The American journal of managed care
-
The approval of the humanized monoclonal antibody trastuzumab in 1998 changed the trajectory of treatment and subsequent outcomes for patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer and is now the standard of care in the neoadjuvant, adjuvant, and metastatic settings. However, as with most biologic drugs, trastuzumab comes with a relatively high price tag compared with traditional cytotoxic chemotherapy and contributes to healthcare budgets. ⋯ Barriers to their use, including physician uncertainty to switch patients from the reference drug to the therapeutic biosimilar and patients' lack of understanding about biosimilars, are common in the United States. It is also important that all stakeholders, including managed care professionals, pharmacists, and practice administrators, understand how to incorporate trastuzumab biosimilars into formulary discussions, clinical care plans and processes, and educational initiatives for healthcare providers and patients.
-
Oncology biologics are one of the fastest-growing segments of pharmaceutical development, bringing more options to patients, including those with human epidermal growth factor receptor 2 (HER2)-positive breast cancer. The advent of multiple oncology biosimilars is affecting this patient population, as 5 trastuzumab biosimilars had been FDA approved as of the end of 2019; only 2, however, have been commercially marketed. Trastuzumab serves as the foundation for treatment for patients with HER2-positive breast cancer. ⋯ The Biologics Price Competition and Innovation Act established an abbreviated regulatory approval pathway for biosimilars to create a catalyst for innovation and competition in the biologics market and to lower the costs of biologics. Challenges to adoption of therapeutic oncology biosimilars continue in the United States and include a lack of directed education to providers and patients, residual concerns regarding efficacy and safety, and practices including "pay-for-delay." The uptake of oncology biosimilars is also affected by multiple issues stemming mainly from cost of care, including drug cost, patient access, formulary inclusion, and treatment management algorithms. Managed care organizations and payers need to be familiar with the biosimilar approval process, the concerns of stakeholders (eg, providers and patients), and factors influencing HER2-directed therapies, including the use of biosimilars and antibody-drug conjugates in today's market.
-
Up to 10% of the US adult population will experience chronic insomnia, with women and elderly individuals at particularly high risk. Cognitive behavioral therapy is the core treatment for insomnia. When cognitive behavioral therapy is not enough, medications can help patients overcome the barriers and learned behaviors that prevent a good night's sleep. ⋯ To date, only suvorexant and lemborexant have been approved for the treatment of insomnia. However, several other agents are in later stages of development. This article will review the available pharmacotherapeutic options for treating insomnia.
-
Empirical evaluation of market power that hospitals gain over health plans through hospitals' ability to cancel their contracts with plans while keeping large shares of plans' emergency patients and getting paid for them at above-market rates. ⋯ In hospital-payer negotiation, many hospitals have an upper hand: Their threat to retain large portions of their emergency patients and revenues after becoming out of network is credible and it imposes disproportionate costs on the payers, which partially explains the continuing rise in hospital prices.
-
Insomnia is a common sleep disorder in adults that can have many negative health impacts. The aggregate total of direct and indirect insomnia healthcare costs has been estimated to be as high as $100 billion US dollars per year. In addition to the societal cost burden, insomnia also negatively affects patients' quality of life (QOL), including social and occupational functioning or productivity as well as impaired cognition or mood. ⋯ Many medications for the treatment of insomnia have adverse effect (AE) profiles that increase the risk of falls and related injuries, cognitive impairment, and motor vehicle accidents. These AEs place additional burden on the already vulnerable older adult population and those with comorbidities. Managed care organizations must evaluate clinical considerations, including safety profiles and the negative impact of disease on patients' QOL, to develop strategies for cost-effective treatment plans for patients with insomnia and to ensure appropriate use of these medications.