Utilization, Expenditure, and Treatment Patterns Associated With Calcitonin Gene-Related Peptide Monoclonal Antibodies Reimbursed Subject to a Managed Access Protocol in Ireland.

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.

Disparities in Oral Nutritional Supplement Usage and Dispensing Patterns across Primary Care in Ireland: ONSPres Project.

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.

A Logic Model Framework for Planning an International Refugee Health Research, Evaluation, and Ethics Committee.

Collaborative approaches to supporting the health of refugees and other newcomer populations in their resettlement country are needed to address the complex medical and social challenges they may experience after arrival. Refugee health professionals within the Society of Refugee Healthcare Providers (SRHP)-the largest medical society dedicated to refugee health in North America-have expressed interest in greater research collaborations across SRHP membership and a need for guidance in conducting ethical research on refugee health. This article describes a logic model framework for planning the SRHP Research, Evaluation, and Ethics Committee. A logic model was developed to outline the priorities, inputs, outputs, outcomes, assumptions, external factors, and evaluation plan for the committee. The short-term outcomes include (1) establish professional standards in refugee health research, (2) support evaluation of existing refugee health structures and programs, and (3) establish and disseminate an ethical framework for refugee health research. The SRHP Research, Evaluation, and Ethics Committee found the logic model to be an effective planning tool. The model presented here could support the planning of other research committees aimed at helping to achieve health equity for resettled refugee populations.

Healthcare professionals' perceptions of malnutrition management and oral nutritional supplement prescribing in the community: A qualitative study.

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.

Overcoming Communication Barriers in Refugee Health Care.

Research demonstrates that language and cultural barriers negatively affect care for patients with limited English proficiency, resulting in significant and costly health disparities. Legal standards emphasize working with qualified interpreters, but training for providers on communicating effectively through interpreters is inconsistent. Knowing the difference between a translator and interpreter, an interpreter's role, and who can be a qualified interpreter are key for providers. Generally accepted best practice for working with medical interpreters includes tips for before, during, and after an interpreted encounter. Potential solutions exist for ethical dilemmas and challenges commonly experienced when working with interpreters.

Prescriber Variation in Relation to Prescribing Trends within the Preferred Drugs Initiative in Ireland (2012-2015): An Interrupted Time-Series Study Using Latent Curve Models.

OBJECTIVES: To examine the impact of the Preferred Drugs Initiative (PDI), an Irish health policy aimed at reducing prescribing variation. DESIGN: Interrupted time series spanning 2012 to 2015. SETTING: Health Service Executive pharmacy claims data for General Medical Services (GMS) patients, approximately 40% of the Irish population. PARTICIPANTS: Prescribers issuing preferred drug group items to GMS adults before and after PDI guidelines. PRIMARY OUTCOME: The percentage coverage of PDI medications within each drug class per calendar quarter per prescriber. METHODS: Latent curve models with structured residuals (LCM-SRs) were used to model coverage of the preferred drugs over time. The number of GMS adults receiving medication and the percentage who were 65 years and older at the start of the study were included as covariates. RESULTS: In the quarter following PDI guidelines, coverage of the preferred drugs increased most in absolute terms for proton pump inhibitors (PPIs) (1.50% [SE 0.15], P < 0.001) and selective and norepinephrine reuptake inhibitors (SNRIs) (1.17% [SE 0.26], P < 0.001). Variation between prescribers remained relatively unchanged and increased for urology medications. Prescribers who increased coverage of the preferred PPI also increased coverage of the preferred statin immediately following guidelines (correlation 0.47 [SE 0.13], P < 0.001). Where guidelines were disseminated simultaneously, coverage of one preferred drug did not significantly predict coverage of the other preferred drug in the next calendar quarter. Prescribing of preferred drugs was not moderated by prescriber-level factors. CONCLUSIONS: Modest changes in prescribing of the preferred drugs have been observed over the course of the PDI. However, the guidelines have had little impact in reducing variation between prescribers. Further strategies may be necessary to reduce variation in clinical practice and enhance patient care.

An evaluation of prescribing trends and patterns of claims within the Preferred Drugs Initiative in Ireland (2011-2016): an interrupted time-series study.

OBJECTIVE: To examine the impact of the Preferred Drugs Initiative (PDI), an Irish health policy aimed at enhancing evidence-based cost-effective prescribing, on prescribing trends and the cost of prescription medicines across seven medication classes. DESIGN: Retrospective repeated cross-sectional study spanning the years 2011-2016. SETTING: Health Service Executive Primary Care Reimbursement Service pharmacy claims data for General Medical Services (GMS) patients, approximately 40% of the Irish population. PARTICIPANTS: Adults aged ≥18 years between 2011 and 2016 are eligible for the GMS scheme. PRIMARY AND SECONDARY OUTCOMES: The percentage of PDI medications within each drug class per calendar quarter. Linear regression was used to model prescribing of the preferred drug within each medication group and to assess the impact of PDI guidelines and other relevant changes in prescribing practice. Savings in drug expenditure were estimated. RESULTS: Between 2011 and 2016, around a quarter (23.59%) of all medications were for single-agent drugs licensed in the seven drug classes. There was a small increase in the percentage of PDI drugs, increasing from 4.64% of all medications in 2011 to 4.76% in 2016 (P<0.001). The percentage of preferred drugs within each drug class was significantly higher immediately following publication of the guidelines for all classes except urology, with the largest increases noted for lansoprazole (1.21%, 95% CI: 0.84% to 1.57%, P<0.001) and venlafaxine (0.71%, 95% CI: 0.15% to 1.27%, P=0.02). Trends in prescribing of the preferred drugs between PDI guidelines and the end of 2016 varied between drug classes. Total cost savings between 2013 and 2016 were estimated to be €2.7 million. CONCLUSION: There has been a small increase in prescribing of PDI drugs in response to prescribing guidelines, with inconsistent changes observed across therapeutic classes. These findings are relevant where health services are seeking to develop more active prescribing interventions aimed at changing prescribing practice.

