Background Axial Spondyloarthritis (AS) is an umbrella term for both inflammatory conditions known as Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis. AS generally develops in younger people. Symptoms typically start in the late teenage years to early twenties (with the average age of onset being 24). Hence this condition has a life-long impact, which could increase if left untreated. Average delay to diagnosis is over eight years after the appearance of symptoms. There are currently 220,000 people in the UK living with this painful and progressive form of inflammatory arthritis. While people wait for a diagnosis, many withdraw from socialising and find it harder to establish careers, form relationships, and start families. In addition to healthcare costs, that include multiple visits to GPs, prescription of unnecessary medication and extensive use of over the counter painkillers, there are intangible costs that have large impacts on patients and society. For example, quality of life for the patient, their earning and saving for retirement capacity, social care costs. Objectives To determine the full economic cost, including medical productively loss and other out of pocket related costs of delayed diagnosis for AS in the UK. Methods We are building an economic Markov model to determine a total cost per patient per year of delay. The model will project disease progression forward in time-steps with feedback loops to allow movement in states back and forth. Transition states within each time-step will be constructed according to the various stage of the disease and they will be used primarily to demonstrate an assessment of the costs in the time taken to a confirmed diagnosis. The model will capture symptoms and impacts of AS leading up to that diagnosis and before initiation of treatment. Assuming the one-year maximum ‘gold standard’ time to diagnosis that NASS would like to see to, the sum of costs prior to this in each consecutive cycle will be estimated. The inputs will consist of the average delay to diagnosis per gender and age group, the health resources utilisation, the cost of managing the symptoms, cost related to productivity losses and any other parameters and costs reflecting real resources required to diagnose, confirm, treat, cope with, manage and accommodate AS symptoms. Data include anonymised diagnosed patient data with the pathways they followed pre-diagnosis shared under strict confidentiality data sharing agreement from the secondary health units participating in the project. Cost data gathered from national sources and research into AS, NHS unit costs reports, productivity related reports and interviews with people with AS and clinicians providing valuable insight into the condition. The model will be validated by experts in the field and sufferers of AS to ensure accurate representation of actual events. Results The results will be provided at the conference and this is work in progress. A preliminary analysis of anonymised data of the pathway of 513 people towards an AS diagnosis show that the delay on female patients is slightly longer (mean of 9.85 years) compared to male patients (mean of 9.39 years). In both genders the delay is higher if the patient present symptom after the age of 31 years increasing the mean of previous age groups by 5 to 9 yrs. Table 1. Female Male Age Group Obs. Mean 95% CI Obs. Mean 95% CI 0-15 1 1 - 2 1.00 0.00, 13.71 16-30 49 3.59 2.69, 4.49 144.00 4.01 3.45, 4.57 31-45 50 11.72 9.64, 13.80 161.00 9.61 8.58, 10.65 46-60 24 18.17 13.05, 23.28 60.00 15.90 13.30, 18.50 61+ 3 17.33 0.00, 52.58 19.00 28.58 21.14, 36.02 Conclusion The results will help the National Axial Spondyloarthritis Society (NASS) to build an economic case for earlier diagnosis. The interactive model will support decision making in the future by allowing assumptions to be changed e.g., changing prices over time; varying wage rates depending on staff and skill mix; and the anticipated scale of savings in actual practice. References [1]Standfield et al. (2014). Markov Modelling and DES in health care: a comparison. Journal of technology Assessment in Health C 30 (2) 166-172 Acknowledgements With thanks to the National Axial Spondyloarthritis Society for commissioning this research and special thanks to Dale Webb and Jill Hamilton for their valuable support to contact clinician and sufferers of AS and for accessing necessary data. Importantly, thank you to the clinicians and sufferers of AS for their contribution to the research. Disclosure of Interests None declared

