North Central London Joint Formulary Committee FreeStyle Libre for glucose monitoring: Interim Position Statement for GPs & Patient FAQ GPs should not prescribe FreeStyle Libre sensors on the NHS until local funding arrangements are agreed. FreeStyle Libre readers will not be prescribable on the NHS. FreeStyle Libre measures glucose levels via a sensor as an alternative to routine finger-prick blood glucose testing. Finger-prick testing remains necessary for driving and monitoring during acute illness or hypoglycaemic episodes. FreeStyle Libre has not been demonstrated to be cost-effective and does not have a positive recommendation by NICE. The NHS in London is working collaboratively to establish which patients are most likely to benefit from FreeStyle Libre. This position statement will be updated when the NHS in London have established access criteria, and NCL CCGs have approved funding. This positioning is consistent with the East of England Priorities Advisory Committee (PrescQIPP) interim recommendations. Background FreeStyle Libre measures glucose levels from a sensor applied to the skin as an alternative to routine finger-prick blood glucose testing, and can produce a near-continuous record of measurements which can be accessed on demand. 1 Finger-prick testing is still required during times of rapidly changing glucose levels (i.e. acute illness), if hypoglycaemia is reported, if impending hypoglycaemia is reported, or if symptoms do not match the system reading. Finger-prick testing is also required prior to and during driving to meet current DVLA requirements. 2 FreeStyle Libre will be added to the NHS Drug Tariff in November 2017. NICE has not issued guidance on the use of FreeStyle Libre; it issued a Medtech innovation briefing which summarised the costs, evidence base and perceived benefits, however, it did not include a recommendation. NHS networks in London are working collaboratively to identify the patient groups most likely to benefit from FreeStyle Libre. NCL CCGs recommend that GPs do not prescribe FreeStyle Libre sensors until NHS networks have agreed the access criteria and local funding approval is achieved. Patients who are self-funding FreeStyle Libre should continue to do so. This position statement will be updated when the approach to prescribing has been agreed. North Central London Joint Formulary Committee 1 of 5
References 1. National Institute for Health and Care Excellence. MIB110: FreeStyle Libre for glucose monitoring. (2017). Available at: https://www.nice.org.uk/advice/mib110/chapter/summary. (Accessed: 25th September 2017) 2. The East of England Priorities Advisory Committee. Guidance Statement - FreeStyle Libre Glucose Monitoring System. PAC interim recommendations. (2017). Groups / Individuals who have overseen the development of this guidance: Groups which were consulted and have given approval: File name: Sheldon Russell (Barnet), Sharon McCarthy (RFL) NCL Diabetes Meter working group, NCL Clinical Commissioning Groups Position Statement_Freestyle Libre_V1.0_FINAL.Docx Version number: V1.0 Available on: Disseminated to: Equality impact assessment: NCL MON website All Trusts and CCGs in NCL Low NCL Joint Formulary Committee Approval date: October 2017 Review date: March 2018 North Central London Joint Formulary Committee 2 of 5
North Central London Joint Formulary Committee FreeStyle Libre Frequently Asked Questions (FAQ) for patients What is FreeStyle Libre? FreeStyle Libre flash glucose monitoring system measures glucose levels in people with diabetes using a sensor applied to the skin. FreeStyle Libre is an alternative to finger-prick blood glucose testing, and can produce a nearcontinuous record of measurements which can be accessed on demand. 1 Readings are taken by scanning the sensor with a FreeStyle Libre reader or some mobile phones a. People using FreeStyle Libre still need to use finger-prick blood glucose testing: when they feel unwell; for example when they have the flu, diarrhoea or are vomiting when the FreeStyle Libre reader shows low glucose readings (hypoglycaemia) or warns that hypoglycaemia is likely when symptoms do not match meter readings before they drive and during driving (to meet DVLA requirements). Who has had access to FreeStyle Libre before November 2017? GPs are not currently able to prescribe Freestyle Libre on the NHS. People may have chosen to self-fund FreeStyle Libre by purchasing it directly from the manufacturer (Abbott). What changes on 1 st November 2017? On the 1 st November 2017, Freestyle Libre sensors will be added to the NHS Drug Tariff therefore it would be possible for GPs to prescribe FreeStyle Libre sensors on the NHS but only with local health group approval. The Drug Tariff is a complete list of medicines and medical devices that can be prescribed on the NHS. a Android mobile phones with Near-field Communication (NFC) capabilities North Central London Joint Formulary Committee 3 of 5
If a drug or device can be prescribed, does it mean it should be prescribed? Not necessarily. There are lots of drugs and devices that can be prescribed but not all offer good value for money to the NHS (this is known as being costeffective). The NHS has processes in place to identify cost-effective drugs or devices; these are then recommended nationally (e.g. National Institute for Health and Care Excellence [NICE] guidance) or locally. What does NICE say about FreeStyle Libre? NICE have not provided national guidance on the use of this device. They issued a Medtech innovation briefing which summarised the costs, evidence base and perceived benefits, however, it did not include a recommendation. 1 What is the NHS in London doing about FreeStyle Libre? The NHS in London is keen to avoid variability in availability depending where patients live. In order to achieve this aim, a London-wide agreement is required. Specialist clinicians in North Central London (NCL) will be working with diabetes networks in London organisations, which include service user representatives living with diabetes, to establish which patients are most likely to benefit from FreeStyle Libre. When this is agreed, Clinical Commissioning Groups (CCGs) will be asked to fund the device. The CCGs will then consider FreeStyle Libre alongside other drugs, devices or services that are also competing for access to their limited funding. This process will ensure that local decisions are robust and informed by a review of evidence to demonstrate clinical and cost-effectiveness. It is not possible to place an exact completion date on these discussions, but clinicians and commissioners will be meeting regularly over the coming months and updates will be circulated via normal communication routes. If accepted for funding and in line with Diabetes UK s own recommendations, such patients will be closely monitored (audited) to determine if their blood glucose can be maintained with optimal limits. This will be a requirement for long-term use and will be subject to annual review. Should patients ask GPs to prescribe FreeStyle Libre? The health community in NCL ask that patients do not request FreeStyle Libre from their GP. Patients who chose to self-fund Freestyle Libre should continue to do so. North Central London Joint Formulary Committee 4 of 5
This advice will change when the NHS in London has established which groups of patients are most likely to benefit from FreeStyle Libre (ie. the patients in whom FreeStyle Libre is likely to be cost-effective) and local funding is secured. The work outlined above will be taken forward as quickly as possible. It should not be assumed that people who chose to self-fund FreeStyle Libre will meet criteria for NHS provision and therefore some people may need to continue to self-fund. Will this position statement affect those currently funded for CGM by the NHS? This interim position statement will have no impact on patients currently funded for Continuous Glucose Monitoring (CGM) by the NHS. North Central London Joint Formulary Committee 5 of 5