The American journal of managed care
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This study analyzed annual trends in the distribution of beneficiaries entering each benefit phase and the utilization of and expenditures for prescription drugs among Medicare Part D beneficiaries from 2008 to 2015. ⋯ Although this study provides support for reductions in financial barriers to prescription drugs under the ACA, substantial increases in both total drug spending and the proportion of high-cost beneficiaries in the Part D program indicate a growing burden of Part D spending on the Medicare program, which is expected to continue to grow in the future.
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The burden of Alzheimer disease (AD) on the US healthcare system is substantial and increasing. AD progresses along a continuum from preclinical disease characterized by normal cognition and abnormal brain biomarkers to mild cognitive impairment and then clinically apparent dementia. Diagnosis early in the AD continuum has benefits for patients and caregivers and appears cost-effective, but often, the clinical diagnosis of AD may be delayed. ⋯ Within the past few years, significant achievements that will advance clinical trials in early AD include the Research Framework to define and stage the AD continuum, FDA guidance on study design in early AD, and development of scales to measure cognition that are suitable for early AD. In October 2019, the AD community was re-invigorated by unexpected news that a Biologics License Application will be submitted for aducanumab to treat AD. This article explores the current state of biomarker-driven drug development across the AD continuum and reviews investigational drugs in phase 2/3 clinical development for AD.
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To mark the 25th anniversary of the journal, each issue in 2020 will include an interview with a health care thought leader. The August issue features a conversation with Mandy K. Cohen, MD, MPH, secretary of the North Carolina Department of Health and Human Services.
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In the coronavirus disease 2019 (COVID-19) era, clinical registries and innovative virtual care delivery tools should be leveraged to engage populations in effective chronic disease management.
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Long-chain fatty acid oxidation disorders (LC-FAODs) are rare, life-threatening, autosomal recessive genetic disorders characterized by acute crises of energy production and chronic energy deficiency. Patients may present with rhabdomyolysis induced by exercise; fasting or illness; hepatic dysfunction, including severe hypoglycemia and hyperammonemia; and cardiomyopathy. These clinical manifestations can lead to frequent hospitalizations and premature death. ⋯ Due to favorable safety and efficacy data from clinical trials, this novel agent has the potential to transform the treatment of LC-FAODs and improve patient outcomes in this patient population. This article provides an overview of the epidemiology, pathophysiology, clinical manifestations, and current management approaches for the diagnosis and management of LC-FAODs. It also provides the most recent clinical safety and efficacy data for triheptanoin and other therapies under investigation.