Cmmissining Plicy: Suth Warwickshire CCG (SWCCG) Treatment Indicatin Criteria FreeStyle Libre Flash Cntinuus Glucse Mnitring System Type I Diabetes Prir apprval must be requested frm the Individual Funding Request (IFR) Department at NHS Cventry and Rugby CCG. Applicatins can be made by secndary care t crccg.ardenifr@nhs.net in line with the Prir Apprval Prcess. 1 It is recmmended that FreeStyle Libre shuld nly be used fr peple with Type 1 diabetes, aged 4 and abve, attending specialist Type 1 care using multiple daily injectins r insulin pump therapy, wh have been assessed by the specialist clinician and deemed t meet tw r mre f the belw criteria. Patients wh undertake intensive mnitring, 8 r mre times daily (and fr whm this frequency f mnitring is deemed clinically apprpriate); AND at least ne f the fllwing Thse wh meet the current NICE criteria fr insulin pump therapy (HbA1c >8.5% (69.4mml/ml) r disabling hypglycaemia as described in NICE TA 151) where a successful trial f FreeStyle Libre may avid the need fr pump therapy; Thse wh have recently develped impaired awareness f hypglycaemia. It is nted that fr hypglycaemia unawareness, NICE recmmend cntinuus glucse mnitring with alarms and FreeStyle Libre des nt currently have that functin; Frequent admissins (>2 per year) with DKA r hypglycaemia; Thse wh require third parties t carry ut mnitring and where cnventinal bld testing is nt pssible; Additinally amng children and yung peple aged 4 and ver with Type 1 diabetes, the fllwing grups may be apprpriate fr a FreeStyle Libre trial despite ptimised use f insulin therapy and cnventinal bld glucse mnitring: Children and yung peple wh undertake high levels f physical activity (fr example, sprt at a reginal, natinal r internatinal level). Children and yung peple wh have c-mrbidities (fr example anrexia nervsa) r wh are receiving treatments (fr example 1 www.suthwarwickshireccg.nhs.uk/abut-us/publicatins-and-plicies/cmmissining-plicies Suth Warwickshire Clinical Cmmissining Grup Freestyle Libre Glucse Mnitring plicy Final Versin May 18 1
crticsterids) that can make bld glucse cntrl difficult. Children and yung peple wh cntinue t have hyperglycaemia despite insulin adjustment and additinal supprt. All patients (r carers) must be willing t undertake training in the use f FreeStyle Libre and cmmit t nging regular fllw-up and mnitring (including remte fllw-up where this is ffered). Adjunct bld testing strips shuld be prescribed accrding t lcally agreed best value guidelines with an expectatin that demand/frequency f supply will be reduced. Review and cntinuatin Fr patients meeting the criteria FreeStyle Libre shuld be initially prescribed fr a maximum 6 mnth perid during which time data shuld be cllected n the belw indicatrs. 1. Reductins in severe/nn-severe hypglycaemia 2. Reversal f impaired awareness f hypglycaemia 3. Episdes f diabetic ketacidsis 4. Admissins t hspital 5. Changes in HbA1c 6. Testing strip usage 7. Quality f Life changes using validated rating scales. 8. Cmmitment t regular scans and their use in self-management. A review shuld take place with the respnsible clinician at the end f the initial trial perid; if n imprvement is demnstrated in ne r mre f these areas the use f Freestyle Libre shuld discntinued and an alternative methd f mnitring used. Expectatins regarding patient cmpliance and cntinuatin criteria shuld be made clear t the patient befre initiatin f the trial perid. Patients wh have btained a Flash Cntinuus Glucse Mnitring System thrugh clinical trials r private treatment, r wh have been self-funding, must demnstrate that they satisfied the prescribing criteria when they cmmenced the use f the Flash Cntinuus Glucse Mnitring System as well as meet the cntinuatin criteria, t receive Flash Cntinuus Glucse Mnitring System n NHS prescriptin. Equality Impact See EIA attached Suth Warwickshire Clinical Cmmissining Grup Freestyle Libre Glucse Mnitring plicy Final Versin May 18 2
VERSION CONTROL Versin 1.0 Ratified by Gverning Bdy Date ratified 23 rd May 2018 Name f riginatr/authr Jint CCG Clinical Cmmissining Plicy Develpment Grup Name f respnsible Clinical Quality and Gvernance Cmmittee cmmittee Date issued 25 th May 2018 Review date May 2019 Suth Warwickshire Clinical Cmmissining Grup Freestyle Libre Glucse Mnitring plicy Final Versin May 18 3
Equality Impact Assessment (EIA) Plicy/Service FreeStyle Libre Flash Cntinuus Glucse Mnitring System Persn cmpleting EIA Jint Plicy Develpment Grup Date f EIA February 2018 Accuntable CCG Lead Anna Hargrave NHS Suth Warwickshire Clinical Cmmissining Grup Aim f Wrk The Public Sectr Equality Duty (PSED) requires us t eliminate discriminatin, advance equality f pprtunity, and fster gd relatins with prtected grups. This EIA assesses the impact f the plicy n prtected grups. Prtected Grup Likely t be a differential impact? Prtected Grup Likely t be a differential impact? Age Yes Race Yes Disability Yes Religin r belief N Gender reassignment N Sex N Marriage and civil partnership N Sexual rientatin N Pregnancy and maternity N Describe any ptential r knwn adverse impacts r barriers fr prtected/vulnerable grups and what actins will be taken (if any) t mitigate. If there are n knwn adverse impacts, please explain. Since CCGs perate within finite budgetary cnstraints the plicies detailed in this dcument make explicit the need fr the CCG t priritise resurces and prvide interventins with the greatest prven health gain. The intentin is t ensure equity and fairness in respect f access t NHS funding fr interventins and t ensure that interventins are prvided within the cntext f the needs f the verall ppulatin and the evidence f clinical and cst effectiveness. The plicy prvides a cnsistent clinically based criteria fr decisin making, benefitting patients within the CCG area by prviding cnsistency and equity f service prvisin. The plicy prvides an avenue thrugh the Individual Funding Requests plicy t seek funding in exceptinal clinical circumstances. The impact f this plicy has been discussed at length by the Cventry and Warwickshire Jint Plicy Develpment grup and all prtected characteristics and Human Rights values given due regard and nly patient demgraphic issues that culd impact n individual risk and/r clinical effectiveness were taken int accunt when reaching a 4
decisin. All three lcal Clinical Cmmissining Grups, Cventry and Rugby CCG; Suth Warwickshire CCG and Warwickshire Nrth CCG, have a cmmissining plicy n FreeStyle Libre. Age: This plicy relates nly t child ver 4 years f age. Disability: This plicy is expected t have a psitive impact in terms f imprving the ability f peple with learning difficulties and certain mental health cnditins t manage their diabetes, with ptential cnsequences f reducing inequities in health utcmes related t Type 1 diabetes. Race: Type 1 diabetes tends t be mre prevalent in peple f Eurpean rigin, s there is ptential fr verrepresentatin f this grup in terms f uptake f this plicy (cmpared t the general ppulatin distributin by ethnicity). This plicy will be applied equally t all patients with diabetes Type 1 irrespective f ethnic backgrund. Please summarise where further actin is required and when the prjects/decisin will be reviewed. The plicy will be reviewed 12 mnths after ratificatin by Gverning Bdy, when evidence n patient utcmes will be reviewed. 5