Following a health technology assessment, the Health Service Executive (HSE) supported reimbursement of dupilumab subject to a managed access protocol (MAP) being implemented. Reimbursement is restricted to a subgroup of the fully licensed indication, that is, moderate-to-severe refractory atopic dermatitis (AD) in adults and adolescents 12 years and older. This study provides an overview of the first year of the MAP.

All reimbursement applications submitted to the HSE Medicines Management Programme between 1 April 2021 and 31 March 2022 were reviewed. Key demographic and clinical characteristics of the approved population were analyzed. Reimbursement claims data within the specified period were extracted from the HSE Primary Care Reimbursement Services national pharmacy claims database. All data were compiled and analyzed using SPSS Statistics 27. Expenditure estimates were based on wholesale prices and were exclusive of value-added tax, fees, and confidential rebates.

During the study period, 382 applications were submitted, 96 percent (n=365) of which were approved. Among approved patients, the mean age was 35 years (range 12 to 79 years), the mean number of years between AD diagnosis and approval was 22.65 years (range 1 to 78 years), and 65 percent (n=238) were men. The mean Eczema Area and Severity Index score was 28.72 and the mean (Children’s) Dermatology Life Quality Index score was 19.72. Approved patients who had unsuccessfully tried other systemic immunosuppressants had trialed up to five different medicines (mean=1.6). Year one expenditure was EUR2.4million, with 70 percent of approved patients accessing treatment.

Most applications submitted through the MAP were approved. These patients met the predefined evidence-based eligibility criteria for treatment. Patient numbers were higher than estimated, suggesting that the MAP did not hinder access. Utilizing health technology management by way of a MAP has facilitated access to expensive medicines for patients with the greatest need, while controlling expenditure for the payer.

The calcitonin gene-related peptide monoclonal antibodies (CGRP MABs) erenumab, fremanezumab, and galcanezumab are reimbursed in Ireland under the High Tech Arrangement, subject to a managed access protocol (MAP), for the prophylaxis of chronic migraine in adults in whom three or more prophylactic treatments have failed. This study provides an overview of submitted reimbursement applications and the utilization of CGRP MABs.

The MAP for CGRP MABs was introduced on 1 September 2021 and is operated by the Health Service Executive (HSE) Medicines Management Programme. Individual patient reimbursement applications for CGRP MABs submitted through an online reimbursement application system between 1 September 2021 and 30 April 2023 were reviewed. Utilization data from 1 September 2021 to 30 April 2023 were extracted from the HSE Primary Care Reimbursement Service national pharmacy reimbursement claims database for the High Tech Arrangement. Analysis was performed using SAS® 9.4 software.

A total of 1,517 reimbursement applications were submitted in the study period. Reimbursement was approved for 96.1 percent (n=1,458) of the applications. A total of 1,399 individual patients (mean age 45 years) were dispensed a CGRP MAB under the High Tech Arrangement between September 2021 and April 2023, the majority of whom were women (n=1,141). Almost 90 percent of patients were considered treatment adherent. In April 2023, the market share of the individual CGRP MABs on the High Tech Arrangement was 56 percent (n=599) for fremanezumab, 38.3 percent (n=409) for erenumab, and 5.7 percent (n=61) for galcanezumab.

MAPs are part of the health technology management approach to drug reimbursement in the Irish healthcare setting, ensuring that reimbursement is in line with approved subgroups of the licensed indication. Used in conjunction with health technology assessment, MAPs enable access to high-cost drug treatments for patients with the greatest unmet need, while providing budgetary oversight and certainty for the payer.

Increasingly in Ireland, there are specific criteria attached to reimbursement approval for new medicines. Health technology assessment (HTA) identifies where uncertainty is greatest in relation to clinical and cost-effectiveness evidence and budget impact estimates; our health technology management (HTM) approach uses these outputs from HTA to design protocols to manage these uncertainties in the post-reimbursement phase.

A bespoke managed access protocol (MAP) is developed for each medicine reimbursed under this approach, informed by uncertainties highlighted in the HTA, directions from the decision-maker, and relevant particulars arising from commercial negotiations. Individual patient reimbursement applications are submitted via an online application system linked directly to the national pharmacy claims system. Pharmacists review the applications and approve reimbursement support where the patient meets the reimbursement criteria. The process is adaptive, allowing expansion of the criteria to include previously excluded patient cohorts, and the addition of new indications. It can also work across differing reimbursement arrangements (hospital/primary care).

