Maternity Advocates Challenge High Cost of Preterm Birth Drug


Many doctors are particularly frustrated with the price hike because to date, KV Pharmaceuticals has not had to bear the cost of the clinical trials used to get the drug approved, but they have announced plans to conduct further trials in the future.

"All the upfront development of the drug was done by the National Institute of Health. You and I paid for that with our tax dollars, it's not like this pharmaceutical company is trying to recoup its investments in research and development, as is usually the reason for the price of new drugs," says Dr. Kevin Ault, associate professor of gynecology and obstetrics at Emory University School of Medicine.

"And at $1,500 a shot ... to put it in perspective: If I were your obstetrician, and you had a normal delivery, including about eight office visits, I would be paid $2,500 in total for that. It's hard for me to believe that we're going to tack on 10 times that amount just for one treatment," he says.

Is Financial Assistance for Low-Income Households Enough?

Dr. M. Kathryn Menard, the Director of Maternal Fetal Medicine at the University of North Carolina School of Medicine, has been working for several years to expand the use of Hydroxyprogesterone caproate for high-risk pregnant women in North Carolina. The drug's importance, she says, cannot be understated. "This is the only evidenced based approach we have, medication we have to prevent pre-term birth."

Menard said, like others in the field, she had supported efforts to win FDA approval for the drug, believing it "would make it easier for our patients to get the drug." Now, she says, she is outraged. "This financial barrier, we see it as insurmountable."

After weeks of public opposition to KV pharmaceutical's pricing of Makena the March of Dimes, American College of Obstetrics and Gynecology, the American Academy of Pediatrics and the Society for Maternal Fetal Medicine will meet today with the company to urge them to reconsider their pricing.

KV Pharmaceutical's response to the price controversy has been to announce a Comprehensive Patient Assistance Program for Makena in which households, both insured and uninsured, making less than $100,000 a year will be subsidized.

In a statement to ABC News, drugmakers KV Pharmaceuticals and partner company Ther-Rx, write: "We are committed to taking the appropriate steps to help ensure that all clinically-eligible patients have access to Makena."

This translates into providing the drug for free to households making less than $60,000 annually who "apply for and are eligible for patient assistance." Those making $60,000 to $100,000 will be able to obtain it "at a cost that is comparable to the average copay assigned by commercial insurance," and those who are insured and make less than $100,000 will have a copay of $20 or less guaranteed to them, according to a company statement.

This contingency plan raises concerns for doctors, however. Those households making more than $100,000 a year cannot necessarily afford to devote as much as a third of their income to pay for Makena if their insurance does not cover the procedure, says Lindsay.

In addition, those receiving financial assistance will need to go through an approval process that may delay treatment, which could result in preterm birth for many patients, Moritz says.

ABC News' Lisa Stark contributed on this report

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