Status In progress
Decision Selected
Process TA
ID number 3957

Project Team

Project lead Toni Gasse

Email enquiries

External Assessment Group Warwick Evidence, Warwick Medical School, University of Warwick

Stakeholders

Companies sponsors Advanced Therapeutics (UK) Ltd]
  Air Liquide Healthcare Ltd
  CamDiab Ltd
  DexCom International Ltd
  Medtronic Ltd
  Tandem Diabetes Care, Inc
  Ypsomed Ltd
Others Department of Health and Social Care
  NHS England
  Welsh Government
Patient carer groups Diabetes UK
  Juvenile Diabetes Research Foundation (JDRF)
  National Children and Young People‚Äôs Diabetes Network
Professional groups Diabetes Technology Network - UK
  Royal College of Physicians
  The Royal College of Pathologists
Assessment group Warwick Evidence
Comparator companies Abbott Diabetes Care
  Insulet International Ltd
General commentators All Wales Therapeutics and Toxicology Centre
  British National Formulary
  Department of Health, Social Services and Public Safety for Northern Ireland
  Healthcare Improvement Scotland
  Medicines and Healthcare Products Regulatory Agency
  Scottish Medicines Consortium
  Welsh Health Specialised Services Committee

Timeline

Key events during the development of the guidance:

Date Update
07 November 2023 - 28 November 2023 Final draft guidance
30 October 2023 Following the consultation on the case for extending the statutory 3-month period for funding of hybrid closed loop systems for managing blood glucose levels in type 1 diabetes, we will issue the Final Appraisal Document (FAD) to stakeholders for appeal and publish it on the NICE website on Tuesday 7th November. We anticipate publishing final guidance on this appraisal in December 2023.
21 August 2023 Statement
21 August 2023 The following statement and document have been added to the project documents section of the webpage: Following the Technology Appraisal Committee meeting on 24 May 2023, we are consulting with consultees and commentators on the case for extending the statutory 3-month period for funding of hybrid closed loop systems for managing blood glucose levels in type 1 diabetes. Once this consultation has ended, we will issue the Final Appraisal Document (FAD) for appeal and anticipate publishing final guidance on this appraisal in December 2023. The request to vary the funding requirement timeframe for implementation received from NHS England has been added to the website for information.
31 July 2023 Declaration of interests
28 June 2023 The appraisal for hybrid closed loop systems as an option for managing blood glucose levels in type 1 diabetes was discussed by the diagnostics advisory committee on 24 May 2023. The committee has reached a conclusion to recommend hybrid closed loop systems as an option for managing blood glucose levels in type 1 diabetes. Companies will now be invited to engage with NHS England (NHSE) on a commercial exercise to offer cost-effective value propositions for HCL systems. NHSE have asked NHS Supply Chain to issue a Request for Information (RFI) to provide an opportunity to test scenarios for roll out of HCL technology to patients, including the price and requirements for the future procurement. To support this exercise there will be a number of supplier engagement opportunities planned over the summer. Further details will be published on the NHS Supply Chain website in the coming weeks. The commercial exercise will last a maximum of 16 weeks and is expected to conclude by 13 October 2023. NHSE have also indicated their intention to request a variation to the funding requirement for this technology and, if accepted by NICE, consultees and commentators will be given the opportunity to participate in a consultation on this during the 16-week period. Consultees and commentators will be alerted to this when the consultation begins. The detail of the committee discussion and draft recommendations will be provided in a Final Draft Guidance document following the commercial exercise. We anticipate this will be sent to stakeholders in the week commencing 16 October 2023 and will be published on the NICE website seven days later.
24 May 2023 Committee meeting: 2
09 March 2023 The public consultation on the Appraisal Consultation Document has now closed and we would like to thank all those who contributed. We have received a large number of consultation comments and are currently reviewing these. The timelines for the topic are currently being reviewed to allow for further engagement with NHS England and therefore the date of the second committee meeting will need to be rescheduled. In the first instance, potential suppliers should contact NHS Supply Chain via leigh.carr@supplychain.nhs.uk and england.ndp-pmo@nhs.net to register their interest in submitting cost effective value propositions for HCL systems as part of this ongoing appraisal. Please accept our apologies for any inconvenience this rescheduling will cause. Details of the revised timelines for the second committee meeting will be circulated in due course soon. If you have any questions in the meantime, please get in touch at diagnostics@nice.org.uk
10 January 2023 - 31 January 2023 Draft guidance: 1
29 November 2022 Committee meeting: 1
11 October 2022 Assessment report sent for information
20 June 2022 Evidence submission received
12 July 2021 This assessment is paused while NHS England and NHS Improvement collect real world data on the use of hybrid closed loop systems for people with type 1 diabetes in the NHS. This is to ensure that the committee are able to make recommendations based on all available information from the NHS. We will write to stakeholders and update the topic webpage with details of the revised timelines for the assessment in due course.
06 April 2021 In progress. This topic began as a diagnostic assessment and became a multiple technology appraisal during scoping.
18 December 2020 Invitation to participate

For further information on our processes and methods, please see our CHTE processes and methods manual