The Neurologist's Guide to Drug Pricing in the United States.

ABSTRACT: As newer, innovative neurology drugs enter the US health care system, neurologists should consider the cost of these treatments in addition to their efficacy, safety, and tolerability. To do so thoughtfully requires an understanding of how prescription drugs are priced in the United States. The process of drug pricing is linked to the distribution supply chain and the many stakeholders involved. Stakeholders include pharmaceutical manufacturers; wholesalers; pharmacies; pharmacy benefit managers; payers, including health insurers; hospital systems; neurologists and other clinicians; and patients. Drug pricing has taken center stage as the Inflation Reduction Act of 2022 has set maximum out-of-pocket expenses for Medicare beneficiaries for the first time in the program's history and limits drug price increases for a select group of Medicare Part D drugs. This article describes the US drug distribution supply chain and its stakeholders and introduces key drug pricing terms; a brief description of how rebates are generally estimated will also be discussed. Finally, as newer neurology outpatient drugs enter the market, the "value" of drugs will be described through cost-effectiveness terminology and their utility for the clinical neurologist.

[Role of Neurologists in Dementia Practice].

The September 2013 issue of this journal contains an article titled "The Role of Neurologists in Dementia Practice" in which I have highlighted the contributions of neurologists to dementia care. I have emphasized the importance of proactive leadership within interdisciplinary teams that include general practitioners and psychiatrists. Following the implementation of the Basic Act on Dementia to Promote an Inclusive Society and advances in medical science, such as introduction of the anti-Alzheimer drug lecanemab, neurologists are expected to play a more active role in dementia management and require more specialized skills. The emergence of lecanemab has led to more direct involvement of neurologists in dementia practice, which has resulted in the emergence of "novice" dementia specialists. However, a shortage of neurologists who specialize in behavioral neurology remains a significant concern in Japan. This challenge is compounded by the inadequate education of general neurologists in this domain, because dementia management requires deep knowledge and skills in behavioral neurology. The most important and urgent issue is to promptly address this shortage. Although neurologists' involvement in dementia practice is attributable to the introduction of lecanemab, I sincerely look forward to neurologists transitioning from "novice" to "real" experts in dementia. I reiterate this call as a recommendation to fellow neurologists, emphasizing the need to evolve into true specialists in the field.

[Role of Neurologists in Stroke Treatment].

Determination of indications for acute reperfusion therapy (intravenous recombinant tissue plasminogen activator administration and mechanical thrombectomy) and identification of stroke mimics and chameleons are essential components of effective stroke treatment. Moreover, neurologists select the appropriate medications and manage the patient's general condition. Therefore, a neurologist's solid diagnostic skills based on neurological symptomatology and an internist's broad knowledge and insight play key roles clinically.

[Peripheral Neuropathy (Numbness): Role of Neurologists as Primary Gatekeepers].

The prevalence of peripheral neuropathies has increased over the years, and novel treatments for management of several neuropathies have emerged over the past decade. Following a literature search of the ICHUSHI database, we observed that recent literature on peripheral neuropathy most frequently includes reports from the orthopedic specialty, followed by studies reported by the neurology service. Notably, the number of studies reported by the neurology departments has increased over the past decade. However, most patients with common peripheral neuropathies do not visit the neurology department. Therefore, it is necessary to highlight the role of neurologists for comprehensive evaluation and management of neuromuscular disorders. This may result in acknowledgement of neurology as the primary gatekeeper of peripheral neurological diseases.

Are 5-2-1 Delphi criteria and MANAGE-PD useful screening tools for general neurologists for qualification to device-aided therapies in advanced Parkinson's Disease?

