KV Pharmaceutical Increases Prematurity Drug Costs by 100 Times

A compounded form of a natural female hormone, progesterone, has been used for decades to help prevent premature birth. In February, the FDA approved a branded synthetic version of the drug, called Makena, with exclusive rights going to the manufacturer, KV Pharmaceuticals. On the surface, this sounds like a good thing. The company claims that its version is better than the compound because it is "manufactured in an FDA-regulated and FDA-compliant sterile facility to ensure quality and consistency from dose to dose." The problem comes with their pricing policy. Typically, progesterone injections are given weekly to high risk patients for up to 20 weeks. The compounded version costs on average between $10 and $20 a dose. A single dose of Makena will cost $1500. Though the company has introduced plans for a patient financial assistance program, many in the medical field are outraged and believe patient assistance will not be enough to outweigh the negative impact of such an increase. In an editorial in the New England Journal of Medicine, Joanne Armstrong, MD, MPH argues: "no program providing short-term financial assistance to some patients will mitigate the harm that this new cost will cause to publicly funded programs, including Medicaid, and the women who rely on them. Nor will it mitigate the cost to employers and individuals who purchase insurance coverage and therefore directly bear all increases in health care costs." The cost of prematurity is exorbitant — about $26 billion a year, according to the March of Dimes (MOD), which makes it even more surprising that the MOD medical director, Dr. Alan Fleischman, was quoted by TIME Healthland as supporting the new drug: "An FDA-approved product is a good thing. The drug is expensive but it's a very important drug for a very important purpose."