In the large community-based SCOOP trial, systematic fracture risk screening using FRAX® led to greater use of AOM and greater adherence, in women at high fracture risk, compared with usual care. In the SCreening of Older wOmen for Prevention of fracture (SCOOP) trial, we investigated the effect of the screening intervention on subsequent long-term self-reported adherence to anti-osteoporosis medications (AOM). SCOOP was a primary care–based UK multicentre trial of screening for fracture risk. A total of 12,483 women (70–85 years) were randomised to either usual NHS care, or assessment using the FRAX® tool ± dual-energy X-ray absorptiometry (DXA), with medication recommended for those found to be at high risk of hip fracture. Self-reported AOM use was obtained by postal questionnaires at 6, 12, 24, 36, 48 and 60 months. Analysis was limited to those who initiated AOM during follow-up. Logistic regression was used to explore baseline determinants of adherence (good ≥ 80%; poor < 80%). The mean (SD) age of participants was 75.6 (4.2) years, with 6233 randomised to screening and 6250 to the control group. Of those participants identified at high fracture risk in the screening group, 38.2% of those on treatment at 6 months were still treated at 60 months, whereas the corresponding figure for the control group was 21.6%. Older age was associated with poorer adherence (OR per year increase in age 0.96 [95% CI 0.93, 0.99], p = 0.01), whereas history of parental hip fracture was associated with greater rate adherence (OR 1.67 [95% CI 1.23, 2.26], p < 0.01). Systematic fracture risk screening using FRAX® leads to greater use of AOM and greater adherence, in women at high fracture risk, compared with usual care.

A reduction in hip fracture incidence following population screening might reflect the effectiveness of anti-osteoporosis therapy, behaviour change to reduce falls, or both. This post hoc analysis demonstrates that identifying high hip fracture risk by FRAX was not associated with any alteration in falls risk. To investigate whether effectiveness of an osteoporosis screening programme to reduce hip fractures was mediated by modification of falls risk in the screening arm. The SCOOP study recruited 12,483 women aged 70–85 years, individually randomised to a control (n = 6250) or screening (n = 6233) arm; in the latter, osteoporosis treatment was recommended to women at high risk of hip fracture, while the control arm received usual care. Falls were captured by self-reported questionnaire. We determined the influence of baseline risk factors on future falls, and then examined for differences in falls risk between the randomisation groups, particularly in those at high fracture risk. Women sustaining one or more falls were slightly older at baseline than those remaining falls free during follow-up (mean difference 0.70 years, 95%CI 0.55–0.85, p < 0.001). A higher FRAX 10-year probability of hip fracture was associated with increased likelihood of falling, with fall risk increasing by 1–2% for every 1% increase in hip fracture probability. However, falls risk factors were well balanced between the study arms and, importantly, there was no evidence of a difference in falls occurrence. In particular, there was no evidence of interaction (p = 0.18) between baseline FRAX hip fracture probabilities and falls risk in the two arms, consistent with no impact of screening on falls in women informed to be at high risk of hip fracture. Effectiveness of screening for high FRAX hip fracture probability to reduce hip fracture risk was not mediated by a reduction in falls.

