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FDA Will Regulate Diagnostics; High-Cost Drugs Removed from Formulary

IP Blog | Dave Melin | August 10, 2014

BioBlogWeeklyThis 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.

Express Scripts drops Amgen anemia drugs from formulary

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.”

FDA takes steps to help ensure the reliability of certain diagnostic tests

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.”

New Bundled Payment Model Nets 34% Reduction in Medical Costs

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.”

HIStalk Interviews Amy Abernethy, MD, PhD, Chief Medical Officer, Flatiron Health

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.”

Can Big Data cure cancer?

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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