A landscape analysis of formulary guidelines across England
By Dr. Zoe Blumer, Emilia Broadbent and Dr. Murtada Alsaif, IPG Health Global Market Access
Hypoglycaemia is a common and unpredictable consequence of diabetes therapy.1 In a UK-based study, the incidence rate for hypoglycaemia events amongst Type 2 diabetes patients on insulin was 3.84 per person-years.2 These patients could be better supported by switching from traditional strips and lancets to continuous glucose monitors (CGM), which alert the patient if the blood glucose level goes too high or too low. CGM devices have been shown to reduce the frequency of hypoglycaemia in diabetes patients on insulin in clinical trials3,4 and real-world studies.5
A CGM device automatically measures blood glucose levels in the interstitial fluid and stores the information, consequently allowing the patient to monitor their sugar levels without needing to go through the pain of frequently using traditional finger lancets. In England and Wales, NICE guidance recommends full NHS access to CGMs for adults and children living with Type 1 diabetes, and for Type 2 diabetes patients on multiple daily insulin therapy who have recurrent or severe hypoglycaemia or are advised to do a finger prick test at least 8 times a day.6 Patients in England have the right to treatments that have been recommended by NICE in a technology appraisal7; as CGM is not recommended in a NICE technology appraisal,6 the NHS is not legally obliged to fund CGM.8
As CGM guidance is non-binding, we explored the variability in formulary recommendations and uptake of CGMs across the 42 Integrated Care Boards (ICBs) in England. CGM prescribing guidelines from a search of ICB public formulary websites were used to develop a standardised traffic light system; see the figure below. Specialist recommendation was differentiated from specialist initiation; a ’recommendation’ was thought to be a smaller patient access barrier potentially requiring an email from a specialist to the patient’s GP, while "specialist initiation" was interpreted as requiring the patient to have an appointment with the specialist, who would then issue the first prescription before the GP could continue prescribing. Findings are plotted on the heatmap below.
Of the 42 ICBs, we found that only 5 ICBs allowed CGM initiation in primary care, 8 allowed continuation of prescribing in primary care following specialist recommendation, 23 allowed continuation of prescribing in primary care following specialist initiation, 3 did not commission CGMs and 3 had no published information on their guidelines.
To understand the context that the formulary positioning applies to, we calculated the variability in uptake of the device across ICBs in England by building a patient funnel that estimated the total number of eligible patients, according to NICE resource impact template10 using the mid-2020 population estimates for each ICB.11 To calculate the CGM percentage uptake, actual prescribing data of CGMs in each ICB was collected for the year to November 2022.12 We estimated the number of patients who received a prescription for CGM by extracting prescribing data for the available CGM devices in the UK (Freestyle Libre, Freestyle Libre 2, Dexcom ONE, GlucoMen Day and GlucoRx AiDEX); equivalent patients were calculated using the manufacturers’ guidance on how often the CGM sensor needed to be changed. The percentage uptake was calculated by dividing the estimated patients from prescribing data by the total eligible population according to NICE.
Despite the variation in formulary guidelines, uptake was present in all ICBs across England, including 6 ICBs that had no guidelines or had rejected CGMs. The average percentage uptake of CGM was 45% (standard deviation, 8.5%) with a median of 44% (range, 26-62%). In 3 ICBs, CGMs were not routinely commissioned. Of these, Shropshire, Telford & Wrekin ICB had lower than average levels of uptake at 39%, whilst Derby & Derbyshire ICB had one of the highest uptakes with 57% of its eligible diabetic population prescribed CGMs. Cambridgeshire & Peterborough ICB fell into the lowest category, with only a 28% uptake despite CGMs being initiated in either primary or secondary care (easiest to access). Details of the variability in uptake amongst the 42 ICBs are plotted in the figure below.
The discrepancies in formulary positioning and uptake of CGMs may have several causes, as ICBs set their own eligibility criteria that may differ from NICE. Prescribers may also still refer to the now superseded NHS England policy, which had more restrictive criteria.13 In other cases, guidelines may not be systematically applied by prescribers and specialists. Where CGMs are not commissioned but prescribing does occur, the prescriber may judge use of the device to be in the best interest of the patient based on the available evidence, and this may go unchallenged by Payers.14,15 The uptake in primary care prescribing may represent a trend for specialist initiation/recommendation that is then continued in general practice, irrespective of the local formulary recommendations. Specialists may consider current NICE guidelines alongside local formulary recommendations.
Our analysis has shown a disconnect between prescribers and formulary guidelines in at least some ICB localities. Broader access to CGM devices has been shown to improve patient outcomes by improving glycaemic control16,17 and reducing commissioner spending on hypoglycaemia episodes.18-22 Standardisation of access to CGMs across England could benefit patient outcomes and associated diabetes spending.
The NHS and ICBs have a finite amount of money, but people with diabetes should not be put at a detriment compared with those with other conditions. To enable standardised access throughout England, formulary positioning should not be stigmatised by guidance from NICE.
Key stakeholders should provide updates on CGM recommendations, including determinants of access, and provide or support standardised training for healthcare providers and people with diabetes using CGM.
Dr. Zoë Blumer is a Senior Director at IPG Health Global Market Access with 17 years of diverse product, portfolio and disease area experience. Diabetes therapy and associated medical technologies are a key interest for Zoë and something she has focused on throughout her career.
With personal experience of Type 1 diabetes, she has valuable insights into the unmet needs of patients, prescribers and payers.
Please reach out to Zoe.Blumer@ipghealth.com with any questions.