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Utah doctors are considering alternative ways to prevent premature births in the wake of an astronomical increase in the price of a drug used to reduce the risks of preterm labor.
Until now, a form of progesterone given as a weekly shot has cost as little as $10 per injection. But starting this week the price shot up to $1,500 a dose, meaning the total cost during a pregnancy could be as much as $30,000.
"It's simply untenable. It's just too expensive for society," said Utah physician Robert Silver, chief of the University of Utah's division of maternal fetal medicine, which oversees high-risk pregnancies.
"Obviously the problem we're worried about is [fewer] patients will have access to the medication," leading to more premature births, he said.
The drug has been made cheaply for years, mixed in pharmacies that make custom-compound treatments that are not federally approved.
But recently, KV Pharmaceutical of St. Louis won exclusive government approval to sell the drug, known as Makena. The March of Dimes and many obstetricians supported that because it means quality will be more consistent and it will be easier to get.
None of them anticipated the dramatic price hike, though — especially since most of the cost for development and research was shouldered by others in the past.
Doctors say the price hike may deter low-income women from getting the drug, leading to more premature births. And it will certainly be a huge financial burden for health insurance companies, which will have to raise premiums or other costs to their other customers, and government programs that have been paying for it.
"Every state in the union is concerned about it," said Tim Morley, director of Utah's Medicaid pharmacy program. "It's not a good time to increase costs."
He is still calculating what it will do to Utah's Medicaid budget. The cost for Medicaid-funded pregnancies that involve the drug will increase by $20,000 per pregnancy.
Morley said Medicaid must cover Makena but will also continue to cover the less-expensive compounded version until further notice from the U.S. Food and Drug Administration, which approved Makena but was not involved in setting the price.
Last month, KV sent cease-and-desist letters to compounding pharmacies, telling them they could face FDA enforcement actions if they kept making the drug.
The FDA doesn't recommend the use of compounded versions of drugs when an FDA-approved version is available.
Silver said doctors who treat high-risk pregnancies at the U. and Intermountain Healthcare hospitals are considering a policy to use alternative and less-expensive preparations — creams instead of injections.
While studies haven't compared the effectiveness of progesterone gels versus the shots, Silver said studies have shown the gels work.
"They seem to work as well. Physicians may choose to use those instead because they're cheaper," Silver said.
Makena's cost is justified to avoid the mental and physical disabilities that can come with very premature births, said KV Pharmaceutical chief executive Gregory J. Divis Jr. The cost of care for a preemie is estimated at $51,000 in the first year alone.
To get FDA approval, the company is spending hundreds of millions of dollars in additional research, including an international study involving 1,700 women, Divis said.
"Makena can help offset some of those costs," Divis told The Associated Press. "These moms deserve the opportunity to have the benefits of an FDA-approved Makena."
Because of the outcry about the cost, KV subsidiary Ther-Rx Corp. recently announced a patient assistance program. It promises free injections or much-reduced prices based on income. Uninsured households making less than $100,000 are eligible for a copayment of $20 or less.
But gaps remain, according to the American Academy of Pediatrics, American College of Obstetricians and Gynecologists and The Society for Maternal Fetal Medicine. They wrote a letter to Ther-Rx noting that undocumented immigrants may not be covered and that uninsured patients with household incomes greater than $100,000 and those with high insurance deductibles may not be able to afford the shots.
Tribune reporter Heather May and Associated Press medical writer Mike Stobbe contributed to this report. —
What is Makena, and who uses it?
Makena is a synthetic form of the hormone progesterone that first came on the market more than 50 years ago to treat other problems.
It's believed the treatment calms the muscles of the uterus, experts said. A 2003 study of women at risk for preterm birth found that only about 36 percent of those given the progesterone drug had preterm births, compared with 55 percent among those not on the drug.
By some estimates, about 130,000 women a year might benefit from the drug. Only a fraction of them get it, but the number has been growing steadily.
These very early births produce children who — if they survive — need months of intensive care and often suffer disabilities. The cause of sudden preterm delivery is not understood, but it occurs in black mothers at much higher rates than whites or Latinos.
Mike Stobbe, AP medical writer