How do you solve a problem like Makena?
In February, when the Missouri-based pharmaceutical firm Ther-Rx received from the Food and Drug Administration the exclusive right to market a progesterone injection formerly known as 17P, maternal-fetal health advocates cheered.
The drug 17-alpha Hydroxyprogesterone caproate, or 17P, had originally received FDA approval in the 1950s for multiple indications, one of which was preventing preterm labor, but it came off the market in 2000 because of a manufacturing issue. After a publicly funded 2003 study of 463 women found weekly injections of 17P effective in preventing preterm labor among women at high risk (N. Engl. J. Med. 2003;348:2379-85), the drug gained widespread use, even though practitioners had to order it from compounding pharmacies.
In February, the March of Dimes lauded the FDA’s decision to approve 17P under its orphan drug program, guaranteeing market exclusivity to Ther-Rx, which will market 17P as Makena. The March of Dimes praised the FDA’s decision as likely to standardize the quality and consistency of the product and, presumably, to lessen the "logistical and financial barriers" to patient access, the organization said in a press statement.
And then everyone learned Makena’s price. This month, Ther-Rx revealed that each Makena shot would cost $1,500 – where it had previously cost between $10 and $50. The ideal treatment starts at approximately 16-18 weeks’ gestation and continues until 36 weeks’ gestation, so a woman might receive as many as 20 doses of 17P during her pregnancy. Although the company offered to offer the drug free to lower-income uninsured households, the full cost to insurers including Medicaid, according to an estimate provided by the American College of Obstetricians and Gynecologists, would be about $30,000 per pregnancy.
Dr. Christopher Harman, director of the Center for Advanced Fetal Care and chief of obstetrics and gynecology at the University of Maryland Medical Center, Baltimore, called Makena’s pricing "an outrage."
"This stuff is really cheap to make – this would be as if a brand-new company somehow got a patent on Tylenol or aspirin and decided to sell it at $100 a pill," said Dr. Harman. Makena’s pricing "strikes at the core of women at highest risk for preterm birth already" – young African American women. "We may remove their best hopes for having a close-to-term birth," he said in an interview.
Ther-Rx did not answer calls seeking comment. On its Web site, the company said: "We appreciate the concerns expressed by multiple audiences and are committed to working collaboratively with all interested parties to make this vital medication even more available and affordable to women across the country."
Dr. Harman said he has been using 17P for about 5 years in his patients, mostly low-income women in inner-city Maryland, and that between 100,000 and 140,000 women a year are probably eligible for treatment with 17P in the United States.
"Nobody is saying the company was out to deprive any group of women, but as often occurs when financial decisions are made, they have a disproportionate impact on the people who need the treatment the most," he said.
Other physicians were quick to express outrage online when they learned about the price – mostly at the manufacturer, but also at the March of Dimes for supporting Makena’s approval.
Dr. Jennifer Gunter, an ob.gyn, author, and pain physician at Kaiser Permanente in San Francisco, used her informational Web site, The Preemie Primer, to criticize what she considered to be March of Dimes’ naivete in celebrating the approval of Makena before learning of KV Pharmaceutical Company’s pricing intentions.
On March 11, three professional organizations, the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, and the Society for Maternal-Fetal Medicine, published a joint letter to Ther-Rx, a subsidiary of KV Pharmaceutical Company, critical of the pricing, stating that: "in our current climate of controlling health care costs in the United States an added cost of $30,000 for as many as 140,000 pregnancies per year, or 4.2 billion dollars, is a staggering figure."
Sen. Sherrod Brown (D-OH), slammed the pricing in his own letter to the company, stating that the $1,500 per shot price tag was "exorbitant," and that Ther-Rx was "taking advantage of FDA approval at the expense of women, children, and federal and state budgets." A spokesman for Sen. Brown said that, as of March 15, he had not received a response from the company.
Dr. Harman said the best people to pressure the FDA and government to reexamine the Makena decision were patients and the public. Last week, patients were among the most outspoken critics of Ther-Rx and KV Pharmaceutical Company, and to a lesser degree March of Dimes, which issued another statement March 14 in the form of a letter to the manufacturer saying that it was "deeply concerned that the cost of this lifesaving treatment could be put out of reach to thousands of women at risk for preterm delivery."