Implementation of Flash Glucose Monitoring

Transcription

1 Equality Analysis (Health Inequalities, Human Rights, Social Value) Implementation of Flash Glucose Monitoring Before completing this equality analysis it is recommended that you: Contact your equality and diversity lead for advice and support Take time to read the accompanying policy and guidance document on how to complete an equality analysis

2 1. Background EA Title Implementation of Flash Glucose Monitoring EA Author Michelle Dunne Team Quality & Safety Date Started 21 Feb 2018 Date Completed 2 May 2018 EA Version V0.1 Reviewed by E&D What are the intended outcomes of this work? Include outline of objectives and function aims To assist in the development of a CCG policy decision on the availability of Flash Glucose Monitoring for the local area and to review equality impact of the NHS England Regional Medicines Optimisation Committee (RMOC) position statement on the introduction of Flash Glucose Monitoring. Current Service: Patients with type 1 diabetes are required to periodically test their blood glucose through use of a standard finger prick test and use of a blood glucose testing monitor. NICE clinical guidance recommends testing up to 10 times a day and clinical practice reflects this. Proposed Service Flash Glucose Monitoring removes the need for finger prick testing through the use of a skin sensor that adheres to the skin surface and is minimally invasive. The sensor is scanned by a handheld meter that records the interstitial fluid glucose levels. Evidence supports the premise that these glucose levels are clinically acceptable as a measurement system and are comparable to blood glucose monitoring. It should be noted that introduction of Flash Glucose Monitoring would not completely remove the need to carry out blood glucose monitoring (Patients would still need to do prior to driving or if a hypoglycaemia episode is suspected), Introduction of flash glucose monitoring has been recommended by NHSE through the Regional Medicines Optimisation Committee (RMOC) where a specific cohort of patients with type 1 diabetes has been recommended and subsequently modified locally by the BSOL Diabetes Medicines Management Advisory Group (DMMAG) In a letter to CCGs from NHS England (Publications Gateway Reference 07630, 30 January 2018) it was stated: The Department of Health and Social Care has now authorised the flash glucose monitoring system Freestyle Libre to be made available on Part IX of the Drug Tariff from 1st November 2017 and that Reducing variation in the management and care of people with diabetes is a key objective for the NHS in England and we are therefore keen to ensure that technology is made available to those that guidelines suggest might benefit. Indications are that, taking into account the overall impact on healthcare costs from improved control of diabetes, the overall costs from the use of Flash Glucose monitoring can be less than

3 those that arise from self-monitoring. However, the cost / benefit analysis only holds true provided that the device is used to treat particular cohorts of patients. It is therefore important that CCGs give careful consideration to the available evidence in developing their policies on funding FreeStyle Libre. Acceptance for reimbursement by the NHS (i.e. being available on the Drug Tariff) is not clinical approval of the product. NHS England Regional Medicines Optimisation Committee (RMOC) issued a position statement on the use of flash glucose monitoring which stated: Until further trial data is available, it is recommended that audit data on the use of Freestyle Libre is collected through its use in limited and controlled settings where patients are attending for Type 1 diabetes care. It is recommended that Freestyle Libre should only be used for people with Type 1 diabetes, aged four and above, attending specialist Type 1 care using multiple daily injections or insulin pump therapy, who have been assessed by the specialist clinician and deemed to meet one or more of the following: 1. Patients who undertake intensive monitoring >8 times daily 2. Those who meet the current NICE criteria for insulin pump therapy (HbA1c >8.5% (69.4mmol/mol) or disabling hypoglycemia as described in NICE TA151) where a successful trial of FreeStyle Libre may avoid the need for pump therapy. 3. Those who have recently developed impaired awareness of hypoglycaemia. It is noted that for persistent hypoglycaemia unawareness, NICE recommend continuous glucose monitoring with alarms and Freestyle Libre does currently not have that function. 4. Frequent admissions (>2 per year) with DKA or hypoglycaemia. 5. Those who require third parties to carry out monitoring and where conventional blood testing is not possible. In addition, all patients (or carers) must be willing to undertake training in the use of Freestyle Libre and commit to ongoing regular follow-up and monitoring (including remote follow-up where this is offered). Adjunct blood testing strips should be prescribed according to locally agreed best value guidelines with an expectation that demand/frequency of supply will be reduced. The following concerns were noted with regard to the clinical evidence and costing information supplied: Trials contain only small numbers (n=700) of patients with well controlled Type 1 diabetes. Limited trial duration (6-12 months only) Limited data comparing to Continuous Glucose Monitoring

