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The Health Service Executive, responsible for operating the Irish health service, has introduced health technology management (HTM) initiatives to manage expenditure on medicines. One such approach is managed access protocols (MAPs) to support access to high-cost medicines, while providing oversight, governance and budgetary certainty to the payer. Herein we describe the development and operation of MAPs, using case studies of liraglutide (Saxenda®), dupilumab (Dupixent®) and calcitonin gene-related peptide monoclonal antibodies. A MAP imposes the eligibility criteria attached to reimbursement support of a medicine. Criteria applied include controls on prescribing authority, clinical diagnostic and severity criteria, previous lines of treatment, concomitant treatments, outcome data collection, and validations within the reimbursement claims system. The choice of criteria are specific to each medicine, dictated by the areas of uncertainty highlighted in the health technology assessment report, such as the place in treatment, population, duration of treatment, etc., the commercial arrangements reached with the marketing authorisation holder, and specific recommendations made by the decision maker. By December 2023, there were 28 medicines reimbursed subject to a MAP in Ireland. Across the three case studies outlined, over 3000 patients were accessing novel treatments for chronic illnesses in September 2023. Managed access protocols can provide some cost certainty for the payer by aligning utilisation and expenditure with committed funds, while enabling access where unmet need is highest. Managed access protocols are now established in the drug reimbursement process in Ireland, meeting the needs of both payers, patients and industry, and are likely to remain a feature of the reimbursement landscape.

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OBJECTIVES: Calcitonin gene-related peptide monoclonal antibodies (CGRP mAbs) are novel high-cost treatments for the prevention of migraine. This study presents data on utilization, expenditure, and treatment patterns with CGRP mAbs available under a managed access protocol in Ireland, to a cohort of treatment refractory patients (failed 3 or more previous treatments) with chronic migraine. METHODS: Data were extracted from the Primary Care Reimbursement Service High Tech claims database and special drug request online system and analyzed using Microsoft Excel and SAS. Treatment persistence was evaluated by refill patterns, and adherence was evaluated using the proportion of days covered method. Expenditure data were extracted directly from the database. RESULTS: Between September 1, 2021 and April 30, 2023, 1517 applications for reimbursement approval for a CGRP mAb were received; 1458 (96.1%) were approved for reimbursement. Total expenditure on CGRP mAbs in year 1 (September 1, 2021 to August 31, 2022) was €3.2 million. The majority of patients initiated treatment with fremanezumab (60.8%) or erenumab (37.1%). Almost 90% of patients were considered adherent, and treatment persistence was high, with more than 75% of patients receiving more than 12 months of treatment in our 18-month study time frame. CONCLUSIONS: This study demonstrates the importance of active health technology management, after reimbursement, in enabling cost-effective use of high-cost treatments while providing budget certainty for the healthcare payer. High levels of adherence and persistence suggest that treatment is successfully targeted in situations which unmet clinical need is greatest.

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BACKGROUND: Malnutrition is underdiagnosed in primary care. GPs are key healthcare contacts for older adults at risk of protein-energy malnutrition; however, lack of knowledge and confidence in its diagnosis and treatment is often reported. AIM: To evaluate the impact of a bespoke online education module on GP malnutrition knowledge and management. DESIGN & SETTING: A prospective pre-post pilot study with 23 GPs and eight GP trainees in the Republic of Ireland. METHOD: The module included units on the following: 'malnutrition definition, prevalence, and latest evidence'; 'identifying malnutrition in clinical practice'; 'food-first advice'; 'reviewing malnutrition'; and 'oral nutritional supplements'. Participant knowledge was measured using a multiple choice questionnaire (MCQ) before and after the module (n = 31), and 6 weeks following completion (n = 11). Case studies assessing identification and management of malnutrition were evaluated by a clinical specialist dietitian with expertise in managing malnutrition. Changes in assessment performance were calculated using paired t-tests. Acceptability was evaluated using a questionnaire. RESULTS: Post-training, 97% of GPs increased MCQ scores from baseline (+25%, P<0.001), with the greatest improvement in 'identifying malnutrition in clinical practice' (mean increase 47%, P<0.001). Eleven GPs completed the 6-week MCQ with scores remaining significantly higher than baseline (mean increase 15%, P = 0.005); 'identifying malnutrition in clinical practice' remained the most highly scored (mean increase 40%, P<0.001). Seventeen GPs completed the case studies; 76% at baseline and 88% post-module correctly calculated malnutrition risk scores. Appropriate malnutrition management improved for 47% of GPs after module completion. CONCLUSION: This e-learning module improved malnutrition knowledge, with good short-term retention in a small cohort. Development of online evidence-based nutrition education may improve GP nutrition care.

