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ACOG and SMFM weigh in on FDA decision about Compounding Drug used to prevent preterm babies

The following press releases from ACOG, SMFM, FDA, and K-V Pharmaceutical discuss the controversy over Makena.

 Makena™ Price Reduction Is Inadequate
Medical and Clinician Groups Say Price Remains Prohibitive  

Washington, DC, April 1, 2011 -- K-V Pharmaceutical Company announced that it is reducing the cost of its drug Makena™ from $1,500 per dose to $690 per dose, clearly acknowledging the negative impact of their original pricing strategy. Although this may seem like a relatively significant price reduction, unfortunately it remains a woefully inadequate response. This 'lower' price still remains prohibitively high for a safe and effective treatment that is currently available at a much lower price in the form of compounded 17 hydroxyprogesterone caproate (17P).

The American College of Obstetricians and Gynecologists (The College) applauds the US Food and Drug Administration's (FDA) statement that it will not prevent compounding pharmacies from continuing to produce valid prescriptions for 17P, a medication that has been safely used for years to help prevent preterm labor in certain high-risk pregnant women. Although there are clear benefits to having an FDA-approved version of 17P, there is no evidence that Makena™ is more effective or safer than the currently used compounded version. In fact, the evidence used to obtain FDA approval for Makena™ relied primarily on data obtained using the compounded product.

The College, along with the Society for Maternal-Fetal Medicine, American Academy of Pediatrics, American College of Osteopathic Obstetricians & Gynecologists, National Medical Association, American Academy of Family Physicians, American College of Nurse-Midwives, and the Association of Women's Health and Obstetric and Neonatal Nurses, will continue to collaborate to ensure that this medication is accessible and affordable to every pregnant woman who needs it. The US health care system simply cannot be expected to absorb the cost of Makena™ at its current prohibitive price without significant negative repercussions.

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The American College of Obstetricians and Gynecologists (www.acog.org) is the nation's leading group of physicians providing health care for women. As a private, voluntary, nonprofit membership organization of approximately 55,000 members, The American College of Obstetricians and Gynecologists strongly advocates for quality health care for women, maintains the highest standards of clinical practice and continuing education of its members, promotes patient education, and increases awareness among its members and the public of the changing issues facing women's health care. Follow us on Twitter at www.twitter.com/acognews.



Ther-Rx Corporation Takes Action to Further Ensure High-Risk Women
Are Able to Access FDA-Approved Makena™

Announces Reduction in Price and Expansion of Patient Assistance Program for Makena™

St. Louis, April 1, 2011 – As part of its ongoing efforts to ensure that high-risk women have access to FDA-approved Makena instead of unapproved, unregulated compounded drugs, Ther-Rx Corporation, a subsidiary of K-V Pharmaceutical Company (NYSE: KVa/KVb) (the "Company"), announced today important initiatives to reduce the cost of Makena™ (hydroxyprogesterone caproate injection) and encourage stakeholders to provide timely access to this important FDA-approved medication. Effective immediately, Ther-Rx has:

  • Reduced the list price of Makena by nearly 55 percent, to $690 per injection;
  • Will offer supplemental rebates that, in conjunction with the list price reduction and the standard Medicaid rebate of 23.1 percent, will result in a substantially reduced cost per injection for state Medicaid agencies compared to list price. This will help ensure that every woman who is prescribed Makena – regardless of her ability to pay – has the comfort of knowing a medication that has been rigorously reviewed by FDA for safety and efficacy is available to her;
  • Capped the costs for a full course of therapy to a maximum of three vials (15 injections) for contracted health insurance plans and state Medicaid agencies; and
  • Expanded the Company’s patient assistance program for patients who are prescribed this important medication by removing income caps to qualify for financial assistance. 85 percent of patients will pay $20 or less per injection for FDA-approved Makena, and patients whose financial need is greatest would receive FDA-approved Makena at no out-of-pocket cost.

Under the new pricing structure, the Company believes that the use of Makena by eligible patients will deliver net cost savings to Medicaid programs and private insurance plans in year one, based on third-party economic modeling of costs associated with the condition.

“Ensuring access to an FDA-approved sterile, injectable medication, manufactured under mandatory strict quality controls, is in the best interests of all high-risk women,” said Greg Divis, Chief Executive Officer, K-V Pharmaceutical Company and President, Ther-Rx Corporation. “We understand the concerns that key stakeholders raised under our original pricing structure. We also recognize the current budget challenges facing state Medicaid programs and other payers. In conjunction with our substantial reduction in price, it is our sincere hope that all committed stakeholders will take appropriate action to provide timely access to this important FDA-approved medication.”