4 Limited or no data of use in unstable patients, pregnancy, young people and children. Projected reductions in finger-prick testing are unrealistic given the need to test before driving (current DVLA requirement) and during illness. Costing information with regard to testing strips does not recognize significant reductions that have already been achieved in this area of prescribing. Who will be affected by this work? e.g. staff, patients, service users, partner organisations etc. CCG as a Commissioner; Trusts and GPs providing care for patients with diabetes; patients with diabetes. It is difficult to assess likely numbers that sit within the suggested cohort by RMOC (as detailed above in points 1 to 5); it is estimated that there would be 1,056 patient s that would qualify under the RMOC criteria. 2. Research What evidence have you identified and considered? This can include national research, surveys, reports, NICE guidelines, focus groups, pilot activity evaluations, clinical experts or working groups, JSNA or other equality analyses. Research/Publications Working Groups Clinical Experts NHS England Regional Medicines Optimisation Committee Position Statement Letter from NHS England - Publications Gateway Reference Impact and Evidence: In the following boxes detail the findings and impact identified (positive or negative) within the research detailed above; this should also include any identified health inequalities which exist in relation to this work. Age: Describe age related impact and evidence. This can include safeguarding, consent and welfare issues: Local Area: Birmingham has a relatively young population compared to other cities in England, with a larger proportion of children and young people, and a smaller proportion of people in older age groups. However, Birmingham s population is far from stable and the rate of growth for various age groups varies widely. 46%

5 of the Birmingham population is under % is over 65 years. There is also a sizeable years population due to the large student population. The Solihull population is relatively stable with the older population; with the greatest increase in the 65+ population. 19% of the population are over 65 years, compared to 13% in Birmingham. The number of children and young people (aged 15 and below) in Solihull is, at 19%, in-line with the England average, although it is notable the borough has a relatively low proportion of pre-school age children; those aged 0-4 years represent 29% of all children in Solihull compared to 34% nationally. Life Expectancy Diabetes is currently the fifth most common reason for death in the world. Around 1 in 8 people between 20 and 79 years old have their death attributed to diabetes and it is expected to rise. The life expectancy on average now is reduced by more than 20 years for people with Type 1 diabetes Prevalence: Type 1 diabetes is much less common than type 2 diabetes. Although the condition usually appears before the age of 40 and more than half the people with type 1 are diagnosed under the age of 15, type 1 diabetes may occur at any age, according to Diabetes UK. Whilst type 1 diabetes is less common, overall, than type 2 diabetes, the vast majority of children with diabetes will have type 1. There is a separate NICE guideline for the management of Type 1 diabetes in children. According to National Audit figures for GP registrations for people with Type 1 diabetes by age are: Age Aged Aged Aged Aged under to to and over Age unknown Bham CrossCity Bham SouthCentral Solihull

6 Potential Impact of Flash Glucose Monitoring/RMOC criteria: The RMOC statement recommends that Freestyle Libra should only be used for people with Type 1 diabetes, aged four and above, attending specialist Type 1 care using multiple daily injections or insulin pump therapy, who have been assessed by the specialist clinician and deemed to meet on or more of the following (5 criteria listed previously). Therefore, any patient over the age of four who meets the criteria has the potential to benefit from this monitoring system (no children under the age of 4 were used in the trials of Freestyle Libre). Local data shows that people under the age of 40 are the largest group of Type 1 registrants in the local area. The five RMOC criteria proposed do not appear to signal any direct or indirect discriminatory impacts in relation to age. patients who currently have access to a readily available and suitable blood glucose testing system. Disability: Describe disability related impact and evidence. This can include attitudinal, physical, communication and social barriers as well as mental health/ learning disabilities, cognitive impairments: Local Data According to census data across Birmingham as a whole 9.1% of the population either have a disability that limits their day to day activities a lot, compared to 8.2% for Solihull and 8.3% for England. When you look at activities limited a little, the figure for Birmingham is the same as England at 9.3%, though the figures for Solihull are higher at 9.7%.

