You gotta hand it to Big Business. They sure know how to work Big Government.
ATLANTA — The price of preventing preterm labor is about to go through the roof.
A drug for high-risk pregnant women has cost about $10 to $20 per injection. Next week, the price shoots up to $1,500 a dose, meaning the total cost during a pregnancy could be as much as $30,000.
That's because the drug, a form of progesterone given as a weekly shot, has been made cheaply for years, mixed in special pharmacies that custom-compound treatments that are not federally approved.
But recently, KV Pharmaceutical of suburban St.Louis won government approval to exclusively sell the drug, known as Makena (Mah-KEE'-Nah). The March of Dimes and many obstetricians supported that because it means quality will be more consistent and it will be easier to get.
None of them anticipated the dramatic price hike, though — especially since most of the cost for development and research was shouldered by others in the past.
But Snow and others said someone is going to have to pay the higher price. Some of the burden will fall on health insurance companies, which will have to raise premiums or other costs to their other customers. And some will fall on cash-strapped state Medicaid programs, which may be forced to stop paying for the drug or enroll fewer people.
"There's no question they can't afford this," said Matt Salo, executive director of the National Association of Medicaid Directors.
Salo and Snow said they do not know how many state Medicaid programs currently pay for Makena, which as a generic was recommended by the American College of Obstetricians and Gynecologists.
Aetna will continue to pay for the drug, Armstrong said, but it will be an expensive pill to swallow. Aetna currently covers it for about 1,000 women a year, so the new federal endorsement is likely to cost an estimated $30 million more each year.
Ther-Rx and its parent company became involved about three years ago and acquired rights to the drug from a Massachusetts company named Hologic Inc., said Divis, who is also Ther-Rx's president.
To get FDA approval, the company is spending hundreds of millions of dollars in additional research, including an international study involving 1,700 women, Divis said. The FDA last month signed off and gave Makena orphan drug status. That designation ensures Ther-Rx will be the sole source of the drug for seven years.
The March of Dimes, which gets hundreds of thousands of dollars in funding from Ther-Rx, celebrated the approval in a press release, saying if all women eligible for the shots receive them, nearly 10,000 spontaneous premature births could be prevented each year.
"For the first time, we have an FDA-approved treatment to offer women who have delivered a baby too soon, giving them hope that their next child will have a better chance at a healthy start in life," said Dr. Alan Fleischman, the organization's medical director.
As for the cost, he said the drug maker's financial assistance program will ensure no eligible woman is denied the drug due to inability to pay.
Some doctors said they were happy getting the cheaper version from compounding pharmacies, and Aetna's Armstrong said she was unaware of any quality concerns.
Still, doctors will use the Ther-Rx brand, in part because of legal worries.
Not that they have a choice: Last month, KV sent cease-and-desist letters to compounding pharmacies, telling them they could face FDA enforcement actions if they kept making the drug.
So let me see. We had a generic that worked so the FDA created a non-generic by fiat and the price went out of sight.
And politicians actually wonder why we have no faith in the government.
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