AIM OF STUDY: We sought to compare MANAGE-PD and 5-2-1 Delphi criteria which are two commonly used and approved screening tools in Parkinson's Disease, in order to highlight their strengths and limitations. CLINICAL RATIONALE FOR STUDY: Timely intervention with device-aided therapies is vital as it enables improving motor symptoms, lowering the dosage and side-effects of dopaminergic treatment, and improving patients' and caregivers' quality of life. Various screening tools have been created to help clinicians find the best candidates for device-aided therapies (DAT) for advanced Parkinson's Disease. In this study, we aimed to compare the 5-2-1 Delphi criteria to MANAGE-PD to determine how they could be used specifically to maximise their potential. MATERIAL AND METHODS: All of the patients (260) included in this study were DAT-naive, > 18 years of age, diagnosed with Parkinson's Disease, and had been referred to the Department of Neurology for qualification for advanced therapies over a 4-year period (2019-2022). They were subjected to both 5-2-1 Delphi criteria and MANAGE-PD tools and divided into subgroups based on the results of the screening. The data of patients was then statistically analysed. RESULTS: In the study group, 51 patients (19.5%) met all three of the 5-2-1 criteria, and 123 (47.1%) patients were categorised as '3' in MANAGE-PD, meaning that they may benefit from DAT. Finally, at the local centre level, 64 (24.5%) patients were qualified for DAT. 22 (34.4%) patients who were qualified for DAT by a clinician did not meet the 5-2-1 criteria. CONCLUSIONS: The 5-2-1 scheme based on the data from this study was characterised by a 92.5% specificity level and 65.1% sensitivity level compared to 69.5% specificity and 98.4% sensitivity level of MANAGE-PD. CLINICAL IMPLICATIONS: We found that MANAGE-PD has a better screening potential of DAT admission than 5-2-1 criteria. While both tools are reliable and valuable in daily practice, our study suggests that some patients may be omitted when using only less complicated tools such as 5-2-1 during the assessment.

[Chat messenger use in the care of patients with Parkinson's disease]. / Chat-Messenger-Nutzung in der Parkinson-Versorgung.

BACKGROUND: The demand for chat messaging apps for communication between physicians, therapists and patients is increasing. The expectations for this form of communication and uncertainties regarding introduction and use are heterogeneous. OBJECTIVE: The implementation of chat messengers in the care of patients with Parkinson's disease should be facilitated by recommendations regarding introduction and usage. METHODS: Semi-structured interviews with neurologists and physiotherapists were conducted to capture the expectations and needs regarding the use of chat messengers. From the data analysis, recommendations were derived. RESULTS: The expectations for technical functionality exceeded the chat messenger functions. This concerns, e.g., the connection of the chat messenger to the electronic patient file. There is a great deal of uncertainty, particularly when it comes to the applicable General Data Protection Regulations (GDPR). The recommendations relating to the use of chat messengers, data protection aspects, the design of such tools and methodological considerations can help to implement the tool as an additional communication channel. CONCLUSION: Practical recommendations regarding functionality, the use of chat messengers in everyday life and in relation to data protection are derived from the results. By improving knowledge, physicians and therapists can contribute to the successful establishment of chat messengers as an additional communication tool.

Global impact of a virtual neurology morning report.

The global shortage and inequitable distribution of neurologists has led to significant gaps not only in neurology care, but also in neurology education. In order to increase access to neurology education, we developed neurology virtual morning report (NVMR), a virtual, open-access, case-based clinical reasoning conference available to learners worldwide. To evaluate NVMR's impact on participants' perception of, interest in, and confidence in neurology, we conducted a survey. Respondents represented 25 different countries of various income levels. The majority of respondents reported that NVMR decreased their perception of difficulty in understanding neurology and increased confidence in various clinical reasoning domains in neurology. Additionally, the majority of medical student participants showed an increased interest in pursuing neurology as a future specialty after participating in NVMR. NVMR represents a potential model for virtual educational conferences and highlights the opportunities digital education has to improve equitable access to neurology education.

The emotional burden of caring for patients with Lennox-Gastaut syndrome, Dravet syndrome, and tuberous sclerosis complex-associated epilepsy: A qualitative study in Japan.