7 National Data Type 1 diabetes affects over 370,000 adults in the UK. It results from destruction of the cells that normally make insulin. Loss of insulin secretion results in high blood glucose and other metabolic and haematological abnormalities, which have both short term and long term adverse effects on health. Over years, type 1 diabetes causes tissue damage which, if not detected and managed early, can result in disability: blindness, kidney failure and foot ulceration leading to amputation, as well as premature heart disease, stroke and death. The risk of all of these complications is greatly reduced by treatment that keeps circulating glucose levels to as near normal as possible, reducing tissue damage. Disability from complications that are not avoided can often be prevented by early detection and active management. Learning Disability The number of patients on the Learning Disability register (in Birmingham) in 2015/16 was 4324 which is in line with the national average of 4.3 per 1,000 populations. Downs Syndrome is associated with a higher risk of autoimmune phenomenon, including Type 1 diabetes (Guaraldi et al, 2017). This may therefore account for much of the higher rates of Type 1 diabetes seen in people with a learning disability. Diabetic crises are a common cause of hospital admissions amongst people with a learning disability, accounting for between 7 and 7.5% of these potentially avoidable admissions (Glover and Evison, 2013). Poor glycaemic control has been reported from younger obese individuals (who have a learning disability) with Type 1 diabetes, either living independently or with parents (Taggart et al, 2013). Low literacy and comprehension levels can make it difficult to learn new skills such as: Monitoring blood glucose levels Injecting insulin or Learning how to use a new insulin device NICE published a document in July 2017 providing advice on the use of FreeStyle Libre for monitoring glucose levels in diabetes to aid local decision-making (FreeStyle Libre for glucose monitoring; Medtech innovation briefing [MIB110]). The following statement was included within the publication: NICE is committed to promoting equality, eliminating unlawful discrimination and fostering good relations between people with particular protected characteristics and others. In producing guidance and advice, NICE aims to comply fully with all legal obligations to: promote race and disability equality and equality of opportunity between men and women, eliminate unlawful discrimination on grounds of race, disability, age, sex, gender reassignment, marriage and civil partnership, pregnancy and maternity (including women postdelivery), sexual orientation, and religion or belief (these are protected characteristics under the Equality Act 2010).

8 People with learning difficulties or certain mental health problems and pregnant women may particularly benefit from FreeStyle Libre. People with certain skin conditions or allergies may be unable to wear the sensor. Potential Impact of Flash Glucose Monitoring/RMOC criteria: The NICE Medtech Innovation Briefing suggests that people with a learning difficulty or certain mental health problems may particularly benefit from Flash Glucose Monitoring. Type 1 diabetes is likely to come under the definition of a disability under the Equality Act 2010 which defines a disability as a physical or mental impairment that has a substantial long-term negative effect on a person s ability to carry out normal day-today activities. Where this is the case, CCGs and Service Providers have a responsibility to make reasonable adjustments. Under the Equality Act (2010), employers and service providers have a legal duty to make reasonable adjustments for disabled people. This duty arises when there are factors that would place a disabled person at a substantial disadvantage compared with a non-disabled person. Flash Glucose Monitoring systems may be a reasonable adjustment in particular for people with a Learning Disability/ Mental Health impairment. However, the adoption of a full scale Flash Glucose Monitoring systems for all Type 1 diabetic patients would require the criteria for reasonableness to be met including financial, practical, and avoiding substantial disadvantage. As a suitable blood glucose system is already in established and available substantial disadvantage would not occur. Therefore, it would not qualify as a reasonable adjustment for all Type 1 diabetic patients but would need to be considered on a case for case basis for people with a Learning Disability/ Mental Health impairment through the IFR process and in accordance with the IFR policy. The five RMOC criteria proposed do not appear to signal any direct or indirect discriminatory impacts in relation to disability. patients who currently have access to a readily available and suitable blood glucose testing system. Gender reassignment (including transgender): Describe any impact and evidence on transgender people. This can include issues such as privacy of data and harassment: There is a lack of good quality statistical data regarding trans people in the UK. Current estimates indicate that some 650,000 people are likely to be gender incongruent to some degree There is research evidence which indicates that trans people experience fear and discrimination when accessing health services.