The MAP for liraglutide for weight management confines reimbursement to patients with a body mass index greater than or equal to 35 kg/m², prediabetes, and high risk for cardiovascular disease. Phase I reimbursement support lasts for six months; patients not attaining greater than or equal to five percent weight loss are deemed non-responders as per the HTA, and reimbursement support is discontinued. The MAP for dupilumab confined reimbursement support to adults with refractory moderate-to-severe atopic dermatitis, where cost-effectiveness was plausible in the HTA. The MAP for calcitonin-gene-related-peptides monoclonal antibodies confines reimbursement support to patients with chronic migraine, refractory to at least three prophylactic treatments, where cost-effectiveness was plausible in the HTA.

Across these MAPs, over 3,000 patients accessed novel treatments for chronic illnesses in September 2023. HTM provides an effective mechanism to facilitate access to high-cost medicines for targeted patient groups, while providing increased oversight and budgetary certainty. Key to acceptance is utilization of HTA outputs to implement evidence-based HTM measures targeting specific uncertainties as highlighted in the HTA report.

No established risk prediction tool exists in United Kingdom and Irish Paediatric Cardiology practice for patients undergoing cardiac catheterisation. The Catheterisation RISk score for Paediatrics is used primarily in North American practice to assess risk prior to cardiac catheterisation. Validating the utility and transferability of such a tool in practice provides the opportunity to employ an already established risk assessment tool in everyday practice.

To ascertain whether the Catheterisation RISk score for Paediatrics assessment tool can accurately predict complications within United Kingdom and Irish congenital catheterisation practice.

Clinical and procedural data including National Institute for Cardiovascular Outcomes Research derived outcome data from 1500 patients across five large congenital cardiology centres in the United Kingdom and Ireland were retrospectively collected. Catheterisation RISk score for Paediatrics were then calculated for each case and compared with the observed procedural outcomes. Chi-square analysis was used to determine the relationship between observed and predicted events.

Ninety-eight (6.6%) patients in this study experienced a significant complication as qualified by National Institute for Cardiovascular Outcomes Research classification. 4% experienced a moderate complication, 2.3% experienced a major complication and 0.3% experienced a catastrophic complication resulting in death. Calculated Catheterisation RISk score for Paediatrics scores correlated well with all observed adverse events for paediatric patients across all CRISP categories. The association was also transferable to adult congenital heart disease patients in lower Catheterisation RISk score for Paediatrics categories (CRISP 1–3).

The Catheterisation RISk score for Paediatrics score accurately predicts significant complications in congenital catheterisation practice in the United Kingdom and Ireland. Our data validated the Catheterisation RISk score for Paediatrics assessment tool in five congenital centres using National Institute for Cardiovascular Outcomes Research-derived outcome data.

To examine patterns of taxed and untaxed food and beverage shopping across store types after Mexico’s sugary drink and non-essential food taxes, the nutritional quality of these patterns and the socio-economic characteristics associated with them.

We performed k-means cluster analyses using households’ percentage of food and beverage purchases from each store type (i.e. convenience stores, traditional shops (e.g. bodegas, tiendas, mom-and-pop shops), supermarkets, wholesalers and others). We calculated adjusted mean proportions of taxed and untaxed products (ml or g/capita per d) purchased in each pattern. We studied the associations between households’ SES and shopping patterns using multinomial logistic regressions. Within shopping patterns, we obtained mean volumes and proportions of taxed and untaxed food and beverage subgroups and calculated the proportion of products purchased at each store type.

Mexico.

Urban Mexican households (n 5493) from the Nielsen Mexico Consumer Panel Survey 2015.

We found four beverage shopping patterns and three food shopping patterns, driven by the store type where most purchases were made. For beverages, 48 % of households were clustered in the Traditional pattern and purchased the highest proportion of taxed beverages. Low-SES households had the highest probability of clustering in the Traditional beverage shopping pattern. For foods, 35 % of households were clustered into the Supermarket pattern. High-SES households had the highest probability of clustering in the Supermarket food shopping pattern.

The combination of store types where Mexican households purchase packaged foods and beverages varies. However, households in all shopping patterns and SES purchase taxed beverages mainly at traditional stores. Store-level strategies should be developed to intervene on traditional stores to improve the healthfulness of purchases.

Understanding the association between diet quality and cardiometabolic risk by education level is important for preventing increased cardiometabolic risk in the Mexican population, especially considering pre-existing disparities in diet quality. The present study examined the cross-sectional association of overall diet quality with cardiometabolic risk, overall and by education level, among Mexican men and women.

Cardiometabolic risk was defined by using biomarkers and diet quality by the Mexican Diet Quality Index. We computed sex-specific multivariable logistic regression models.

Mexico.

Mexican men (n 634) and women (n 875) participating in the Mexican National Health and Nutrition Survey 2012.

