The average cost of delivering a healthy baby in the United States is $6,378– $10,638 for a caesarian section. These numbers do not include the countless doctors’ visits and purchases the average woman makes during her pregnancy.
And now the cost of a popular drug that prevents preterm labor is increasing exponentially. The drug, 17P, currently costs $10-20 per dose and is covered by both of western Pennsylvania’s major health insurance providers. Now the drug’s exclusive rights have been acquired by KV Pharmaceuticals and 17P will be sold for $1,500 per dose under the new name Makena.
A preterm birth is defined as a “birth that happens too soon, before 37 completed weeks of pregnancy.” 17P is the hormone progesterone. Pregnant women receive the first dose of the drug in shot form between the first 16 and 20 weeks of pregnancy and can continue to receive injections through their 37th week of pregnancy. A full term pregnancy is 40 weeks.
Preterm labor is a major concern with any pregnancy. Once preterm labor starts it cannot be stopped and there is no clear reason why it occurs. There are many risks associated with preterm labor for the baby including low birth weight, breathing problems, underdeveloped organs, and potentially life threatening diseases. Children who are born premature also are at greater risk for learning, developmental, and behavioral disabilities. Mothers of prematurely born children sometimes have a high stress level related to the condition of their child.
Litigation and Trial recently wrote that the United States spends $25 billion per year caring for premature babies. The Examiner made an excellent point, stating the new cost of the drug would discourage insurance companies from covering it:
Now, at $1,500 per shot, many medical directors, Medicaid officials and insurance companies wonder how many mothers in need will go without the treatment. That would actually cause an increase in the number of premature births, exactly what the drug is supposed to prevent.
Overall, Makena will increase the price of pregnancy for those women who need the drug to around $30,000.
Recently, KV Pharmaceuticals issued a cease and desist letter to pharmacies that have continued to produce and provide the $10 per dose version of the drug, threatening that these pharmacies will have to face FDA enforcement.
This whole situation makes a person question, what is in a name? KV Pharmaceuticals have made no efforts to make the drug affordable for low-income women, or to appeal to insurance companies to cover the drug. The major effect of dramatically increasing the cost of this drug will simply have the effect of increasing the premature birth rate in the United States.
We need the help of lawyers to fight the FDA ruling that once there is a FDA approved drug, compounding pharmacies can not compound a similar medication.
If you can help remove the “cease and desist” order by KV then we doctors and health plans can continue ordering the 17OHP from the same compounding pharmacies we have been using for the past 7 years.
Please use your lawyer skills to help us.