9 The five RMOC criteria proposed do not appear to signal any direct or indirect discriminatory impacts in relation to gender reassignment. patients who currently have access to a readily available and suitable blood glucose testing system. Marriage and civil partnership: Describe any impact and evidence in relation to marriage and civil partnership. This can include working arrangements, part-time working, and caring responsibilities: The five RMOC criteria proposed do not appear to signal any direct or indirect discriminatory impacts in relation to marriage and civil partnership. patients who currently have access to a readily available and suitable blood glucose testing system. Pregnancy and maternity: Describe any impact and evidence on pregnancy and maternity. This can include working arrangements, part-time working, and caring responsibilities: NICE published a document in July 2017 providing advice on the use of FreeStyle Libre for monitoring glucose levels in diabetes to aid local decision-making (FreeStyle Libre for glucose monitoring; Medtech innovation briefing [MIB110]). The following statement was included within the publication: NICE is committed to promoting equality, eliminating unlawful discrimination and fostering good relations between people with particular protected characteristics and others. In producing guidance and advice, NICE aims to comply fully with all legal obligations to: promote race and disability equality and equality of opportunity between men and women, eliminate unlawful discrimination on grounds of race, disability, age, sex, gender reassignment, marriage and civil partnership, pregnancy and maternity (including women postdelivery), sexual orientation, and religion or belief (these are protected characteristics under the Equality Act 2010). People with learning difficulties or certain mental health problems and pregnant women may particularly benefit from FreeStyle Libre. People with certain skin conditions or allergies may be unable to wear the sensor. Potential Impact of Flash Glucose Monitoring/RMOC criteria: The NICE Medtech Innovation briefing suggests that pregnant women may particularly benefit from such a system. The five RMOC criteria proposed do not appear to signal any direct or indirect discriminatory impacts in relation to pregnancy and maternity.

10 patients who currently have access to a readily available and suitable blood glucose testing system. Race: Describe race related impact and evidence. This can include information on different ethnic groups, Roma gypsies, Irish travellers, nationalities, cultures, and language barriers: According to National Audit figures for GP registrations for people with Type 1 diabetes by ethnicity are: Ethnicity White Minority Ethnic Origin Ethnicity unknown /Not Stated Local Population data (Census) White Local Population data (Census) BME Bham CrossCity 63.5% 19.7% 16.6% 58% 42% Bham SouthCentral 56.5% 38.6% 4.8% Solihull 79.3% 6.5% 14.2% 89% 11% Potential Impact of Flash Glucose Monitoring/RMOC criteria: The data from the national audit of patients with type 1 registered with a local GP by ethnicity shows that: For Birmingham the number of White patients with Type 1 is broadly representative of the local population; For Solihull the number of white patients with Type 1 diabetes is less than the figures for the local population (79.3% Type 1 registrants compared to 89% population)

