NICE has published the set of Board papers for its next regular meeting.
General Update Points:
- The NICE Senior Management Team has reviewed the impact of Coronavirus on the health care system and its treatment capacities. Three short guidelines are being produced per week on treatment within certain healthcare settings.
- From 20 March, the NICE office is working from home, arrangements are to be reviewed on 25 March by a special Coronavirus Response Group and the Senior Management Team.
- The combined impact of exiting the EU and impending changes to European device regulations on NICE’s guidance recommendations for medical devices and diagnostics is being closely monitored.
- Confirmation has been received from the Department of Health and Social Care that
the expansion of the Medical Technologies and Diagnostics programmes will be funded.
Recruitment to the newly created posts has started.
- New responsibilities have recently been added to NICEs work. For example, the Accelerated Access Review, the government’s response to it, the Life Sciences Sector Deal 2, the 2019 Voluntary Scheme for Branded Medicines Pricing and Access, and the NHS Long Term Plan. All these policy initiatives place greater demands on NICE to issue guidance and advice on more topics. New technologies have also emerged that are not explicitly included in existing processes, such as integrated technologies which could include a combination of digital, diagnostic or treatment components, and NICE are to consider where these topics should be routed.
Guidance outputs have been produced by the NICE Centre for Health Technology Evaluation (CHTE) on the below areas:
- Diagnostics guidance (DG)
- Interventional procedures guidance (IPG)
- Highly specialised technologies guidance (HST)
- Medical technologies guidance (MTG)
- Technology appraisals guidance (TA)
The paper aims to consolidate existing selection criteria to improve clarity, align decision making processes and stakeholder engagement to improve efficiency and better describe the selection processes to improve transparency.
Suitability selection will apply to:
- Devices, including medical devices and digital health technologies.
- Diagnostics, including prognostic, predictive (targeted) screening or monitoring technologies, techniques, and strategies, including in-house diagnostics and companion diagnostics.
- Medicines, all new active substances to the UK market in their first indication, or that have extensions to their regulatory approval for a significant new indication including therapeutic vaccines, advanced therapy medicinal products (such as gene therapies and stem cells).
Technologies that are not sought include those unavailable in the UK in the next 24 months, those without regulatory approval outside of research purposes, those already widely used and understood by the UK population or prophylactic vaccinations in the remit of the Joint Committee on Vaccination and Immunisation.
Importantly, availability of evidence is not used as a criterion in the new selection criteria.
Routing options are set out in a table showing the selection steps; the analysis required, the type of NICE guidance to be given and finally, the NICE committee guidance. Diagnostics and medical devices will require cost utility health economic analysis and cost consequence analysis followed by NICE guidance on devices, technology and diagnostics. Finally, the NICE committees of Diagnostics Assessment and Medical Technologies Evaluation advise on the routing.
It is now proposed that all diagnostic, irrespective of the value proposition will now be routed to the Diagnostics Assessment programme.
At the routing stage, questions will be asked such as whether the device is considered to be part of standard UK care or in the scope of a new or existing NICE guideline that is in development or being updated.
Topic prioritisation will flag necessary new guidance to be issued based on high levels of topics sent forward for Appraisal.
The requirement for ‘scoping’ to be completed will be removed. Instead, this will occur closer to the guidance development stage with the aim of confirmation of a routing decision into either the Technology Appraisal or Highly Specialised Technologies programmes.
A formal process for stakeholders to challenge routing selection decisions will be put into action.
Steps will be taken to standardise presentation of information and provide this clearer on the NICE website, such as a transparent lay-out of finalised decision results with only relevant information on the product and application timeline.
NICE is also reviewing the criteria used to decide whether a new technology should be routed to Highly Specialised Technologies or Technology Appraisals. The changes to topic selection for health technology evaluation will not impact on the overall process followed and time taken to develop and publish guidance on a topic.