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.

Evaluation and Modification of a Shared Decision-Making Tool for Peanut Allergy Management.

PURPOSE OF REVIEW: Based on shared decision-making (SDM) principles, a decision aid was previously developed to help patients, their caregivers, and physicians decide which peanut allergy management approach best suits them. This study refined the decision aid's content to better reflect patients' and caregivers' lived experience. RECENT FINDINGS: Current standard of care for peanut allergy is avoidance, although peanut oral immunotherapy has been approved by the Food and Drug Administration for use in patients 4-17 years old. An advisory board of allergy therapy experts (n = 3) and patient advocates (n = 3) informed modifications to the decision aid. The revised tool underwent cognitive debriefing interviews (CDIs) among adolescents (12-17 years old) with peanut allergy and caregivers of patients 4-17 years old with peanut allergy to evaluate its relevance, understandability, and usefulness. The 20 CDI participants understood the information presented in the SDM tool and reported it was important and relevant. Some revisions were made based on participant feedback. Results support content validity of the Peanut Allergy Treatment SDM Tool.

Effects of red meat taxes and warning labels on food groups selected in a randomized controlled trial.

BACKGROUND: High consumption of red and processed meat contributes to both health and environmental harms. Warning labels and taxes for red meat reduce selection of red meat overall, but little is known about how these potential policies affect purchases of subcategories of red meat (e.g., processed versus unprocessed) or of non-red-meat foods (e.g., cheese, pulses) relevant to health and environmental outcomes. This study examined consumer responses to warning labels and taxes for red meat in a randomized controlled trial. METHODS: In October 2021, we recruited 3,518 US adults to complete a shopping task in a naturalistic online grocery store. Participants were randomly assigned to one of four arms: control (no warning labels or tax), warning labels only (health and environmental warning labels appeared next to products containing red meat), tax only (prices of products containing red meat were increased 30%) or combined warning labels + tax. Participants selected items to hypothetically purchase, which we categorized into food groups based on the presence of animal- and plant-source ingredients (e.g., beef, eggs, pulses), meat processing level (e.g., processed pork versus unprocessed pork), and meat species (e.g., beef versus pork). We assessed the effects of the warning labels and tax on selections from each food group. RESULTS: Compared to control, all three interventions led participants to select fewer items with processed meat (driven by reductions in processed pork) and (for the tax and warning labels + tax interventions only) fewer items with unprocessed meat (driven by reductions in unprocessed beef). All three interventions also led participants to select more items containing cheese, while only the combined warning labels + tax intervention led participants to select more items containing processed poultry. Except for an increase in selection of pulses in the tax arm, the interventions did not affect selections of fish or seafood (processed or unprocessed), eggs, or plant-based items (pulses, nuts & seeds, tofu, meat mimics, grains & potatoes, vegetables). CONCLUSIONS: Policies to reduce red meat consumption are also likely to affect consumption of other types of foods that are relevant to both health and environmental outcomes. TRIAL REGISTRATION: NCT04716010 on www. CLINICALTRIALS: gov .

Demographic and Socioeconomic Correlates of Disproportionate Beef Consumption among US Adults in an Age of Global Warming.

Concern for the environment when making dietary choices has grown as the contribution of the food sector to global greenhouse gas emissions becomes more widely known. Understanding the correlates of beef eating could assist in the targeting of campaigns to reduce the consumption of high-impact foods. The objective of this study was to identify the demographic, socioeconomic, and behavioral correlates of disproportionate beef consumption in the United States. We analyzed 24-h dietary recall data from adults (n = 10,248) in the 2015-2018 National Health and Nutrition Examination Survey (NHANES). Disproportionate beef consumption was defined as an intake greater than four ounce-equivalents per 2200 kcal. Associations of this indicator variable with gender, age, race/ethnicity, education, family income, diet knowledge, and away-from-home meals were assessed using logistic regression, incorporating survey design and weighting. Disproportionate beef diets were consumed by 12% of individuals, but accounted for half of all beef consumed. Males were more likely than females (p < 0.001) to consume these diets. This relationship was seen in all bivariate and multivariable models. Older adults, college graduates, and those who looked up the MyPlate educational campaign online were less likely (p < 0.01) to consume a disproportionate beef diet. While almost one-third of reported consumption came from cuts of beef (e.g., steak or brisket), six of the top ten beef sources were mixed dishes: burgers, meat mixed dishes, burritos and tacos, frankfurters, soups, and pasta. Efforts to address climate change through diet modification could benefit from targeting campaigns to the highest consumers of beef, as their consumption accounts for half of all beef consumed.

