Pricey Preemie Drug

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Wednesday, March 16, 2011 - 3:55pm

Drug that prevents preterm delivery faces massive cost hike, outraging doctors and patients.

A drug that prevents preterm delivery has the potential to spare 10,000 babies from an early arrival each year.

It was recently approved by the Food and Drug Administration, and while that gives more doctors access to the drug, the new price is actually shutting women out.

Lauren Fleming celebrated her 7th birthday last month, a day her parents worried would never come.

Lauren was born three-and-a-half months early.

"She had multiple surgeries, while she was in the NICU, she spent roughly 5 months in the NICU," recalls mother Nikki Fleming.

She still has some medical problems linked to her premature birth, but is otherwise healthy and now a big sister thanks to a drug Nikki's doctor prescribed.

"He informed me that should we get pregnant again we would have to have progesterone injections to prevent a subsequent premature birth," Nikki says.

Progesterone injections have been recommended for women at risk of premature delivery since 2004.

Until recently the shots were available from compounding pharmacies.

Recently the FDA gave KV Pharmaceuticals the exclusive rights to produce the drug, called Makena, something the March of Dimes supported.

"It's important that drugs that are used by the public are approved by the FDA," says March of Dimes medical director Dr. Alan Fleischman.

What they don't support is the new price.

The shots used to cost $10 each.

Now KV pharmaceuticals plans to charge $1,500 per dose, an estimated $30,000 per pregnancy.

"We were surprised, we think its too high," Fleischman says.

The manufacturer says the cost is justified to avoid the mental and physical disabilities linked to prematurity and promises that every woman who needs the drug will get it through the company's patient assistance program.

Yet some doctors fear even with financial help the cost for some women will be insurmountable.

Moms say a healthy family shouldn't have a price tag.

"I have two full term pregnancies as a result of this drug and I just want more women to be able to have this drug available to them," says Nikki Fleming.


 

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