INTRODUCTION: Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS) are rare, childhood-onset conditions associated with severe, treatment-resistant epilepsy and developmental issues, including motor and cognitive impairment. Tuberous sclerosis complex (TSC) is a rare genetic disease commonly associated with epilepsy and other neuropsychiatric disorders. This cross-sectional, interview-based study examined the qualitative impact of caring for patients with LGS, DS, and TSC-associated epilepsy on caregivers in Japan, from the perspective of both caregivers and physicians. METHODS: The survey included a pre-interview worksheet to describe caregivers' emotional journeys, followed by a ≤ 60-minute one-on-one interview. Eligible participants were Japanese caregivers of patients with LGS, DS, or TSC treated for epilepsy symptoms, and Japan-residing pediatricians or neurologists treating ≥ 3 patients with LGS, DS, and/or TSC. Interview question responses were subjected to content analysis to identify the most common response tendencies and themes. RESULTS: Twenty-six caregivers responded (mean [standard deviation (SD)] age, 45.9 [9.5] years; age range 29-68; 92 % female), caring for patients with LGS (n = 5), DS (n = 10), and TSC (n = 11); patient mean (SD) age, 13.6 (10.0) years; age range 2-44; 27 % adults; 50 % female. Nineteen physicians, treating patients with LGS (n = 9), DS (n = 7), and TSC (n = 10), participated. Caregivers and physicians generally aligned on the factors affecting caregivers' emotional states / quality of life (QoL). The most frequently reported caregiver emotions at the time of diagnosis were shock and discouragement, anxiety for the future, and relief at receiving a diagnosis. Negative emotions throughout disease progression up until the time of survey were mainly caused by worsening of seizures, burden of constant caregiving / lack of free time, and patient's developmental issues. Positive emotions were linked to effective treatment / reduced seizures; more free time owing to the use of facilities, services, or other caregiving support; and developmental progress. Physicians acknowledged that caregivers required consultation services to support their emotional needs. In terms of unmet needs, caregiver and physician responses were aligned on the insufficient availability of services/facilities, the lack of effective treatments, and the uncertainties of adult patient care. CONCLUSIONS: Caregivers of patients with LGS, DS, or TSC-associated epilepsy in Japan reported a high degree of emotional burden related to frequent seizures, developmental issues, and constant caregiving. The burden of suboptimal treatment effectiveness, limited access to support services, and uncertainties in long-term care emphasize important unmet treatment needs.

Seizures, medical child abuse, and the pediatric neurologist.

Previously known as Munchausen syndrome by proxy, medical child abuse is a form of child maltreatment whereby the caregiver creates an environment in which medical care harms or threatens the wellbeing of a child. Approximately 40-50 % of medical child abuse cases involve neurological symptoms, with fabricated or induced seizures accounting for a significant proportion. Identifying fictitious seizures is often difficult even for the most experienced clinicians. Therefore, having a low threshold for clinical suspicion is essential in the timely diagnosis of medical child abuse. This article provides a review of the epidemiology, diagnosis, and management of medical child abuse when it involves seizures.

Assessing expert reliability in determining intracranial EEG channel quality and introducing the automated bad channel detection algorithm.

Objective.To evaluate the inter- and intra-rater reliability for the identification of bad channels among neurologists, EEG Technologists, and naïve research personnel, and to compare their performance with the automated bad channel detection (ABCD) algorithm for detecting bad channels.Approach.Six Neurologists, ten EEG Technologists, and six naïve research personnel (22 raters in total) were asked to rate 1440 real intracranial EEG channels as good or bad. Intra- and interrater kappa statistics were calculated for each group. We then compared each group to the ABCD algorithm which uses spectral and temporal domain features to classify channels as good or bad.Main results.Analysis of channel ratings from our participants revealed variable intra-rater reliability within each group, with no significant differences across groups. Inter-rater reliability was moderate among neurologists and EEG Technologists but minimal among naïve participants. Neurologists demonstrated a slightly higher consistency in ratings than EEG Technologists. Both groups occasionally misclassified flat channels as good, and participants generally focused on low-frequency content for their assessments. The ABCD algorithm, in contrast, relied more on high-frequency content. A logistic regression model showed a linear relationship between the algorithm's ratings and user responses for predominantly good channels, but less so for channels rated as bad. Sensitivity and specificity analyses further highlighted differences in rating patterns among the groups, with neurologists showing higher sensitivity and naïve personnel higher specificity.Significance.Our study reveals the bias in human assessments of intracranial electroencephalography (iEEG) data quality and the tendency of even experienced professionals to overlook certain bad channels, highlighting the need for standardized, unbiased methods. The ABCD algorithm, outperforming human raters, suggests the potential of automated solutions for more reliable iEEG interpretation and seizure characterization, offering a reliable approach free from human biases.