Abstract Background Atrial fibrillation (AF) is the most common sustained atrial arrhythmia. AF significantly affects patients' quality of life and increase morbidity and mortality. Patients with AF need to be appropriately anticoagulated to reduce the risk of stroke. Approximately every fifth stroke is due to AF and average costs for both health and social care is £44,000 over the first five years. Recent updated guidelines on the management of AF have recommended that all patients over the age of 65 be offered screening in the community using either short term ECG or manual pulse palpation. Purpose To determine the feasibility of an innovative community pharmacy led AF detection service incorporating referral for review and treatment to a specialist arrhythmia centre. Method Community pharmacists received intensive training on AF, how to record an ECG using a Kardia monitor and documenting the consultation on a referral form hosted on a national pharmacy database called PharmOutcomes. Targeted opportunistic detection was undertaken by the pharmacists for anyone over the age of 65 years with risk factors for AF. Patients were referred by the pharmacist to the specialist team via PharmOutcomes if they had possible new AF, previous AF and not anticoagulated, anticoagulated but experiencing side effects or adherence issues or a high AF symptom burden. Patients initated on anticoagulation by the specialist team were referred back to the community pharmacist via the New Medicines Service (NMS) for adherence monitoring. Results During a proof of concept phase (May to October 2016) and an upscale phase (May 2018-May 2019) 28 pharmacies were recruited and 1737 participants were enrolled in the study. 891 (51.3%) were male, 851 (41%) were aged over 75 years. 299 patients were referred by the pharmacists and 99 of these were seen by the specialist team in clinic. 28 patients (1.6%) were diagnosed with AF. 20 out of 28 (71.0%) were initiated on anticoagulation. 29 out of 146 patients (19.9%) had previous AF with either a high symptom burden (11) or a heart rate below 50 or above 100 beats per minutes (18). 7 patients (4.3%) with previous AF were started on anticoagulation. 48 out of 99 patients (48.4%) had their medication optimised. This included rate control titration and adjustment of anticoagulation doses. 31 out of 99 patients (31.3%) required further interventions such as holter monitors, echocardiograms or referral to other specialists. Conclusions The results demonstrate that the this service is a robust multidisciplinary process for the detection, protection and perfection of AF. The direct referral pathway ensures that patients are reviewed by a specialist team and receive optimal treatment and management. Referral back to the community pharmacist via the NMS enhances concordance with anticoagulation. Further analysis is being undertaken to assess the cost-effectiveness and health impact of this service. Funding Acknowledgement Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): The Health Foundation; ASHN in collaboration with BMS Pfizer

AIMS:Adolescents with Type 1 diabetes commonly experience episodes of ketoacidosis. In 2014, we conducted a nationwide survey on the management of diabetic ketoacidosis in young people. The survey reported how individual adolescents with diabetes were managed. However, the costs of treating diabetic ketoacidosis were not reported. METHODS:Using this mixed population sample of adolescents, we took a 'bottom-up' approach to cost analysis aiming to determine the total expense associated with treating diabetic ketoacidosis. The data were derived using the information from the national UK survey of 71 individuals, collected via questionnaires sent to specialist paediatric diabetes services in England and Wales. RESULTS:Several assumptions had to be made when analysing the data because the initial survey collection tool was not designed with a health economic model in mind. The mean time to resolution of diabetic ketoacidosis was 15.0 h [95% confidence interval (CI) 13.2, 16.8] and the mean total length of stay was 2.4 days (95% CI 1.9, 3.0). Based on data for individuals and using the British Society of Paediatric Endocrinology and Diabetes (BSPED) guidelines, the cost analysis shows that for this cohort, the average cost for an episode of diabetic ketoacidosis was £1387 (95% CI 1120, 1653). Regression analysis showed a significant cost saving of £762 (95% CI 140, 1574; P = 0.04) among those treated using BSPED guidelines. CONCLUSION:We have used a bottom-up approach to calculate the costs of an episode of diabetic ketoacidosis in adolescents. These data suggest that following treatment guidelines can significantly lower the costs for managing episodes of diabetic ketoacidosis.