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When treating malnutrition, oral nutritional supplements (ONSs) are advised when optimising the diet is insufficient; however, ONS usage and user characteristics have not been previously analysed. A retrospective secondary analysis was performed on dispensed pharmacy claim data for 14,282 anonymised adult patients in primary care in Ireland in 2018. Patient sex, age, residential status, ONS volume (units) and ONS cost (EUR) were analysed. The categories of 'Moderate' (<75th centile), 'High' (75th-89th centile) and 'Very High' ONS users (≥90th centile) were created. The analyses among groups utilised t-tests, Mann-Whitney U tests and chi-squared tests. This cohort was 58.2% female, median age was 76 years, with 18.7% in residential care. The most frequently dispensed ONS type was very-high-energy sip feeds (45% of cohort). Younger males were dispensed more ONSs than females (<65 years: median units, 136 vs. 90; p < 0.01). Patients living independently were dispensed half the volume of those in residential care (112 vs. 240 units; p < 0.01). 'Moderate' ONS users were dispensed a yearly median of 84 ONS units (median cost, EUR 153), 'High' users were dispensed 420 units (EUR 806) and 'Very High' users 892 yearly units (EUR 2402; p < 0.01). Further analyses should focus on elucidating the reasons for high ONS usage in residential care patients and younger males.

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BACKGROUND & AIM: Protein-energy malnutrition is under-recognised in the community despite being common in older adults due to physiological and social changes which are often compounded by chronic disease. This qualitative study aimed to explore the opinions of healthcare professionals (HCPs) working in the primary care and community settings about the management of malnutrition and the prescription of oral nutritional supplements (ONS), often included in the treatment of malnutrition. METHODS: Twelve healthcare professional (HCP) focus groups with 75 participants were conducted: community dietitians (n = 17), registered dietitians working in industry (n = 5), community and residential care nurses (n = 22), physiotherapists (n = 12), pharmacists (n = 9), occupational therapists (n = 6) and speech and language therapists (n = 4). Focus group discussions were audio-recorded and transcribed verbatim. The data were coded and analysed using thematic analysis and key themes with illustrative quotes extracted are presented. RESULTS: Similar views on malnutrition management existed across professions. 'Gaps in Primary Care Management' was the first key theme wherein HCPs identified limitations in malnutrition management in the community. Barriers included limited or no dietetic services available in primary care and poor communication between general practitioners and wider primary care team members which resulted in inappropriate or delayed treatment. The second key theme, 'Challenges with ONS use in the Community', encapsulated several issues HCPs experienced with ONS usage including inappropriate prescribing and lack of monitoring of treatment goals. Conflicts of interest regarding dietitians working in industry assessing and treating older adults in residential care settings was highlighted by participants. CONCLUSIONS: This study highlights that more emphasis is needed to identify patients when they are at risk of malnutrition to avoid advanced or severe malnutrition presentations currently seen. Community dietitians for older people are required to address many of the issues raised including the need for awareness, education and training, resources, and malnutrition care pathway structures.

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BACKGROUND & AIMS: Understanding how older adults perceive their nutritional needs and malnutrition risk is important to inform strategies to improve prevention and management of the condition. This scoping review aimed to identify, characterize and summarize the findings from studies analysing community-dwelling older adults' opinions and perceptions towards their nutritional needs and malnutrition risk. METHODS: An electronic literature search was carried out using three databases, Pubmed, Embase, and CINAHL up to January 2020. Articles were reviewed following PRISMA guidelines. RESULTS: A total of 16,190 records were identified and reviewed with 15 studies being included, all of which were conducted in high income countries. Common conceptual categories that were identified included; older community-dwelling adults consider that a healthy diet for them is the same as that recommended for the general population, consisting of fruits, vegetables, reduced fat and reduced sugar. Weight loss was seen as a positive outcome and a normal component of the ageing process. Lack of appetite was identified by participants in the majority of studies as a barrier to food intake. CONCLUSIONS: This review shows how older community-dwelling adults, with a high risk of malnutrition, follow dietary public health recommendations for the general population and have a greater awareness of the risks of overweight. The implementation of nutritional guidelines that consider the nutritional needs of all older adults and education of non-dietetic community healthcare professionals on providing appropriate nutritional advice to this population are warranted.

