Commissioning Policy

Transcription

1 Commissioning Policy Abbott FreeStyle Libre Flash Glucose Monitoring System Individual Funding Request Date Adopted: 09 September 2018 Version:

2 Title of document: Authors job title(s): Document version: Supersedes: Document Control Abbott FreeStyle Libre Flash Glucose Monitoring System Policy IFR Manager, BNSSG CCG Principal Medicines Optimisation Pharmacist, BNSSG CCG v NEW Clinical Approval received from: BNSSG CCG Commissioning Executive & BNSSG Clinical Policy Review Group Clinical Approval date received: 10 th May 2018 & 20 th June 2018 Discussion and Approval by Clinical Policy Review Group (CPRG): Discussion and Approval by CCG Commissioning Executive: 20 th June 10 th May Date of Adoption: September 2018 Publication/issue date: August 2018 Review due date: Equality Impact Assessment Screening (date completed): Earliest of either NICE publication or three years from approval. 30/05/2018 Version Control Version Date Reviewer Comment v DRAFT v1 v DRAFT v2 16/05/2018 IFR Manager Initial draft sent to Medicines Management following Commissioning Executive decision 19/06/2018 IFR Coordinator Prepared for presentation at CPRG 20/06/2018 v /08/2018 IFR Manager Finalised for website publication, specific go live date to be updated once notice given v /11/2018 Commissioning Policy Development Support Officer Updated for policy go live date Page 2

3 THIS TREATMENT IS NOT ROUTINELY COMMISSIONED FOR ANY PATIENTS AND INDIVIDUAL FUNDING PANEL APPROVAL MUST BE SOUGHT PRIOR TO REFERRAL THIS POLICY RELATES TO ALL PATIENTS Abbott FreeStyle Libre Flash Glucose Monitoring System Policy General Principles Funding approval will only be given in line with these general principles. Where patients are unable to meet these principles in addition to the specific treatment criteria set out in this policy, funding approval will not be given. 1. The routine use of FreeStyle Libre for all patients with Type 1 and Type 2 Diabetes is not recommended. 2. FreeStyle Libre has not been demonstrated to be cost-effective and in the absence of a positive recommendation from a technology appraisal (TA), produced and published by the National Institute for Health and Care Excellence (NICE), is not recommended for routine funding in Primary or Secondary Care. 3. This recommendation will be reviewed in the light of new evidence to support the cost effective use of FreeStyle Libre. 4. It is important to note that the FreeStyle Libre is not the same as continuous glucose monitoring. Background The FreeStyle Libre (FSL) is a flash glucose monitoring system which monitors glucose levels in interstitial fluid rather than capillary blood glucose levels from finger-prick testing. The FSL system consists of a sensor worn on the upper arm that measures interstitial glucose every minute and a reader device that is scanned over the sensor to get a result. It can produce a near continuous record of measurements for the last eight hours which can be accessed on demand. It can also indicate glucose level trends over time. The sensors last for 14 days. The FSL system is indicated for measuring interstitial fluid glucose levels in people (aged 4 years and older) with Diabetes Mellitus. The product is classified as a device and received European CE Mark certification in August The sensors may also be read with an appropriate application on a smart phone which has near-field communication. This new Page 3