Inhibition of discoidin domain receptor (DDR)-1 with nilotinib alters CSF miRNAs and is associated with reduced inflammation and vascular fibrosis in Alzheimer's disease.

Discoidin Domain Receptor (DDR)-1 is activated by collagen. Nilotinib is a tyrosine kinase inhibitor that is FDA-approved for leukemia and potently inhibits DDR-1. Individuals diagnosed with mild-moderate Alzheimer's disease (AD) treated with nilotinib (versus placebo) for 12 months showed reduction of amyloid plaque and cerebrospinal fluid (CSF) amyloid, and attenuation of hippocampal volume loss. However, the mechanisms are unclear. Here, we explored unbiased next generation whole genome miRNA sequencing from AD patients CSF and miRNAs were matched with their corresponding mRNAs using gene ontology. Changes in CSF miRNAs were confirmed via measurement of CSF DDR1 activity and plasma levels of AD biomarkers. Approximately 1050 miRNAs are detected in the CSF but only 17 miRNAs are specifically altered between baseline and 12-month treatment with nilotinib versus placebo. Treatment with nilotinib significantly reduces collagen and DDR1 gene expression (upregulated in AD brain), in association with inhibition of CSF DDR1. Pro-inflammatory cytokines, including interleukins and chemokines are reduced along with caspase-3 gene expression. Specific genes that indicate vascular fibrosis, e.g., collagen, Transforming Growth Factors (TGFs) and Tissue Inhibitors of Metalloproteases (TIMPs) are altered by DDR1 inhibition with nilotinib. Specific changes in vesicular transport, including the neurotransmitters dopamine and acetylcholine, and autophagy genes, including ATGs, indicate facilitation of autophagic flux and cellular trafficking. Inhibition of DDR1 with nilotinib may be a safe and effective adjunct treatment strategy involving an oral drug that enters the CNS and adequately engages its target. DDR1 inhibition with nilotinib exhibits multi-modal effects not only on amyloid and tau clearance but also on anti-inflammatory markers that may reduce cerebrovascular fibrosis.

Popular diets as selected by adults in the United States show wide variation in carbon footprints and diet quality.

BACKGROUND: Carbon footprints of vegetarian, pescatarian, and other popular diets have been studied previously, but mostly as idealized versions modeled to meet dietary recommendations. Less is known about the footprints of popular diets as they are consumed by US adults, and thus the potential trade-offs with diet quality for free-living individuals. OBJECTIVES: This study estimated the carbon footprint and diet quality of popular diets as selected by a nationally representative sample of US consumers, including the recently trending keto- and paleo-style diets. METHODS: The 2005-2010 NHANES 24-h recall data were used to categorize individual adult diets (n = 16,412) into 6 types: vegan, vegetarian, pescatarian, paleo, keto, and all other diets, referred to here as omnivore diets. Average daily greenhouse gas emissions in kilograms of carbon dioxide equivalents per 1000 kcal (kg CO2-eq/1000 kcal) were calculated for each diet by matching our previously developed database to NHANES individual diet data. Diet quality was determined using the Healthy Eating Index (HEI) and the Alternate Healthy Eating Index. Survey-weighted ordinary least-squares regression was used to assess mean differences in diets. RESULTS: The average carbon footprints of vegan (0.69 ± 0.05 kg CO2-eq/1000 kcal) and vegetarian (1.16 ± 0.02) diets were lower (P < 0.05) than those of the pescatarian (1.66 ± 0.04), omnivore (2.23 ± 0.01), paleo (2.62 ± 0.33), or keto (2.91 ± 0.27) diets. Mean HEI scores were highest for pescatarian diets (58.76 ± 0.79) and higher (P < 0.05) for vegetarian (51.89 ± 0.74) than for omnivore (48.92 ± 0.33) or keto (43.69 ± 1.61) diets. CONCLUSIONS: Our results highlight the nuances when evaluating the nutritional quality of diets and their carbon footprints. On average, pescatarian diets may be the healthiest, but plant-based diets have lower carbon footprints than other popular diets, including keto- and paleo-style diets.

