In follow up to the KV Pharmaceuticals and its pricing of the preemie drug, Makena, story -- the St. Louis Post Dispatch recounts today that insurers are actively choosing to bypass the drug in favor of one, known as 17P, compounded at the pharmacy. The latter, 17P, costs about $15 per dose. Makena is still priced at $590 per dose (down from $1500) despite the beating it took back when approved.
Centene Corp, which manages Medicaid services in several states, is encouraging physicians to go with the cheaper drug and helped them to procure it at lower prices. Since the FDA has refused to force physicians to prescribe the approved Makena -- the move by 3rd party payers towards 17P likely will force another price reduction for Makena. The unusual FDA move by the way was supported by the American Academy of Pediatrics, the Amercian College of Obstetricians and Gynecologists, the Society for Maternal-Fetal Medicine, the March of Dimes and America's Health Insurance Plans. Oops!
Through its bungling pricing decisions, KV Pharmaceuticals now sits with a coommitment for $200 million in licensing fees to Hologic, Inc for rights to Makena. Now it continues to struggle back from 2 years of trouble with the FDA during which time most of its products were subjected to recalls, three quarters of its staff was laid off, and criminal convictions were obtained among its management. Maybe another set of reasons FDA is not sheltering the approved Makena?
Said Lori McLaughlin, a spokesman for the Wellpoint insurance conglomerate (also a provider of Medicaid services), "Drugs like Makena are one of the reasons for increases in health care costs. We'd like the manufacturer to reduce the price of the drug...so that it more accurately represents its investment in the product" KV Pharmaceuticals did not invent or patent Makena, and outsources its manufacture.
KV by the way has several other women's health products awaiting approval in the FDA queue. We'll have to wait and see if they learn anything this second time around.......
Posted by Bruce Lehr May 1st 2011.