FDA and CMS Issue Important Updates on Makena®
FDA Emphasizes That it is Applying its Normal Enforcement Policies for Compounded Drugs to Compounded Hydroxyprogesterone Caproate
CMS Reminds States of their “…responsibility to cover FDA-approved products"
St. Louis, MO—June 18, 2012— K-V Pharmaceutical Company (“the Company”) (NYSE: KV.A/KV.B) announced today that the U.S. Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS) both issued updated statements on Makena® that affirm the importance of the only FDA-approved drug for treatment of women with a history of preterm birth. Prior statements by both agencies had been cited by some payers as the basis for denying patients’ access to FDA-approved Makena in favor of unapproved compounded hydroxyprogesterone caproate (17P) formulations.
FDA’s June 15, 2012 update highlights:
For more information about FDA and Pharmacy Compounding, please see the following links:
FDA’s statement also summarized the results of its investigation of a limited number of samples of compounded hydroxyprogesterone caproate API and finished 17P, including the following:
In addition, the Company’s previously reported research found:
More recently, the Company has identified and provided information to the FDA relating to multiple instances of intentionally mislabeled hydroxyprogesterone caproate API sourced from multiple Chinese suppliers.
CMS’s June 15, 2012 update:
In a related statement, CMS also issued an update, which reiterated FDA’s comments that approved drug products, such as Makena, provide a greater assurance of safety and effectiveness compared to compounded products, and also that the compounding of any drug, including hydroxyprogesterone caproate, should not exceed the scope of traditional pharmacy compounding. Additionally, in its June 15 update, CMS:
The Company has identified and informed CMS of certain States that are acting contrary to these established policies by imposing unreasonable conditions, including so-called “prior authorization” procedures that have effectively denied Medicaid participants’ access to Makena. Based on the updated CMS statement of June 15, 2012, we look forward to these States promptly removing these unreasonable conditions and providing unimpeded coverage for FDA approved Makena.
“This is an important day for pregnant women who can benefit from Makena,” said Greg Divis, President and CEO. “Healthcare providers have advocated for unencumbered access to FDA-approved Makena. We believe the announcements from these two key agencies are a clear signal that the compounding of hydroxyprogesterone caproate should not exceed the scope of traditional pharmacy compounding and that payers who have made access to Makena difficult should remove roadblocks that have prevented patients from receiving the only FDA-approved drug for their condition.”
As part of its commitment to patients and healthcare providers, the Company has made substantial efforts to work with payers to facilitate insurance coverage of Makena®. The Company’s significantly reduced pricing to both commercial and Medicaid payers make the cost of a full course of therapy a small fraction of the cost of the average preterm birth. Further, patient co-pays are averaging approximately $8 per injection (often less than the cost to patients for compounded 17P formulations). The Company provides Makena at no out-of-pocket cost to uninsured women through its financial assistance programs.
The Company has entered into agreements with a number of States that provide unencumbered access to Makena for eligible patients. With the support of the June 15 statement by CMS, the Company looks forward to working with all payers to help ensure patient access to Makena, especially Medicaid payers, because low-income pregnant women are known to be at higher risk for premature birth.
“As a high-risk pregnancy specialist caring for women who are at risk of preterm birth, I need to be able to prescribe medications that have been tested and proven effective,” said Sean C. Blackwell, MD, Interim Chair, Department of Obstetrics, Gynecology and Reproductive Sciences at the University of Texas Health Science Center in Houston, Texas. “Pregnant women deserve to have access to FDA-approved medications. I am hopeful that the policy modification from CMS will help to remove obstacles that have prevented some Medicaid participants from getting the same 17P formulation that was utilized in the NICHD Maternal Fetal Medicine Units Network clinical trial and was compliant with Good Manufacturing Practices.”
The full FDA and CMS updates can be found here.
New Global Report Says U.S. Lags Behind 130 other Nations in Preterm Birth Rate
The report, containing the first-ever estimates of preterm birth rates by country, was published in May 2012 by The March of Dimes Foundation, The Partnership for Maternal, Newborn & Child Health, Save the Children, and The World Health Organization, and represents almost 50 United Nations agencies, universities, and organizations.
Preterm babies are born at a higher rate in the United States than in 130 other countries of the world, including many poorer nations, according to the just-released report Born Too Soon: The
Global Action Report on Preterm Birth. The report ranks the U.S. 131st in the world in terms of its preterm birth rate of 12.0 per 100 live births. Nearly half a million babies are born too soon in the U.S. each year.
About Makena® (hydroxyprogesterone caproate injection)
Makena is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. The effectiveness of Makena is based on improvement in the proportion of women who delivered <37 weeks of gestation. There are no controlled trials demonstrating a direct clinical benefit, such as improvement in neonatal mortality and morbidity.
Limitation of use: While there are many risk factors for preterm birth, safety and efficacy of Makena has been demonstrated only in women with a prior spontaneous singleton preterm birth. It is not intended for use in women with multiple gestations or other risk factors for preterm birth.
Important safety information for Makena (hydroxyprogesterone caproate injection)
About K-V Pharmaceutical Company
K-V Pharmaceutical Company is a specialty branded pharmaceutical company with a primary focus in the area of women’s healthcare. As such, we are committed to advancing the health of women across all the stages of their lives.
For further information about K-V Pharmaceutical Company, please visit the Company’s corporate website at www.kvpharmaceutical.com.
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