17P, Makena, and Preterm Birth: The Controversy Continues

A year after the Food and Drug Administration (FDA) quickly and controversially green-lighted the pre-term birth prevention drug Makena® to compete directly with long-used 17P, some arguments have cooled, but the battle for marketplace dominance continues.

Makena® and its developer KV Pharmaceuticals met harsh backlash last year from providers, payers, and professional societies, when the drug received FDA approval, won an instant monopoly, and immediately set the cost per weekly injection at $1,500. Until then, the unapproved, compound drug 17P, priced at $10 per dose, was the only therapy proven to stave off premature births.

Makena® supporters pointed to FDA regulations and consistency standards as proof it was a superior product. However, there’s still no evidence indicating it is more effective than 17P, said Bob Silver, M.D., maternal and fetal medicine division chief at University of Utah Health Sciences.

“There’s no proven clinical benefit to using one over the other. They both have the same biologically active compound,” he said. “The only difference is one is FDA approved. That may mean the drug is more consistent and less likely to have contaminants, but most reputable compounding pharmacies do a very good and safe job.”

Clinically, both 17P and Makena® reduce the likelihood of early deliveries by one-third among women who have experienced a previous premature birth. As of 2008, according to the National Vital Statistics Report, pre-term birth accounts for nearly 13 percent of births nationwide.

What’s changed, however, is KV Pharmaceuticals’ approach. According to company February reports, the price tag for patient co-pay per injection has plummeted to approximately $10 – comparable to 17P charges. That reduction softened much of the industry’s initial negative reaction.

Based on the same report, doctors and patients have received 6,500 vials of the drug, and approximately 3,700 patients have either started treatment or are in the process of either doing so or awaiting insurance approval. In addition, more than 250 payers, both commercial and Medicaid, now reimburse for Makena® injections.

But the cheaper price and growing positive sentiment still isn’t enough for some providers to choose Makena® over 17P. Prescribing 17P is a long-term practice for many, often preceding the 2003 New England Journal of Medicine study heralding the compound’s efficacy, and they aren’t likely to change it without substantial evidence showing another drug is better, Silver said.

Makena® prescription rates will likely vary by region, he said, based on marketing efforts, physician preferences, and agreement from third-party payers to cover the injection. But in Utah, 17P remains largely the drug of choice.

“A lot of doctors in my community are using 17P because of the cost, and they’re accustomed to working with a compounding pharmacy,” he said. “There are also plenty of third-party payers in Utah who work with the compounding pharmacies.”

For some providers, Makena® symbolizes the bloated U.S. healthcare system – an overpriced network built to support the pharmaceutical industry’s bottom line.
For these physicians, prescribing Makena® will never be an option.

“The big problem is KV Pharmaceuticals decided to price the drug, which had already gained widespread acceptance through a well published study, at approximately $1,500 a week. The cost of healthcare is destroying this country, and this is an area in which we cannot afford to give in,” said Nicholas Fogelson, M.D., an obstetrician with Palmetto Health Richland Hospital in Columbia, S.C., “As an Ob/Gyn physician, I will not write a single dose of this drug, and I encourage my colleagues to do the same.”

Some third-party payers, such as UnitedHealthcare, have policies covering Makena® injections, but women still face roadblocks to access, said Sarah Verbiest, DrPH, MSW, MPH, University of North Carolina Center for Maternal and Infant Health executive director. That’s why, she said, the state launched an initiative in April 2011 to increase 17P availability.

“There’s no silver bullet or single answer that will allow us to address all pre-term births,” she said. “When we think of 17P, it’s one clinical tool we have in our toolbox. So, we provide support for use in practice, including how bill for it, how to find a compounding pharmacy, and how to get it quickly to ensure women get all the shots.”

And, it’s increased access to this preventive therapy that’s most important, Utah’s Silver said, regardless of concerns over previous pricing or the safety of compound versus manufactured drugs.

“Pre-term birth is such a bad problem,” he said. “All of the preparations are relatively safe and can reduce risk. The one patients can get from a reputable pharmacy and they can afford is the one they should use.”