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The cost of a drug used to prevent premature birth in high-risk mothers will rise from around $10 per dose to $1,500, now that the FDA has approved a branded version of the medication. The new medication is a form of progesterone, which has already been prescribed for decades and is currently made for this purpose by specialty drug stores known as compounding pharmacies.

Now, KV Pharmaceutical Company, the maker of the new drug called Makena, has warned compounding pharmacies that they face FDA action if they continue to sell nonbranded versions of the drug, technically known as 17-hydroxyprogesterone caproate. KV's new price means the drug could cost mothers up to $30,000 per pregnancy — but some doctors and pharmacists say there may be ways to avoid the massive price increase. 

But first, why has a drug that has been used for decades suddenly become so expensive? Premature birth affects 1 in 8 pregnancies — some 543,000 annual births — resulting in intensive care and often lifelong disabilities in the child. It's responsible for $26 billion a year in medical expenses — a figure KV cites to justify the new price of Makena.

To help offset the cost of the weekly injection, KV just announced a patient-assistance program for families in financial need. "We established this comprehensive patient-assistance program as part of our commitment to ensure that all eligible women have access to FDA-approved Makena," KV's CEO Greg Divis said in a statement.

The March of Dimes — which has received hundreds of thousands of dollars in donations from KV's subsidiary Ther-RX, which will market Makena — supports the introduction of the new drug. "An FDA-approved product is a good thing," says Dr. Alan Fleischman, medical director of the March of Dimes. "The drug is expensive but it's a very important drug for a very important purpose. The company has promised that every eligible woman whose doctor prescribes it will [be able to receive it] and ability to pay will not preclude that." 

But many other doctors expressed outrage over the price hike. "This is ridiculous. This medicine has been used for 40 or 50 years," says Dr. Sam Kim, division director for reproductive endocrinology and infertility at the University of Kansas Hospital.

"It's going to be prohibitively expensive for a lot of patients," says Dr. Robin Kalish, director of clinical maternal-fetal medicine at New York-Presbyterian/Weill Cornell Hospital in Manhattan. She adds that much of the research on the drug— including a major 2003 study showing that the drug cuts premature birth by one third in women carrying single pregnancies who'd previously had premature babies—was funded by the government.

Since low-income women are at high risk for premature birth, the burden of cost for Makena is likely to fall to Medicaid, which is already facing massive budget cuts in many states. Matt Salo, executive director of the National Association of Medicaid Directors told the AP: "There's no question they can't afford this."

The March of Dimes' Fleischman responds: "The Medicaid programs and the insurance companies have only begun their discussions with the company." 

Already, many patients and doctors may be wondering whether they can use other types of progesterone to lower the risk of premature birth, without paying for Makena. Indeed several types are already on the market. Almost all women who have been through in-vitro fertilization (IVF) have taken some form of the hormone, either as a vaginal suppository or intramuscular injections, which are one of the most uncomfortable parts of the procedure. Those drugs will still be available at their current prices, but they must be used daily, rather than once a week like Makena.

"It is possible to use daily gels, creams, suppositories [or injections]," says John Preckshot, director of marketing of the Professional Compounding Centers of America, the leading trade organization representing specialty pharmacies. Many of these drug stores currently make versions of weekly hydroxyprogesterone to prevent premature birth.

A small Brazilian study found that daily vaginal progesterone does work to reduce the risk of premature birth, notes Kalish, but that was just one small study. 

Preckshot adds that compounding pharmacies may still be able to make a different version of hydroxyprogesterone that would not violate the patent on Makena. "There's the possibility of using different vehicles, other oils, than the one used in Makena," says Preckshot, who is also a compounding pharmacist himself.

"Compounding pharmacies have already been making this for the patient," says Dr. Kim. "The problem is that depending on the pharmacy and depending on who is making it, it varies — there is not always the same level [of the hormone in the product]. That's the reason the company took over, but I don't have any problem if compounding pharmacies can continue to do it."

Still, liability issues may deter doctors from using other options, now that a branded product has been federally approved. Moreover, the alternatives have not been tested. "Theoretically, you could use any progesterone. The problem is, there are no studies [of most of these alternatives]. And it's impractical to give daily intramuscular shots for so many months," says Dr. Zev Rosenwaks, director of the Cohen/Perelman Center for Reproductive Medicine at New York-Presbyterian/Weill Cornell.

Now, it seems the business interests of KV, insurance companies, compounding pharmacies, government policies and doctors will determine how Makena will affect prematurity rates and high-risk women's access to a substance which could mean the difference between a normal life and one of severe disability for thousands of babies.