11 For both Birmingham and Solihull, the number of BME Type 1 registrants are less than the total BME population for each area. Type 1 diabetes appears to affect more people from a White background than the BME population and so the cohort who might meet the RMOC criteria (and therefore benefit from the new system) may include more White patients than BME. The five RMOC criteria proposed do not appear to signal any direct or indirect discriminatory impacts in relation to race. patients who currently have access to a readily available and suitable blood glucose testing system. Religion or belief: Describe any religion, belief or no belief impact and evidence. This can include dietary needs, consent and end of life issues: Christianity is the largest religion in Birmingham however at 46.1% this is lower than that of England as a whole which is 59.4%. Birmingham has more Muslims (21.8%), Sikhs (3%) and Hindus (2.1%) than England (5%, 0.8% and 1.5% respectively). The majority of Solihull residents describe themselves as Christian (65.6%), with no religion the 2nd largest group (21.4%). There are significantly more Muslims (+3,610, 221%), Sikhs (+1,938, 124%) and Hindus (+1,834, 99%) than in The majority of Solihull Muslims and Hindus live in the Urban West of the Borough and therefore are local to the Solihull site. Sikh communities are more dispersed across the Borough. The five RMOC criteria proposed do not appear to signal any direct or indirect discriminatory impacts in relation to religion and belief. patients who currently have access to a readily available and suitable blood glucose testing system. Sex: Describe any impact and evidence on men and women. This could include access to services and employment: Birmingham has a slightly higher number of women 545,239 (50.8%) than men 527,806 (49.2%) this reflects the picture for England as a whole. Life expectancy for men is 77.6 years compared to a national average of 79.4 years, for women it is 82.2 years compared to a national average of 83.1 years. Birmingham has a gap in life expectancy between the most deprived and least deprived areas of 7.4 years for men and 4.9 years for women.

12 In Solihull it is slightly different, where again women are in the majority but by a higher figure than for that of Birmingham and England (51.4%). Life expectancy in Solihull is higher than the national average; however, the gap ranges by up to nearly 10 years between the best and worst wards. Life expectancy is 80.3 years for men and 84.8 years for women. Local data on GP registrations indicate that more men than women registered with their GP as having Type 1 diabetes: Male Female Bham CrossCity 57.5% 42.5% Bham SouthCentral 55.6% 44.4% Solihull 52.7% 46.7% Potential Impact of Flash Glucose Monitoring/RMOC criteria: Type 1 diabetes appears to affect more men than women and so cohort who might meet the RMOC criteria (and therefore benefit from the new system) may include more men than women. The five RMOC criteria proposed do not appear to signal any direct or indirect discriminatory impacts in relation to gender. patients who currently have access to a readily available and suitable blood glucose testing system. Sexual orientation: Describe any impact and evidence on heterosexual people as well as lesbian, gay and bisexual people. This could include access to services and employment, attitudinal and social barriers:

13 According to ONS, in 2015, 1.7% of the UK population identified themselves as lesbian, gay or bisexual (LGB). More males (2.0%) than females (1.5%) identified themselves as LGB in Of the population aged 16 to 24, there were 3.3% identifying themselves as LGB, the largest percentage within any age group in In the last five years alone, 24 per cent of patient-facing staff have heard colleagues make negative remarks about lesbian, gay and bisexual people, and one in five have heard negative comments made about trans people. Lesbian, gay and bisexual staff echoed this, with a quarter revealing they had personally experienced bullying from colleagues over the last five years. One in ten health and social care staff across Britain have witnessed colleagues express the dangerous belief that someone can be cured of being lesbian, gay or bisexual. (Stonewall Unhealthy Attitudes Report) Data on the sexual orientation of patients with Type 1 diabetes is unavailable. The five RMOC criteria proposed do not appear to signal any direct or indirect discriminatory impacts in relation to sexual orientation. patients who currently have access to a readily available and suitable blood glucose testing system. Carers: Describe any impact and evidence on part-time working, shift-patterns, general caring responsibilities: The 2011 Census indicated that 107,380 people in Birmingham provide unpaid care (10% of usual resident population). Of those who provided unpaid care over 26% provided 50 or more hours a week. There are nearly 21,000 carers in Solihull equating to 10.5% of the total population, higher than the national average of 9.9%. This correlates with the larger 65+years population in Solihull Unpaid Carers - data shows that a higher proportion of the CCG s population are undertaking care for family / relatives than the England average, this can be linked to the diverse communities identified within the population and must be considered in Commissioning decisions. - According to diabetes.co.uk - not everyone with diabetes requires specific caring for but certain people, notably the young and old may need help and support with managing their diabetes Potential Impact of Flash Glucose Monitoring/RMOC criteria: If the 5 th RMOC criteria is utilised as part of the recommendations (those who require third parties to carry out monitoring and where conventional blood testing is not

