The cost of a popular drug to help prevent preterm labor is increasing by 100 times, a revelation that has stunned pregnant women, their doctors and pharmacists this week.
"I'm ready to have a heart attack," Janice Watkins, a Pittsburgh resident who is pregnant and has been taking the generic drug known as 17P, said Thursday after she learned of the price increase from her doctor's office. "I'm nervous now because I have to go home and call my insurance company to see if they'll cover me."
Typical doses of 17P that now cost $10 to $20 per dose will have a list price of $1,500 under the brand name Makena. That's because KV Pharmaceutical of suburban St. Louis last month won government approval to exclusively market and sell Makena, a synthetic version of the hormone progesterone.
Doctors and health care advocates worry that some women who need the drug will not be able to afford it or their insurance companies will no longer cover it.
"I don't think there's any question that fewer women will use it now," said Ronald Thomas, director of maternal-fetal medicine for West Penn Allegheny Health System, where 60 to 80 women a year use the drug. "Insurance companies may be happy to approve it if it was $250 to $300 (per person) but they may take a second look at it if it's a $25,000 to $30,000 charge."
The drug's estimated total cost during a pregnancy could reach $30,000. High-risk women -- those who've had difficulty bringing a prior birth to full term -- can take the drug for up to 20 weeks during pregnancy.
When Thomas first heard about the price increase Thursday, he said, "I thought it must have been a misinterpretation of the cost. You can't describe this as anything other than greed."
KV Pharmaceutical said in a statement that it "has made significant investments to advance Makena through the FDA-approval process and make it available to patients who need it and have a significant obligation in the form of a large, ongoing clinical study. The company has also made a significant investment in developing a network of specialty pharmacies, specialty distributors and a comprehensive customer support center."
The list price is $1,500; the company said the actual cost to patients should be substantially lower than that, depending on their coverage. It also said it would assist low- and no-income women in paying for the drug at little or no cost.
What bothers doctors, pharmacists and patients about the cost is that Makena is merely a rebranded version of a drug that had been in use for 50 years but had gone out of use 11 years ago, earning the "orphan" drug status. It had been used for disorders of the adrenal glands or the ovaries.
It gained new attention after a 2003 National Institutes of Health-funded study found that only 36 percent of women at risk of preterm labor who were given 17P had premature birth, compared with 55 percent of women who were not given the drug.
Since then, with no FDA-approved version of the drug commercially available, special pharmacies that custom- compound treatments have been churning out individual doses -- typically five or 10 doses per vial -- with positive results.
Because of KV's exclusivity right, compounding pharmacies are no longer allowed to produce the drug beginning next week.