Spike in cost of pregnancy drug draws sharp criticism

Mary Lou Jay

What would you do if the cost of a medication you needed suddenly rose from $15 to $1,500 a dose?

That's the dilemma that pregnant women and their doctors recently faced when KV Pharmaceutical Co. announced the pricing for Makena, a prescription hormone medicine that reduces the probability of premature birth.

Makena (its generic form is known as 17P) is a form of progesterone found to be effective in preventing pre-term births. Pregnant women facing risks of premature labor receive a shot of 17P starting around 16 weeks of pregnancy and continue the weekly dose through their 37th week, according to the March of Dimes.

Until 2011, 17P was a so-called orphan drug, meaning that instead of getting it from pharmaceutical companies, physicians would send prescriptions for the drug to compounding pharmacies that would make it cheaply.

In February 2011, the U.S. Food and Drug Administration (FDA) announced that it was giving KV Pharmaceutical the exclusive right to manufacture 17P under the brand name Makena. The news was welcomed by groups like the March of Dimes. They hoped that the approval would allow a safer, more standardized version of the drug, and that it would become more available as a result. They also hoped that more insurers would pay for the drug under their plans if it was standardized.

The cost of the generic 17P cost was about $15 a dose. Although everyone expected the price for the drug to rise somewhat, no one was prepared when KV Pharmaceutical announced that it would be charging $1,500 per dose for Makena.

The criticism of KV Pharmaceutical was immediate and vocal. In a joint letter, the presidents of the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine pointed out that the new pricing could add $30,000 to the cost of a pregnancy at a time when the country (and patients) cannot easily afford such increases.

The president of the March of Dimes called for a "significant reduction" in the price of Makena and a justification for KV Pharmaceutical's pricing strategy.

Two U.S. senators -- Sherrod Brown, D-Ohio, and Amy Klobuchar, D-Minn. -- asked the Federal Trade Commission to investigate KV Pharmaceutical for price-gouging. In a letter to KV Pharmaceutical, Brown expressed his concern that health insurance companies would stop covering the drug or charge their customers higher premiums.

KV Pharmaceutical justified the price of Makena by saying that it would be manufacturing the drug under more controlled, sterile conditions, and that it would be conducting testing and FDA reporting not required of the pharmacies that had produced 17P. It also announced a patient assistance program that would provide some financial relief to women with and without health insurance, depending on their income.

But critics have called these programs insufficient. Meanwhile, the FDA announced at the end of March 2011 that it would not prevent compounding pharmacies from continuing to make 17P unless it finds they're not meeting FDA standards. This means that the more affordable generic version of the drug still will be available.