FDA nod boosts price of drug
Cost of dose jumps from $20 to $1,500
LOS ANGELES – The price of a drug used to delay birth in women at high risk of delivering prematurely is going to skyrocket following Food and Drug Administration approval of a prescription form of the product, a synthetic form of the hormone progesterone.
Since 2003, the American Congress of Obstetricians and Gynecologists has recommended that doctors offer the progesterone shots to high-risk women. But because there has not been a commercial product available, women have obtained the drug from so-called compounding pharmacies, which make it to order. The pharmacies have typically charged about $10 to $20 per shot for the drug, which is given weekly.
Last month, however, the FDA approved a commercial form of the drug, called Makena, manufactured by K-V Pharmaceutical Co. of St. Louis. The company said Wednesday that the drug will be available for shipping March 14 and that it will cost $1,500 per dose, meaning the total cost during a pregnancy could be as much as $30,000.
The company said, however, that it would establish a “comprehensive patient assistance program” to ensure that the drug was available to every woman who needs it.
Physicians were incensed at the high price K-V plans to charge.
“That’s a huge increase for something that can’t be costing them that much to make. For crying out loud, this is about making money,” said Dr. Roger Snow, deputy medical director for Massachusetts’ Medicaid program.
“I’ve never seen anything as outrageous as this,” said Dr. Arnold Cohen, an obstetrician at Albert Einstein Medical Center in Philadelphia.
The burden for many will fall on insurance companies, which may have to raise rates. The increase also will affect already strapped Medicaid programs.
The cost is justified to avoid the mental and physical disabilities that can come with very premature births, said K-V 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 said. “These moms deserve the opportunity to have the benefits of an FDA-approved Makena.”
About 500,000 U.S. infants are born prematurely each year. The March of Dimes estimates that about 10,000 of those premature births could be prevented if eligible women received Makena.
Meanwhile, women are unlikely to be able to continue to get the drug at compounding pharmacies. K-V sent letters to the pharmacies warning them of potential FDA action if they keep distributing the drug.