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.

Congress directed the Secretary of Defense (DoD) to conduct a Pilot program to increase the National Disaster Medical System’s (NDMS) surge capacity, capabilities, and interoperability to support patient movement during a large-scale overseas contingency operation.

The Pilot conducted a mixed methods exploratory study, the Military-Civilian NDMS Interoperability Study (MCNIS), identifying 55 areas of solutions for NDMS innovation that align with interagency stakeholder interests. Priorities were determined via facilitated discussions, refined and validated by all five Pilot sites.

As the DoD provides essential support for the patient movement component within NDMS, the results highlighted areas for improvement between receiving patients at an airfield and moving them to NDMS definitive care partners during a large medical surge event. This includes patient tracking capabilities, transportation processes and patient placement.

In collaboration with the Departments of Health & Human Services, Homeland Security, Transportation, and Veterans Health Administration, the Pilot is addressing these areas for improvement, by executing site-specific projects that will be validated and identified for export across the system. Leaders across the Pilot site healthcare networks are working to enhance patient movement and tracking. Ultimately, the Pilot will deliver dozens of proven solutions to enhance the NDMS’s patient movement capabilities.

Optic nerve hypoplasia (ONH) and septo-optic-pituitary dysplasia (SOD) are neurodevelopmental disorders associated with congenital visual impairment. Our aim was to investigate associations between several ophthalmic and neuroimaging features in patients with ONH/SOD.

A retrospective chart and neuroimaging review was performed in patients with ONH/SOD. Ophthalmic signs (e.g., monocular best-corrected visual acuity [BCVA], nystagmus, and strabismus) and neuroimaging data were extracted and their associations were investigated.

There were 128 patients (70 males) with ONH/SOD who had neuroimaging. Their mean age at the end of the study was 13.2 (SD: 7.5) years. Ophthalmic data were available on 102 patients (58 males). BCVA varied from normal to no light perception. There were statistically significant associations between: (A) Reduced optic nerve or chiasm size on neuroimaging and more severely impaired BCVA and (B) laterality of the reduced optic nerve or chiasm size on neuroimaging and laterality of: (1) The eye with reduced BCVA, (2) small optic disc size, and (3) RAPD, if present (p ≤ 0.0002 each). The presence of symmetrically small optic nerves on MRI was significantly more common in patients with nystagmus than when nystagmus was absent (N = 96, 75% vs. 38.6%, p < 0.0001). The presence of neuronal migration disorders, their type and laterality were not associated with BCVA and laterality of the reduced BCVA.

The functional and structural associations in ONH are consistent with the impaired visual function that results from the hypoplastic anterior visual pathways. However, these associations were not perfectly concordant making prediction of adult BCVA challenging in these patients.

Social determinants of health (SDoH) are structural elements of our living and working environments that fundamentally shape health risks and outcomes. The Healthy People 2030 campaign delineated SDoH into five distinct categories that include: economic stability, education access/quality, healthcare access, neighborhood and built environment, and social and community contexts. Recent research has demonstrated that minoritized individuals have greater disadvantage across SDoH domains, which has been linked to poorer cognitive performance in older adulthood. However, the independent effects of SDoH on everyday functioning across and within racial groups remains less clear. The current project explored the association between SDoH factors and 10-year change in everyday functioning in a large sample of community-dwelling Black and White older adults.

Data from 2,505 participants without dementia enrolled in the Advanced Cognitive Training for Independent and Vital Elderly (ACTIVE) study (age M=73.5; 76% women; 28% Black/African American). Sociodemographic, census, and industry classification data were reduced into five SDoH factors: economic stability, education access and quality, healthcare access and quality, neighborhood and built environment, and social and community contexts. The Observed Tasks of Daily Living, a performance-based measure of everyday functioning with tasks involving medication management, finances, and telephone use, was administered at baseline, 1-, 2-, 3-, 5, and 10-year follow up visits. Mixed-effects models with age as the timescale tested (1) racial group differences in OTDL trajectories, (2) race x SDOH interactions on OTDL trajectories, and (3) associations between SDoH and OTDL trajectories stratified within Black and White older adults. Covariates included sex/gender, vocabulary score, Mini-Mental Status Examination, depressive symptoms, visual acuity, general health, training group status, booster status, testing site, and recruitment wave.

