FAQs about November 2023’s NICE recommendations on hybrid closed loop

When will the new guidance come into effect?

The final appraisal document has been issued to stakeholders for appeal. NICE anticipate publishing final guidance in December 2023. Once published, it is expected to take five years to get everyone who is eligible onto HCL technology.

Who will be eligible for hybrid closed loop (HCL) under the new guidance?

NICE recommends HCL as a treatment option for the following groups of people with type 1 diabetes:

Adults with an HbA1c of 58 mmol/mol (7.5%) or more, or have disabling hypoglycaemia, despite best possible management with at least one of the following: an insulin pump OR CGM OR flash. Disabling hypoglycaemia is defined as the repeated and unpredictable occurrence of hypoglycaemia that results in persistent anxiety about recurrence and is associated with a significant adverse effect on quality of life.

The phrase ‘best possible management’ and the list of devices is not intended to be something that excludes people but rather something that shows clinicians the pathway towards best care. If you’re not on one of those three devices, rather than your clinic saying you don’t meet the criteria for HCL, they should offer you a pump, CGM or flash as the next step in improving your glucose management.

All children and young people, whatever their HbA1c.

Women who are pregnant or planning a pregnancy, whatever their HbA1c.

These recommendations are not intended to affect use of HCL systems that were started on the NHS before this guidance was published. People using HCL systems outside of these recommendations may continue to do so.

Why is it only available to a limited number of people?

NICE’s decision is based on a range of research, evidence and health economic data. It applies to over 100,000 people with type 1 diabetes. NICE will review this guidance in the coming years as part of their usual process, and we hope the criteria will be expanded at that time to cover everyone with type 1. We won’t rest until everyone who could benefit from HCL has access free at the point of need across the four nations.

Does the five-year plan mean ICBs or clinics can put everything off for four years?

No.

The law normally requires integrated care boards (ICBs), NHS England and, with respect to their public health functions, local authorities to comply with the recommendations in this appraisal within three months of its date of publication.

The normal timescale has been extended to five years for this technology because of the following considerations:

• People will need to be trained to use HCL systems effectively.
• Variation in access due to expertise and staff numbers in the clinic teams.
• The need to recruit and train staff to support effective use of HCL systems and reduce variation in access across the country.
• The need to address the current inequalities in access to diabetes technology caused by health inequalities related to age, socioeconomic status, ethnicity, language barriers, and access to smartphones and the internet, all of which could affect uptake of HCL systems.
• The fact that adding HCL will help to improve glycaemic management but the lack of HCL while you wait will not make things worse than they currently are as nothing is being withdrawn.
• Variation in purchasing of diabetes technologies. In order to ensure all clinics, large or small, pay the same price for the same device, NHS England will need to develop a new commercial framework through a formal process.

For context, NICE technology appraisal 151 about insulin pump therapy was updated in 2008, and it has taken 15 years to get 26,000 adults in England on to pumps and there are still thousands of eligible people who are not using pumps. In order to get well over 100,000 people onto HCL within five years, it will take careful planning and big changes in the way clinics train new users.

I have particular needs – how can I make sure I’m prioritised?

The five-year roll out plan will be a guide, but local clinic teams can use their clinical judgement to decide if individual people need to access HCL sooner.

How do I get hybrid closed loop?

Speak to your Diabetes Healthcare Team at your next appointment to find out about access and their timescales for rolling out the technology.

I don’t qualify under the new recommendations, why do these recommendations seem to penalise people who are managing their type 1 well?

This is NICE’s decision based on a range of research, evidence and health economic data. We understand the frustration of those who don’t qualify. We expect the criteria to be reviewed in coming years as part of the normal NICE process, and we won’t rest until everyone who could benefit from HCL has access free at the point of need across the four nations.

Do these recommendations cover Wales/Scotland/Northern Ireland?

The recommendations cover England and Wales. Scotland has already approved HCL under its own recommendations. We will work to open up access to type 1 diabetes technology and HCL in Northern Ireland.

Is HCL available in Scotland?

