FDA Will Regulate Diagnostics; High-Cost Drugs Removed from Formulary
This week in healthcare, Express Scripts excludes higher-cost cancer supportive care and anemia drugs from formulary and the FDA will issue guidance on approval for cancer diagnostics.
Massive pharmacy benefit manager Express Scripts announced that it would be dropping 25 drugs from its formulary of preferred products for 2015, including two anemia drugs sold by Amgen. In an email, the company explained that they had removed the drugs because they “cost significantly more than other available options but… fail to provide additional health benefit.”
Recently the FDA announced it would be taking steps to issue “a final guidance on the development, review and approval or clearance of companion diagnostics.” These tests are commonly used with patients who may have gene-based cancer “to identify patients who will benefit from or be harmed by treatment with a certain drug.”
According to a recent study published in the Journal of Oncology Practice, UnitedHealthcare led a program “involving 5 oncology groups that focused on best treatment practices and health outcomes, rather than the number of drugs that oncologists prescribe” that “resulted in a 34% reduction in medical costs.”
In this one-on-one interview, Dr. Amy Abernethy explains why she feels that the oncology needs to be “disrupted”: “I have found that by disrupting even our way of thinking about learning health systems so that the patient is the central unit of what we’re thinking about as opposed to the health system being the central unit of what we’re thinking about, we approach solving a lot of problems much differently and smarter.”
Meet the innovative young entrepreneurs behind Flatiron Health, a tech startup that has an ambitious goal. The two twenty-something founders, with the help of a pile of money from Google, “hope to collect and analyze mountains of clinical data to make inroads into one of medicine’s most complex, research-dependent, and difficult fields: cancer care.”
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