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BACKGROUND: Oral nutritional supplements (ONS) are recommended for patients who are malnourished or at risk of malnutrition. Appropriate ONS prescribing requires regular monitoring to assess its continued requirement. Previous research identified long-term ONS prescriptions (>6 months) without review, with 70% of these influenced by social factors. AIM: To investigate the characteristics of long-term ONS users in Ireland and the determinants of larger volumes of ONS dispensing. DESIGN & SETTING: Secondary analysis of anonymous dispensed pharmacy claims data of patients dispensed standard ONS for 12 consecutive months in 2018 (n = 912). METHOD: Factors showing significant (P<0.05) univariate associations with above the median consumption of ONS units were entered into a multivariable model. RESULTS: Median age was 76 (range 18 to 101) years, with 66.9% of the sample being ≥65 years. Almost 70% of the samples were on polypharmacy (45.6%; ≥5 medications) or excessive polypharmacy (21.5%; ≥10 medications). Younger age and being on polypharmacy for drugs having an effect on the central nervous system (CNS) were significantly associated with being dispensed more ONS units in univariate and multivariate analysis. Those patients in the age range 18 to 44 were 2.5 fold more likely to be prescribed more ONS units (odds ratio [OR] 2.5; 95% confidence interval [CI] 1.5 to 4.3; P<0.001). Patients using CNS drugs or on CNS polypharmacy were more likely to be prescribed more ONS units (ORs 1.2 and 2.4; 95% CI 0.9 to 1.4 and 1.3 to 4.4 respectively; P = 0.029). CONCLUSION: Older age and polypharmacy characterise long-term ONS users in this study. Younger age and CNS medication polypharmacy are predictors of more ONS units prescribed over a year.

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BACKGROUND & AIMS: Malnutrition or undernutrition, arising from a deficiency of energy and protein intake, occurs commonly among community-dwelling individuals in developed countries. Once identified, malnutrition can be effectively treated in the majority of cases with dietary advice and the prescription of oral nutritional supplements (ONS) for patients who can eat and drink orally. However, previous research has reported inadequate screening and treatment of malnutrition in the community. The aim of this qualitative study was to explore general practitioners' (GPs) experiences and opinions on the management of malnutrition and the prescription of ONS in the primary care/community setting in Ireland. METHODS: Sixteen semi-structured interviews including chart stimulated recalls (CSR) were conducted with GPs. The interviews and CSRs explored, among others, the following domains; barriers and facilitators in the management of malnutrition, ONS prescribing in the primary care/community setting, and future directions in the management of malnutrition and ONS prescribing. Recorded interviews were transcribed and analysed following a generic qualitative approach with inductive thematic analysis using NVIVO 12 to facilitate data management. RESULTS: Three main themes were identified. Theme 1: 'Malnutrition is a secondary concern', encapsulating the idea that the identification of malnutrition is usually secondary to other clinical issues or disease rather than an independent clinical outcome. This theme also includes the idea that obesity is viewed as a dominant nutritional issue for GPs. Theme 2: 'Responsibility for malnutrition and ONS management in the community', highlighting that GPs feel they do not know who is responsible for the management of malnutrition in the community setting and expressed their need for more support from other healthcare professionals (HCPs) to effectively monitor and treat malnutrition. Theme 3: 'Reluctance to prescribe ONS', emerging from the GPs reported lack of knowledge to prescribe the appropriate ONS, their concern that ONS will replace the patient's meals and the costs associated with the prescription of ONS. CONCLUSIONS: GPs in Ireland do not routinely screen for malnutrition in their clinics as they feel unsupported in treating and managing malnutrition in the community due to limited or no dietetic service availability and time constraints. GPs also view malnutrition as a secondary concern to disease management and prioritise referral to dietetic services for patients with overweight and obesity. GPs reported that they have insufficient knowledge to change or discontinue ONS prescriptions. This study demonstrates that there is a clear need for primary care training in malnutrition identification, treatment and management and more community dietetic services are needed in order to support GPs and deliver high quality care to patients.

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