Will the FDA go back on a decision it made years ago? I am referring to a story that has a lot of buzz: whether or not the FDA will take recommendations from its advisory committee and change the restrictions on Avandia (rosiglitazone). Avandia was approved in 1999 and shortly became the top-selling type 2 diabetes medication in the world. In 2010, data from a number of trials convinced the FDA to severely restrict the medication through implementation of a Risk Evaluation and Mitigation Strategy (REMS), while Europe banned it entirely.
Managed Care’s Top Ten Articles of 2016
There’s a lot more going on in health care than mergers (Aetna-Humana, Anthem-Cigna) creating huge players. Hundreds of insurers operate in 50 different states. Self-insured employers, ACA public exchanges, Medicare Advantage, and Medicaid managed care plans crowd an increasingly complex market.
They bring a different mindset. They’re willing to work in teams and focus on the sort of evidence-based medicine that can guide health care’s transformation into a system based on value. One question: How well will this new generation of data-driven MDs deal with patients?
A flood of tests have insurers ramping up prior authorization and utilization review. Information overload is a problem. As doctors struggle to keep up, health plans need to get ahead of the development of the technology in order to successfully manage genetic testing appropriately.
More companies are self-insuring—and it’s not just large employers that are striking out on their own. The percentage of employers who fully self-insure increased by 44% in 1999 to 63% in 2015. Self-insurance may give employers more control over benefit packages, and stop-loss protects them against uncapped liability.