Essential components of an effective transition from paediatric to adult neurologist care for adolescents with Duchenne muscular dystrophy; a consensus derived using the Delphi methodology in Eastern Europe, Greece and Israel.

PURPOSE: An increasing number of patients with Duchenne muscular dystrophy (DMD) now have access to improved standard of care and disease modifying treatments, which improve the clinical course of DMD and extend life expectancy beyond 30 years of age. A key issue for adolescent DMD patients is the transition from paediatric- to adult-oriented healthcare. Adolescents and adults with DMD have unique but highly complex healthcare needs associated with long-term steroid use, orthopaedic, respiratory, cardiac, psychological, and gastrointestinal problems meaning that a comprehensive transition process is required. A sub-optimal transition into adult care can have disruptive and deleterious consequences for a patient's long-term care. This paper details the results of a consensus amongst clinicians on transitioning adolescent DMD patients from paediatric to adult neurologists that can act as a guide to best practice to ensure patients have continuous comprehensive care at every stage of their journey. METHODS: The consensus was derived using the Delphi methodology. Fifty-three statements were developed by a Steering Group (the authors of this paper) covering seven topics: Define the goals of transition, Preparing the patient, carers/parents and the adult centre, The transition process at the paediatric centre, The multidisciplinary transition summary - Principles, The multidisciplinary transition summary - Content, First visit in the adult centre, Evaluation of transition. The statements were shared with paediatric and adult neurologists across Central Eastern Europe (CEE) as a survey requesting their level of agreement with each statement. RESULTS: Data from 60 responders (54 full responses and six partial responses) were included in the data set analysis. A consensus was agreed across 100% of the statements. CONCLUSIONS: It is hoped that the findings of this survey which sets out agreed best practice statements, and the transfer template documents developed, will be widely used and so facilitate an effective transition from paediatric to adult care for adolescents with DMD.

Forensic Neurology and the Role of Neurologists in Forensic Evaluations.

Forensic psychiatrists may be asked to opine on neurological evidence or neurological diseases outside the scope of their expertise. This article discusses the value of involving experts trained in behavioral neurology in such cases. First, we describe the field of behavioral neurology and neuropsychiatry, the subspecialty available to both neurologists and psychiatrists focused on the behavioral, cognitive, and neuropsychiatric manifestations of neurological diseases. Next, we discuss the added value of behavioral neurologists in forensic cases, including assisting in the diagnostic evaluation for complex neuropsychiatric diseases, using expertise in localization to provide a strong scientific basis for linking neurodiagnostic testing to relevant neuropsychiatric symptoms, and assisting in relating these symptoms to the relevant legal question in cases where such symptoms may be less familiar to forensic psychiatrists, such as frontal lobe syndromes. We discuss approaches to integrating behavioral neurology with forensic psychiatry, highlighting the need for collaboration and mentorship between disciplines. Finally, we discuss several forensic cases highlighting the additional value of experts trained in behavioral neurology. We conclude that forensic psychiatrists should involve behavioral neurology experts when encountering neurological evidence that falls outside their scope of expertise, and the need for further cross-disciplinary collaboration and training.

Forensic Neurology and the Role of Neurologists in Forensic Evaluations.

There is a clear need for experts with the requisite knowledge and experience to offer medicolegal opinions pertaining to various neuropsychiatric conditions. There is also an important distinction between clinical and medicolegal roles, and the need for training and expertise applicable to forensic assessment. But there remain few available experts with credentials spanning neuropsychiatry and forensic assessment. This creates a dilemma whereby parties involved in litigation featuring neuropsychiatric illness or injury are frequently forced to choose between experts with either knowledge and skills applicable to neuropsychiatric conditions or experts with skills and experience applicable to forensic assessment. Either choice introduces risk. Whether flawed medicolegal opinions are a consequence of deficient medical knowledge or an inadequate forensic evaluation process, the result remains the same, with triers of fact potentially being exposed to problematic testimony. There is, however, a more fundamental problem that implicates patient care more broadly: spurious dichotomies created by the historical segregation of psychiatry and neurology. Optimizing clinical care for patients with neuropsychiatric conditions, improving medical education in support of such care, and enabling forensic neuropsychiatric assessment must then start with more proactive efforts to reintegrate psychiatry and neurology.