Proteasome inhibition targets the KMT2A transcriptional complex in acute lymphoblastic leukemia.

Rearrangments in Histone-lysine-N-methyltransferase 2A (KMT2Ar) are associated with pediatric, adult and therapy-induced acute leukemias. Infants with KMT2Ar acute lymphoblastic leukemia (ALL) have a poor prognosis with an event-free-survival of 38%. Herein we evaluate 1116 FDA approved compounds in primary KMT2Ar infant ALL specimens and identify a sensitivity to proteasome inhibition. Upon exposure to this class of agents, cells demonstrate a depletion of histone H2B monoubiquitination (H2Bub1) and histone H3 lysine 79 dimethylation (H3K79me2) at KMT2A target genes in addition to a downregulation of the KMT2A gene expression signature, providing evidence that it targets the KMT2A transcriptional complex and alters the epigenome. A cohort of relapsed/refractory KMT2Ar patients treated with this approach on a compassionate basis had an overall response rate of 90%. In conclusion, we report on a high throughput drug screen in primary pediatric leukemia specimens whose results translate into clinically meaningful responses. This innovative treatment approach is now being evaluated in a multi-institutional upfront trial for infants with newly diagnosed ALL.

Malignant Progression of an Ancestral Bone Marrow Clone Harboring a CIC-NUTM2A Fusion in Isolated Myeloid Sarcoma.

Myeloid sarcoma is a rare condition consisting of extramedullary myeloid blasts found in association with acute myeloid leukemia or, in the absence of bone marrow involvement. We identified an infant with isolated myeloid sarcoma whose bone marrow was negative for involvement by flow cytometry. Sequencing revealed the fusion oncogene CIC-NUTM2A and identified the sarcoma to be clonally evolved from the bone marrow, which carried the fusion despite the absence of pathology. Murine modeling confirmed the ability of the fusion to transform hematopoietic cells and identified receptor tyrosine kinase (RTK) signaling activation consistent with disruption of the CIC transcriptional repressor. These findings extend the definition of CIC-rearranged malignancies to include hematologic disease, provide insight into the mechanism of oncogenesis, and demonstrate the importance of molecular analysis and tracking of bone marrow involvement over the course of treatment in myeloid sarcoma, including patients that lack flow cytometric evidence of leukemia at diagnosis. IMPLICATIONS: This study illustrates molecular involvement of phenotypically normal bone marrow in myeloid sarcoma, which has significant implications in clinical care. Further, it extends the definition of CIC-rearrangements to include hematologic malignancies and shows evidence of RTK activation that may be exploited therapeutically in cancer(s) driven by these fusions.

CELER: A 365-Participant Corpus of Eye Movements in L1 and L2 English Reading.

We present CELER (Corpus of Eye Movements in L1 and L2 English Reading), a broad coverage eye-tracking corpus for English. CELER comprises over 320,000 words, and eye-tracking data from 365 participants. Sixty-nine participants are L1 (first language) speakers, and 296 are L2 (second language) speakers from a wide range of English proficiency levels and five different native language backgrounds. As such, CELER has an order of magnitude more L2 participants than any currently available eye movements dataset with L2 readers. Each participant in CELER reads 156 newswire sentences from the Wall Street Journal (WSJ), in a new experimental design where half of the sentences are shared across participants and half are unique to each participant. We provide analyses that compare L1 and L2 participants with respect to standard reading time measures, as well as the effects of frequency, surprisal, and word length on reading times. These analyses validate the corpus and demonstrate some of its strengths. We envision CELER to enable new types of research on language processing and acquisition, and to facilitate interactions between psycholinguistics and natural language processing (NLP).

