21st December 2023
The National Institute of Health Care and Excellence (NICE) has announced final appraisal recommendations on hybrid closed-loop systems for managing blood glucose levels in type 1 diabetes.
This represents a huge advance in glucose management for those with type 1 diabetes and we recognise how important this is to you.
NICE have indicated that access to this technology will be rolled out over a 5-year period (rather than the usual implementation period of 3 months). It is likely they will stipulate which groups of patients will be eligible and when.
What does this mean for me as an individual with type 1 diabetes?
The NICE TA will have eligibility criteria – at your next routine diabetes review you will be assessed to see if you meet the criteria.
If you are eligible, you will be put on to a Hybrid Closed Loop (HCL) pathway of care. Due to the numbers of potentially eligible individuals, we expect there will be waiting lists. This is why NICE is expecting the roll out of the TA to be over five years.
Until the TA is finalised, and funding is approved, we will continue to use our existing criteria for access to insulin pumps and/or continuous glucose monitoring (CGM).
If I am eligible – can I choose any approved HCL system?
NICE are currently negotiating costs for these Hybrid Closed Loop Systems. Once prices have been agreed the Integrated Care System, which is a partnership of organisations who work together to deliver health and care services, will collaboratively review this and decide together which systems will be made available. Access to systems may vary from region to region.
Your clinical team may also advise one particular system over another to best suit your glucose management.
Where does this guidance apply?
Guidance for NICE technical appraisals applies to England and Wales but can also be formally adopted in Northern Ireland, with work underway to start that process. Scotland already has guidance for hybrid closed-loop systems and will continue to implement this.
What are hybrid closed-loop systems?
Sometimes known as an ‘artificial pancreas’ – hybrid closed-loop systems work by linking insulin pumps and continuous glucose monitors (CGM) with a computer algorithm that can calculate the amount of insulin someone needs based on blood sugar readings.
This allows the system to do some of the work to help manage blood sugar levels. Manual input is still needed to alert the system when eating or doing exercise.
There’s lots of evidence to show that the technology can help people with type 1 diabetes to improve their blood sugar levels, have less hypos and make self-managing the condition easier.
NICE is responsible for assessing medicines and medical technologies to see if they are beneficial and cost effective for use in the NHS in England and Wales. We’ve been working with NICE and its evaluation of hybrid closed-loop from its early stages.
We’ve also supported NHS England in their pilot rollout of the technology, which produced valuable real-world data that fed into NICE’s evaluation.
Choice of systems
This appraisal is intended to assess hybrid closed-loop systems as a whole and not individual systems so can apply to various approved devices. The final appraisal document says that these recommendations above only apply to hybrid closed-loop systems which meet a cost-effective price agreed by NICE.
The NHS have been negotiating with manufacturers of closed-loop systems to agree which ones will be available nationally under this agreement and we are awaiting the outcome of these discussions.
What happens next?
These recommendations are the result of a three-year process which involved extensive consultation with stakeholders and a national real-world pilot of the tech to assess its benefits.
NICE’s recommendations are just the beginning of the journey. This guidance means that hybrid closed-loop will be offered to many more people with type 1 diabetes and position the UK as a world leader in offering this tech over the next few years.
This will require significant changes to the way specialist diabetes services are delivered and, in order to manage workforce pressures and ensure people are supported to use the tech confidently and safely, a phased five-year implementation plan has been developed to guide the roll-out.
Managing the rollout in this way is designed to help the NHS deliver the tech in a way that offers the greatest benefit to people with the greatest unmet need.
As part of this plan, priority will initially be given to children and young people under 18 and women who are pregnant or planning a pregnancy – where the need to optimise care is often highest – and existing pump users interested in upgrading, as capacity to offer it to more people is developed . Further information on prioritization will also be developed as part of wider engagement that we will be involved in.
This means that not everyone eligible will be able to get it straightaway, but should enable the rollout to be managed to ensure fairness and adapt to local circumstances.
The implementation will also be subject to regular monitoring through an oversight group set up by NHS England. Diabetes UK will sit on this group which will scrutinise audit and other data and reports to ensure that access and uptake of the technology are fair and not driving inequalities.