Price of early-labor prevention drug won't soar, FDA says
A widely used drug that prevents preterm labor won't surge in cost after all.
The Food and Drug Administration announced on Wednesday that it won't prevent compounding pharmacists from producing the drug at a cost to patients of $10 to $20 per injection.
In February, KV Pharmaceutical Co. of suburban St. Louis acquired FDA approval for the drug and exclusive rights to sell it under the name Makena for seven years. This month, the company increased the price per dose to $1,500 and sent cease-and-desist orders to pharmacies that had produced the drug for years.
"We are really relieved for our patients," said Dr. Jennifer Celebrezze of the Division of Maternal and Fetal Medicine with the West Penn Allegheny Health System. "It was going to be a potential hardship for them."
KV Pharmaceutical said yesterday that it was committed to making sure all women who need the drug have access to it. The company said it plans another announcement by the end of the week about the drug's price.
Dr. Hyagriv Simhan, medical director of obstetrical services at Magee-Womens Hospital of UPMC in Oakland, said some of his patients delayed getting their initial injections while waiting to see if the cost would change. The drug is usually administered weekly from week 16 to week 36 of pregnancy.
"Women who otherwise wouldn't have batted an eyelid about it were saying it really depended if insurance companies would cover it," Simhan said. "I have not had a patient who would have needed it who would not get it, but it would have happened."
Dr. Douglas MacKay, an obstetrics/gynecology physician with St. Clair Hospital in Mt. Lebanon, said he'd like to see the pharmacies' version of the drug get FDA approval.
"If we're subject to liability, we're still not going to be able to use it," MacKay said.
Makena is a synthetic form of the hormone progesterone. Medical studies have reported that it helps prevent early births in women with histories of spontaneous preterm deliveries.
This month, KV Pharmaceutical Chief Executive Gregory J. Divis Jr. said the increase in cost was justified. A premature baby's care is estimated at $51,000 in the first year alone.
"Makena can help offset some of those costs," he said. "These moms deserve the opportunity to have the benefits of an FDA-approved Makena."
Doctors feared the price hike would deter women from getting the drug and burden insurance companies and government programs.
MacKay said he still does not understand how the company was permitted to dramatically increase the cost of a drug that had been used in the medical community for years. Had the 140,000 women who could benefit from the drug received it at the inflated rate, it could have cost in excess of $4.2 billion a year, he said.
"It shouldn't happen, especially with a medical system that's so strapped right now," MacKay said.
Simhan expressed concern about how insurance companies will react now that an FDA-approved version of the drug is available.
"I hope they cover both Makena and the compound version," he said.
KV Pharmaceutical previously announced a patient assistance program that would discount the price for women who met certain guidelines. The company said yesterday that it was "exploring additional ways to help provide affordable access for all patients who are prescribed Makena."