This makes me so sad. I know a lot of people who took progesterone injections and had healthy babies. It would be horrible if more babies are born early because families can't afford the medication. There is now an FDA approved progesterone shot. Before the FDA approval it was $10.00. Now it's $1500.00. That is just ridiculous in my humble opinion. The manufacturer of the drug Makena responds in this article. So take a look and see what you think.
FROM NBC NEWS: A drug that prevents preterm delivery called Makena has the potential to spare ten thousand babies from an early arrival each year. It was recently approved by the FDA, and while that gives more doctors access to the drug -- the new price is actually shutting some pregnant women out.
Lauren Fleming celebrated her seventh birthday last month, a day her parents worried would never come. Lauren was born three-and-a-half months early. Nikki Fleming/Mother: "She had multiple surgeries, while she was in the NICU, she spent roughly 5 months in the NICU." She still has some medical problems linked to her premature birth, but is otherwise healthy -- and now a big sister -- thanks to a drug Nikki Fleming's doctor prescribed. Nikki Fleming/ Mother: "He informed me that should we get pregnant again we would have to have progesterone injections to prevent a subsequent premature birth."
Progesterone injections have been recommended for women at risk of premature delivery since 2004. Until recently the shots were available from compounding pharmacies. Recently the Food and Drug Administration gave KV Pharmaceuticals the exclusive rights to produce the drug, called Makena, something the March of Dimes supported. Dr. Alan Fleischman - Medical Director/March of Dimes: "It's important that drugs that are used by the public are approved by the FDA."
What they don't support is the new price. The shots used to cost ten dollars each, now KV Pharmaceuticals plans to charge fifteen hundred a dose -- an estimated thirty thousand dollars per pregnancy. Dr. Alan Fleischman - Medical Director, March of Dimes: "We were surprised, we think its too high." The manufacturer says the cost is justified to avoid the mental and physical disabilities linked to prematurity -- and promises that every woman who needs the drug will get it through the company's patient assistance program.
Yet some doctors fear even with financial help -- the cost for some women will be insurmountable. Nikki Fleming/Mother:"I have two full term pregnancies as a result of this drug and I just want more women to be able to have this drug available to them." Moms say a healthy family shouldn't have a price tag. KV Pharmaceuticals has sent letters to compounding pharmacies threatening potential FDA action if they continue making the drug. Insurance companies may have to raise premiums to cover the increased cost.
Statement from Aetna: ""The price for the newly FDA-approved drug Makena frankly has us shocked and concerned that it will place this drug out of reach for women who need it," said Aetna Chief Medical Officer Lonny Reisman, M.D. "Makena demonstrates no discernable difference from the quality and safety of 17P, a drug already on the market and widely used, but costs 10,000 times more and prevents the availability of 17P. That is just wrong." Makena decreases the risk for preterm delivery by one third.
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