"I hope I deliver before the new price kicks in," says Devika Ross, 36, who has been taking the nonbranded form of the shot, called 17-hydroxyprogesterone caproate, for the past 11 weeks. Her first child was born about three months premature and after a combined 232 days in the neonatal intensive care unit, died from pulmonary hypertension.
When Ross became pregnant again this past fall, she was at high risk of another preterm pregnancy and was placed on the progesterone shots 16 weeks into her pregnancy. She is now almost a month further along than she was when her first child was born, and she has a good chance of delivering full-term.
"My insurance pays for the [nonbranded] shots, but I don't know if they would cover it if it cost $1,500 a shot. That doesn't seem fair, especially because not everyone has insurance," she says.
Beatrice Diaz, of Chapel Hill, North Carolina also relied on the shots for two of her pregnancies. Her first child, Garrison, was born three months early. He survived, but is permanently disabled. Diaz told ABC News, "Once I had my son, we questioned whether or not we wanted to have more children." But she says, with the help of the weekly injections, she carried two daughters full term. One is now three, the other 19 months old.
Diaz said if the drug had been $1500 a shot, "I think the price would have definitely locked me out, which means I could have potentially had a second or third premature child with disabilities." She added, "I would say to the pharmaceutical company, if there is any way they can cut the cost. I would ask them to consider these are lives at stake. "
Hydroxyprogesterone caproate injections have been around since 1956, and were commercially available up until 1999 when Squibb, the pharmaceutical company making them, withdrew the product from the market. In the past few years however, studies have shown that these injections had a positive effect in preventing pre-term birth among women who had previously had a spontaneous pre-term birth in the past. Since then, doctors have been able to fill prescriptions for the synthetic progesterone using compounding pharmacies at a price of $10 to $15 per injection.
Most health insurances did not cover these shots as they were not FDA approved, but given the low price of progesterone, women were able to pay out of pocket for the treatment, says Moritz.
It wasn't always easy to find places that made the medication, however, says Dr. Michael Lindsay, division director of Maternal-Fetal Medicine at Emory University School of Medicine, so "we were excited at first to hear it be FDA-approved."
"My mind-set was that now everyone could get it, but no one is going to be able to afford that," he says.
Many doctors are particularly frustrated with the price hike because to date, KV Pharmaceuticals has not had to bear the cost of the clinical trials used to get the drug approved, but they have announced plans to conduct further trials in the future.
"All the upfront development of the drug was done by the National Institute of Health. You and I paid for that with our tax dollars, it's not like this pharmaceutical company is trying to recoup its investments in research and development, as is usually the reason for the price of new drugs," says Dr. Kevin Ault, associate professor of gynecology and obstetrics at Emory University School of Medicine.