Janice Watkins drops off her daughter, Gracelyn, 8, and son, Gerald, 13, not pictured, for evening classes at the Sara Heinz Center. Ms. Watkins, who is pregnant with twins, takes a drug known as 17P. The FDA recently gave a drug company exclusive rights to produce the drug, dramatically raising the cost.
By Sean D. Hamill Pittsburgh Post-Gazette
The revelation this week that the cost of a popular drug to help prevent preterm labor is going to go up 100 times its current price has stunned pregnant women, their doctors and pharmacists in Western Pennsylvania.
"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 are worried that because of the massive price increase, 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 the division 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."
It's estimated that the total cost of the drug during a pregnancy could reach $30,000. High-risk women -- women who have had difficulty bringing a prior birth to full term -- can take the drug for up to 20 weeks during pregnancy, though some take it for less than that.
When Dr. 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," he said.
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."
While 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.
Whether or not women in Western Pennsylvania will have the same access to the drug as they do now is not clear.
The region's two leading health insurers -- Highmark and UPMC Health Plan -- said they wouldn't know for several months whether they will cover Makena. Until then, requests for coverage will be dealt with on a case-by-case basis, officials at both companies said.
UPMC Health Plan said it currently covers the generic version, 17P; Highmark said it does not because "we consider it to be experimental," said spokesman Aaron Billger.
However, some women contacted by the Post-Gazette did say Highmark had been covering their use of 17P.
The Pennsylvania Department of Public Welfare, which administers the state's Medicaid program, said the drug would be covered once the federal Centers for Medicare and Medicaid Services say the drug is covered by a rebate agreement. KV Pharmaceutical said Makena is already covered by such an agreement, but the state could not confirm that.
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.
Before it became an orphan drug, it was used for disorders of the adrenal glands or the ovaries.
But it found a new use 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.
In the years since, 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 -- patient-by-patient with positive results.
"This is incredibly effective. It reduces premature births by one-third," said Dr. Hyagriv Simhan, chief of the division of maternal-fetal medicine at Magee-Womens Hospital of UPMC, where 200 to 300 women use the drug annually. "So, to not make it available to everyone who needs it is just unjust."
"I was shocked," said Beth Begleiter, deputy director of the Maternity Care Coalition, a Pennsylvania advocacy group that has sought to reduce premature pregnancies. "I had no idea that there could be that kind of spike in costs."
Dr. Simhan worries that even if insurance companies cover it, if KV Pharmaceutical allows it to be sold only one dose at a time -- instead of patients being able to buy five or 10 doses at a time as they do now -- it will simply cost patients too much if they have to pay 20 co-pays instead of two, and they will choose not to take the drug.
Elly Wallin, a spokeswoman for KV Pharmaceutical, said that as part of its exclusivity agreement, the FDA is requiring that each dose -- an injection in the hip -- be done by a doctor in the office. That could mean additional co-pays.
Amy Belcastro, a compounding pharmacist at Jeffrey's Drugstore in Canonsburg, which has made, or compounded, the drug, said she found out about the price increase last week.
"I don't know how they justify it. We pass it on for not more than $10 a dose [now]," she said.
Because of KV's exclusivity right, compounding pharmacies are no longer allowed to produce the drug beginning next week.
That may be too soon for Ms. Watkins.
She is in her fourth week of taking 17P, and she has about five doses left, which means in about a month she would need to get some more doses -- or start getting a once-a-week shot in her doctor's office.
She has two children -- a son, Gerald, 13, and a daughter, Gracelyn, 8 -- but she has had two miscarriages since giving birth to Gracelyn.
"I have a horrible history of sustaining pregnancy," she said. "And I believe that the reason this birth now has been so smooth is because of the drug.
"But now I might not be able to obtain this drug?" she said. "I just can't believe there's nothing in the law that makes it illegal to do that."