14 possible) then the impact on carer s will be a positive one, allowing better management of the patient s diabetes will alleviate some of the pressures of the carer s which will not require their presence at all times. Carer information of the cohort of patients receiving this treatment is not known. The Bsol Diabetes Medicines Management Advisory Group (DMMAG) have considered not supporting the fifth criterion on the basis that it could not be specified objectively, measured or audited. It maybe that the first part of this criterion those who require third parties relates to patients who require a carer to carry out the testing on their behalf For the second part of that criterion where conventional blood testing is not possible this cohort has not been quantified, though may include patients with poor peripheral circulation making the use of finger prick testing very difficult. This criterion may also relate to patients with functional impairment that impacts on their ability to read and act on standard finger prick testing. patients (and their carers) who currently have access to a readily available and suitable blood glucose testing system. Other disadvantaged groups: Describe any impact and evidence on groups experiencing disadvantage and barriers to access and outcomes. This can include lower socio-economic status, resident status (migrants, asylum seekers), homeless, looked after children, single parent households, victims of domestic abuse, victims of drugs / alcohol abuse: (This list is not exhaustive) Deprivation: Birmingham has some of the most deprived wards in the country (Nechells and Ladywood). These wards also have a high BME population. Solihull is one of the least deprived in the country although is polarised having some of the 10% most deprived wards (Chelmsley Wood, Kingshurst & Fordbridge, Smith s Wood wards and north Bickenhill). Deprivation is strongly associated with higher levels of obesity, physical inactivity, unhealthy diet, smoking and poor blood pressure control. All these factors are inextricably linked to the risk of diabetes or the risk of serious complications for those already diagnosed. Potential Impact of Flash Glucose Monitoring/RMOC criteria: Diabetes arising from social issues connected to deprivation is more likely to be Type 2 which is not within scope of the RMOC criteria. Patients can purchase the system themselves however, this is likely to be cost prohibitive for some patients. Irrespective of any decision around the implementation of the Flash Glucose Monitoring system all patients with diabetes have access to a readily available and suitable alternative (blood glucose testing). No perceivable impact related to other disadvantaged groups is foreseen.

15 4. Health Inequalities Yes/No Evidence Could health inequalities be created or persist by the proposals? Is there any impact for groups or communities living in particular geographical areas? Is there any impact for groups or communities affected by unemployment, lower educational attainment, low income, or poor access to green spaces? No Possible How will you ensure the proposals reduce health inequalities? No Health inequalities could be exacerbated at a national level if CCGs choose to deviate from the national RMOC guidance. It should be noted that there is a readily available and alternative system currently in place which is funded (blood glucose testing) The product is available without the need of a prescription. However, the cost of the system might be prohibitive for some, particularly given the high levels of deprivation within the area. It should be noted that there is a readily available and alternative system currently in place which is funded (blood glucose testing) Implementation of the RMOC criteria could reduce the post-code lottery of healthcare provision of this system, though there is a readily available alternative system currently in place, which is funded. 5. FREDA Principles/ Human Rights Fairness Fair and equal access to services Question How will this respect a person s entitlement to access this service? Response Patients meeting the eligibility criteria will be referred into the service. The eligibility criteria is based on clinical factors and does not discriminate on access. There is an prior approval process in

16 5. FREDA Principles/ Human Rights Respect right to have private and family life respected Equality right not to be discriminated against based on your protected characteristics Dignity the right not to be treated in a degrading way Autonomy right to respect for private & family life; being able to make informed decisions and choices Right to Life Right to Liberty Question How will the person s right to respect for private and family life, confidentiality and consent be upheld? How will this process ensure that people are not discriminated against and have their needs met and identified? How will this affect a person s right to freedom of thought, conscience and religion? How will you ensure that individuals are not being treated in an inhuman or degrading way? How will individuals have the opportunity to be involved in discussions and decisions about their own healthcare? Will or could it affect someone s right to life? How? Will or could someone be deprived of their liberty? How? Response place for consideration of exceptional circumstances All providers of NHS health services are required to uphold the NHS constitution and have in place policies regarding confidentiality and consent. The eligibility criteria is based on clinical factors and does not discriminate on access. There is an prior approval process in place for consideration of exceptional circumstances No impact All providers of NHS health services are required to uphold the NHS constitution and uphold patient dignity. All patients being referred into this service have a choice and options will be discussed with them. No impact No impact 6. Social Value Consider how you might use the opportunity to improve health and reduce health inequalities and so achieve wider public benefits, through action on the social determinants of health. Marmot Policy Objective Enable all people to have control over their lives and maximise their capabilities Create fair employment and good work for all What actions are you able to build into the procurement activity and/or contract to achieve wider public benefits? Despite the lack of a compelling clinical evidence base, implementation of the RMOC criteria has the potential to have a positive

