Flash glucose monitoring – frequently asked questions for commissioners

There is no further guidance on this element as the potential scenarios are too varied in nature to be able to be meaningfully reflected in guidance, and therefore patients selected using this criterion should reflect individual clinical judgement.

The criteria are considered to be sufficient in range to be appropriate for all age groups (taking into account that flash glucose monitoring is not licenced for children aged under 4) and so separate criteria for children were not considered to be necessary.

As flash glucose monitoring is an innovative technology, part of the learning will arise from the ongoing evaluation to identify and act upon any impact on health inequalities. There are plans to collect data on flash glucose monitoring as part of the National Diabetes Audit (NDA) and linking flash glucose monitoring with other NDA data will support identification of any inequalities issues. As part of the clearance processes for publication the draft guidance was reviewed by NHS England’s Experience, Participation and Equalities team and it was supported, on condition that a Health and Inequalities Impact Assessment is also developed.

CCGs are advised to conduct an equality and health inequalities assessment when planning the local implementation of the provision of the flash glucose monitoring devices in their locality.

There are plans to collect data on flash glucose monitoring as part of the National Diabetes Audit (NDA) and linking flash glucose monitoring with other NDA data will be used to help evaluate the impact of the national guidance on patient outcomes and NHS expenditure. In addition, NHS England will review the uptake and spread of flash glucose monitoring prescribing for each financial quarter.

The need for appropriate means for the safe disposal of sensors existed prior to the national funding arrangements and so local arrangements for these should be in place. For disposal guidance in relation to specific flash glucose monitoring devices, please refer to the manufacturer’s website.

Although we can identify prescriptions issued by Trusts, we cannot accurately identify the appropriate CCG for reflection in their allocation. After considering this, and that the data suggests that longer term prescribing in Trusts is the exception rather than the rule, on balance the view was taken that it would be appropriate for reimbursement to be based only on primary care prescribing.

The approach taken reflects that the majority of CCGs have arrangements for ongoing prescribing of flash glucose monitoring sensors to take place in primary care. As the guidance highlights, this does not preclude overall clinical responsibility for the management of a person’s diabetes remaining within secondary care where appropriate. We recognise that some localities may wish to revisit their prescribing arrangements for flash glucose monitoring sensors in the light of this.

Although NHS England can identify prescriptions issued by Trusts, we cannot accurately identify the appropriate CCG for reflection in their allocation. Taking this, and that the data suggests that longer term prescribing in Trusts is the exception rather than the rule, on balance the view was taken that it would be appropriate for reimbursement to be based only on primary care prescribing.

The approach taken reflects that the majority of CCGs have arrangements for ongoing prescribing of flash glucose monitoring sensors to take place in primary care. As the guidance highlights, this does not preclude overall clinical responsibility for the management of a person’s diabetes remaining within secondary care where appropriate. We recognise that some localities may wish to revisit their prescribing arrangements for flash glucose monitoring sensors in the light of this.

In order to support a consistent approach to reimbursement, it is desirable for this to be based on a single, consistent data source. Therefore, the ePACT data has been identified for this purpose.

The approach taken reflects that the majority of CCGs have arrangements for ongoing prescribing of flash glucose monitoring sensors to take place in primary care (although with initiation being in secondary care in many cases) and so, on balance, it was considered that this was the appropriate approach to take. As the guidance highlights, this does not preclude overall clinical responsibility for the management of a person’s diabetes remaining within secondary care where appropriate. We recognise that some localities may wish to revisit their prescribing arrangements for flash glucose monitoring sensors in the light of this.

The only flash glucose monitoring sensor currently available on the market is the Freestyle Libre by Abbott Laboratories, which is listed as £35 on the NHS Tariff.

