Entries in Makena (4)


KV Pharma Cuts Price of Costly Premature Birth Prevention Drug

Paul Tearle/Thinkstock(BRIDGETON, Mo.) -- Bowing to heavy pressure from the medical community and the Food and Drug Administration, KV Pharmaceuticals slashed the cost of its expensive drug to prevent premature births, Makena, Friday by half.

KV cut the price of a dose of Makena, its branded version of a progesterone shot that previously sold for $20 a pop, from $1,500 per dose to $690. The company also announced an expanded financial assistance program for obtaining the drug.

But many advocates and organizations working on behalf of maternal health -- such as the March of Dimes, the American College of Obstetrics and Gynecology, the American Academy of Pediatrics and the Society for Maternal Fetal Medicine -- say this pricing Band-Aid won't cut it.

The March of Dimes, which has had a corporate relationship with KV for years, announced it would sever all ties with the pharmaceutical company over the Makena ordeal.

"The company's handling of the launch of Makena, and the initial list price, were highly unsatisfactory and unacceptable to the March of Dimes and the families we represent," the organization said in a press release.

But a recent move by the FDA could open a low-cost way to obtain the progesterone shot.

Under FDA exclusivity rules, production of the cheaper version of the drug by specialty compounding pharmacies would ordinarily have to cease. Following the public outcry over KV's pricing, however, the FDA announced Wednesday that it had no intention of enforcing its own rules, reopening the doors for women to continue to obtain an affordable version of the drug, known clinically as 17P.

KV had sent cease-and-desist letters to compounding pharmacies regarding 17P in error, the FDA said Wednesday, saying it would only step in to halt production when the safety of the product was in question.

The FDA granted KV approval to produce this already-in-use drug in February, a move many maternity experts hoped would offer a more regulated and readily available version of the shot. When KV announced it would charge about hundred times what patients were paying at compounding pharmacies, a firestorm of criticism ensued, and he pharmaceutical company has backpedaled on its pricing.

Even if doctors continue to use compounding pharmacies to get 17-P for their patients, Medicaid and health insurance providers will have to contend with the high price of Makena, leaving maternity care experts asking about patients' access to this important drug, said Dr. M. Kathryn Menard, director of the Center for Maternal and Infant Health at the University of North Carolina School of Medicine.

Several letters were sent to the company in past weeks by leading maternity advocates and public officials, voicing concerns that the price would prevent many women in need from receiving the drug and put a heavy burden on the health care system as a whole, especially Medicaid.

"KV wanted to listen to our concerns. They apologized sincerely for the way this was handled, said they were working with incomplete information. Basically, they're going to take all that listening and go back to the board and make a decision," Menard reported from a meeting with KV.

Copyright 2011 ABC News Radio


FDA May Allow De Facto Generic of Pricey Preemie Drug Makena

Paul Tearle/Thinkstock(WASHINGTON) -- The Food and Drug Administration has no intention of enforcing a regulation that one drug company sought to exploit to drive out competitors, an FDA official told ABC News.

The regulation invoked earlier this month by KV Pharmaceuticals would have allowed the company to corner the market for a drug used to prevent preterm births and sell it for 150 times what had been the going price.

KV Pharmaceuticals gained exclusive rights in February to produce a progesterone shot used to prevent preemie birth that it branded Makena. The shot had been offered by compounding pharmacies for between $10 and $20 per dose, but KV planned to sell it for $1,500 per dose.

The company then sent cease-and-desist letters to compounding pharmacies, saying the FDA would take action against them if they continued to synthesize the drug.

Though the FDA has not made an official statement, an official there, speaking on the condition of anonymity, told ABC News that this "is not correct" -- the FDA would not take action against these companies.

Because the FDA has no control over how companies it grants drug approval set prices, some health care experts said these comments, couched in anonymity, seem like an attempt to lessen the unintended consequences of the decision to grant KV Pharmaceuticals seven years of exclusive rights to the drug under the Orphan Drug Act.

Doctors, however, say they will need more than an anonymous comment to feel comfortable prescribing the unregulated, compounding pharmacy-made version of the drug.

KV Pharmaceutical have responded to the price controversy by announcing 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, KV Pharmaceuticals and partner company Ther-Rx, wrote: "We are committed to taking the appropriate steps to help ensure that all clinically-eligible patients have access to Makena."

Copyright 2011 ABC News Radio


Price of Preventing Premature Births Skyrockets

Comstock/Thinkstock(NEW YORK) -- Preventing preterm births just got 150 times more expensive, now that KV Pharmaceuticals has gained exclusive rights to produce a progesterone shot used to prevent premature births in high-risk mothers.

Although the shot has been available in unregulated form from specialty compounding pharmacies for years for $10 a pop, the Food and Drug Administration recently granted KV Pharmaceuticals sole rights to produce the drug, which will be marketed as Makena and cost $1,500 per dose -- an estimated $30,000 in total per pregnancy.

"Progesterone is so cheap to make and we never had a problem with the compounding pharmacies making it. There's probably some variation between pharmacies, which nobody likes, but nobody likes $1,500 a shot either. That seems like highway robbery," says Dr. Jacques Moritz, director of gynecology at St. Luke's-Roosevelt Hospital in New York.

Though KV Pharmaceuticals plans to offer financial assistance to low-come households in need of the drug, how private health insurance companies and Medicaid will respond to this price spike remains to be seen, leaving many doctors fearing that access to this treatment will become severely limited or interrupted for those currently mid-treatment.

And because FDA laws prohibit compounding pharmacies from making FDA-approved products, doctors will be legally obligated to stop using the cheaper version of this drug, a representative for the company told ABC News.

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.

Dr. Alan Fleischman, medical director of the March of Dimes, which supported the FDA approval, says that the company has promised to make Makena available to all, regardless of ability to pay and the March of Dimes "stands ready to watch that process and hold them to their promise."

Copyright 2011 ABC News Radio 


New Drug May Prevent Premature Births

Photo Courtesy - Getty Images(WASHINGTON) -- The U.S. Food and Drug Administration has approved the first drug to help prevent premature birth in women who have had at least one previous preterm delivery.

"The most common risk factor for preterm birth is recurrence," said Dr. Alan Fleischman, March of Dimes senior vice president and medical director. "This is the first approved drug to prevet recurrence for women who have had a singleton preterm baby and now have a singleton baby," he added.

Makena, expected to reduce the risk of premature births, will in turn, lower the risk of infant complications at delivery, lifelong disabilities such as cerebral palsy and death.

Preterm birth affects one in eight babies born in the United States, according to the March of Dimes.

Copyright 2011 ABC News Radio

ABC News Radio