Hybrid closed loop systems for managing blood glucose levels in type 1 diabetes

Section 7 of the National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013 requires integrated care boards, NHS England and, with respect to their public health functions, local authorities to comply with the recommendations in this appraisal within 3 months of its date of publication. 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:

• 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.
  
  This extension is made under Section 7(5) of the Regulations.

Based on the commercial framework and the recommendations in this guidance, NHS England has developed a 5-year implementation plan with advice and guidance to NHS providers on the phased uptake approach. The strategy will centre on improving health outcomes and reducing health inequalities. The phased rollout will initially start with:

• children

• young people

• women, trans men and non-binary people who are pregnant or planning to become pregnant and

• adults who already use pumps who want to transition to an HCL system (over time, this will be extended to people who want to start using a pump for the first time).
  
  Key elements of the strategy will include workforce, patient education, commercial, stakeholder engagement and data.

The Welsh ministers have issued directions to the NHS in Wales on implementing NICE technology appraisal guidance. When a NICE technology appraisal recommends the use of a drug or treatment, or other technology, the NHS in Wales must usually provide funding and resources for it within 2 months of the first publication of the final appraisal document. For HCL systems, the period of compliance in Wales is extended to 5 years. This is for the reasons in section 4.1 and is in line with NHS England's funding variation request. The NHS Wales Executive will develop a 5‑year implementation plan for this technology with guidance and support to health boards on the phased approach.

When NICE recommends a treatment 'as an option', the NHS must make sure it is available within the 5‑year period set out in the paragraphs above. This means that, if a person has type 1 diabetes and the doctor responsible for their care thinks that an HCL system is the right treatment, it should be available for use, in line with NICE's recommendations, the funding variation request and NHS England's implementation plan.

The funding variation assumes that NHS England and NHS Wales are able to maintain cost-effective prices as per NICE's recommendations. NHS England, or NHS providers, will only purchase HCL systems in line with these recommendations. As new technology emerges, NHS England or NHS providers reserve the right to do further commercial activity to ensure HCL systems continue to deliver value for the NHS.