We did not find associations of diet quality with cardiometabolic risk factors in the total sample or in men by education level. However, we observed that for each 10-unit increase in the dietary quality score, the odds of diabetes risk in women with no reading/writing skills was 0·47 (95 % CI 0·26, 0·85) relative to the odds in women with ≥10 years of school (referent). Similarly, for each 10-unit increase of the dietary quality score, the odds of having three v. no lipid biomarker level beyond the risk threshold in lower-educated women was 0·27 (95 % CI 0·12, 0·63) relative to the odds in higher-educated women.

Diet quality has a stronger protective association with some cardiometabolic disease risk factors for lower- than higher-educated Mexican women, but no association with cardiometabolic disease risk factors among men. Future research will be needed to understand what diet factors could be influencing the cardiometabolic disease risk disparities in this population.

The present study evaluated the association of two measures of diet quality with BMI and waist circumference (WC), overall and by education level, among Mexican men and women.

We constructed two a priori indices of diet quality, the Mexican Diet Quality Index (MxDQI) and the Mexican Alternate Healthy Eating Index (MxAHEI), which we examined relative to BMI and WC. We computed sex-specific multivariable linear regression models for the total sample and by education level.

Mexico.

Mexican men (n 954) and women (n 1356) participating in the Mexican National Health and Nutrition Survey 2012.

Total dietary scores were not associated with BMI in men and women, but total MxDQI was inversely associated with WC in men (−0·10, 95 % CI −0·20, −0·004 cm). We also found that some results differed by education level in men. For men with the lowest education level, a one-unit increase in total MxDQI and MxAHEI score was associated with a mean reduction in BMI of 0·11 (95 % CI −0·18, 0·04) and 0·18 (95 % CI −0·25, −0·10) kg/m2, respectively. Likewise, a one-unit increase in total MxDQI and MxAHEI score was associated with a mean change in WC of −0·30 (95 % CI −0·49, −0·11) and −0·53 (95 % CI −0·75, −0·30) cm, respectively, in men with the lowest level of education. In women, the association of diet quality scores with BMI and WC was not different by education level.

Our findings suggest that a higher diet quality in men with low but not high education is associated with lower BMI and WC.

To examine snacking patterns, food sources and nutrient profiles of snacks in low- and middle-income Chilean children and adolescents.

Cross-sectional. Dietary data were collected via 24 h food recalls. We determined the proportion of snackers, snacks per day and energy from top food and beverage groups consumed. We compared the nutrient profile (energy, sodium, total sugars and saturated fat) of snacks v. meals.

South-east region of Chile.

Children and adolescents from two cohorts: the Food Environment Chilean Cohort (n 958, 4–6 years old) and the Growth and Obesity Cohort Study (n 752, 12–14 years old).

With a mean of 2·30 (se 0·03) snacks consumed daily, 95·2 % of children and 89·9 % of adolescents reported at least one snacking event. Snacks contributed on average 1506 kJ/d (360 kcal/d) in snacking children and 2218 kJ/d (530 kcal/d) in snacking adolescents (29·0 and 27·4 % daily energy contribution, respectively). Grain-based desserts, salty snacks, other sweets and desserts, dairy foods and cereal-based foods contributed the most energy from snacks in the overall sample. For meals, cereal-based foods, dairy beverages, meat and meat substitutes, oils and fats, and fruits and vegetables were the top energy contributors.

Widespread snacking among Chilean youth provides over a quarter of their daily energy and includes foods generally considered high in energy, saturated fat, sodium and/or total sugars. Future research should explore whether snacking behaviours change as the result of Chile’s national regulations on food marketing, labelling and school environments.

This study investigated the characteristics of subjective memory complaints (SMCs) and their association with current and future cognitive functions.

A cohort of 209 community-dwelling individuals without dementia aged 47–90 years old was recruited for this 3-year study. Participants underwent neuropsychological and clinical assessments annually. Participants were divided into SMCs and non-memory complainers (NMCs) using a single question at baseline and a memory complaints questionnaire following baseline, to evaluate differential patterns of complaints. In addition, comprehensive assessment of memory complaints was undertaken to evaluate whether severity and consistency of complaints differentially predicted cognitive function.

SMC and NMC individuals were significantly different on various features of SMCs. Greater overall severity (but not consistency) of complaints was significantly associated with current and future cognitive functioning.

SMC individuals present distinctive features of memory complaints as compared to NMCs. Further, the severity of complaints was a significant predictor of future cognition. However, SMC did not significantly predict change over time in this sample. These findings warrant further research into the specific features of SMCs that may portend subsequent neuropathological and cognitive changes when screening individuals at increased future risk of dementia.