Serial assessment of the index of microcirculatory resistance during primary percutaneous coronary intervention comparing manual aspiration catheter thrombectomy with balloon angioplasty (IMPACT study): a randomised controlled pilot study.

OBJECTIVE: Utilising a novel study design, we evaluated serial measurements of the index of microcirculatory resistance (IMR) in patients undergoing primary percutaneous coronary intervention (PPCI) for ST-segment elevation myocardial infarction (STEMI) to assess the impact of device therapy on microvascular function, and determine what proportion of microvascular injury is related to the PPCI procedure, and what is an inevitable consequence of STEMI. DESIGN: 41 patients undergoing PPCI for STEMI were randomised to balloon angioplasty (BA, n=20) or manual thrombectomy (MT, n=21) prior to stenting. Serial IMR measurements, corrected for collaterals, were recorded at baseline and at each stage of the procedure. Microvascular obstruction (MVO) and infarct size at 24 h and 3 months were measured by troponin and cardiac MRI (CMR). RESULTS: IMR did not change significantly following PPCI, but patients with lower IMR values (<32, n=30) at baseline had a significant increase in IMR following PPCI (baseline: 21.2±7.9 vs post-stent: 33.0±23.7, p=0.01) attributable to prestent IRA instrumentation (baseline: 21.7±8.0 vs post-BA or MT: 36.9±25.9, p=0.006). Post-stent IMR correlated with early MVO on CMR (p=0.01). There was no significant difference in post-stent IMR, presence of early MVO or final infarct size between patients with BA and patients treated with MT. CONCLUSIONS: Patients with STEMI and less microcirculatory dysfunction may be susceptible to acute iatrogenic microcirculatory injury from prestent coronary devices. MT did not appear to be superior to BA in maintaining microcirculatory integrity when the guide wire partially restores IRA flow during PPCI. TRIAL REGISTRATION NUMBER: ISRCTN31767278.

A brief intervention for weight management in primary care: study protocol for a randomized controlled trial.

BACKGROUND: Obesity affects 25% of the UK adult population but modest weight loss can reduce the incidence of obesity-related chronic disease. Some effective weight loss treatments exist but there is no nationally available National Health Service (NHS) treatment service, and general practitioners (GPs) rarely discuss weight management with patients or support behavior change. Evidence shows that commercial weight management services, that most primary care trusts have 'on prescription', are more effective than primary care treatment. METHODS/DESIGN: We propose a controlled trial where patients will be randomized to receive either the offer of help by referral to a weight management service and follow-up to assess progress, or advice to lose weight on medical grounds. The primary outcome will be weight change at 12-months. Other questions are: what actions do people take to manage their weight in response to the two GP intervention types? How do obese patients feel about GPs opportunistically discussing weight management and how does this vary by intervention type? How do GPs feel about raising the issue opportunistically and giving the two types of brief intervention? What is the cost per kg/m2 lost for each intervention? Research assistants visiting GP practices in England (n = 60) would objectively measure weight and height prior to GP consultations and randomize willing patients (body mass index 30+, excess body fat, 18+ years) using sealed envelopes. Full recruitment (n = 1824) is feasible in 46 weeks, requiring six sessions of advice-giving per GP. Participants will be contacted at 3 months (postintervention) via telephone to identify actions they have taken to manage their weight. We will book appointments for participants to be seen at their GP practice for a 12-month follow-up. DISCUSSION: Trial results could make the case for brief interventions for obese people consulting their GP and introduce widespread simple treatments akin to the NHS Stop Smoking Service. Likewise, the intervention could be introduced in the Quality and Outcomes Framework and influence practice worldwide. TRIAL REGISTRATION: Current Controlled Trials ISRCTN26563137.

Elective coronary stenting increases fractional flow reserve in other arteries due to an increase in microvascular resistance: clinical implications for assessment of multivessel disease.

INTRODUCTION: Fractional flow reserve (FFR) can guide percutaneous coronary intervention (PCI) in multivessel disease (MVD). However, the effect of target vessel (TV) stenting on subsequent FFR measurements in remote non-TVs (NTVs) is unknown. We investigated the effect of TV stenting on NTV FFR in patients with MVD. METHODS: Patients with MVD (>50% stenosis, ≥2 vessels >2.5 mm diameter; n = 51) undergoing elective PCI were studied. NTV distal pressure, aortic pressure, and saline-bolus thermodilution transit time (Tmn) were measured at baseline and during maximal hyperemia to derive FFR, index of myocardial resistance (IMR), and coronary flow reserve (CFR). PCI was then performed to the TV and the measurements repeated. Collaterals were assessed by modified Rentrop score before and after TV stenting. RESULTS: Mean FFR increased in the NTV after stenting the TV (0.79 ± 0.02 vs. 0.81 ± 0.02; P < 0.01), particularly in patients with normal baseline IMR (0.77 ± 0.02 vs. 0.80 ± 0.02; P = 0.001; n = 41). In this group, PCI to the TV increased remote microvascular resistance (NTV IMR increased from 12.5 ± 0.7 to 16.3 ± 1.4; P = 0.007; and CFR decreased from 3.0 ± 0.2 to 2.4 ± 0.2; P = 0.008). This change was independent of angiographic loss of coronary collaterals from the NTV. CONCLUSION: Elective TV PCI increases NTV FFR due to an increase in remote coronary microvascular resistance in patients with normal microvascular function. The effect of stent deployment on subsequent FFR measurements in other arteries should be considered.