the scheme or agreement is operating and consider whether it would be appropriate to make any changes to simplify and improve its operation. Any changes to a patient access scheme or commercial access agreement are subject to discussion with, and agreement by, NHS England.

NICE's guidance executive uses this information to consider the review proposal and decides if and how the published guidance should be updated.

NICE proposes to update the published guidance if there is new evidence available that is likely to change the existing recommendations. Evidence that may lead to a change in the clinical or cost effectiveness of the technology, or an extension or revision to the marketing authorisation or CE mark for the technology could lead NICE to propose that the guidance should be updated.

The guidance executive decides on one of the following options if the published guidance needs updating:

• Plan an appraisal to update the published guidance.

• Plan an appraisal that combines the published guidance with 1 or more related pieces of published guidance (including terminated appraisals) or ongoing appraisals.

• Update the published guidance within another guidance-producing centre (for example in a clinical guideline). See NICE's document on updating technology appraisals within clinical guidelines.

The guidance executive decides on one of the following options if the published guidance does not need updating:

• The guidance is valid and does not need an update because the evidence base is not likely to change substantially. It is therefore designated as static guidance.

• Incorporate the published guidance into guidance from another guidance-producing centre. The technology appraisal is then designated as static guidance and remains in force.

When the guidance executive decides that guidance can be designated as static, it may also decide that a consultation with consultees and commentators is not needed. NICE will notify consultees and commentators of the decision to designate the guidance as static guidance and will share the paper considered by the guidance executive. NICE publishes the review decision on its website 7 calendar days after notifying consultees and commentators.

If the guidance executive has agreed to consult with consultees and commentators on the review proposal, NICE asks consultees and commentators to comment on the proposal and to identify any other interested parties that NICE needs to consult with. NICE publishes the review proposal, together with the list of consultees and commentators, on its website 7 calendar days after sending for consultation.

Consultees and commentators must send comments to NICE within 28 calendar days of the date of sending for the comments to be considered.

After considering the comments received during consultation, the NICE Technology Appraisal Programme agrees a review decision. If the review decision differs from the original proposal, the guidance executive will agree the most appropriate option, taking consultation comments into account.

NICE writes to consultees and commentators informing them of the final decision and attaches a table of responses to the comments on the review proposal for information. NICE publishes the final decision and the table of comments on its website 7 calendar days after contacting consultees and commentators.

If guidance needs updating within the Technology Appraisal Programme, the update is scheduled.

For guidance designated as static guidance, NICE considers whether a review is needed 5 years after the guidance is added to the static list. This is called a 'static list review'. NICE does a literature search to see if there is any new evidence to update the existing recommendations.

If it is decided that the evidence base has changed significantly, then a full review proposal is developed to assess whether an update of the guidance is needed. If a review of the static guidance uncovers no new evidence that is likely to change the existing recommendations, it remains on the static list.

NICE notifies consultees and commentators of the outcome of the static list review, and publishes this information on the NICE website 7 calendar days after sending it to consultees and commentators.

At any point during the development of a review proposal, NICE may decide that the consideration of a review is not appropriate. This may be because evidence not yet available is considered likely to change the existing recommendations. In this instance, NICE notifies stakeholders of the decision to defer the review proposal. The decision is also published on the NICE website. NICE also identifies the likely time for the next consideration of a review. This is usually within 6 months of the availability of the required evidence.

NICE will normally review its guidance for a drug funded through the Cancer Drugs Fund within 24 months of publishing it. The aim of the Cancer Drugs Fund guidance review is to decide whether or not the drug can be recommended for routine use. The drug (or indication) may not remain in the Cancer Drugs Fund once the guidance review has been completed.

Progress with data collection will be reviewed regularly. An annual report, provided by the company or the organisation collecting the data, will be submitted to NICE to check whether the data collection is on track, and to establish whether any additional action is needed. Guidance may be considered for review before the published review date if there is significant new evidence that either supports the original case for clinical and cost effectiveness, or when the evidence points to the likelihood that the original recommendations are not valid. The steps involved are shown in table 6, table 7, table 8 and figure 12.

The published guidance will be withdrawn, and the drug removed from the Cancer Drugs Fund, if the company stops data collection for reasons other than an early guidance review.

Review of guidance for cancer drugs funded by the Cancer Drugs Fund will be scheduled into the technology appraisal work programme to coincide with the end of the data collection period determined at the point of entry of the drug into the Cancer Drugs Fund. This will normally not be longer than 24 months. If NICE considers it reasonable to review the published guidance earlier than at the end of the designated data collection period, the decision to do so will be subject to consultation with consultees and commentators.

The guidance review will be done through a shortened technology appraisal process, which will normally take a maximum of 6 months. The company will have 28 calendar days to submit the new evidence from data collection, and the evidence review group (ERG) will have 28 calendar days to critique the new evidence (see table 7).

Following the ERG critique, the technical team will compile the technical report within 21 calendar days and issue it for technical engagement with consultees and commentators for 14 calendar days.

The Cancer Drugs Fund guidance review will take into account the data that have become available since the original appraisal, together with any change to the patient access scheme or commercial access agreement proposed by the company. No changes to the scope of the appraisal will be considered.

Companies must provide an evidence submission to support the Cancer Drugs Fund guidance review. The managed access agreement signed at the time of the original appraisal includes this obligation.

After the first committee meeting for the guidance review, a FAD will be produced if its recommendations are consistent with the original conditions for use in the Cancer Drugs Fund. In all other circumstances, an ACD will be produced.