Monday, July 2, 2012

FDA Issues Further Guidance About Makena ($KV)

Mostly, more blah blah about how people should order name brand Makena instead of much cheaper compounded product. This part was interesting though,

"Policies imposed by certain state Medicaid agencies force a pregnant woman at high risk for recurrent preterm birth to 'try and fail' or be 'unable to tolerate' compounded 17P formulations before the state will approve Makena® for her; others require that she and her physician must demonstrate 'medical necessity' for Makena® instead of compounded formulations. These coverage policies disregard guidance issued by FDA and CMS, including the most recent statements. Notably, some states with such policies in place also have prematurity rates above the national average of 12.2 percent - an outcome with heartbreaking results for families and the potential for high life-long medical costs, a significant portion of which will likely be borne by Medicaid."
Very interesting the lengths that health care payers are going to avoid overpaying for this stuff.

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