The cost of drugs, to prevent premature birth in high dams will increase from around $ 10 per dose to gold, since the FDA approved the branded version of the treatment.? New medicines is a form of progesterone, which have already been defined for decades and now is made for this purpose by the specific demand known as pharmacies capitalisation.
Now pharmaceutical company, KV new drug named Makena, has warned the capitalisation pharmacies have to bear the FDA action if they still sell nonbranded version drugs, technically known as 17-hydroxyprogesterone caproate. KV for the new drug can cost price means the mother to 30,000 on pregnancy — but some doctors and pharmacists say may be a way to avoid an increase in the prices of mass. (More on time.com: prolonged pregnancy: a new drug to help prevent premature birth)
However, for the first time, why the drug, which has been used for decades suddenly became so expensive? Premature birth affects 1 in 8 pregnancies — some 543,000 deaths annually — resulting in: semi-intensive care and often throughout the life of the disabled child. Is responsible for 26 billion USD per year in medical costs — figure KV refers to justify new prices of Makena.
To help offset the costs of injection weekly, KV only announced the program of the patient assistance for families in financial need. "We established that a comprehensive programme of patient aid as part of our commitment to ensure access to approved FDA Makena all eligible women," KV by CEO Greg Divis said in a statement.
March of Dimes — hundreds of thousands of dollars in donations from KV subsidiary-RX, which will market Makena, which received — supports the introduction of a new drug. "Approved by the FDA the product is good," says Dr. Alan Fleischman, Medical Director of March for Dimes. "Drugs are expensive, but it is very important drugs to very important. The company promised that each woman is eligible whose Doctor recommend it [will be able to obtain it], and the ability to payment shall not preclude the possibility of that. "(More on time.com: expected? The text of the "BABY" for tips for a healthy pregnancy)
However, many other doctors expressed outrage route prices. "This is ridiculous. This medicine has been used for 40 or 50 years, "says Dr. Sam Kim, Director of the Division of reproductive endocrinology and fertility in a hospital at the University of Kansas.
"It's going to be prohibitively expensive for a lot of patients," says Dr. Robin Kalish, Director of maternal fetal medicine clinical at New York Presbyterian/Weill Cornell Hospital in Manhattan.? Adds much research on drugs — including a major study of 2003 showing that drug cuts premature birth by one-third of pregnancies in women carrying one, who previously had premature babies — were financed by the Government.
Because low-income women are at high risk for premature birth, the burden of costs for Makena is falls to Medicaid, which already face massive budget cuts in many countries. Matt Salo, Executive Director of the National Association of Directors of Medicaid told the AP: "there is no question they are inadmissible."
Corresponds to the March of Dimes Fleischman: "programs, Medicaid and insurance companies may only began their discussions with the company". (More on time.com: save lives of mothers with Magic marker)
Already many of the patients and doctors may be wondering whether you can use other types of progesterone to reduce the risk of premature birth, without paying for Makena. In fact, several types are already on the market. Almost all women who have been through in vitro fertilization (IVF) have some form of hormone, or as a Suppository vaginal or intramuscular injections, which are one of the most difficult part of the procedure. These drugs will continue to be available at their current prices, but must be used on a daily basis, rather than once a week as Makena.
"It is possible to use a daily gels, creams, suppositories [or injections]," says John Preckshot, Director of marketing, Professional Compounding centers of America, the leading trade organization representing the specialty pharmacies.? Many of these demand makes version weekly hydroxyprogesterone to prevent premature birth.
A study of Brazilian small stated that daily progesterone vaginal work to reduce the risk of premature birth, notes Kalish, but this was only one small study. (More on time.com: stress does not Hurt the chances of success with IVF)
Preckshot adds that capitalisation pharmacies may still have the option of a different version of hydroxyprogesterone, which would not patent on Makena. "There is the possibility of applying different vehicles, other than used in Makena," says Preckshot, who is also the capitalisation of the pharmacist himself.
"Capitalisation pharmacies have already been at for the patient," says Dr. Kim. "The Problem is, depending on the Pharmacy and depending on who makes it, it changes the — there is always the same level of [hormone in product]. That is the reason, the company took over, but I don't have any problems if the capitalisation of pharmacies, you can continue to do so. "
Still, issues of responsibility may prevent doctors from using the other option, now that the product is branded Federally approved. In addition, have not been tested alternatives. "In theory, you can use any of progesterone. The Problem is, there are no studies [most of these alternatives]. And it is impractical to daily intramuscular fat shots for so many months, "says Dr. Zev Rosenwaks, Director of the Centre Cohen/Perelman Reproductive Medicine at New York Presbyterian/Weill Cornell.
Now it seems with the interests of the KV, insurance companies, the capitalisation of pharmacies, government policies and doctors will determine the impact of Makena prematurity rate and high-risk women access to the substance, which can mean the difference between a normal life and one severe disability of thousands of children.
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