The aim of surveillance is to monitor guidance to make sure it is up to date and decide what action to take if it is no longer valid or accurate. NICE will regularly monitor its published technology guidance to check for any new evidence or information that could affect the recommendations. Guidance will not have a fixed review date, except for guidance with recommendations for use with managed access, when a surveillance review will be scheduled at the end of the data collection period.
NICE will monitor the following information and sources to decide when a guidance topic should be reviewed:
changes in the evidence base
changes to regulatory status
guidance age
the safety of the recommendations
changes in the care pathway
changes to costs
ongoing and completed data collections for technologies recommended with managed access.
NICE is keen to hear about any new evidence or other information that could affect the recommendations (please send information to nice@nice.org.uk, stating the guidance topic it relates to). NICE will assess the likely effect of the new evidence on the recommendations and will start a surveillance review if needed. NICE may proactively contact companies and other stakeholders requesting information as a normal part of its monitoring activities.
NICE will regularly review the information it receives through monitoring activities. When monitoring information indicates that the guidance recommendations are likely to be unsafe, invalid or inaccurate, NICE will do a more detailed surveillance review.
NICE develops a surveillance proposal after gathering relevant information. The proposal is used as the basis for a decision on whether the guidance should be amended, updated, withdrawn or not updated.
NICE will publish on its website when a surveillance review has started and contact stakeholders and any specialist committee members involved in the original guidance development as needed to gather information to develop the surveillance review. NICE will update the stakeholder list from the original guidance.
To develop the surveillance proposal NICE will aim to identify the following information as appropriate:
changes to the evidence base or other sources (including asking companies or stakeholders to provide new evidence that has become available since publication of the guidance)
changes to the care pathway
changes to costs, prices and other factors that affect the financial information in the guidance
changes in the regulatory status of the technology or regulatory extensions to its approved indication.
If, while developing the surveillance review, NICE becomes aware of ongoing studies or other information that is likely to be an important or significant consideration when reaching a surveillance decision, NICE may defer its review to a later date when the relevant information is available.
NICE considers the surveillance review and determines if it should have a public consultation. A consultation will only take place when the review has identified significant uncertainty in the appropriate decision option. NICE expects that consultations will not be needed routinely.
When a consultation takes place, NICE asks stakeholders to comment on the surveillance review. NICE publishes the surveillance review, together with the list of stakeholder organisations, on its website.
The consultation will be open for 28 days.
NICE will consider the surveillance review and any consultation comments received and approve the final surveillance decision. Stakeholders are informed of the surveillance decision. The surveillance decision is published on the NICE website 7 days after stakeholders are informed. If a consultation has taken place, NICE also publishes the comments and NICE's response to them.
Guidance will remain unchanged if:
the evidence base, clinical pathway and costs are similar to those NICE considered when developing the original guidance and are unlikely to change the recommendations, and
the guidance is factually correct.
If the guidance remains valid but newer versions of the technology (often diagnostic or digital) are available, NICE may develop a technical supplement.
A technical supplement may be developed outside of a surveillance review when new versions of technologies become available shortly after guidance is published.
Technical supplements are normally developed for NICE by an external assessment group and:
provide up-to-date technical information about newer versions of 1 or more of the technologies covered in the guidance
are factual, do not make recommendations or evaluate if technologies are comparable in performance
only contain publicly available information
do not update or change the guidance recommendations.
Technical supplements contain the following information for each technology, in a way that allows different technologies and versions to be compared:
technology name and version
regulatory information
technical specification
cost.
The external assessment group contacts companies to get technical and pricing information, and use information obtained during the surveillance process. NICE sends the draft technical supplement to the company for a factual accuracy check.
The technical supplement is updated and published on the website alongside the existing guidance.
Guidance will be amended if:
the technology name, owner, version or functionality has changed but the recommendations and evidence used in the original evaluation are still valid
the costs have changed but the cost effectiveness or cost-saving outcome in the guidance remains broadly valid
the terminology has changed or to make sure the language is consistent with other guidance.
As part of the review process, NICE may reassess how the costs in the original guidance have changed. This is usually done on guidance that is cost saving.
The proposed guidance amendments are set out in the surveillance decision. The amendments to the guidance will be made when the surveillance decision is published.
Guidance will be updated by the committee if there are changes to the evidence base, clinical pathway or economic case that are likely to have a material effect on the recommendations.
Guidance can be updated in the following ways:
through an evaluation, publishing new guidance to replace the existing guidance
within an evaluation of other technologies
within another guidance-producing centre (for example in a NICE guideline).
The surveillance decision will clearly state how the guidance will be updated, using which guidance type and process, and what will happen to the original guidance once the updated guidance is published.
Guidance will be permanently or temporarily withdrawn if:
the technology or the recommendations are no longer considered safe, or their safety becomes uncertain
NICE issues new guidance that replaces the existing guidance
the technology is withdrawn from the market or loses its regulatory approval for the populations or uses in the guidance
advice or guidance from professional societies, evidence or other accredited sources that lead NICE to conclude that the recommendations on the technology are no longer aligned with accepted clinical practice
changes to the technology or the care pathway are such that the original guidance cannot be updated
after a period of managed access if:
commitments in the data collection agreement have not been met and corrective actions will not address the issues arising
a guidance update would be futile (for example, the assumptions that led to the original recommendation for use with managed access are not supported in the new evidence being generated)
the company has not made a complete submission to NICE to enable a guidance update
the company has not paid the relevant fee for the guidance update process.