The FDA granted Makena orphan drug status and approved the drug on February 3, 2011

Importance of an FDA-Approved Medication

Prior to FDA approval of Makena, women who could benefit from therapy faced potential barriers to access due to the absence of a commercially-available, FDA-approved product. In a survey of 345 obstetricians/gynecologists published in the American Journal of Perinatology in March 2009, more than one in three OB/Gyns were “very concerned” about drug availability in the absence of an FDA-approved product. In a survey of over 200 obstetricians/gynecologists and maternal fetal medicine specialists conducted in 2010, the lack of FDA-approved treatment options was cited as the greatest challenge in communicating about the condition with patients.

Physicians recognize the value of prescribing an FDA-approved therapy over an unapproved compounded drug, especially for this high risk patient population. FDA has previously commented that “when pharmacy compounders both operate like drug manufacturers and engage in high-volume distribution, the risk of patient harm increases.” The process for compounding drugs does not require that the drug be made exactly the same way every time, and there are no processes in place to monitor non-FDA approved versions for patient safety. Compounders are not required to test their ingredients or to check the final product for potency or sterility. In a study conducted by the FDA five years ago, one-third of drugs made in compounding pharmacies in that study failed quality testing because the drugs were either too weak or too strong. FDA concluded that “such variability can lead to uncertainty in dosing and raises concern for patient therapy. The results of the survey suggest that problems with the quality of compounded drugs occur throughout the country.”

There are important differences between Makena – an FDA-approved and regulated medication – and individually compounded formulations that are made by hand. As an FDA-approved drug, Makena is manufactured in an FDA-regulated and FDA-compliant, sterile facility. The manufacturing process is tightly controlled to ensure quality and consistency from dose to dose. This also includes follow-up testing and reporting requirements that continue for the lifecycle of the medication.

Investment in Makena

Ther-Rx has made significant investments to advance Makena through an FDA-approval process that began in 2006 and to ensure Makena’s availability. Ther-Rx has invested or committed over a quarter of a billion dollars to-date to bring Makena to market, including more than $60 million in research and clinical trial costs associated with conducting major, multi-year follow-on health studies of Makena involving 1,700 mothers and more than 500 infants. These studies, required by FDA as a condition for Makena’s approval, are being funded by the Company, and such studies are four times larger and approximately 12 times more expensive than the initial National Institutes of Health trial submitted for FDA approval. This research will add important new medical and scientific knowledge and is critical to patients, families and society as a whole.

Because specialty injectable products like Makena are not typically carried by retail pharmacies, Ther-Rx has also made a significant investment in developing a network of specialty pharmacies, specialty distributors, and a comprehensive customer support center to facilitate access to Makena and ensure national availability.

“We reiterate our commitment to patient access to FDA-approved Makena, as exemplified by these important initiatives,” said Divis. “We remain committed to investing in clinical, scientific and product advances to create innovative products and services that will make a difference in the lives of the patients we serve.”

Because of the importance of this medication to high-risk women with a prescription for Makena, the Company will vigorously support the exclusivity of Makena.

About K-V Pharmaceutical Company

K-V Pharmaceutical Company is a fully-integrated specialty pharmaceutical company that develops, manufactures, markets, and acquires technology-distinguished branded prescription pharmaceutical products. The Company markets its technology-distinguished products through Ther-Rx Corporation, its branded drug subsidiary.

For further information about K-V Pharmaceutical Company, please visit the Company’s corporate Website at www.kvpharmaceutical.com.

 


SOCIETY FOR MATERNAL-FETAL MEDICINE COMMENDS FDA ON MAKENA ANNOUNCEMENT   

FDA Announcement Allows Continued Compounding of Drug 

WASHINGTON, DC, March 30, 2011 – The Society for Maternal-Fetal Medicine (SMFM) weighed in on today’s FDA announcement to continue to allow pharmacies to compound hydroxyprogesterone caproate, also known as 17P.  This FDA announcement comes in response to an outcry from SMFM, ACOG and others regarding the costs of the just-released pharmaceutical version of the drug.  The new drug, Makena, made by KV Pharmaceuticals, is being sold at $1,500 per dose as opposed to the pharmacy compound which typically costs $10 to $20 per dose.