Female terminalia morphology and cladistic relations among Tok-Tok beetles (Tenebrionidae: Sepidiini).

Tok-tokkies are one of the most iconic lineages within Tenebrionidae. In addition to containing some of the largest darkling beetles, this tribe is recognized for its remarkable form of sexual communication known as substrate tapping. Nevertheless, the phylogenetic relationships within the group remain poorly understood. This study investigates the usefulness of female terminalia morphology for delimiting Sepidiini and reconstructing relationships among it. Data on the structure of the ovipositors, genital tubes and spicula ventrali have been generated for >200 species representing 28 Pimeliinae tribes. This dataset was used in a comparative analysis at the subfamilial level, which resulted in recognition of several unique features of tok-tokkie terminalia. Additionally, new features linking phenotypically challenging tribes also were recovered (Cryptochilini + Idisiini + Pimeliini). Secondly, 23 characters linked to the structure of female terminalia were defined for tok-tok beetles. Cladistic analysis demonstrates the nonmonophyletic nature of most of the recognized subtribes. The morphological dataset was analysed separately and in combination with available molecular data (CAD, Wg, cox1, cox2, 28S). All obtained topologies were largely congruent, supporting the following changes: Palpomodina Kaminski & Gearner subtr.n. is erected to accommodate the genera Namibomodes and Palpomodes; Argenticrinis and Bombocnodulus are transferred from Hypomelina to Molurina; 153 species and subspecies previously classified within Psammodes are distributed over three separate genera (Mariazofia Kaminski nom.n., Piesomera stat.r., Psammodes sens.n.). Psammodes sklodowskae Kaminski & Gearner sp.n. is described. Preliminary investigation of the ovipositor of Mariazofia basuto (Koch) comb.n. was carried out with the application of microcomputed tomography, illuminating the muscular system as a reliable reference point for recognizing homologous elements in highly modified ovipositors.

Protocol for a scoping review on transition-related surgery procedures, outcome measures and access to care.

INTRODUCTION: Transgender and gender diverse (TGD) individuals often identify with a gender different to the one assigned at birth. Transition is a term used to describe the process TGD individuals take to live as their true gender. Surgery can be a very important aspect of care for members of TGD communities. Transition-related surgery (TRS) refers to many different types of surgeries completed to meet a TGD individual's gender-related goals. While various systematic reviews have attempted to synthesise the existing peer-reviewed literature around aspects of TRS, there are few scoping reviews in this area. Our scoping review aims to address this gap through providing an up-to-date overview of the TRS literature in order to provide an overarching view of the topic. METHOD AND ANALYSIS: This review will follow the methods outlined by the Joanna Briggs Institute's methodology for scoping reviews and will be reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews. A search of nine scientific databases resulted in 20 062 potential articles. After removing duplicates, articles will be screened for inclusion using Covidence. Data extraction and synthesis will be carried out using NVivo and reviewed by team members. ETHICS AND DISSEMINATION: As this study is a scoping review of the existing literature, no ethics review is required. The findings from this review will be disseminated through multiple pathways including open access publication, submission to conferences, social media and Listservs. The findings of the study will also be readily available to clinicians, organizations, interest groups, and policy-makers.

Do diets with higher carbon footprints increase the risk of mortality? A population-based simulation study using self-selected diets from the USA.

