The great #gbdoc CGM debate – an alternative approach to NHS funding…

Following yesterday’s NNF conference on Continuous Glucose Monitoring (CGM) and the ensuing Twitter debate that frequently happens with these types of event, I gave some thought to an alternative approach to funding CGM.

What it boils down to is that, instead of being tied to Self Monitoring of Blood Glucose (SMBG) using finger prick strips, the budget that NICE allocates for ten times daily finger prick testing could be applied to both CGM and SMBG, and the patient would be responsible for managing that budget and making up the difference in any costs that arose. A perfect example of patient centric care.

What does NICE say about Diabetes and Glucose Monitoring?

So let’s be clear here, and define some key rules with regard to how CGM is supplied within the NHS. I’m not suggesting that the current NICE guidelines are ignored. In fact, what I’m proposing builds on those very guidelines as they provide a framework within which one can manage a model. Let’s take a quick look at what NICE says about SMBG, CGM, and while we are at it, Sensor Augmented Pumps, courtesy of NG17 and DG21.

NG17 states a few things:

1. Patient centred care should be expected: “Treatment and care should take into account individual needs and preferences. Patients should have the opportunity to make informed decisions about their care and treatment, in partnership with their healthcare professionals.”

2. “Support adults with type 1 diabetes to aim for a target HbA1c level of 48 mmol/mol (6.5%) or lower, to minimise the risk of long‑term vascular complications.”

3. Provide support in SMBG to aim for targets that are between 4 and 7 mmol/l: “Support adults with type 1 diabetes to test at least 4 times a day, and up to 10 times a day [… &] Enable additional blood glucose testing (more than 10 times a day) for adults with type 1 diabetes if this is necessary because of the person’s lifestyle” and most of us realise that this number will be 10 times or more rather than 4 times if the Hba1C target is really to be met.

4. Apply for CGM where certain specific circumstances arise: “Consider real‑time continuous glucose monitoring for adults with type 1 diabetes who are willing to commit to using it at least 70% of the time and to calibrate it as needed, and who have [one of the five listed issues in section 1.6.22]”

DG21 states:

1. Sensor augmented pump therapy is only recommended as an option where: “they [the patient] have episodes of disabling hypoglycaemia despite optimal management with continuous subcutaneous insulin infusion”

What’s clear here is that there is NICE guidance as to when both CGM and Sensor Augmented Pump Therapy should be provided to patients, and these should be used and encouraged to be used. As a result of this proposal, it is not suggested that these are stopped. For many though, the auspices of NG17 and DG21 do not cover them. The use of CGM is in addition to the SMBG that is considered essential and the resultant benefits to Hba1C are not one of the list of five things in section 1.6.22. This list is:

· More than 1 episode a year of severe hypoglycaemia with no obviously preventable precipitating cause.

· Complete loss of awareness of hypoglycaemia.

· Frequent (more than 2 episodes a week) asymptomatic hypoglycaemia that is causing problems with daily activities.

· Extreme fear of hypoglycaemia.

· Hyperglycaemia (HbA1c level of 75 mmol/mol [9%] or higher) that persists despite testing at least 10 times a day (see recommendations 1.6.11 and 1.6.12). Continue real‑time continuous glucose monitoring only if HbA1c can be sustained at or below 53 mmol/mol (7%) and/or there has been a fall in HbA1c of 27 mmol/mol (2.5%) or more.

For many, these conditions provide direct qualification to ask for CGM and they should be pursued with alacrity. There are also many of us that do not face these challenges. Even without CGM that we have already purchased ourselves.

So then, for those of us who don’t qualify, how do we get CGM funded? The idea is not to add additional cost to the NHS. We have to work on the basis of a flat budget – it cannot come at a cost to other services.

That’s where we need to consider the section on target levels and SMBG in sections 1.6.6 to 1.6.15. The targets provided are tight. Many have stated an opinion that they are unfeasibly tight. The evidence that NICE gathered and the modelling undertaken for NG17 (section 8.2.5 of the Full Guideline) states that SMBG 8 or 10 times daily were the most cost effective and SMBG 10 resulted in the best Hba1C outcome. In reality, for most to achieve these targets, SMBG needs to be done at least ten times daily. Beyond that, there isn’t a great deal of data.