A systematic review was conducted to understand the societal costs and consequences of heroin dependence. The systematic review evaluated published literature (2006–2016; Europe, Australia, New Zealand, Canada) of patient populations addicted to heroin or seeking treatment for heroin dependence. Searches were made in three key areas: healthcare-related costs and resource use; crime; and wider societal impacts. From 1,611 abstracts, 72 full-text papers met inclusion/exclusion criteria. Data were extracted from 25 papers with costs and effects suitable for economic analysis. Costs and consequences from 16 papers (meeting the highest NICE checklist rating for economic appraisals) were evaluated. The review identified six major costs/outcomes associated with heroin addiction: cost/cost-effectiveness of interventions; crime and violence; health and societal outcomes with different interventions; housing, homelessness, employment and education; health and public health outcomes; and maternal and infant care. No study incorporated wider societal costs (housing, employment, etc.) in a comprehensive manner. Making comparisons across papers was difficult because of different data sources, time periods, cost years, cost items included and methodologies adopted, although evidence suggests costs could be reduced through treatment. For example overall cost estimates ranged, depending on what items were included, from £15,805/patient for 26 weeks (health, social services, criminal justice) to £17,290/patient annually for successfully treated patients (victim costs included), to £37,864/patient annually for unsuccessfully treated patients (victim costs included). The broader societal costs of heroin addiction remain inconsistently estimated in the literature making comparisons very difficult and creating uncertainty in the true cost. A consistent framework for reporting of heroin-associated societal costs would be beneficial (as other studies have suggested) – helping to quantify the impact of heroin addiction, and inform decision making surrounding its treatment and management.

Approximately every fifth stroke in UK is due to AF and costs the UK National Health Service are between $12,000 and $17,500 per stroke. The aim of this study was to undertake a retrospective health economic analysis of the cost-effectiveness and implications related to opportunistic Atrial Fibrillation (AF) screening in primary care and the detection of previously undiagnosed AF cases in patients, and create a novel modelling solution that can empower individual users and organisations in England, Wales and Northern Ireland in their decision making, technology assessment, comparison of various anticoagulation drug groups cost effectiveness decisions A model was built on Microsoft Excel suite and it combined advance Excel Functions Data with Visual Basic Macros with assumptions based on a feasibility study and a new patient pathway on which community pharmacist perform opportunistic AF checks using one lead mobile ECG device. Apart from Cost-Effectiveness, Return of investment and QALYS of the new pathway was also calculated. Finally, the model was tested using through a cost assessment scenario utilizing input data from various well-established sources: Background research into the NHS and NICE guideline content, current clinical practice, published information and available data. Gathering expert opinion. Testing the model, including the assumptions and outcomes. Our results suggested that the opportunistic AF checks can be cost-effective for the NHS presenting a ROI of 60% and the model presents quick and accurate results without sacrificing customisation options. this innovative modelling solution can provide policy makers with an accurate estimation of the costs related to AF incidences in various CCG population mixtures without sacrificing customisation options empowering users with the flexibility to adopt the model to their own variables findings and organisation.

Objective Cardiac disease is the leading cause of indirect maternal mortality. The aim of this study was to analyse to what extent socioeconomic factors influence the outcome of pregnancy in women with heart disease. Methods The Registry of Pregnancy and Cardiac disease is a global prospective registry. For this analysis, countries that enrolled ≥10 patients were included. A combined cardiac endpoint included maternal cardiac death, arrhythmia requiring treatment, heart failure, thromboembolic event, aortic dissection, endocarditis, acute coronary syndrome, hospitalisation for cardiac reason or intervention. Associations between patient characteristics, country characteristics (income inequality expressed as Gini coefficient, health expenditure, schooling, gross domestic product, birth rate and hospital beds) and cardiac endpoints were checked in a three-level model (patient–centre–country). Results A total of 30 countries enrolled 2924 patients from 89 centres. At least one endpoint occurred in 645 women (22.1%). Maternal age, New York Heart Association classification and modified WHO risk classification were associated with the combined endpoint and explained 37% of variance in outcome. Gini coefficient and country-specific birth rate explained an additional 4%. There were large differences between the individual countries, but the need for multilevel modelling to account for these differences disappeared after adjustment for patient characteristics, Gini and country-specific birth rate. Conclusion While there are definite interregional differences in pregnancy outcome in women with cardiac disease, these differences seem to be mainly driven by individual patient characteristics. Adjustment for country characteristics refined the results to a limited extent, but maternal condition seems to be the main determinant of outcome.

