Here is a list of the various types of guidance produced by NICE relating to diabetes technology. The type 1 technology guides written by INPUT, Diabetes UK and JDRF provide a summary of all the guidance along with their criteria.
Technology appraisals guidance
NICE says “These assess the clinical and cost effectiveness of health technologies – such as new pharmaceutical and biopharmaceutical products – but also include procedures, devices and diagnostic agents. This ensures that all NHS patients have equitable access to the most clinically and cost-effective treatments that are available.
Regulations require clinical commissioning groups, NHS England and local authorities to comply with recommendations in a technology appraisal within 3 months of its date of publication.”
This means that if you meet the criteria and your clinic says you need the device, the funding body (your CCG for adults or NHS England for children & young people) MUST provide funding.
Guidelines (used to be called Clinical Guidelines)
NICE says “NICE guidelines make evidence-based recommendations on a wide range of topics, from preventing and managing specific conditions to planning broader services and interventions to improve the health of communities.”
This means they are recommendations for best care. Unlike technology appraisals, funding does not have to be provided for devices recommended by this type of guideline.
NICE says “These focus on the evaluation of innovative medical diagnostic technologies in order to ensure that the NHS is able to adopt clinically and cost-effective technologies rapidly and consistently.”
Again these are recommendations for innovative technologies, and the funding of devices covered by this type of guidance is not mandatory.
Click here to read our note on interpreting this guidance.
NICE says “Quality standards set out the priority areas for quality improvement in health and social care. Quality standards are developed independently, in collaboration with health and social care professionals, practitioners and service users. They are based on NICE guidance and other NICE-accredited sources. (They are not mandatory but) they can be used to plan and deliver services to provide the best possible care.”
QS125 (July 2016) – Diabetes in children and young people (note particularly quality statement 4 concerning CGM)
Medtech Innovation Briefings
NICE says “MIBs provide a description of the medical technology, including its likely place in therapy, the costs of using the technology and a critical review of the strengths and weaknesses of the relevant published evidence.
Their purpose is to provide objective information on device and diagnostic technologies to aid local decision-making by clinicians, managers and procurement professionals. By making this information available, NICE helps to avoid the need for NHS organisations to produce similar information for local use.
MIBs are not NICE guidance. They differ in format, contain no judgement on the value of the technology and do not constitute a guidance recommendation.”
The National Institute for Health and Care Excellence (NICE) provides national guidance and advice to improve health and social care. NICE was originally set up in 1999 as the National Institute for Clinical Excellence, a special health authority, to reduce variation in the availability and quality of NHS treatments and care.
NICE’s role is to improve outcomes for people using the NHS and other public health and social care services. They do this by:
- Producing evidence based guidance and advice for health, public health and social care practitioners.
- Developing quality standards and performance metrics for those providing and commissioning health, public health and social care services.
- Providing a range of informational services for commissioners, practitioners and managers across the spectrum of health and social care.
Since it was established, NICE has provided an increasing range of advice on effective, good value healthcare. Some types of NICE guidance mean that funding must be provided if a patient meets criteria for something and their healthcare provider believes they should have it (for example, NICE technology appraisals). Other types of NICE guidance are more like suggestions for good clinical practice but there’s no requirement that they be implemented or funded (for example, NICE clinical guidelines). Some documents from NICE provide information but are not guidance (for example, medical innovation briefings).
Current NICE guidance on CGM
The 2015 NICE Guidelines on type 1 diabetes (see NG17 for adults and NG18 for children and young people – links above) identify some clinical situations in which ongoing (or ‘24/7’) CGM should be offered or considered. However, these clinical guidelines are suggestions only, and they do not mean NHS funding must be provided for CGM in any case.
Responding to the new guidelines, commissioners in some local areas have decided that individual funding requests (IFRs) are no longer appropriate for CGM and other funding arrangements are under discussion. In other places, IFR remains the route for diabetes specialists to pursue funding for CGM in exceptional cases. At present, there is no ‘best practice’ or ‘standard’ way of providing funding for ongoing (‘24/7’) CGM use.
If your team need / are willing to make an IFR application, your consultant will need to read this policy and will need to complete and return this application form. showing that you stand to benefit from using this technology more than anyone else in the clinic. A brief guide to IFRs has been written for patients and can be viewed here.
In certain clinics, diabetes teams provide a certain number of CGM sensors to some patients for occasional (intermittent) ‘diagnostic’ use. Diagnostic use of CGM also includes wearing a sensor for a few days without seeing the data at the time. Diagnostic use of CGM is typically funded through the hospital trust budget (directly via your clinic).
Local arrangements can lead to inequality within the health service, so NICE offers specific guidance to commissioners as well as clinical guidelines.
NICE guidance on commissioning provided through TAG is mandatory in England and Wales: if a patient meets criteria for something described in a NICE TAG document and their doctor recommends it, the funding must be provided by the NHS. Scotland and Northern Ireland usually incorporate NICE TAG documents into their own structures as well. If your diabetes clinic says they can’t provide a pump because there is not enough funding, please contact INPUT if you live in England, Wales or Northern Ireland, or iPAG (email email@example.com) if you live in Scotland.
A future NICE TAG on CGM will probably recommend CGM for people using insulin who meet certain clinical criteria. To benefit from using an insulin pump, people with type 1 diabetes need to be actively engaged with their care, have taken and understood structured education, and be willing to make frequent decisions about adjustments to their insulin and diet, and this is likely to be the case with CGM as well.
INPUT is sometimes asked whether it’s possible to self-fund a portion of the cost for a pump or CGM. It is not possible to have part-funding for a pump because pumps are covered under TA151, which is a TAG document. If someone meets the criteria for a pump, all the funding must be provided by the NHS. If they don’t meet the criteria, then they must self-fund the entire cost. Because CGM is not currently covered by TAG, it remains possible to have a combination of self-funding and NHS funding for CGM.
How about a petition?
INPUT will not sign or endorse any petitions to get CGM funded by the NHS. Petitions are aimed at politicians, and politicians are not able to force the NHS to fund a treatment or device which NICE has not appraised.
CGM manufacturers are keen to see their products available on the NHS, as NHS funding will mean more business. To this end, the CGM manufacturers are conducting research that will generate data for NICE to assess.
If a petition is asking NICE to appraise any particular technology asap, this could be counterproductive: without strong evidence in favour of that technology, the appraisal could be negative. After a negative first appraisal, we would have to wait several years for NICE to take another look.
So what does INPUT suggest?
- Talk with your diabetes care team. Are they discussing CGM with the hospital trust and local commissioners? If not, why not?
- Ask your diabetes consultant to develop a business case for widening the use of CGM in line with the NICE Clinical Guidelines released in August 2015. The ABCD Diabetes Technology Network can help them.
- Write to your commissioners to ask whether they intend to commission in line with NICE Clinical Guidelines released in August 2015, and if not, why not? Below are links to excerpts from the relevant NICE guidelines, ready for you to print and enclose with your letter (or include as links if you’re emailing)
- 8 North West London CCGs now commission CGM for adults in line with NICE NG17. A great example for other CCGs.
- Share this article with friends and on social media