“The Society for Maternal-Fetal Medicine commends the FDA on its recently released position that it will exercise enforcement discretion with respect to compounding hydroxyprogesterone caproate,” stated George Saade, president of SMFM.  “This action will ensure that this life-saving treatment will continue to be available for all those who need it.  Affordable access to hydroxyprogesterone caproate is critical in ensuring the health and full-term birth of babies in the U.S.”

Typically, once a drug is approved by the FDA, pharmacy compounding is no longer allowed. The FDA stated that KV Pharmaceuticals had sent “letters to pharmacists indicating that FDA will no longer exercise enforcement discretion with regard to compounded versions of Makena.” The FDA statement goes on to state that “This is not correct.”

The research for Makena was funded by taxpayer dollars which funded the initial clinical trial in 2003 under the auspices of the National Institute of Child Health and Human Development (NICHD) at the National Institutes of Health.  Additional trials were funded by NICHD through its multicenter network of medical institutions over several years.  The studies found that pregnant women who had previously delivered a preterm baby, if treated with weekly injections of hydroxyprogesterone caproate, had fewer preterm babies, and the babies had fewer complications of prematurity.  The drug was also found to be effective in both African American and Non-African American women.  An economic analysis authored by Dr. Balit of Case Western Reserve University showed that weekly injections of compounds similar to Makena, given to at risk women, would dramatically reduce the incidence of premature births—and more over it could save the health care system at least $2 billion per year. 

“When you consider that the ideal treatment for these at-risk women is administered during weeks 16-36 of pregnancy, under KV Pharmaceuticals dramatic increase the total cost for treatment per pregnancy could soar as high as $30,000,” Saade further explained. “This financial barrier could discourage and lockout at-risk women, especially low income women, from receiving this life-saving injection. The FDA announcement will allow all women to continue to receive affordable treatment.”

The Society for Maternal-Fetal Medicine (est. 1977) is a non-profit membership group for obstetricians/gynecologists who have additional formal education and training in maternal-fetal medicine.  The society is devoted to reducing high-risk pregnancy complications by providing continuing education to its 2,000 members on the latest pregnancy assessment and treatment methods.  It also serves as an advocate for improving public policy, and expanding research funding and opportunities for maternal-fetal medicine.  The group hosts an annual scientific meeting in which new ideas and research in the area of maternal-fetal medicine are unveiled and discussed.  For more information, visit www.smfm.org.

 


FDA STATEMENT ON MAKENA

On February 3, 2011, the U.S. Food and Drug Administration approved the drug Makena (hydroxyprogesterone caproate) for the reduction of the risk of certain preterm births in women who have had at least one prior preterm birth. KV Pharmaceuticals, the drug’s owner, received considerable assistance from the federal government in connection with the development of Makena by relying on research funded by the National Institutes of Health to demonstrate the drug’s effectiveness. It also obtained seven years of exclusivity under the Orphan Drug Act, obtained approval under FDA’s accelerated approval program, and received expedited review.

For many years, a version of the active ingredient of Makena, which is a synthetic progestin, has been available to patients whose physicians requested the drug from a pharmacist who compounded the drug. Generally, FDA has exercised enforcement discretion with respect to most products made through traditional pharmacy compounding. This has included products made from the active ingredient in Makena, hydroxyprogesterone caproate.

Because Makena is a sterile injectable, where there is a risk of contamination, greater assurance of safety is provided by an approved product. However, under certain conditions, a licensed pharmacist may compound a drug product using ingredients that are components of FDA approved drugs if the compounding is for an identified individual patient based on a valid prescription for a compounded product that is necessary for that patient. FDA prioritizes enforcement actions related to compounded drugs using a risk-based approach, giving the highest enforcement priority to pharmacies that compound products that are causing harm or that amount to health fraud.

FDA understands that the manufacturer of Makena, KV Pharmaceuticals, has sent letters to pharmacists indicating that FDA will no longer exercise enforcement discretion with regard to compounded versions of Makena. This is not correct.

In order to support access to this important drug, at this time and under this unique situation, FDA does not intend to take enforcement action against pharmacies that compound hydroxyprogesterone caproate based on a valid prescription for an individually identified patient unless the compounded products are unsafe, of substandard quality, or are not being compounded in accordance with appropriate standards for compounding sterile products. As always, FDA may at any time revisit a decision to exercise enforcement discretion.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm249025.htm


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