Local OB/GYNs React to the New Cost of Preventing Preterm Labor

Maternal-fetal medicine specialists at Richmond-based medical practice, Virginia Women's Center, react to exorbitant new cost of a previously affordable drug. End Quote

Richmond-Petersburg, VA (1888PressRelease) March 26, 2011 - In an age where government, providers and patients alike are challenged with the goal of reducing health care costs, Virginia Women's Center maternal-fetal medicine specialists, Doctors Jessica DeMay, Rodrick Love and Lisa Troyer, join many who are outraged with the recently released cost structure of Ther-Rx/KV Pharmaceutical, Makena™. Compounded versions of the drug, a form of progesterone which has been proven to help prevent preterm labor, were previously available at the cost of $10 or $20 a dose. Now, Makena™ is available with an astounding price tag - $1500 per dose.

In February of this year, the U.S. Food and Drug Administration gave Ther-Rx/KV Pharmaceutical exclusive rights to sell a branded version of the drug. As Dr. DeMay expressed "we, like others in the field of obstetrics and gynecology, had hoped that the FDA approval would improve the consistency of the drug and increase the accessibility to pregnant women who could benefit from it." It appears that because of the pricing structure of Makena™, as mandated by Ther-Rx/KV Pharmaceutical, the opposite has occurred.

Despite Ther-Rx/KV Pharmaceutical's attempt to implement a financial assistance program to help cover some of the drug's exorbitant costs, physicians question the timeliness and efficiency of treatment, the expense for insurers and government programs and the results that limited access of this drug will have on pregnant women and their newborns.

Patients will now undoubtedly have to navigate paperwork and logistics before meeting the eligibility requirements as set forth by Ther-Rx/KV Pharmaceutical. This will require a great deal of health literacy on the part of the patient, something which cannot be expected of all those in need of treatment. Doctors DeMay, Love and Troyer echo a letter from the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine, which states concern that the Comprehensive Patient Assistance Program "will create a bureaucratic barrier for pregnant women receiving therapy in a timely and efficient manner."

Ideal treatment with Makena™ would begin at approximately 16-18 weeks gestation and continue weekly until 36 weeks gestation. That means that a woman could receive as many as 20 doses during her pregnancy at a cost of approximately $30,000. In the United States, there are over 500,000 preterm births, of which 130,000 to 140,000 may medically qualify for treatment with Makena™. It is unclear how insurers and Medicaid will be able to bear the cost of treatment with Makena™ and it begs the question: which programs will be cut in order to cover the costs of this medication?

The tremendous cost increase in Makena™ will naturally cause less of a demand and therefore less access to this effective drug. Currently, about one in 10 infants are born preterm. Many infants who are born preterm can experience serious illness and even death. The cost of caring for a preterm infant is estimated at $51,000 in the first year alone.

Doctors DeMay, Love and Troyer join other obstetrician gynecologists and professional societies to request that Ther-Rx/KV Pharmaceutical reexamine its pricing structure to ensure that exceptional patient care is at the forefront of the decision. As Dr. Love says, "we have seen this drug allow women to carry babies to full term. These financial barriers will hinder our ability to prevent preterm birth - and that would be heartbreaking."

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