NHS Scotland has recommended that hybrid closed loop systems should be pro-actively discussed with all patients with type 1, particularly those who have:

• suboptimal blood glucose management
• a high risk of severe hypoglycaemia
• impaired awareness of hypoglycaemia
• experience severe diabetes-related distress that adversely affects quality of life and is likely to be improved by using a closed loop system.

It also recommended that people already using both a CGM and an insulin pump should be offered a hybrid closed loop system, but if people are managing well with how they already manage their type 1, they should stay on that care plan.

Read the recommendations in full for more detail.

Which CGMs and pumps can be used for hybrid closed loop?

There are several HCL systems available that work with a variety of pumps and CGMs. Talk to your Diabetes Healthcare Team about what might be available to you.

How quickly will I be able to get HCL if I’m eligible?

We don’t know at the moment. Your first conversation should be with your Diabetes Healthcare Team, who will be able to advise you on timescales. Once the roll out plan starts it will take five years to train all those who are eligible.

I currently self-fund HCL. Will I now be able to get it free on the NHS?

It depends on whether you meet the access criteria. The best thing to do is to speak to your Diabetes Healthcare Team. And remember, once the roll out plan starts, it will take five years to cover all those who are eligible.

Will the eligibility criteria be expanded in the future?

We hope so. NICE reviews all their recommendations. We expect the outcomes from the early adopters of this technology will influence the criteria when it is reviewed in the future.  We won’t rest until everyone who would benefit from this technology is offered it free at the point of need.

I’m not using a pump at the moment. Can I get a pump and HCL in one go?

Yes! Most people who are eligible will be currently using insulin pens, not a pump.

My clinic already has a two-year waiting list for pump starts. How will I get to the front of the queue now HCL is being rolled out?

NICE technology appraisals, unlike NICE clinical guidance, puts an obligation on the ICB to fund this treatment for those who meet criteria and have clinical support. The NICE technology appraisal about insulin pumps was updated in 2008, and it has taken 15 years to get 26,000 adults in England on to pumps. We now want to get well over 100,000 people onto HCL within five years.

The Diabetes Technology Network is encouraging clinics to establish new ways to train and onboard new HCL users so that they can be on HCL in a reasonable timescale. It’s unlikely to be a step up of current practice, more likely to be a radically different way of getting large numbers of users trained. So, if you are on a waiting list for a pump don’t feel defeated – change is coming. We will update this page when we have more information.

What should I do if I think that I’m eligible, but my healthcare team disagree?

NICE technology appraisals set out the legal obligations for the ICB, and guidance for clinical staff. There are no legal obligations on your clinical team though, they will use their clinical judgement. If you think you meet the criteria but are being declined access, contact us through our contact form.

My clinic hasn’t put many people on pumps and I don’t think they’ll offer HCL, what can I do?

The NHS is legally obliged to fund and resource medicines and treatments recommended by NICE’s technology appraisals.

The NHS Constitution states that patients have the right to drugs and treatments that have been recommended by NICE for use in the NHS, if their doctor believes they are clinically appropriate.

When NICE recommends a treatment ‘as an option’, every ICB must make sure it is available. This means that, if a patient has a disease or condition and the doctor responsible for their care thinks that the technology is the right treatment, it should be available for use, in line with NICE’s recommendations.

If your Diabetes Healthcare Team is unfamiliar with HCL you can ask your GP to refer you to another clinic. As long as you have a good reason, your GP should agree. Not being offered the treatment you consider you need is a good reason. You do not need to ask your current clinic to refer you, it has to come from your GP. And remember, once the roll out plan starts, it will take five years to cover all those who are eligible.

Will people with other conditions be considered?

NICE considered other types of diabetes that could benefit from HCL systems, including type 3c diabetes (in which the pancreas is damaged) and cystic fibrosis-related diabetes. NICE noted that whilst there is no evidence on the use of HCL systems for these conditions, the clinical benefits were likely to be similar to the clinical benefits for people with type 1. Therefore, NICE concluded that HCL systems could be useful in these groups but this was outside the scope for this document.

How can I find out more?

Take a look at our website about hybrid closed loop systems.

You can find out more about what the experts think about different devices on the DTN network.

Read the NICE final appraisal document for reference.

Still have questions?

Contact us by using our contact form.