The Institute for Clinical and Economic Review (ICER) has released the official procedures for conducting its sixth assessment of major drugs that experienced substantial price increases without adequate evidence to justify the increases. The drug pricing watchdog will identify 10 drugs with net price hikes that have generated the largest increase in drug spending at the federal level and is seeking public input for an additional three drugs that have experienced similar price increases over the same timeframe but won’t...

FDA’s Center for Drug Evaluation and Research (CDER) is launching a new center that will focus on promoting innovative clinical trial approaches through internal and external collaboration, to be known as the Center for Clinical Trial Innovation (C3TI). The center will kick off with projects on point-of-care or pragmatic trials, Bayesian analyses, and trials using selective safety data collection. The center was announced in a Federal Register notice Monday (April 15). “CDER’s long-standing efforts to embed innovation in clinical...

Democratic leaders of the House Education & the Workforce Committee are urging the Department of Labor to take a close look at the ERISA Advisory Council’s recommendations on ending disability benefits’ discriminatory treatment of conditions related to mental health/substance abuse and let lawmakers know whether additional authorities or resources are needed to implement the proposals. Most long-term disability plans, which are accessible to about 35% of private workers, currently treat disabilities arising from behavioral health conditions differently than those that...

Most people who were enrolled in Medicaid prior to the unwinding either retained coverage or reenrolled into the program (83%), another 8% of that population is in other coverage and 8% are uncovered, resulting in millions of newly uninsured individuals, according to a Friday (April 12) report on a recent Kaiser Family Foundation survey. The survey also found that about a quarter of the about 20% of enrollees who were kicked off at some point in 2023 remain uninsured, and...