FDA Issues Further Guidance About Makena®
FDA recommends healthcare providers prescribe FDA-approved Makena first-line for clinically-indicated patients
St. Louis, MO – July 2, 2012 – K-V Pharmaceutical Company (the “Company”) (NYSE: KV.A/KV.B) today addressed the additional guidance provided by the U.S. Food and Drug Administration (FDA), which issued a Questions and Answers document on June 29 to clarify its June 15, 2012 statement on compounded versions of hydroxyprogesterone caproate (the active ingredient in Makena®). FDA provides further guidance to healthcare providers and pregnant women at high risk for recurrent preterm birth, recommending the use of FDA-approved Makena® rather than compounded drug formulations of hydroxyprogesterone caproate. The agency also describes its enforcement policy towards compounded formulations of hydroxyprogesterone caproate. Makena® is the only FDA-approved medication indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.
FDA’s June 29, 2012 Q&A can be found here:
FDA’s Questions and Answers document recommends that healthcare providers prescribe FDA-approved Makena® first-line for clinically indicated patients and provides guidance on how patients can know if they are receiving Makena®. FDA states, in part:
“It is important for healthcare providers to take the time to read and understand FDA’s Questions and Answers document issued on June 29, and counsel patients accordingly,” said Douglas Laube, M.D., M.Ed., Professor, Department of Obstetrics and Gynecology, University of Wisconsin Medical School, and Former President, ACOG. “I encourage the medical community to help resolve issues in disparity of care that may have resulted from confusion about the differences between FDA-approved and compounded products, and work together towards addressing the issue of prematurity in the United States.”
FDA also describes its enforcement policy towards compounded formulations of hydroxyprogesterone caproate. FDA states:
Tens of thousands of pregnant women at high risk for recurrent preterm birth are being denied FDA-approved Makena® by certain payers whose coverage policies cite outdated March 2011 statements from FDA and the Center for Medicare and Medicaid Services (CMS). As a result of these unreasonable coverage policies, in certain states, Medicaid participants, in particular, have been denied access to the only FDA-approved medication for their condition - despite the clinical judgment made by many healthcare providers that FDA-approved Makena® is the appropriate choice for their patients, and despite FDA’s repeated statements that Makena® offers greater assurance of safety and effectiveness than compounded 17P formulations.
Low-income pregnant women are known to be at higher risk for premature birth. Policies imposed by certain state Medicaid agencies force a pregnant woman at high risk for recurrent preterm birth to “try and fail” or be “unable to tolerate” compounded 17P formulations before the state will approve Makena® for her; others require that she and her physician must demonstrate “medical necessity” for Makena® instead of compounded formulations. These coverage policies disregard guidance issued by FDA and CMS, including the most recent statements. Notably, some states with such policies in place also have prematurity rates above the national average of 12.2 percent - an outcome with heartbreaking results for families and the potential for high life-long medical costs, a significant portion of which will likely be borne by Medicaid.
"Babies born early put a very large financial strain on our healthcare delivery system, and many of these children have persistent developmental delay or lifelong disability. The patient population for Makena® is known to be at particularly high risk for having repeat preterm births,” said Casey Younkin, MD, Associate Professor, Division of General OB/GYN, Southern Illinois University School of Medicine. “Potency and purity can vary in compounded formulations. I want to ensure that all of my patients, regardless of their socioeconomic status, have access to FDA-approved Makena®. It is important for State Medicaid programs - including my home state of Illinois - to examine their coverage policies to ensure they are in alignment with both FDA’s guidance and evidence-based protocols. No other form of progesterone has been determined by FDA to be effective in this patient population.”
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 fraction of the average cost of a preterm birth. Further, patient co-pays are averaging approximately $8 per injection (often less than the cost to patients for compounded drug formulations). The Company provides Makena® at no out-of-pocket cost to clinically-indicated uninsured women through its financial assistance programs.
KV President and CEO Greg Divis commented, “FDA’s further guidance issued on June 29 underscores the need for payers who have made access to Makena difficult to promptly remove roadblocks that have prevented patients from receiving the only FDA-approved drug for their condition. Changing their coverage policies is in the best interests of pregnant women.”
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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