Pfizer Questions Drug ‘Total Content’ in Biosimilar Guidance: As more biologics go “generic,” the question of similarity to the reference product has come up. Pfizer is asking for a definition of what “demonstrating that both products have the same total content of drug substance (in mass or units of activity)” actually means.
Magellan Rx Management Medical Pharmacy Trend Report. Ninth Edition 2018: The report details costs for pharmaceuticals across the healthcare system. Of special note is that commercial costs are about $30 per member per month (PMPM)- a 68% increase over 5 years; Medicare is about $52 PMPM, or 22% five year increase; Medicaid is about $8.30, reflecting a 17% five year increase, though costs actually decreased in the last year. More than 90% of spending for all three groups are for specialty pharmaceuticals (such as biologics) that are administered to small percentages of patients. The overwhelming expenses for this latter category are not new. Unlike all other countries, the FDA does not use comparative effectiveness or other cost data in approving medications. Indeed it is prohibited from doing so.
‘Everyone is at fault’: With insulin prices skyrocketing, there’s plenty of blame to go around: Speaking of the high cost of pharmaceuticals, this article is a very nice summary of the history and reasons behind the high prices for insulin.
FDA Recognizes Polish, Slovenian Inspections: This article might seem strange, but I point it out to remind all that the FDA does not have the time or resources to inspect all foreign plants for Good Manufacturing Practices (GMPs). In undertaking cooperative action, the FDA has granted other jurisdictions the authority to inspect plants making products for the US market.
About the public’s health
A Growing American Crisis: Who Will Care for the Baby Boomers? Our country has had a shortage of caretakers for our elderly for many years. Tasks are often provided by low wage/low skilled workers, many of whom are newly arrived immigrants. Some other countries (like Sweden) have professionalized this job category by providing training and a living wage for the work. Today, Elizabeth Warren announced a plan for universal childcare. Where does she think we are going to get adequately trained and compensated people for her program when we haven’t begun to address the issue of eldercare?
Association of Primary Care Physician Supply With Population Mortality in the United States, 2005-2015: The association between primary care availability and population health has long been assumed. This study quantifies the benefit: “In this epidemiological study of US population data, every 10 additional primary care physicians per 100 000 population was associated with a 51.5-day increase in life expectancy. However, from 2005 to 2015, the density of primary care physicians decreased from 46.6 to 41.4 per 100 000 population.” So what are we doing to make sure our supply of PCPs is adequate? We make them responsible for coordinating patient care (including all the paperwork, such a preauthorizations) and we pay them less than procedural specialists. We can do better.