4 technology helps to reduce the burden of finger-prick blood tests but as yet there is limited data to confirm that use of FreeStyle Libre will result in better controlled diabetes and an improvement in patient orientated outcomes such as reduction in complications due to poorly controlled diabetes, hospitalisation rate or ambulance/gp call out rates, improvement in overall long-term diabetes control or quality of life. From 1 November 2017 the FreeStyle Libre sensors were allowed to be prescribed on an NHS FP(10) prescription. The reader device is provided free-of-charge by the company. It is important to note that the DVLA requires self-monitoring of blood glucose, i.e. the finger prick method, prior to driving as the FreeStyle Libre system is not recognised as an appropriate method. In addition a finger-prick test is still required during times of rapidly changing glucose levels when interstitial fluid glucose levels may not accurately reflect blood glucose levels (i.e. acute illness such as influenza, diarrhoea and vomiting), if hypoglycaemia or impending hypoglycaemia is reported, or the symptoms do not match the system readings. There is not a NICE directive for CCGs to fund this new technology but NICE have undertaken a Medtech innovation briefing 1 which highlights the key uncertainty around the evidence in the randomised controlled trial of people with Type 1 Diabetes included only adults whose diabetes was well controlled and that the resource impact is uncertain. The North RMOC 2 produced a position statement on behalf of all RMOCs with advice to Area Prescribing Committees on the recommendations for the use of FreeStyle Libre but did not provide robust costing data. Their recommendation is not supported by a robust costeffectiveness analysis. No studies on the cost-effectiveness of FreeStyle Libre in the UK have been identified. Definitions of Terms Used Self-monitoring blood glucose Where a patient uses the finger prick method to test blood glucose levels. Regional Medicines Optimisation Committee (RMOC) National Institute of Health and Care (NICE) HbA1c Established by NHS Clinical Commissioners and NHS England four RMOCs operate as a single system to provide advice and make recommendations on the optimal use of medicines for the benefit of patients and the NHS. Position statements, advice and recommendations are not statutory. Provides national guidance and advice to improve health and social care. Only Technology Appraisal Guidance has a statutory mandate to fund. Hemoglobin A1c, often abbreviated HbA1c, is a form of hemoglobin (a blood pigment that carries oxygen) that is bound to glucose. The blood test for HbA1c level is routinely performed in people with Type 1 and Type 2 Diabetes Mellitus. Blood HbA1c levels are reflective of how well Diabetes is controlled. Page 4

5 NHS FP(10) prescription The FP10 is a prescription that can be issued by a GP, nurse, pharmacist prescriber, supplementary prescriber or a hospital doctor in England. FP10 is green and is used by GP's for prescriptions in England. NHS Prescription Services Under the NHSE Business Services Authority the NHS Prescription Services calculates the remuneration and reimbursement of dispensing prescriptions to contractors (community pharmacies) across England. POLICY CRITERIA NOT COMMISSIONED INDIVIDUAL FUNDING PANEL APPROVAL REQUIRED The provision of Abbott Freestyle Libre Flash Glucose Monitoring System, i.e. sensor and reader device, is not routinely commissioned by the CCG. Position statement from BNSSG CCG Commissioning Executive 1. The use of FreeStyle Libre for all patients with type 1 and type 2 diabetes is not recommended for routine funding in primary or secondary care. 2. FreeStyle Libre has not been demonstrated to be cost-effective and in the absence of a positive recommendation from a technology appraisal (TA), produced and published by the National Institute for Health and Care Excellence (NICE), is not recommended for routine funding in primary or secondary care. 3. This recommendation will be reviewed in the light of any new evidence to support the cost effective use of FreeStyle Libre. Patients may only be considered on an individual basis where their GP or consultant believes exceptional circumstances exist that warrant deviation from the rule of this policy. A patient may be considered exceptional to the general standard Policy if both of the following apply: Page 5

6 He/she is different to the general population of patients who would normally be refused the healthcare intervention, and There are good grounds to believe that the patient is likely to gain significantly more benefit from the intervention than might be expected for the average patient with that particular condition. In assessing exceptionality, the IFR Panel will not consider social, demographic or employment circumstances. Individual cases will be screened by the IFR Team and may then be reviewed at the CCG s Individual Funding Request Panel upon receipt of an appropriate and fully completed application from the patient s GP, consultant or clinician. Applications cannot be considered from patients personally. Connected Policies Continuous Glucose Monitoring System Policy This policy has been developed with the aid of the following references: 1. NICE Medtech Innovation Briefing [MIB 110]: FreeStyle Libre for glucose monitoring NICE July Available at 2. Flash Glucose Monitoring Systems,Position Statement. Regional Medicines Optimisation Committee. October (attached) 3. ABCD Type 1 Diabetes Clinical Collaborative: Information to help a formulary case for Freestyle Libre System October Available at 4. Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial.prof Jan Bolinder, Ramiro Antuna, Petronella Geelhoed-Duijvestijn, Jens Kröger, Raimund Weitgasser. 5. BNSSG FreeStyle Libre costings April BANES Policy for FreeStyle Libre Jan18. (attached) OPCS Procedure codes Page 6