OBJECTIVE: Are diets with a greater environmental impact less healthy? This is a key question for nutrition policy, but previous research does not provide a clear answer. To address this, our objective here was to test whether American diets with the highest carbon footprints predicted greater population-level mortality from diet-related chronic disease than those with the lowest. DESIGN: Baseline dietary recall data were combined with a database of greenhouse gases emitted in the production of foods to estimate a carbon footprint for each diet. Diets were ranked on their carbon footprints and those in the highest and lowest quintiles were studied here. Preventable Risk Integrated Model (PRIME), an epidemiological modelling software, was used to assess CVD and cancer mortality for a simulated dietary change from the highest to the lowest impact diets. The diet-mortality relationships used by PRIME came from published meta-analyses of randomised controlled trials and prospective cohort studies. SETTING: USA. PARTICIPANTS: Baseline diets came from adults (n 12 865) in the nationally representative 2005-2010 National Health and Nutrition Examination Survey. RESULTS: A simulated change at the population level from the highest to the lowest carbon footprint diets resulted in 23 739 (95 % CI 20 349, 27 065) fewer annual deaths from CVD and cancer. This represents a 1·83 % (95 % CI 1·57 %, 2·08 %) decrease in total deaths. About 95 % of deaths averted were from CVD. CONCLUSIONS: Diets with the highest carbon footprints were associated with a greater risk of mortality than the lowest, suggesting that dietary guidance could incorporate sustainability information to reinforce health messaging.

Cooking at Home, Fast Food, Meat Consumption, and Dietary Carbon Footprint among US Adults.

Shifting consumer behavior towards more sustainable diets can benefit environmental sustainability and human health. Although more frequent home cooking is associated with a better diet quality and fast-food consumption with worse diet quality, the environmental impact of diets based on frequency of cooking or eating fast food is not well understood. The objective of this study was to investigate whether the frequency of cooking dinner at home or eating fast food is associated with dietary greenhouse gas emissions (GHGE). We linked 24-h dietary recall data from adult respondents in the 2007-2010 National Health and Nutrition Examination Survey (NHANES) (N = 11,469) to a database of GHGE factors to obtain a measure of dietary GHGE (kgCO2-eq/2000 kcal) (the sum of emissions released in the production of food for an individual's diet), adjusted by energy intake (kgCO2-eq/2000 kcal). We examined associations between frequency of cooking dinner (the only meal for which cooking frequency was measured), frequency of eating fast food, and dietary GHGE and protein sources (beef, pork, poultry, other meat, and fish and seafood (g/2000 kcal)) using generalized linearized regression models that controlled for age, sex, and other socio-economic characteristics. Greater cooking frequency was associated with higher dietary GHGE. In fully adjusted models, cooking 5-6 times/week was associated with an additional 0.058 kgCO2-eq/2000 kcal (SE 0.033) and cooking 7 times/week was associated with an additional 0.057 kgCO2-eq/2000 kcal (SE 0.027) when compared to cooking 0-2 times/week. Individuals in households who cooked dinner more frequently consumed significantly more meat, poultry, and fish (cooking 7 times/week: 148.7 g/2000 kcal vs. cooking 0-2 times/week: 135.4 g/2000 kcal, p-trend = 0.005), which could explain the association with a higher carbon footprint diet. There were few associations of note between fast-food frequency and GHGE. Policies and interventions that reduce consumption of meat and increase consumption of plants when both cooking meals at home and eating meals out are needed to shift toward diets that will be beneficial for both human health and the health of the planet.

Single-item substitutions can substantially reduce the carbon and water scarcity footprints of US diets.

