The National Institute for Health and Care Excellence (NICE) will mark the start of 2022 by implementing changes to health technology assessments (HTAs), demonstrating adaptability of regulatory bodies as medical technologies continue to evolve. The final HTA changes aim to provide earlier and more equitable access to treatments as well as display increased flexibility in the evaluation of new health technologies [...]
There has been a trend in manufacturers opting to bypass the NICE appraisal process and have struck deals with NHS England directly to support market access for their novel therapies.
In this article, Trinity analyzed existing guidelines and evaluation frameworks for digital health technologies, including mobile health (mHealth) applications, to identify key evidence requirements and areas that should be considered in the clinical assessment of digital health services.
In 2020, Trinity assessed three applications developed to treat Opioid Use Disorders (OUD) (e.g., reSET-O, Connections, DynamiCare) through the lens of ICER conducting a cost-effectiveness evaluation. Only a year later, several more health tech startups have adopted a preventative outlook and seek to address chronic pain with digital health tools (e.g., phone applications) [...]
Executive Summary In March 2020, the FDA amended its classification of add-on insulin products, changing the approval pathway from that of a chemical drug follow-on to a biosimilar and more closely aligning with the EMA’s longstanding biosimilar insulin approval…
Executive Summary The American Society of Cell & Gene Therapy (ASCGT) wrapped up their 2021 conference earlier this year, which covered a range of topics, from new scientific advances to the evolving pricing and market access dynamics surrounding cell…
Executive Summary Given the majority of cell and gene therapies to date have offered the potential of a cure, pricing and access considerations are likely to differ for non-curative agents that are entering this space Although non-curative cell and…
Written by Caspar Kengeter and Manon Ricard
Paige Prostate is the first artificial intelligence (AI)-based software designed to identify areas of concern (i.e., high likelihood of containing cancer) on a prostate biopsy image so they can be flagged for further review by a pathologist. The program…
Executive Summary In June 2021, Walmart announced it is partnering with Novo Nordisk to produce its own private label insulin, ReliOn, at a discount to Novo Nordisk’s currently available fast-acting insulin Through this partnership, Americans with a high-deductible health…