17 Create and develop health and sustainable places and communities Strengthen the role and impact of illhealth prevention effect with patients having more control over their day to day lives. 7. Engagement, Involvement and Consultation If relevant, please state what engagement activity has been undertaken and the date and with which protected groups: Engagement Activity Protected Characteristic/ Group/ Community Date For each engagement activity, please state the key feedback and how this will shape policy / service decisions (E.g. patient told us. So we will..): Engagement has not been undertaken with the public; though clinical advice and expertise has been used to inform decision making. 8. Summary of Analysis Considering the evidence and engagement activity you listed above, please summarise the impact of your work: The five RMOC criteria have been reviewed against protected characteristics and other vulnerable groups. No direct or indirect discrimination has been identified. The current standard is the finger prick test. Flash glucose monitoring is being widely promoted by the manufacturers and by diabetes advocacy groups as a technical innovation that will reduce the need for finger prick testing and help patients with diabetes better manage their condition. Clinical evidence is somewhat less robust and indicates that there is a reduction in episodes of hypoglycaemia (without specifying severity) and a reduction in the number of finger prick tests. There is no evidence of improvement in patient orientated outcomes (mortality or morbidity). Evidence of effect in Disease Orientated Outcomes such as HbA1c measurements show no differences between Flash Glucose monitoring and blood glucose monitoring. Type 1 diabetes is likely to come under the definition of a disability under the Equality Act 2010 which defines a disability as a physical or mental impairment that has a substantial long-term negative effect on a person s ability to carry out normal day-today activities. Where this is the case, CCGs and Service Providers may have a responsibility to make reasonable adjustments. Under the Equality Act (2010), employers and service providers have a legal duty to make reasonable adjustments for disabled people. This duty arises when there are factors that would place a disabled person at a substantial disadvantage compared with a non-disabled person or discrimination arising from disability. Flash Glucose Monitoring systems may be a reasonable adjustment in particular for people with a Learning Disability/ Mental Health impairment. However, the adoption of a full scale Flash Glucose Monitoring systems for all Type 1 diabetic patients would require the criteria for reasonableness to be met including financial, practical, and avoiding substantial disadvantage. As a suitable blood glucose system is already in established and available substantial disadvantage would not occur. Therefore, it

18 would not qualify as a reasonable adjustment for all Type 1 diabetic patients but would need to be considered on a case for case basis for people with a Learning Disability/ Mental Health impairment through the IFR process and in line with the IFR policy. patients who currently have access to a readily available and suitable blood glucose testing system. Exceptional circumstances would be dealt with through the Individual Funding Request system and in accordance with the policy. Key benefits of Flash Glucose Monitoring From the clinical trials, there is some evidence that there is a reduction in the number of episodes of hypoglycaemia and a reduction in the number of finger prick tests required. The major benefits are likely to be in patient convenience and patient satisfaction with the technology. There is anecdotal evidence of substantial benefit in individual patients. Positive impacts and benefits were identified for people with a Learning Disability; Mental Health impairment; carers and pregnant women. The positive impact for carers may not be achieved if a decision is taken to not include the fifth criterion suggested by RMOC: those who require third parties to carry out monitoring and where conventional blood testing is not possible Protected Characteristics Impact Age The RMOC statement recommends that Freestyle Libra should only be used for people with Type 1 diabetes, aged four and above, attending specialist Type 1 care using multiple daily injections or insulin pump therapy, who have been assessed by the specialist clinician and deemed to meet on or more of the following. Therefore, any patient over the age of four who meets the criteria has the potential to benefit from this monitoring system. Local data shows that people under the age of 40 are the largest group of Type 1 registrants in the local area. Disability The NICE Medtech Innovation Briefing suggests that people with a learning difficulty or certain mental health problems may particularly benefit from Flash Glucose Monitoring. Type 1 diabetes falls under the definition of a disability under the Equality Act 2010 which defines a disability as a physical or mental impairment that has a substantial long-term negative effect on a person s ability to carry out normal day-to-day activities. As such, CCGs and Service Providers have a responsibility to make reasonable adjustments. Flash Glucose Monitoring systems whilst adding to the quality and patient experience would not meet the criteria for a reasonable adjustment for all Type 1 diabetic patients but would need to be considered on a case for case basis for