BACKGROUND: Human food systems substantially affect the environment, but the impacts vary widely by food. Guidance to individuals to reduce their dietary impacts would benefit from easy advice, but little is known about the specific population impacts of simple changes on self-selected diets. OBJECTIVES: The objective was to estimate the potential impact of a single dietary substitution on the carbon and water scarcity footprints of self-selected diets in the United States. METHODS: This cross-sectional modeling study used 24-h dietary recall data from the 2005-2010 waves of the NHANES. Greenhouse gas emissions (GHGE) in the production of foods as well as irrigated water use, characterized by its relative scarcity at production locations, were matched to all foods in the recalls using previously developed databases. Impacts were summed to create carbon and water scarcity footprints for diets (n  = 16,800) of adults aged >18 y. Diet quality was assessed using the Healthy Eating Index (HEI). Foods with the highest impact on GHGE and selected additional foods were substituted for calorically equivalent, less impactful items. Footprints were calculated before and after these hypothetical substitutions. RESULTS: The highest impact foods were all beef items, and 19.8% of individuals consumed them (n = 3320). After substitution of these items with poultry or pork, the mean carbon and water scarcity footprints among those with substitutions significantly decreased (P < 0.001) by 48.4 ± 0.6% and 29.9 ± 0.4%, respectively. Across the entire sample, these represented mean reductions of 9.6 ± 0.3% and 5.9 ± 0.2%, respectively. The mean HEI after substitutions was 3.6 ± 0.1% higher than before (P < 0.001). None of the selected additional foods had population impacts as large as the beef substitutions. CONCLUSIONS: Simple substitutions can be made in individuals' diets to substantially reduce their carbon and water scarcity footprints without sacrificing dietary quality. Such substitutions may be easier to promote than complex dietary patterns.

Biomanufacturing in low Earth orbit for regenerative medicine.

Research in low Earth orbit (LEO) has become more accessible. The 2020 Biomanufacturing in Space Symposium reviewed space-based regenerative medicine research and discussed leveraging LEO to advance biomanufacturing for regenerative medicine applications. The symposium identified areas where financial investments could stimulate advancements overcoming technical barriers. Opportunities in disease modeling, stem-cell-derived products, and biofabrication were highlighted. The symposium will initiate a roadmap to a sustainable market for regenerative medicine biomanufacturing in space. This perspective summarizes the 2020 Biomanufacturing in Space Symposium, highlights key biomanufacturing opportunities in LEO, and lays the framework for a roadmap to regenerative medicine biomanufacturing in space.

Essential nutrient element profiles in rice types: a risk-benefit assessment including inorganic arsenic.

Rice is consumed by nearly half of the global population and a significant source of energy and nutrients. However, rice consumption can also be a significant pathway of inorganic arsenic (iAs) exposure, thus requiring a risk-benefit assessment. This study assessed nutrient element (NE) densities in fifty-five rice types (white, brown and wild rice) marketed in the UK. Densities of essential NE were used to rank rice types in meeting daily NE targets under different consumption scenarios through a newly developed optimisation approach. Using iAs data from these rice types, we assessed the margin of exposure (MOE) for low (the UK) and high (Bangladesh) rice intake scenarios. Our results showed that brown and wild rice are significantly higher in many NE and significantly contribute to dietary reference value (DRV). Our modelling showed that switching to brown or wild rice could increase the intake of several essential nutrients by up to eight times that of white rice. Using rice consumption data for mid-to-high-consumption countries, we estimate that brown rice could provide 100 % adult DRV for Fe, Mg, Cr, P and Mo, and substantial contributions for Zn, Se and K. Our results show that the amount of rice primarily determines risk from iAs consumed rather than the type of rice. Therefore, switching from white to brown or wild rice could be beneficial, provided iAs concentration in rice is within the recommended limits.

Trends in strong opioid prescribing in Ireland: A repeated cross-sectional analysis of a national pharmacy claims database between 2010 and 2019.

