Next week, the cost of preventing premature childbirth will skyrocket when a drug given to high-risk pregnant women goes from around $10 a dose to $1,500 a dose. The drug, called Makena, which has been made cheaply for years and is given as a weekly shot, could make the total cost during a pregnancy as much as $30,000. Why? Because KV Pharmaceutical of St. Louis recently won FDA approval to exclusively sell Makena last month.
By receiving “orphan drug status,” KV’s subsidiary Ther-RX Corp. will now be “the sole source of the drug for seven years.” In justifying the 14,900 percent price hike, KV Pharmaceuticals says that pregnant women will be willing to pay the new price because if they don’t, they could have a premature baby, or “preemie,” which could cost much much more:
The cost is justified to avoid the mental and physical disabilities that can come with very premature births, said KV Pharmaceutical chief executive Gregory J. Divis Jr. The cost of care for a preemie is estimated at $51,000 in the first year alone.
“Makena can help offset some of those costs,” Divis told The Associated Press. “These moms deserve the opportunity to have the benefits of an FDA-approved Makena.”
The U.S. Food and Drug Administration is not involved in setting the price for the drugs it approves.
The question, however, is not whether high-risk pregnant women would elect to offset further cost by using the drug, but whether they can afford the elevated price in the first place. The issue, doctors say, is that “the price hike may deter low-income women from getting the drug, leading to more premature births.” “That’s a huge increase for something that can’t be costing them that much to make,” said Massachusetts’s Medicaid deputy medical director Dr. Roger Snow. “For crying out loud, this is about making money,” he added. Ther-RX launched a patient assistance program Tuesday to help alleviate the cost for some women.
What’s more, KV is seeking to prevent other pharmaceutical companies from producing a cheaper version. Last month, KV sent out a letter to compounding pharmacies to cease and desist from producing the drug. KV claims that because the FDA designation now makes Makena “commercially available,” “continuinig to compound this product after FDA-approval of Makena renders the compounded product subject to FDA enforcement of violating certain provisions of the Federal Food, Drug and Cosmetic Act, as well as FDA guidance.” Thus, Ther-RX’s privileged status now threatens companies trying to provide a cheaper version and copay to pregnant women with potential problems.
Sen. Sherrod Brown (D-OH) sent a letter to KV Pharmaceuticals Thursday demanding they “immediately reconsider the massive price increase.” Noting that African-American women have a higher percentage of premature births, and that fewer women will be able to afford the drug, Brown said he is “gravely concerned” that premature birth rates will increase nationwide. “[H]ealth insurance companies could either stop coverage of the treatment or impose higher premiums on consumers,” Brown said, adding that “state Medicaid programs — which are already struggling to make ends meet — will be forced to deal with the financial repercussions” of the “exorbitant” hike. “This isn’t in the interest of children, new mothers, or taxpayers,” Brown told ThinkProgress. As Snow and other health professionals said, “someone is going to have to pay the higher price.”