March 14, 2011
Greg Divis, President
One Corporate Woods
Bridgeton, Missouri 63044
Dear Mr. Divis:
I write to share the serious concern of the March of Dimes about access of clinically eligible women to the newly approved drug for prevention of preterm birth recurrence, MakenaTM. As you are aware, the March of Dimes co-sponsored a scientific symposium in 2004 to review the details of the National Institutes of Health (NIH) prevention trials with the drug, and was among the health care leaders who reviewed the compelling scientific evidence of the effectiveness of 17 α- hydroxyprogesterone caproate (17P) to prevent preterm birth. We supported the clinical guidelines of the American College of Obstetricians and Gynecologists that recommended the use of 17P for selected patients at risk for recurrence of preterm birth. We were supportive of expedited review of 17P by the FDA because of our understanding of the efficacy of the drug and the known benefits to access, quality, and consistency of having the good manufacturing practices of a regulated pharmaceutical company responsible for drug production and distribution.
As FDA approval seemed imminent, March of Dimes leaders met with your staff and were assured that every effort was being made to standardize distribution methods, work with physicians and patients to streamline insurance and managed care issues, and most importantly, to ensure that every eligible patient who is offered the drug by her physician has access to the drug regardless of ability to pay. Your staff described the “care connection” program that has been created to assure all of these aspects of drug supply and availability, including a substantial financial assistance program for uninsured and under-insured women both in the private and public sectors. They also described efforts to work with public payers to assure access to 17P at reasonable costs for Medicaid, and other public health insurance plans.
However, since its approval on February 4, 2011, there have been numerous reports that the price of a course of treatment with MakenaTM could reach $30,000, thus raising questions about whether health plans and public insurance programs like Medicaid and CHIP will cover it. So we remain deeply concerned that the cost of this lifesaving treatment could be put out of reach to thousands of women at risk for preterm delivery.
Therefore, we respectfully request that you reconsider the market price of MakenaTM and commit your company to the promise that every eligible woman who is offered the drug will receive it without regard to ability to pay. The March of Dimes is prepared to work with Ther-Rx to help prevent preterm birth and we hope that you will be responsive to our concerns.
Jennifer L. Howse, PhD Alan R. Fleischman, M.D.
President Senior Vice President and Medical Director
c: Scott Goedeke, Senior Vice President, Marketing -- Ther-Rx Corporation