PURPOSE: Significant increases in opioid utilisation have been reported in many countries in recent decades. This study investigated strong opioid prescribing in Irish General Medical Services (GMS) patients over a 10-year period. METHODS: A retrospective repeated cross-sectional analysis of a national pharmacy claims database between January 2010 and December 2019 was conducted. Strong opioid prescribing in GMS patients was evaluated, including by route of administration, age (16-64 years and ≥65 years) and gender. Measures of consumption included prescribing prevalence and defined daily dose (DDD)/1000 population/day. Prevalence ratios (PRs) with 95% confidence intervals (CIs), and percentage and absolute changes were determined. RESULTS: Strong opioid prescribing prevalence increased from 14.43% in 2010 to 16.28% in 2019, with the greatest increase in the ≥65 years age group. Tramadol was the most frequently prescribed product, constituting 63.9% of total strong opioid prescribing. The prescribing prevalence of oxycodone increased from 0.95% in 2010 to 2.68% in 2019 (PR 2.81, 95% CI 2.76, 2.87), with steep increases in oxycodone-naloxone since it became available (PR 5.23, 95% CI 4.98, 5.50). The prescribing prevalence of tapentadol increased from 0.18% to 1.58% between 2012 (first complete year available for reimbursement) and 2019 (PR 8.79, 95% CI 8.43, 9.16). Strong opioid prescribing was highest in females aged ≥65 years. CONCLUSIONS: This study found an overall increase in strong opioid prescribing in Ireland between 2010 and 2019, particularly in older adults. Tramadol was the most frequently prescribed product, with oxycodone and tapentadol prescribing increasing markedly over the study period.

Uptake of biosimilars for TNF-α inhibitors adalimumab and etanercept following the best-value biological medicine initiative in Ireland.

Background There is over 10 years of clinical experience and evidence to show that biosimilar medicines can be used as safely and effectively in approved therapeutic indications as their originator biological medicines. In Ireland, biosimilar medicine uptake has been very slow, and savings to the health service will only be realised through fostering a competitive biological medicine market. Objective The objective of this study was to investigate the utilisation of biosimilars following a 'best-value biological' medicine initiative for adalimumab and etanercept in the Irish healthcare setting. Methods Data was extracted from the National High Tech claims database and High Tech ordering and management hub for the following drugs; adalimumab (Humira®, Amgevita®, Hulio®, Idacio®, and Imraldi®) and etanercept (Enbrel® and Benepali®). Main outcome measure: uptake of the best-value biological medicines. Results In June 2019, just over 90 patients had been initiated on, or switched to a best-value biological for adalimumab or etanercept. Over the next 12 months this increased to over 8500 patients. With the best-value biologicals accounting for approximately 50 % of market share in June 2020, the combined estimated savings and avoided costs are €22.7 million to date. The gain-share prescribing incentive has raised over €3.6 million for the specialties to invest back into patient care. Conclusion Against the background of a finite healthcare budget, this study shows that increasing use of biosimilars can create the financial savings and space to invest in new innovative therapies for the benefit of many patients.

Effect of an Online Reimbursement Application System on Prescribing of Lidocaine 5% Medicated Plaster in the Republic of Ireland.

BACKGROUND: The lidocaine 5% medicated plaster, Versatis®, has one therapeutic indication listed on the Summary of Product Characteristics-symptomatic relief of post-herpetic neuralgia (PHN) in adults. Increased expenditure on Versatis® suggests that there is considerable off-label use. To support the appropriate use of Versatis®, the Health Service Executive's Primary Care Reimbursement Service (PCRS) introduced a reimbursement application system for Versatis® from 1 September 2017. OBJECTIVE: The aim of this study was to investigate the effect of introducing a reimbursement application system on Versatis® prescribing under the General Medical Services (GMS) scheme. METHODS: This study was carried out using prescription dispensing data from the PCRS pharmacy claims database. We carried out segmented linear regression to assess changes in the Versatis® prescribing rate per 1000 GMS eligible population, before and after the introduction of the online reimbursement application system. RESULTS: The results of the segmented regression analysis show that there was a statistically significant level (- 4.91, p < 0.001) and trend change (- 0.69, p < 0.001) in the rate of Versatis® prescribing post-introduction of the reimbursement application system. In the year prior to the introduction of the system, 2016, the annual GMS expenditure on Versatis® lidocaine 5% patches was over €27 million, whereas the GMS expenditure in 2018 was reduced to just over €2 million. CONCLUSION: In our study, a substantial decrease in the dispensing of Versatis® was seen after the implementation of a reimbursement application system. Prescribing of Versatis® should be restricted to patients with a diagnosis of PHN not only to reduce costs, but to ensure evidence-based use of this medication.