Black older adults had a steeper decline of OTDL performance compared to Whites (linear: b = -.25, quadratic b=-.009, ps < .001). There was a significant race x social and community context interaction on linear OTDL trajectories (b =.06, p=.01), but no other significant race x SDoH interactions were observed (bs =-.007-.05, ps=.73-.11). Stratified analyses revealed lower levels of social and community context were associated with steeper age-related linear declines in OTDL performance in Black (b = .08, p=.001), but not White older adults (b =.004, p=.64). Additionally, lower levels of economic stability were associated with steeper age-related linear declines in OTDL performance in Black (b =.07, p=.04), but not White older adults (b =.01, p=.35). Finally, no significant associations between other SDoH and OTDL trajectories were observed in Black (bs = -.04-.01, ps =.09-.80) or White (bs = -.02-.003, ps=.07-.96) older adults.

SDoH, which measure aspects of structural racism, play an important role in accelerating age-related declines in everyday functioning. Lower levels of economic and community-level social resources are two distinct SDoH domains associated with declines in daily functioning that negatively impact Black, but not White, older adults. It is imperative that future efforts focus on both identifying and acting upon upstream drivers of SDoH-related inequities. Within the United States, this will require addressing more than a century of antiBlack sentiment, White supremacy, and unjust systems of power and policies designed to intentionally disadvantage minoritized groups.

The Functional Assessment of Cancer Therapy-Cognitive scale (FACT-Cog) is one of the most frequently used patient-reported outcome (PRO) measures of cancer-related cognitive impairment (CRCI) and of CRCI-related impact on quality of life (QOL). Previous studies using the FACT-Cog found that >75% of women with breast cancer (BCa) experience CRCI. Distress tolerance (DT) is a complex construct that encompasses both the perceived capacity (i.e., cognitive appraisal) and the behavioral act of withstanding uncomfortable/aversive/negative emotional or physical experiences. Low DT is associated with psychopathology and executive dysfunction. We previously found that women with BCa with better DT skills reported less CRCI on the FACT-Cog. However, this relationship has not been tested using a performance-based cognitive measure. Therefore, the aims of this study were to: (1) assess the relationship between the FACT-Cog and the Telephone Interview for Cognitive Status (TICS), a performance-based cognitive measure; and (2) test whether the association between DT and CRCI (using the FACT-Cog) was replicated with the TICS.

Participants completed the Distress Tolerance Scale (DTS), the FACT-Cog, and the TICS after undergoing BCa surgery and prior to starting adjuvant therapy [101 women, age >50 years, M(SD)= 61.15(7.76), 43% White Non-Hispanic, 34.4% White Hispanic, 10.8% Black, with nonmetastatic BCa, 55.4% lumpectomy, 36.6% mastectomy; median 29 days post-surgery].

Although there was a significant correlation between the TICS total score and the FACT-CogQOL subscale (r = 0.347, p < 0.001), the TICS total score was not correlated with scores on the FACT-Cog perceived cognitive impairment (CogPCI), perceived cognitive abilities (CogPCA), or comments from others (CogOth) subscales. However, the TICS memory item, a 10-word list immediate recall task, had a weak statistically significant correlation with CogPCI (r = 0.237, p < 0.032), CogOth (r = 0.223, p < 0.044), and CogPCA (r = 0.233, p < 0.036). Next, the sample was divided based on the participant’s score on TICS memory item (i.e., < vs. > sample mean of 5.09). Results of independent samples t-tests demonstrated significant differences in mean scores for CogPCI, f(80) = -2.09, p = 0.04, Mdt = -7.65, Cohen’s d = 0.483, and CogQOL, f(80) = -2.57, p = 0.01, Mditt = -2.38, Cohen’s d = 0.593. A hierarchical linear regression found that DTS subscale and total scores did not significantly predict performance on the TICS. However, DTS continued to be a significant predictor of poorer FACT-Cog PCI scores while controlling for TICS scores.

We found a weak relationship between self-reported cognitive impairment and objective cognitive performance (TICS). However, greater self-reported PCI and its impact on QOL was found in participants who scored below the sample mean on a recall task from the TICS. Although perceived ability to tolerate distress continued to predict self-reported PCI on the FACT-Cog, it did not predict overall performance on the TICS. Therefore, responses on the FACT-Cog may be more representative of an individual’s ability to tolerate distress related to perceived CRCI than actual overall cognitive ability or impairment.

