Bartleby
03-29-2011, 08:54 AM
Critics slam cost of FDA-approved drug to prevent preterm births
By Rob Stein, Monday, March 28, 9:07 PM
When a drug to prevent babies from being born too early won federal approval in February, many doctors, pregnant women and others cheered the step as a major advance against a heartbreaking tragedy.
Then they saw the price tag.
The list price for the drug, Makena, turned out to be a stunning $1,500 per dose. That’s for a drug that must be injected every week for about 20 weeks, meaning it will cost about $30,000 per at-risk pregnancy. If every eligible American woman were to get Makena, the nation’s bloated annual health-care tab would swell by more than $4 billion.
What really infuriates patients and doctors is that the same compound has been available for years at a fraction of the cost — about $10 or $20 a shot.
“It’s outrageous,” said Helain J. Landy, chairman of obstetrics and gynecology at Georgetown University Hospital. “Raising the cost of each injection from around $20 to $1,500 is ludicrous.”
The company that owns Makena, KV Pharmaceutical of St. Louis, says the price is reasonable, given that it is spending more than $200 million to develop the drug and conduct follow-up studies that the Food and Drug Administration demands, and because of the savings resulting from preventing preterm births. Through a subsidiary, Ther-Rx Corp., the company created a program to help women who can’t afford it.
“Ther-Rx is fundamentally committed to the community of women, children and families it serves and has been carefully listening to all stakeholders following the announcement of the list price for Makena,” the company said in an e-mail.
Critics are challenging that claim, noting that the main study used to demonstrate the drug’s effectiveness was a $5 million project conducted by the National Institutes of Health — paid by taxpayers.
“It’s not like this drug is something they invented,” said George Saade, president of the Society for Maternal-Fetal Medicine, which, along with the American Congress of Obstetricians and Gynecologists (ACOG) and the American Academy of Pediatrics, sent KV a letter protesting Makena’s price. “I think the company is taking advantage of their FDA approval and their monopoly to make money.”
In addition to making the drug unaffordable for some women, experts fret about the added costs for insurers that choose to pay for it, especially Medicaid programs already being slashed in states struggling with deficits.
“I’m worried about the patients not being able to afford the medication. I’m worried about our health-care system not being able to afford to pay this kind of price for a medication. And I’m worried about a process that enabled a drug that was readily available to go on to be become very expensive,” said Hal C. Lawrence III, vice president of practice activities at ACOG.
The case has put a spotlight on the March of Dimes, which has received about $1 million in donations from Ther-Rx and praised Makena when it was approved, only to later criticize the price.
“They were clearly holding back the price until after the FDA approval process,” said Alan R. Fleischman, March of Dimes’s medical director. “When we found out, we were as outraged as everyone else.”
More than 500,000 of the 4.2 million women who have babies each year give birth prematurely, and many of the babies don’t survive. Those who do are at increased risk for many health problems, including mental retardation, cerebral palsy and autism.
A form of progesterone known as 17P was used for years to reduce the risk of preterm birth, but it fell out of favor after the manufacturing company stopped making it. In 2003, the NIH study showed that 17P could cut the risk of preterm delivery if given in the first 16 to 24 weeks of pregnancy. That led to a resurgence in the use of 17P. Because no companies marketed the drug, women obtained it cheaply from “compounding” pharmacies, which produced individual batches for them.
Doctors and regulators had long worried about the purity and consistency of the drug and were pleased when KV won FDA’s imprimatur for a well-studied version, which the company is selling as Makena.
The approval of Makena gave the company seven years of exclusive rights, and KV immediately fired off letters to compounding pharmacies, warning that they could no longer sell their versions of drug.
More . . .
http://www.washingtonpost.com/national/fda-approval-of-drug-to-prevent-preemies-prompts-price-jump-from-10-to-1500/2011/03/04/AFmRo6qB_story.html?hpid=z3
By Rob Stein, Monday, March 28, 9:07 PM
When a drug to prevent babies from being born too early won federal approval in February, many doctors, pregnant women and others cheered the step as a major advance against a heartbreaking tragedy.
Then they saw the price tag.
The list price for the drug, Makena, turned out to be a stunning $1,500 per dose. That’s for a drug that must be injected every week for about 20 weeks, meaning it will cost about $30,000 per at-risk pregnancy. If every eligible American woman were to get Makena, the nation’s bloated annual health-care tab would swell by more than $4 billion.
What really infuriates patients and doctors is that the same compound has been available for years at a fraction of the cost — about $10 or $20 a shot.
“It’s outrageous,” said Helain J. Landy, chairman of obstetrics and gynecology at Georgetown University Hospital. “Raising the cost of each injection from around $20 to $1,500 is ludicrous.”
The company that owns Makena, KV Pharmaceutical of St. Louis, says the price is reasonable, given that it is spending more than $200 million to develop the drug and conduct follow-up studies that the Food and Drug Administration demands, and because of the savings resulting from preventing preterm births. Through a subsidiary, Ther-Rx Corp., the company created a program to help women who can’t afford it.
“Ther-Rx is fundamentally committed to the community of women, children and families it serves and has been carefully listening to all stakeholders following the announcement of the list price for Makena,” the company said in an e-mail.
Critics are challenging that claim, noting that the main study used to demonstrate the drug’s effectiveness was a $5 million project conducted by the National Institutes of Health — paid by taxpayers.
“It’s not like this drug is something they invented,” said George Saade, president of the Society for Maternal-Fetal Medicine, which, along with the American Congress of Obstetricians and Gynecologists (ACOG) and the American Academy of Pediatrics, sent KV a letter protesting Makena’s price. “I think the company is taking advantage of their FDA approval and their monopoly to make money.”
In addition to making the drug unaffordable for some women, experts fret about the added costs for insurers that choose to pay for it, especially Medicaid programs already being slashed in states struggling with deficits.
“I’m worried about the patients not being able to afford the medication. I’m worried about our health-care system not being able to afford to pay this kind of price for a medication. And I’m worried about a process that enabled a drug that was readily available to go on to be become very expensive,” said Hal C. Lawrence III, vice president of practice activities at ACOG.
The case has put a spotlight on the March of Dimes, which has received about $1 million in donations from Ther-Rx and praised Makena when it was approved, only to later criticize the price.
“They were clearly holding back the price until after the FDA approval process,” said Alan R. Fleischman, March of Dimes’s medical director. “When we found out, we were as outraged as everyone else.”
More than 500,000 of the 4.2 million women who have babies each year give birth prematurely, and many of the babies don’t survive. Those who do are at increased risk for many health problems, including mental retardation, cerebral palsy and autism.
A form of progesterone known as 17P was used for years to reduce the risk of preterm birth, but it fell out of favor after the manufacturing company stopped making it. In 2003, the NIH study showed that 17P could cut the risk of preterm delivery if given in the first 16 to 24 weeks of pregnancy. That led to a resurgence in the use of 17P. Because no companies marketed the drug, women obtained it cheaply from “compounding” pharmacies, which produced individual batches for them.
Doctors and regulators had long worried about the purity and consistency of the drug and were pleased when KV won FDA’s imprimatur for a well-studied version, which the company is selling as Makena.
The approval of Makena gave the company seven years of exclusive rights, and KV immediately fired off letters to compounding pharmacies, warning that they could no longer sell their versions of drug.
More . . .
http://www.washingtonpost.com/national/fda-approval-of-drug-to-prevent-preemies-prompts-price-jump-from-10-to-1500/2011/03/04/AFmRo6qB_story.html?hpid=z3