Fifteen hundred dollars.

That's the cost -- wait, let me restate -- that was the cost of one dose of Makena, the drug that the Food and Drug Administration approved in early February to help prevent preterm birth.

If it weren't for the huge price hike announced by Makena's manufacturer, KV Pharmaceuticals, chances are you would have never heard, or cared, about the drug.

Enough people protested -- loudly -- to cause the company to give in a bit on the pricing.

More on that later.

Makena reduces the risk of a woman giving birth before her 37th week of pregnancy (an early term pregnancy is 37 weeks to just before 39 weeks; full-term is anything after 39 weeks). It's the first and only drug to receive FDA approval for that purpose.

Before Makena's emergence, obstetricians who specialize in high-risk pregnancies had been giving women with a history of at least one unscheduled preterm birth the generic hydroxyprogesterone caproate, also known as 17P.

Both Makena and its generic equivalent, which is custom-made by compounding pharmacies, are used to regulate levels of the hormone progesterone, which helps maintain a pregnancy.

Physicians initially welcomed the FDA's approval of Makena because it meant standardization in manufacturing the drug and, as a result, consistency in quality.

Then in March, KV Pharmaceuticals announced it was pricing Makena at $1,500 per dose. This was considerably higher than the $10 to $20 per injection that compounding pharmacies charge for the generic version. That's a cost increase of 14,900 percent.

The injections to prevent preterm birth are necessary as many as 20 times (once a week) until a woman's pregnancy reaches early term. For Makena treatments, that would mean a cost of up to $30,000, instead of $200 to $400 for the generic drug.

If a woman can't afford Makena, and the generic is not available, she would be at risk of giving birth too early, setting her up for even more costly medical care for her premature baby, who would now be in danger of developmental delays, hearing and vision problems, chronic lung disease and other long-term complications.

According to the most recent annual Premature Birth Report Card, issued last fall by the March of Dimes, Ohio at 12.6 percent is ranked 30th among the 50 states, the District of Columbia and Puerto Rico, for its percentage of preterm births.

Medical organizations wasted no time in broadcasting their displeasure over what was perceived as an insurmountable barrier in making Makena widely available. The American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and the Society for Maternal-Fetal Medicine sent a joint letter to KV Pharmaceuticals on March 11.

The March of Dimes -- one of the biggest proponents of Makena -- followed suit two weeks later with a letter of its own.

If a woman has already had one high-risk pregnancy her physician doesn't wait for complications to occur in a subsequent pregnancy before deciding on whether or not to treat with the drug or its generic form, said Dr. Brian Mercer, director of both the division of Maternal-Fetal Medicine and obstetrics at MetroHealth Medical Center.

"Monitoring and [FDA] approval offers some benefit, but not $1,500 versus $20 per shot," said Mercer, who also is a board member of the Society for Maternal-Fetal Medicine.

Mercer and his colleague, Dr. Jennifer Bailit, appeared with U.S. Sen. Sherrod Borwn, an Ohio Democrat, at a March 22 press conference at MetroHealth decrying the price hike.

Brown also called for investigation by the Federal Trade Commission to see if KV Pharmaceutical had violated any regulations by telling compounding pharmacies to stop selling their own versions of the drug.

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