The objective of this study was to compare the attitudes and beliefs of PCU physicians leaders in the United States versus Canada regarding the subcutaneous method in the administration of medications and hydration in order to gain a better understanding as to why variations in practice exist.

This survey trial took place from November 2022 to May 2023. The MD Anderson Cancer Center institutional review board in Houston, Texas, approved this study. The participants were the physician leaders of the acute palliative care units (PCUs) in the United States and Canada. The survey comprised questions formulated by the study investigators regarding the perceived comfort, efficiency, and preference of using the subcutaneous versus the intravenous method. The consent form and survey links were emailed to the participants.

Sixteen PCUs were identified in the United States and 15 PCUs in Canada. Nine US and 8 Canadian physicians completed the survey. Physicians in Canada were more likely to use the subcutaneous route for administering opioids, antiemetics, neuroleptics, and hydration. They preferred subcutaneous over intravenous or intramuscular routes (p = 0.017). Canadian physicians felt their nursing staff was more comfortable with subcutaneous administration (p = 0.022) and that it was easier to administer (p = 0.02). US physicians felt the intravenous route was more efficient (p = 0.013).

The study results suggest that exposure to the subcutaneous route influences a physician’s perception. Further research is needed to explore ways to incorporate its use to a greater degree in the US healthcare system.

While loss of insight into one’s cognitive impairment (anosognosia) is a feature in Alzheimer’s disease dementia, less is known about memory self-awareness in cognitively unimpaired (CU) older adults or mild cognitive impairment (MCI) or factors that may impact self-awareness. Locus of control, specifically external locus of control, has been linked to worse cognitive/health outcomes, though little work has examined locus of control as it relates to self-awareness of memory functioning or across cognitive impairment status. Therefore, we examined associations between locus of control and memory self-awareness and whether MCI status impacted these associations.

Participants from the Advanced Cognitive Training for Independent and Vital Elderly (ACTIVE) study (mean age=73.51; 76% women; 26% Black/African American) were classified as CU (n=2177) or MCI (amnestic n=313; non-amnestic n=170) using Neuropsychological Criteria. A memory composite score measured objective memory performance and the Memory Functioning Questionnaire measured subjective memory. Memory self-awareness was defined as objective memory minus subjective memory, with positive values indicating overreporting of memory difficulties relative to actual performance (hypernosognosia) and negative values indicating underreporting (hyponosognosia). Internal (i.e., personal skills/attributes dictate life events) and external (i.e., environment/others dictate life events) locus of control scores came from the Personality in Intellectual Aging Contexts Inventory. General linear models, adjusting for age, education, sex/gender, depressive symptoms, general health, and vocabulary examined the effects of internal and external locus of control on memory self-awareness and whether MCI status moderated these associations.

Amnestic and non-amnestic MCI participants reported lower internal and higher external locus of control than CU participants. There was a main effect of MCI status on memory self-awareness such that amnestic MCI participants showed the greatest degree of hyponosognosia/underreporting, followed by non-amnestic MCI, and CU participants slightly overreported their memory difficulties. While, on average, participants were fairly accurate at reporting their degree of memory difficulty, internal locus of control was negatively associated with self-awareness such that higher internal locus of control was associated with greater underreporting (ß=-.127, 95% CI [-.164, -.089], p<.001). MCI status did not moderate this association. External locus of control was positively associated with self-awareness such that higher external locus of control was associated with greater hypernosonosia/overreporting (ß=.259, 95% CI [.218, .300], p<.001). Relative to CU, amnestic, but not non-amnestic, MCI showed a stronger association between external locus of control and memory self-awareness. Specifically, higher external locus of control was associated with less underreporting of cognitive difficulties in amnestic MCI (ß=.107, 95% CI [.006, .208], p=.038).

In CU participants, higher external locus of control was associated with greater hypernosognosia/overreporting. In amnestic MCI, the lower external locus of control associations with greater underreporting of objective cognitive difficulties suggests that perhaps reduced insight in some people with MCI may result in not realizing the need for external supports, and therefore not asking for help from others. Alternatively, in amnestic participants with greater external locus of control, perhaps the environmental cues/feedback translate to greater accuracy in their memory self-perceptions. Longitudinal analyses are needed to determine how memory self-awareness is related to future cognitive declines.