When will the FreeStyle Libre be available on the NHS?
An announcement was made today, September 13th 2017, by Abbott that their FreeStyle Libre System will be available on the NHS from 1st November subject to local criteria. It will be available for reimbursement via the NHS across England and Wales, NHS Scotland and Health and Social Care in Northern Ireland for people with Type 1 and 2 Diabetes (using insulin)
Japan recently confirmed its availability as did France earlier in the year.
There was an ongoing petition asking the government for the FreeStyle Libre to be available on prescription in the UK.
Getting on the NHS Drug Tariff after getting the go-ahead from the NHS Business Services Authority is only half the picture, many questions still remain unanswered. Will the boards in NHS Scotland put it on their formulary? If so what will local criteria be? We will update as further details become available.
This is what the Scottish Government have to say on the announcement:
The Scottish Government notes the announcement by Abbott of the decision to include FreeStyle Libre system on the England and Wales drug tariff.
NHS Scotland has yet to receive official notification of this. Once received, NHS Scotland will follow the established due process for consideration of inclusion on the Scottish Drug Tariff.
At this time NHS Boards and diabetes teams will continue to support people with advice and guidance on the currently available treatments and technology.
We would urge people to keep their planned or scheduled appointments with their diabetes team.
Of today’s news, Karen Addington, JDRF’s UK Chief Executive said:
“Today’s announcement is good news for people living with type 1 diabetes. But it is vital that the technology actually reaches those who want it and would benefit. There is a postcode lottery of NHS provision of type 1 diabetes technology. This is despite such devices making daily life with type 1 diabetes much easier.
“Each and every person with type 1 diabetes who wants this technology, and would benefit, should receive it. JDRF will continue to campaign in Westminster and devolved governments on this issue.”
INPUT, Diabetes UK and other collaborators put together this Guideline for Flash Glucose Monitoring
Leading up to today:
On 12th January 2015 Abbott posted this:
We are incredibly grateful for the positive feedback and support we have received since launching the FreeStyle Libre System. A number of people living with diabetes, as well as patient groups and healthcare professionals, have asked us about the issue of reimbursement. It is Abbott’s intention to collaborate with the relevant authorities to pursue reimbursement for FreeStyle Libre and we are actively working to achieve this.
In March 2014, we announced that we had commenced clinical trials in three EU countries, including the UK, in order to generate patient data to support reimbursement. We are particularly proud that the first patient to enter the EU trial was from Ipswich. These trials have now been extended to nine countries and we expect to see results this year.
When we have patient and outcomes data from these trials, we will be working with regulatory authorities on reimbursement. Thank-you for your on going support.
Then on 5th June 2015:
We are still collaborating with the relevant authorities to pursue reimbursement. In March 2014, we announced that we had commenced clinical trials in three EU countries, including the UK, to generate patient data to support reimbursement. These trials remain on track and we will update you as soon as we can.
Thank you for your ongoing support
The first publicly known positive step is the results of the IMPACT Trial which was announced on the 13th June 2016.
Results of the IMPACT Trial (FreeStyle Libre)
The IMPACT clinical trial is a randomized, controlled six-month trial to evaluate the effectiveness of the FreeStyle Libre system in improving glycemic control for the self-management of type 1 diabetes as compared to self-monitoring of blood glucose (SMBG). The primary endpoint was a difference in number of hours per day in hypoglycemia (<70 mg/dl or <3.9 mmol/l) between the group using the FreeStyle Libre system and the group using traditional finger sticks (SMBG) from days 194-208. Two hundred and fifty-two (252) patients over the age of 18 participated in the trial, which took place across 23 sites in Austria, the Netherlands, Spain, Sweden, and Germany.
Key findings from the study include (FreeStyle Libre users versus traditional Self Monitoring of Blood Glucose):
- 38 percent reduction in time spent in hypoglycemia (<70 mg/dl) (<3.9 mmol/l)
- 40 percent reduction in time spent in nocturnal hypoglycemia at night (11 pm to 6 am)
- 50 percent reduction in serious hypoglycemia (<55 mg/dl) (<3.0 mmol/l)
- No increase in HbA1c at six months
- Glucose monitoring increased to an average of 15 scans per day
- Routine finger sticks were nearly eliminated—reduced by 91 percent
The Edinburgh 16 week Freestyle Libre Study was published in on 26th July 2016, giving more positives outcomes for patients using the Libre.
(Flash Glucose Monitoring Improves Outcomes in a Type 1 Diabetes Clinic
J Diabetes Sci Technol 1932296816661560, first published on July 26, 2016)
1st August 2016, Abbott’s official statement:
FREESTYLE LIBRE REIMBURSEMENT:
In the UK, the FreeStyle Libre system is available to purchase online and by the NHS, though it is not yet available on prescription. We have invested in and completed several large clinical trials to demonstrate the same value to payers that patients and physicians are experiencing now with FreeStyle Libre. We are actively pursuing reimbursement and working closely with the relevant UK authorities to achieve this.
At present the most common way to use the Libre is to self fund like Kerry has done for her son Dylan. He was worried about insertion, but was still waiting in anticipation after it had been inserted!
Compatible phones can now be used with apps in place of the Reader device and sensors cost:
£48.29 +VAT (inc VAT £57.95) each sensors which lasts up to 14 days
(VAT may be wavered as this is for medical use) For VAT Exemption notes see here
More information on the LibreLink app. Other unoffical apps are available and information can be found online.
More information on the Libre here
If you want developments and improvements in treatments and tools to manage Type 1 Diabetes to become available to all (or more!) you need to raise awareness of the Type 1 Diabetes, the benefits of good diabetes management and control, and convince the government and NHS – always talk about it and don’t be afraid to contact your MSP’s and all elected representatives (or MP if you are in England) A list of everyone for your area can be found on www.writetothem.com Your MSP can ask questions or submit PQ’s on your behalf.
Abbott have issued a statement today 23 August 2016
Freestyle Libre NHS availability update
In the UK, the FreeStyle Libre system is available to purchase online and by the NHS, though it is not yet available on prescription in the community.
We have invested in and completed two large clinical trials to demonstrate the same value to payers that patients and physicians are experiencing now with FreeStyle Libre. We are actively pursuing reimbursement and Abbott Diabetes Care has submitted to the NHS Business Service Authority to have FreeStyle Libre Flash Glucose Monitoring System Sensor assessed for listing in the NHS England and Wales Drug Tariff and available on prescription in the community (FP10), which was acknowledged by them in June 2016. The NHS Business Service Authority will be following the procedures agreed between the Department of Health and the Drug Tariff Part IX Forum and the submission will be processed according to the date order in which they were received.
Abbott Diabetes Care are liaising closely with the various bodies and will keep you updated through the process.
In plain English – the process has started, the first stage is the submission to the NHS Business Service Authority, how long it will take – no one knows. The normal process is NHS Scotland takes the lead from the BSA submission – but it is likely to be restricted, so lobbying and campaigning is still encouraged for the Scottish Government, Health Care Professionals, and Health Boards to see the benefits and demand for new technology inc. the Libre.
The latest is Diabetes UK along with patients reps and supportive Health Care Professionals are campaigning for to get flash available on prescription as soon as possible. So that everyone who can benefit from FGM can get access on the NHS in England and Wales. We would hope this should affect Scotland indirectly too.
We believe it should not be about who can afford to benefit but should be free at the point of use – a fundamental principle of the NHS.
Health minister James O’Shaughnessy is due to make a decision in the coming days for England and Wales. You can tweet him your support using #Flash #MakeiItHappen