We therefore have a comparison of what NICE thinks relating to cost effectiveness for SMBG and what NICE estimates the cost to be (£1,059 per annum) for SMBG 10. That’s the evidence base and the cost boundaries.

What we also have is an anecdotal evidence base that says that CGM allows people to better manage their condition (I hold my hands up to that one – my current Sensor Augmented Pump output suggests that I have spent 85% of my time over the past 30 days within a range of 3.8mmol/l to 8.8mmol/l) and that as a result of using CGM type technologies, fewer SMBG tests are undertaken (another item I’d hold my hand up to).

We also know that if you were to purchase sensors for varying CGM systems, they cost around £50 per sensor and that there are peripherals that also need to be acquired. Currently these are mostly purchased privately by patients. In the past we’ve estimated the overall costs to be between £1000 and £1500 annually once all the components are taken into account and things like extending sensors are undertaken. We therefore know that the cost of these systems is more than the SMBG 10 cost of £1,059 that NICE has estimated.

What are you proposing?

Taking all this into account, and using the first identified principle of the NICE guidance, Patient Centric care, instead of mandating that the only way that prescription monitoring can be provided under the NICE guidance for those who fall outside the prescriptive requirements for CGM, it should be possible to apply, through either your Diabetes Care team or your GP for a “Self Monitoring Fund”. It is a similar model to the Personal Health Budget.

Let’s be clear on this one though. This is not for everyone. The standard model of care is the NICE guideline. Each patient gets the standard SMBG provisions and supplies as normal. They can apply for CGM if they qualify under the criteria listed previously. The Self Monitoring Fund is undertaken on application only. It is not the new “Normal”. In patient centric care, the patient gets to decide, in association with their healthcare team, what monitoring would be most appropriate for them. If they feel that a combination of SMBG and CGM is appropriate, then they can apply for and move on to this model. In doing so, they rescind their right to SMBG as standard on the NHS.

But what is it?

It’s very simple. When a patient decides and their HCPs agree that instead of being provided SMBG test strips, they will take management of this into their own hands, they apply, either through their Diabetes Clinic or their GP, to the CCG for the Self Monitoring Fund. The fund provides for £1,059 to be spent by the patient on monitoring supplies and technology. In any way that they elect to do so.

All supplies will need to be available through the NHS Prescription service so that the normal prescription model is followed. This would also allow the GP, for example, to track the cost – most GP prescribing systems contain the cost of prescription items, so it’s a short jump to be able to allocate a cost per patient. When, via the prescription system, the annual fund is exhausted, the patient must purchase additional monitoring supplies out of their own pocket. Whatever those monitoring supplies are. This should come as no surprise to the patient, who should be managing this anyway, and is part of the contract that is signed on application for the fund. Both parties have to go in with their eyes wide open on this one.

Given that the companies that provide these items are already working with the NHS, this shouldn’t be a huge jump.

What are the benefits of this approach?

The benefits to this approach are in better patient care and in evidence gathering for future guidelines and use of NHS funds.

1. This isn’t a one size fits all approach. It’s an “on application” model that means you only do it if you feel you can and your healthcare team agrees.

2. It allows those who want to define their own care model to elect how they monitor themselves and what technologies to use to do this.

3. By including the details of how many patients have applied for and are using the “Self Monitoring Fund” approach in the National Diabetes Audit, it allows a clear picture to be obtained as to the demand on the NHS for CGM. The prescription data also adds to this picture. There is currently doubt that this demand is as high as the Diabetes Online Community (which is very noisy) makes it seem.

That’s the proposal. I’m sure that I’m likely to have missed something, and as with all these things, there will be challenges along the way. The question for the GB Diabetes Online Community is “Would you be willing to work within this type of framework?”. It’s not the panacea in terms of the NHS paying for everything, but I don’t think it should be. The NHS can’t afford to cover everything for everybody. This allows a way for those of us who want it to get better coverage to do so, without causing extra cost and headaches.

Who knows, it might even encourage a better deal on the price of the CGM supplies in the UK if the NHS had signed up!