Limbal Stem Cell Deficiency (LSCD) is a rare condition characterized by the shortage of limbal stem cells in the eye resulting in corneal conjunctivalization, corneal opacity, visual impairment and even blindness. Recently, the first advanced therapy medicinal product (ATMP) containing stem cells (GPLSCD01) has been recommended for approval by EMA in moderate-severe LSCD due to chemical or physical burn. A Cost Effectiveness Analysis (CEA) was performed, from a public payer perspective, to compare GPLSCD01 in LSCD with conservative treatment, given that, currently, no other medicinal product is approved for this disease. We analyzed visual acuity and symptoms from 99 patients (average age 46.8 yrs.) treated with GPLSCD01; data were taken from a retrospective, case-series, non-randomized, non-controlled, multicenter clinical study (HLSTM01), covering up to 10 years follow-up. LSCD-impaired visual acuity and symptoms such as pain, burning and photophobia were used in the model to assess the QoL associated with the condition, and Quality Adjusted Life Years (QALY) to compare the outcomes of GPLSCD01 treatment versus conservative management, in a similar patient pool. Patients under conservative treatment had between 10.29 and 17.24 QALYs, depending on LSCD severity, whereas patients treated with GPLSCD01 showed between 15.93 and 22.49 QALYs, with a total utility gain between 5.25 and 6.04 QALYs in the GPLSCD01 group, this result being already discounted by 3.0%, in compliance with National Institute for Health Care Excellence (NICE) guidelines. Due to the utility gain, GPLSCD01 would meet NICE conventional ICER thresholds (20,000 – 30,000 GBP/QALY) up to a treatment cost of 150,000 GBP. GPLSCD01 is a regenerative medicine, offering long-term, potentially life-long effectiveness after single administration. This CEA shows that GPLSCD01 in moderate-severe LSCD provides a significant gain in QALYs compared to conventional, conservative management of the condition, balancing, from a payer perspective, initial higher acquisition costs.

A cost-effectiveness analysis (CEA) has been performed, from an Italian public payer perspective, to compare the first advanced therapy medicinal product (ATMP) containing stem cells for the treatment of Limbal Stem Cell Deficiency (LSCD) with conservative treatment, a standard alternative pathway. LSCD is a rare condition characterized by the shortage of limbal stem cells in the eye resulting in corneal conjunctivalization, corneal opacity, visual impairment and even blindness. A medicinal product has been recently approved by EMA as the first treatment in moderate-severe LSCD due to chemical or physical burn. Efficacy data derive from a retrospective, case-series, non-randomized, non-controlled, multicenter clinical study in which patients have been treated with ex-vivo expanded autologous human corneal epithelial cells containing stem cells. Symptoms like pain, photophobia and burning, together with visual impairment, contributed to assess quality of life associated with the condition, while Quality Adjusted Life Years (QALYs) have been used to compare the outcomes of the recent approved product with conservative management, in a comparable patient pool. The considered cost data have been obtained from Italian tariff nomenclature databases. Patients treated with conservative management presented QALY values between 6.51 and 9.71, depending on LSCD severity, whereas treatments with ATMP ensured to patients between 10.22 and 13.60 QALY, with a total utility gain between 3.71 and 4.60 QALYs (result being discounted by 3.5% yearly). As a result of this utility gain, the approved product would meet an ICER threshold of 40,000 €/QALY cost of around €160,000 per treatment. Offering long-term, potentially life-long, effectiveness after single treatment, ATMP analyzed delivers cost reduction in the long term management of LSCD, despite higher initial costs compared to conservative approach. The CEA of the product demonstrated a significant gain in terms of QALYs, amortizing the initial outlay for the treatment.

SCOOP is a UK seven-centre, pragmatic, randomised controlled trial with 5-year follow-up, including 11,580 women aged 70 to 85 years, to assess the effectiveness and cost-effectiveness of a community-based screening programme to reduce fractures. It utilises the FRAX algorithm and DXA to assess the 10-year probability of fracture.