A SHOT IN THE ARM TO PREVENT PRETERM BIRTHS

Volume 28, Issue 500 October 1, 2007

Anna Wolke

North Carolina has become one of the first states to implement a state-wide hormone-injection program aimed at preventing preterm births among low-income women. The “17P Project”—named for the drug therapy used—provides qualifying pregnant women with free weekly injections of a hormone shown to reduce the risk of a repeat early birth by 33 percent.

Premature birth is the leading cause of infant death in North Carolina, and based on 2004-2005 data, North Carolina is ranked 45^th in the nation in infant mortality. The health consequences of prematurity can include cerebral palsy, neurodevelopmental disability and chronic illnesses, such as lung disease.

The March of Dimes estimates that it costs, on average, about $2,800 to provide medical care to infants who are carried to term, compared to $41,600 for a preterm baby. Prolonging pregnancy by weeks or even days can dramatically affect both health and cost.

“Overwhelming” Evidence

The evidence that 17P (or alpha hydroxyprogesterone caproate, a drug based on the hormone progesterone) helps to prolong gestation is persuasive. In 2003 the National Institute of Child Health and Human Development released a report showing that weekly injections of 17P reduced the chance of repeat preterm birth by one-third and decreased the rate of neonatal morbidity. The American College of Obstetricians and Gynecologists has strongly endorsed the 17P regimen, and conducted a number of studies demonstrating its cost-effectiveness.

North Carolina has sought to reduce preterm births by persuading pregnant women to quit smoking and lose weight if needed. But in 2006, the state stepped up its campaign. Leaders of North Carolina’s major medical centers and schools, state health officials and legislators drew up a plan to make 17P available, free of charge, to all uninsured women. (Many private health insurance plans cover 17P for the prevention of reoccurring preterm births.) The injections, which cost between $150 and $300 for a full course, are given only to women with a history of preterm birth, with the shots beginning at about the 16^th week of pregnancy.

“(The) evidence is overwhelming that 17P does work in preventing premature births in someone who has previously had a premature birth,” said Senator William Purcell. He helped persuade the General Assembly to appropriate $150,000 to the state Division of Public Health to fund the program. The state then contracted with the University of North Carolina (UNC) School of Medicine’s Center for Maternal and Infant Health to manage the program’s promotion, provider outreach and education. UNC also administers the web-based portal where providers must purchase 17P for uninsured or Medicaid-enrolled patients. The drug, which must be compounded, is not available in most commercial pharmacies.

“In the past eight months, 17P injections have been distributed to over 350 low-income women through the project,” said Dr. Joe Holliday, head of the state's Women's Health Branch. It is too early to say how successful the program has been, but the General Assembly is pleased and funded it for a second year during its 2007 session.

Off-Label but On Target

The Food and Drug Administration (FDA) has not approved 17P for the specific purpose of preventing preterm birth. Nevertheless, in April 2007, North Carolina added the drug to the list of therapies covered for “off-label” use by its Medicaid program.

“17P is not a new drug and its side effects are pretty well known,” said Senator Purcell. “The newness is for this usage. I have no problem with using a well-known drug that can prevent premature birth (and often death) when it is being used in one of our best medical centers where its use will be closely followed.”

Several other states cover 17P through their Medicaid programs. Pennsylvania and South Carolina’s early experiences with both provider outreach and coverage of the drug served as valuable lessons for North Carolina, according to Dr. Holliday. Those states found that provider outreach and education, connections with drug compounding pharmacies, and a diverse network of leaders in medicine and public health are key components of covering 17P.

The Tar Heel State expects significant benefits. In 2004, North Carolina Medicaid spent more than $46 million on medical care for premature infants during their first year of life. The state’s Division of Public Health estimates that if 17P had been administered during that year to all the Medicaid-enrolled pregnant women with prior preterm births, the number of repeat preterm births could have been reduced from 326 to 218.

Anna Wolke is an intern with NCSL’s Forum for State Health Policy Leadership