Guidance will be withdrawn from the NICE website when the surveillance decision is published. The reason for withdrawal will be published on the website.
NICE may withdraw guidance in exceptional circumstances at any point during or outside of the surveillance process when the technology no longer has regulatory approval for use, or the technology or guidance are considered unsafe.
If guidance is withdrawn for a technology with managed access, the company will submit the clinical evidence collected during the managed access period to NICE and NHS England and NHS Improvement. It will then take part in an engagement meeting convened by NICE with attendance from NHS England and NHS Improvement, and professional, patient and carer organisation stakeholders. The company will present the clinical evidence collected during the managed access period and an explanation of reasons for the guidance being withdrawn.
NICE will convene technology-specific managed access oversight groups to oversee each data collection agreement, with representation from NICE, NHS England and NHS Improvement, data custodians and the company. The role, responsibilities and meeting frequency of each managed access oversight group is described in a terms of reference document issued by NICE.
For complex data collection agreements (for example, when real-world data is the primary data source or when a new service is needed to deliver the technology), clinical experts and patient and carer organisations may also be invited to provide representation on the managed access oversight group.
The number of managed access oversight group members will be decided on a case-by-case basis depending on the needs of the topic. In certain circumstances, NICE will issue an expression of interest notification to stakeholders and request application forms to shortlist and confirm the final managed access oversight group membership list after assessing all applications.
The managed access oversight group will regularly review the progress of managed access data collections. Regular reports provided by the company or the data custodian will be submitted to NICE (at a frequency agreed within the data collection agreement). These reports will confirm that the data collection is on track and to assess whether any corrective action is needed to achieve the objectives of the data collection agreement.
Any issues with the performance of managed access data collection or decisions that could impact the final outputs of managed access data collection will be escalated by the managed access oversight group to the joint NICE and NHS England and NHS Improvement managed access governance group. This group will make final recommendations and agree actions to address arising issues.
Managed access data collections may be subject to an interim evidence review, when needed (for example, for agreements longer than 2 years, or complex arrangements). An interim evidence review provides a midpoint opportunity to assess the performance of the data collection and the effect of any changes in clinical pathways. It may involve, but is not limited to, a review of data quality and completeness, and reporting on outcomes and interim or planned analyses. The interim evidence review can address whether the data collection, and therefore the managed access period, should continue for the full duration, or identify corrective actions that need to be addressed, or both.
When an interim evidence review is indicated, the scope and timing of the review will be agreed by the data collection working group and detailed in the data collection agreement.
The interim evidence review will be coordinated by NICE and may involve an external assessment group. NICE will produce recommendations for the consideration of the joint NICE and NHS England and NHS Improvement managed access governance group. This will include whether:
to continue data collection as planned or with corrective actions needed, or
to update the guidance early (for example, when new evidence is available sooner than anticipated), or
to withdraw the guidance (only under exceptional circumstances, see sections 8.4.18 to 8.4.21).
NICE will publish the outcome of the interim evidence review on the NICE website, along with any reports from the external assessment group.
NICE will update its guidance for a technology recommended for use with managed access at the end of the data collection period as specified in the data collection agreement. The aim of the guidance update is to decide whether the technology can be recommended (as an option). The technology cannot be recommended with managed access as part of the guidance update.
NICE may consider a guidance update earlier than the published review date in the data collection agreement, if the joint NICE and NHS England and NHS Improvement managed access governance group agrees. For example, if there is significant new evidence that supports the original case for clinical and cost effectiveness.
NICE will schedule guidance updates into the work programme to coincide with the end of the data collection period determined by the data collection agreement.
NICE will apply the process and methods in place at the time of the invitation to participate to a guidance update after a period of managed access, unless explicitly stated in the data collection arrangement.
A guidance update after a period of managed access will be done through NICE's processes for developing guidance (that is, a single technology appraisal, a multiple technology appraisal or a cost-comparison evaluation) unless otherwise specified by NICE in the data collection agreement. The preferred evaluation type will be confirmed by NICE before the end of the data collection period specified in the data collection agreement.
The guidance update will include the scoping step, making sure that the evolution of the treatment pathway has been considered appropriately during the period of managed access.
Companies must provide an evidence submission to support a guidance update after a period of managed access. If the company does not make an evidence submission, NICE will withdraw the guidance.
NICE will do surveillance of guidance because of loss of marketing exclusivity when:
the original guidance (including for technologies that are used in combination with other technologies) resulted in the technology being recommended (as an option) in specific circumstances (optimised use), recommended only in research context or not recommended
the biosimilars or generics of the technology are licensed for the same indication
the original economic model can be used for the purpose of the update and consent has been received from the originator company for the model to be used for this purpose.
NICE will work with the NHS Commercial Medicines Unit and decide whether to start a rapid update of the guidance.