Unbiased Analysis of Today's Healthcare Issues
According to a paper by Smith et al. 2023, the answer is ‘no’. The authors use data from AHRQ’s Healthcare Cost and Utilization Project (HCUP) State Inpatient Data, Hospital Cost Reporting Information System Data, Office of Pharmacy Affairs Information System Data, and American Hospital Association Annual Survey for 15 states between 2008 to 2014. The…
Last month, FDA released guidance on the use of real-world evidence to support regulatory decision-making for new drugs. Below are some of the key points from this guidance document: Legislative mandate. The 21st Century Cures Act (Cures Act), signed December 2016, mandated that the FDA consider how to incorporate real world data (RWD) into regulator…
Today I’m turning this post over to some of my FTI colleagues in Europe (Antoine Mialhe, Katja Murray and Valeria Fagone among others) who helped summarize the Reform of the EU pharmaceutical legislation that the European Union (EU) adopted on April 26, 2023. The summary below is provided by the FTI Consulting team in Brussels…
That is the title of a very interesting paper by Casey Mulligan (2023) [NBER WP version]. The full title includes the phrase “Peltzman revisited”. This refers to a paper by Peltzman (1973).When speaking of the 1962 “Drug Efficacy Amendment” (EA) to the Federal Food, Drug, and Cosmetic Act a key piece of research was Peltzman…
The year 2022 was a good, but perhaps not great year for innovation. According to the FDA’s Center for Drug Evaluation and Research’s (CDER) New Drug Therapy Approvals 2022 report, there were 37 novel drugs approved in 2022. This number is down from the historical rate of approvals between 2013-2021 (43.4 approvals per year) and…
Part of the Affordable Care Act mandated a medical loss ratio (MLR) for health plans in the individual and small group markets. What this means is that if the MLR is 80% and insurers charge $100 in premiums, plan enrollees must receive $80 in services on average. If they do not (say they only receive…
That is the title of an FTI White Paper published this year where I was a co-author alongside Antoine Mialhe, Sabiha Quddus, Anne-Sophie Deman, Suhail Thahir and Agnes Sipiczki. The role of Intellectual property (IP) in the development of COVID-19 vaccines and therapeutics became a central tenant in discussions on how to ensure access to…
That is the quote from Iga Lipska, MD, PhD, MPH from the Medical University of Gdańsk, Clinical Trials Center in Warsaw, Poland. She was one the panelists at the ISPOR Europe Plenary speech. There were a lot of good sessions, many of which I will be posting on throughout the week. The first plenary was…
As part of The 21st Century Cures Act, FDA is required to consider additional mechanisms to expedite access to new drugs, including those currently under investigation. In fact, the 21st Century Cure Act mandates that pharmaceutical manufacturers have to post their policies on expanded access (a.k.a. “compassionate use”) for investigational drugs by: (1) the first…
It is well known that excessive use of alcohol causes significant health impacts. CDC notes that Excessive alcohol use led to more than 140,000 deaths and 3.6 million years of potential life lost (YPLL) each year in the United States from 2015 – 2019, shortening the lives of those who died by an average of…