The American journal of managed care
-
There is currently no known cure for hepatitis B virus (HBV) infection, and HBV remains a major public health burden in the United States. The US Department of Health and Human Services has established a Viral Hepatitis National Strategic Plan with the goal of eliminating HBV infection in the United States by the year 2030. ⋯ All 4 HBV vaccines are equally recommended as options for the prevention of HBV infection by the Advisory Committee on Immunization Practices. This article provides an overview of emerging considerations based on CDC recommendations and new clinical data around HBV vaccines, as well as the potential of Heplisav-B in fulfilling unmet needs that currently exist in the HBV prevention landscape.
-
Two guidelines-one by the American College of Cardiology (ACC)/American Heart Association (AHA)/The Obesity Society (TOS), and the other by the American Association of Clinical Endocrinologists (AACE)/American College of Endocrinology (ACE)-remain the standard of care in the management of overweight and obesity in adults. However, since the publication of the ACC/AHA/TOS document, several relevant pharmacotherapies have been approved by the FDA, a medication was withdrawn from the market, and several procedures and device types for weight loss have been recommended or FDA-approved. Simultaneously, research in obesity treatment has advanced, and leaders in the field have issued complementary guidance. ⋯ To stage disease severity, weight-related conditions should be assessed. Although lifestyle therapy remains the cornerstone of treatment for this disease, both pharmacotherapy and metabolic and bariatric surgery produce greater and more sustained weight loss in treatment-approved populations as compared with lifestyle modifications alone. An ongoing partnership between the patient and clinician is highly recommended to manage this serious, progressive, chronic disease.
-
Multiple sclerosis (MS) is a chronic, immune-mediated, neurodegenerative condition that results in progressive accumulation of disability over the course of the disease. MS presents heterogeneously, and, as the disease progresses, patients develop a range of physical and neurologic problems that include reduced mobility, cognitive impairment, weakness, fatigue, pain, and defects in speech or vision. Economically, MS is costly, including both direct costs stemming from clinical care and medications and the indirect costs of productivity losses. ⋯ Ongoing research continues to elucidate the exact mechanisms of disease in MS as well as potential new treatment strategies that may better address current gaps, such as disability progression in secondary progressive MS without activity. One of the novel pathways under investigation is the inhibition of Bruton tyrosine kinase, a cytoplasmic tyrosine kinase, which is expressed in B cells and other potentially targetable hematopoietic lineage cells. This review examines emerging hypotheses that targeting both B cells and myeloid cells within the periphery and central nervous system could yield clinical effects in key areas of MS pathophysiology that are currently unaddressed.
-
Standard ocular drug delivery methods generally are safe and effective for treating diseases of the eye. However, many routes of administration carry the risk of adverse effects due to drug exposure to anterior ocular tissues. Additionally, these delivery methods may not result in high and consistent levels of a therapeutic agent delivered to target tissues for diseases affecting the posterior segment of the eye. ⋯ Successful use of SCS injection has been demonstrated with triamcinolone acetonide injectable suspension (Xipere®, Bausch + Lomb), a novel formulation optimized for use with the SCS Microinjector®. FDA approval of this combination drug and device for the treatment of macular edema associated with uveitis (UME) was based on outcomes from the phase 3 PEACHTREE study (NCT02595398); other important studies included its long-term observational extension (MAGNOLIA; NCT02952001) and an open-label safety study (AZALEA; NCT03097315). The SCS Microinjector® together with triamcinolone acetonide injectable suspension for use in the SCS presents an opportunity for safe and effective drug delivery for the treatment of UME and, potentially, for broader use with alternate medications to treat other ocular diseases that impact chorioretinal tissues (eg, age-related macular degeneration, diabetic retinopathy, choroidal melanoma).
-
Nonmedical switching (NMS) is a change in a patient's treatment regimen for reasons other than lack of efficacy, intolerance, adverse effects, or poor adherence. We describe the impact of NMS on patients, health care workers, and health systems, focusing on NMS to in-class biologic alternatives in US patients with chronic, immune-mediated rheumatic and dermatologic conditions. Additionally, we evaluate the ways in which the COVID-19 pandemic may exacerbate the physical, psychological, and economic impacts of NMS. ⋯ The decision to switch treatments should result from shared decision-making between health care providers (HCPs) and patients to achieve the best clinical outcomes and optimal HCRU. The issues related to NMS may be compounded by the financial and psychosocial stress on HCPs and patients created by the COVID-19 pandemic. HCPs should advocate for continuous patient treatment and be familiar with continuity of care legislation, appeals processes, and manufacturer assistance programs.