The reimbursement amount has been offset by modelling that, prior to using flash glucose monitoring, patients would have been using a greater number blood glucose testing strips, representing a cost to the CCG that will no longer be incurred. The savings from two testing strips per day have therefore been built into the reimbursement level. The reimbursement level was originally £26.03 after reflecting this saving, and taking into account Pharmacy Discount. The Department of Health and Social Care has subsequently decided to move the Flash Glucose sensors onto the ‘Discount Not deducted’ list in Part II of the Drug Tariff, effective from 1st July 2019.  Which results in the discount amount being removed. This has resulted in a slight increase in the flash unit cost from £26.03 to £28.56. Therefore, CCGs are now being reimbursed at the higher rate and CCGs indicative budgets have been adjusted to reflect the increased cost.

 

The budget allocations were set at the start of the programme based upon the T1 population from the latest NDA audit results available at that time.

It is intended that the allocations remain constant for the two years of the programme, so the CCG allocations you have for 2020/21 will be the same as 2019/20. This provides a level of consistency across the two year programme and allows CCGs to activity support the programme & budget accordingly. It should also allow them to identify any additional budget requirements, should they recruit more than 20% of their patient cohort.

CCGs need to accrue for outstanding year end prescribing expenditure in line with their usual year end accounting procedures.

Due to the timing of prescribing reports, NHS England and NHS Improvement will only be able to issue allocations to cover Quarters 1 to 3 by March 2020. Quarter 3 allocations will be actioned in March 2020.

CCGs are not able to accrue at year end for outstanding allocations. If CCGs want to account for the outstanding allocations it is suggested that they accrue for the amounts due as miscellaneous income pending the allocations in June 2020 for Quarter 4 2019/20 prescribing costs. CCGs will need to accrue for the miscellaneous income based on local prescribing report costs at the current reimbursement rate.

A flash glucose monitor is a wearable sensor which relays blood glucose levels to a smartphone or e-reader, allowing people living with Type 1 diabetes to better manage their condition. Flash 2 is the second generation of Abbott’s sensor-based technology for people living with diabetes. The new sensor has real-time glucose alarms that notify you if you go too low or too high.

The price of the Flash 2 sensor will be the same as the current flash glucose monitoring sensor. From the 1 July 2019,  the flash glucose monitoring sensor was added to the discount not deducted (DND) (Part II of the drug tariff) list for pharmaceutical products. This will mean that the reimbursement per sensor will be £28.56 from this point forward.

Flash 2 is approved to be prescribed from the 1st November 2020. However, implementation and roll out of access to Flash 2 is expected from January 2021. Local prescribing formulary and GP systems will need to be updated to enable them to prescribe the new sensor.

To manage workload & product supply, Libre 2 will be offered to patients who meet the eligibility criteria for Flash at their next routine appointment with their diabetic healthcare professional. In the current climate, we respectfully request that patients wait until their next routine appointment with their healthcare team in 2021 to enquire about the FreeStyle Libre 2 system.

The existing Flash app is compatible with both the Flash and Flash 2 sensors, however alarms are only received from Flash 2 sensors. Users should check that their Flash app is updated to the latest version (version 2.5 or above). Details on device compatibility can be found in the compatibility guide on the Abbott website.

Just like the Flash system, the Flash 2 system is discreet, convenient and easy to use, now with added benefits. There is a range of education and support available for both patients and Healthcare practitioners from Abbott, including:

  • FreeStyle Academy – Flash 2 Alarms Functionality module
  • Webinars – both on-demand and live webinars highlighting the new features of Flash 2
  • Website information and the FreeStyle Customer Careline
  • Print materials provided to HCPs including: Patient Education Booklet, FreeStyle LibreLink How to Guide, LibreView Guide and more.

Every new user will receive a Patient Education Booklet with their first Flash 2 sensor delivery when ordered as part of a New Starter Clinic. The user is then invited to the New Starter Clinic and they will continue to receive information and support through their first 12 weeks via email*

All existing users will be invited to watch on demand webinars and complete the academy module to support them with their move to the Flash 2 system.* In addition, a full email programme will support users in the first 2 weeks of using the Flash 2 system, as well as multiple patient education materials available for HCPs to send directly to their patients.

*subject to the user opting-in to email marketing permissions.