NICE released their technology appraisal guidance for Hybrid Closed Loops today. You can find it here: https://www.nice.org.uk/guidance/ta943
I think everyone can agree that this is an incredibly exciting moment in Type 1 Diabetes history within the NHS in England and Wales, and judging by what I’ve seen on social media today, it’s generated a huge amount of excitement in the UK diabetes community.
But before everyone goes rushing off to their clinic to ask for Hybrid Closed Loop, it’s worth being aware of what they’ve approved, and what that means for you…
1. Cost effective hybrid closed loop. This means you’ll be offered what’s cost effective to the NHS and not “what you want”, and this is a new national process that will take time and resource to develop and roll out. This may mean “Omnipod5 with Libre2” or “MyLife Loop with Libre2” rather than a Dexcom G6 or G7 set-up…
2. The implementation plan is over a five year period, doesn’t yet exist and each locale can define their own priority list, so you won’t necessarily get it soon. And if CGM is anything to go by, each area will want to develop it’s own plan, further delaying delivery.
3. The phased roll out starts with Children, Young People, “women, trans men and non-binary people” who are pregnant or planning to get pregnant and those who already use pumps who want to transition to HCL. If you’re not on a pump right now, then even if you have an Hba1C greater than 7.5%, it’s unlikely you’d be a short term, or perhaps even mid-term priority.
While this is a massive step forward, don’t try ringing your clinical team and asking for it now. They will struggle to help you because there is a lot of work to do to scale services up to provide this, let alone distribute the pricing data to clinics to determine what you can get.
The guidance is very clear, stating this will require a whole new set of processes and skills, which is why the timeline has been extended to five years.
The normal period of compliance has been extended to 5 years for this technology because NHS England submitted a funding variation request, which was accepted by NICE after a period of public consultation. NHS England’s justification for the funding variation request is:NICE TA493
Need for specialist support:People with diabetes, their families and their carers need training and specialist support to use insulin pumps, glucose monitors and hybrid closed loop (HCL) systems effectively.
Variation in access: Provision of diabetes technologies varies significantly across the country. Expertise in and capacity to provide insulin pump services are often concentrated in larger diabetes teaching centres, with fewer resources at smaller diabetes centres and district general hospitals.
Clinical capacity: There is a lack of adequately trained staff, so investment and time is needed to recruit and train staff to support effective use of HCL systems and reduce variation in access across the country.
Health inequalities: Without a planned introduction of HCL systems and continued investment in staffing capacity and training in HCL systems there is a risk of exacerbating 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.
Patient benefit: The phased rollout is not expected to adversely affect outcomes for people eligible for HCL systems. The National Diabetes Audit has shown that many people with type 1 diabetes have improved glycaemic control using continuous glucose monitors and insulin pumps. Effective implementation of HCL systems will represent a further advance in achieving optimal glycaemic control.
Variation in procurement: Procurement of diabetes technologies varies considerably. To resolve this variation and ensure trusts can access nationally mandated cost-effective prices, NHS England will need to develop a new commercial framework through a formal procurement process. This is expected to take time and resource to develop and test with suppliers.
Essentially, while NICE have agreed, it’s going to take some work (and therefore time) to sort out the details.
Local teams are nowhere near sorting this out. They still need locally agreed guidance. Cost effectiveness is also key and all depends on procurement and prices which aren’t released.
It’s the week before Xmas. Teams have zero staff to pick up calls, as well as the urgent things that happen in this time period.
It’s also a 5yr roll out. If you’re not a priority group it is unlikely you’ll be able to progress anything in the short to medium term.
The feedback is that the level of enquiry is hampering DSN teams ability to do other things.
They will get there, it’s just a long road that we’re only at the start of. So celebrate the good news, but take it in your stead and act sensibly.
And hopefully, by the time we reach the end of that five year implementation plan? We’ll have enough data and volume pricing discounts to extend it to everyone else.