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January 21, 2014 David Moroney, MD Chief Medical Officer BlueCare Tennessee 1 Cameron Hill Circle Chattanooga, TN 37402-0001 Dear Dr. Moroney, As a collective voice of multidisciplinary practitioners who support the health and wellbeing of pregnant mothers and their babies, we respectfully ask for your reconsideration of coverage for Diclegis. Currently, Diclegis is the only U.S. FDA approved, Pregnancy Category A medication for the treatment of Nausea and Vomiting of Pregnancy (NVP), also known as morning sickness, in women who do not respond to conservative management such as dietary and lifestyle modifications. NVP is a very common medical condition in pregnancy and affects 50-90% of pregnant women. Although typically known as morning sickness, nausea and/or vomiting can occur at any time of the day and for varying periods of time during pregnancy. Whether symptoms are mild or severe, NVP can have a major impact on a woman’s quality of life. Maternal stress is known to effect pregnancy and fetal outcomes. Pregnant women should not be forced to ignore symptoms, remain ill, and/or take treatments that are not proven to be safe and effective during pregnancy. Until the approval of Diclegis in April 2013 , there were no FDA-approved therapies to treat NVP in the U.S. In the absence of an approved medicine for NVP, prescribers have had to rely on options including diet and alternative therapies or taking drugs “off label”. Current restrictions affecting access to Diclegis are inconsistent with best clinical practices and often require a vulnerable population to be forced to use treatments that are not yet evaluated or determined to be safe and effective for pregnant women. We ask that you remove restrictions to the use of Diclegis and follow appropriate protocols by giving pregnant women access to the only FDA-approved, Category A medication available to date for NVP. Access to Diclegis should not be conditional on the prior utilization of an unapproved drug that has not been developed or studied for use during pregnancy.

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Respectfully Submitted, National Perinatal Association - Bernadette Hoppe, M.A., J.D., M.P.H., President National Association of Hispanic Nurses – Jose Alejandra, PhD, RN-BC, MBA, CCM, FACHE, President HealthyWomen – Beth Bettaglino, RN, President & CEO National Association of Perinatal Social Workers – Lisa Baker, Ph.D., L.C.S.W., P.I.P., President Alliance for Patient Access – Brian Kennedy, Executive Director National Healthy Mothers, Healthy Babies Coalition – Janice Frey-Angel, CEO Center for Medicine in the Public Interest – Peter Pitts, President