19 people with a Learning Disability/ Mental Health impairment through the IFR process and IFR policy. Pregnancy and Maternity The NICE Medtech Innovation briefing suggests that pregnant women may particularly benefit from such a system. Race Type 1 diabetes appears to affect more people from a White background than the BME population and so the cohort who might meet the RMOC criteria (and therefore benefit from the new system) may include more White patients than BME. Sex Type 1 diabetes appears to affect more men than women and so the cohort who might meet the RMOC criteria (and therefore benefit from the new system) may include more men than women. Evaluation of RMOC Criteria those who require third parties to carry out monitoring and where conventional blood testing is not possible If the 5th RMOC criteria is utilised as part of the recommendations then the impact on carer s will be a positive one, allowing better management of the patient s diabetes will alleviate some of the pressures of the carer s which will not require their presence at all times. The DMMAG have considered not supporting the fifth criterion on the basis that it could not be specified objectively, measured or audited. It maybe that the first part of this criterion those who require third parties relates to patients who require a carer to carry out the testing on their behalf. For the second part of that criterion where conventional blood testing is not possible this cohort has not been quantified, though may include patients with poor peripheral circulation making the use of finger prick testing very difficult. This criterion may also relate to patients with functional impairment that impacts on their ability to read and act on standard finger prick testing.

20 9. Mitigations and Changes : Please give an outline of what you are going to do, based on the gaps, challenges and opportunities you have identified in the summary of analysis section. This might include action(s) to mitigate against any actual or potential adverse impacts, reduce health inequalities, or promote social value. Identify the recommendations and any changes to the proposal arising from the equality analysis. In arriving at a decision to fund or not to fund Flash Glucose Monitoring there are deemed to be no adverse impacts for any protected characteristics apart from the following protected groups: Learning Disabilities Mental Health Physical disabilities (that disable a person from utilising the existing blood glucose testing system) It is recommended that Flash Glucose Monitoring is considered for these patients where there are exceptional clinical circumstances and in line with the IFR process and policy. Providers are required to comply with the Accessible Information Standard and ensure patients with disabilities are provided with reasonable adjustments including communication support, aids and adaptations, and auxiliary services that would enable them to access blood glucose testing. 10. Contract Monitoring and Key Performance Indicators Detail how and when the service will be monitored and what key equality performance indicators or reporting requirements will be included within the contract (refer to NHS Standard Contract SC12 and 13): 11. Procurement Detail the key equality, health inequalities, human rights, and social value criteria that will be included as part of the procurement activity (to evaluate the providers ability to deliver the service in line with these areas): N/A 12. Publication

21 How will you share the findings of the Equality Analysis? This can include: reports into committee or Governing Body, feedback to stakeholders including patients and the public, publication on the web pages. Published on CCG webpages. 13. Sign Off The Equality Analysis will need to go through a process of quality assurance by the Senior Manager for Equality and Diversity, Senior Manager for Assurance and Compliance or Equality and Human Rights Manager and signed-off by a delegated committee Quality Assured By: Which Committee will be considering the findings and signing off the EA? Minute number (to be inserted following presentation to committee) Name Balvinder Everitt Senior Manager Equality and Diversity Date 2 May 2018