Despite passage of the Biologics Price Competition and Innovation Act, there are currently only seven biosimilar products on the U.S. market competing with originator brands. Several factors account for the slow development of competition in this market.
During the 1980s the share of prescriptions sold by retail pharmacies that was accounted for by generic products roughly doubled. The price response to generic entry of brand‐name products has been a source of controversy. In this paper we estimate models of price responses to generic entry in the market for brand‐name and generic drugs. We study a sample of 32 drugs that lost patent protection during the early to mid‐1980s. Our results provide evidence that brand‐name prices increase after generic entry and are accompanied by large decreases in the price of generic drugs.
Background. Drop-out, often accompanied by treatment non-compliance, is common in psychiatric trials. Methodologists have criticized the use of a traditional intention-to-treat (ITT) approach in such cases, and have proposed alternative methods. We set out to describe and assess methods for estimation of a treatment effect when the trial is 'broken'.Method. We describe a stratified method of moments (SMOM) estimator that assesses treatment effects on subjects who are willing to comply with all the treatments under study. A simulation study and a re-analysis of data from an antipsychotics trial are used to compare SMOM to ITT, as-treated, and adequate estimators.Results. The new estimator retains good statistical properties under different levels of non-compliance and drop-out mechanisms. The re-analysis indicates that SMOM yields more precise results.Conclusions. Although the traditional ITT approach provides a valid method to estimate treatment effects, it can be biased in the presence of treatment non-compliance and drop-out. It is critical that researchers move beyond traditional approaches when trials are broken. A key first step is to consider non-compliance and drop-out as two independent phenomena, tracking and reporting rates separately.
Summary We report a case of rebounding severe methaemoglobinaemia secondary to sodium nitrite ingestion, despite several administrations of methylene blue. The patient's clinical course was characterised by a series of alternating improvements and deteriorations and proved challenging for treating clinicians. On discussion with poisoning experts, it was hypothesised that a small amount of sodium nitrite remained in the gastrointestinal tract leading to prolonged absorption of the causative agent. Methaemoglobin levels returned to normal following the administration of multi‐dose activated charcoal via a nasogastric tube 30 h after the initial presentation to hospital.
Americans purchase health insurance in various ways. Some buy individual policies. For them, medical underwriting is common, and preexisting conditions can preclude, limit, or dramatically increase the cost of coverage. Many buy insurance through small employers, which typically offer little or no choice of plan. Their premiums tend to be higher than those of consumers purchasing through large employers, which can bargain effectively on prices. Large employers usually offer a modest selection of high-quality plans at competitive prices. Medicare recipients can join traditional Medicare and then choose drug coverage from any of dozens of stand-alone prescription-drug plans (PDPs) or join MedicareAdvantage and choose among numerous private health plans. Given that plan choices are difficult to make and that large purchasers can whittle down prices, a reformed health care system is likely to employ health insurance exchanges to stand between consumers and insurers. The Massachusetts Health Insurance Connector, in operation since 2007, runs the best-known such organization.
Even with great advances in behavioral health policy in the last decade, the problems of mental illness and addiction persist in the United States—so more needs to be done. In this article, which is part of the National Academy of Medicine's Vital Directions for Health and Health Care: Priorities for 2021 initiative, we describe the steps needed to improve outcomes, focusing on three strategies. We argue for transforming the behavioral health system to meet people where they are, decriminalizing mental illness and substance use disorders to facilitate recovery, and raising awareness of social context and social needs as essential to effective care. We call for supporting structures in the workforce and structures of accountability, outcome measurement, and more generous financing of behavioral health care. These steps have costs, but the enormous benefits of a major transformation in behavioral health policy far outweigh the expenses.
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