Functional neurological disorder: a comparative analysis of experience of Czech, Slovak, and Italian neurologists.

AIM OF STUDY: We aimed to compare knowledge, opinions, and clinical experiences among Czech, Slovak, and Italian neurologists to identify potential educational gaps and unify understanding. CLINICAL RATIONALE FOR STUDY: Functional neurological disorder (FND) is a disabling condition characterised by motor, sensory, or cognitive symptoms which are incompatible with other neurological disorders. Novel diagnostic and treatment approaches have improved FND management. However, the extent of their adoption, and any differences or similarities across European communities, remain to be established. MATERIAL AND METHODS: Members of the Czech and Slovak Neurological Societies were invited via e-mail to participate in a 14- -item web-based survey investigating their approach to FND. This data was compared to results from a previous study involving 492 Italian neurologists. RESULTS: 232 questionnaires were completed by Czech and Slovak neurologists (CZ-SK). Similarities were found between CZ- -SK and Italian neurologists in their preference for the term 'FND' over other psychological-related terms and in explaining symptoms as due to abnormal functioning of the nervous system rather than attributing them to mental illness. However, only fewer than 5% in both groups thought that simulation was highly unlikely. Both groups reported relying on positive signs (e.g. inconsistency, distractibility) according to the current diagnostic criteria, but also a tendency to perform additional tests to exclude other causes. However, some differences were observed: Italian neurologists placed a greater emphasis on psychological factors including litigation. CZ-SK neurologists were more likely to suggest physiotherapy as a treatment option and to provide educational intervention for patients and their relatives. CONCLUSIONS: Overall, our findings suggest that although Czech, Slovak, and Italian neurologists have adopted some new developments in the field of FND, significant gaps still exist in their understanding and common practices regarding conceptualisation, diagnosis, and treatment. CLINICAL IMPLICATIONS: Our results suggest that promoting knowledge through postgraduate curricula and teaching courses for neurologists is necessary to optimise patient management in various European countries.

Preferences for neuromyelitis optica spectrum disorder treatments: A conjoint analysis with neurologists in Spain.

BACKGROUND: The treatment landscape for neuromyelitis optica spectrum disorder (NMOSD) has changed in recent years with the approval of therapies with different efficacy, safety and administration profiles. OBJECTIVE: The aim of this study was to assess neurologists' preferences for different NMOSD treatment attributes using conjoint analysis (CA). METHODS: We conducted an online, non-interventional, cross-sectional study in collaboration with the Spanish Society of Neurology. Our CA assessed five drugs' attributes: prevention of relapse, prevention of disability accumulation, safety risk, management during pregnancy, and route and frequency of administration. Participants were presented with eight hypothetical treatment scenarios to rank based on their preferences from the most preferred to the least. An ordinary least squares method was selected to estimate weighted preferences. RESULTS: A total of 104 neurologists were included. Mean age (standard deviation-SD) was 37.7 (10.3) years, 52.9 % were male, and median time (interquartile range) of experience managing NMOSD was 5.0 (2.9, 10.8) years. Neurologists placed the greatest importance on efficacy attributes, time to relapse (44.1 %) being the most important, followed by preventing disability accumulation (36.8 %). In contrast, route and frequency of administration (4.6 %) was the least important characteristic. Participants who prioritised efficacy attributes felt more comfortable in decision-making, had fewer past experiences of care-related regret and a lower attitude to risk taking than their counterparts. CONCLUSION: Neurologists' treatment preferences in NMOSD were mainly driven by efficacy attributes. These results may be useful to design policy decisions and treatment guidelines for this condition.