Whitney Palmer

Healthcare. Politics. Family.

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

Published on the April 26, 2012, ObGyn.net website

By Whitney L.J. Howell

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.”

To read the story in its original location: http://hcp.obgyn.net/pregnancy-and-birth/content/article/1760982/2065642?pageNumber=2


April 27, 2012 Posted by | Healthcare | , , , , , , , , , , , , , , , , , , , , , , , , , , | Leave a comment

Lung Association’s Cancer CT Screening Recs a Good Start

Published on the April 27, 2012, DiagnosticImaging.com website

By Whitney L.J. Howell

Recent recommendations for lung cancer CT screening from the American Lung Association (ALA) are expected to improve early detection of the disease. They’ll also likely increase your work flow and could change the way insurance providers pay for screenings.

Released on Monday, the ALA guidelines call for CT screening for all current and former smokers from ages 55 to 74 who have smoked a pack of cigarettes a day for at least 30 years. This formal push could lead to additional organizations joining the chorus, calling for improved diagnostic services.

“Hopefully, this recommendation will lead to more encouragement for us to get lung cancer screening approved through third-party payers,” said Reginald Munden, MD, radiology professor with M.D. Anderson Cancer Center. “The ALA has a high profile, so it is one of the organizations that will increase the odds of that happening.”

Although a final cost effectiveness analysis is still forthcoming, Munden posited this pressure could prompt insurance providers to approve funding for lung cancer screenings.

The ALA’s clinical suggestion is rooted in the findings from the National Cancer Institute National Lung Cancer Screening Trial (NLST). The study demonstrated CT screening can detect pre-symptomatic lung cancer in high-risk populations and reduce associated deaths by 20 percent compared to chest X-ray.

ALA chief medical officer Norman H. Edelman, MD, acknowledged the bar for patients to be screened is high, but said current research only supports applying the recommendation to this group.

“There’s always a risk with everything that we do. There’s a risk of unneeded lung biopsies or excessive radiation. All we can do at this time is look at the best data to make a screening recommendation for the 55-to-74-year-old long-term smoking populations,” he said. “We’re not saying yea or nay about other populations – just that there’s not enough scientific evidence to make any recommendations at this time.”

In addition to supporting the use of CT screening in this population, the ALA also recommended providers only conduct screenings in a low-dose CT machine. It’s also important, Edelman said, to run the studies in multidisciplinary centers that offer a variety of care modalities to patients. When a screening identifies a nodule, many types of providers join the care team, and having them in one location is a convenience to the patient.

To read the remainder of the article: http://www.diagnosticimaging.com/ct/content/article/113619/2065828

April 27, 2012 Posted by | Healthcare | , , , , , , , , , , , , , , | Leave a comment


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