Diclegis delayed-release tablets for NVP treatment now eligible for Medicaid coverage

Duchesnay USAJul 9 2013

Duchesnay USA today announced that Diclegis® (doxylamine succinate 10mg, pyridoxine hydrochloride 10mg) delayed-release tablets for the treatment of nausea and vomiting of pregnancy (NVP), more commonly known as morning sickness, is now available for coverage under the state and federal Medicaid program effective July 1st, 2013. July 1st represented the mandatory effective date for state coverage following the execution of a rebate agreement with the Center for Medicare and Medicaid Services (CMS) after the FDA approval of Diclegis on April 8th.

Coverage by Medicaid of Diclegis, the only FDA-approved NVP treatment, complements the numerous commercially insured lives that can currently access the treatment as well. Diclegis is also the only FDA Pregnancy Category A product available to pregnant women in the U.S.

"Having an FDA-approved treatment for nausea and vomiting of pregnancy, or morning sickness, that is safe and effective was just half of the battle," said Gary Hankins, MD, Jennie Sealy Smith Distinguished Professor and Chairman, University of Texas Medical Branch, Department of Obstetrics and Gynecology. "Making it accessible to almost every woman who might need the treatment will finally help fulfill a significant unmet need to the millions of women suffering from NVP."

The Medicaid Drug Rebate Program is a partnership between CMS, state Medicaid agencies, and participating drug manufacturers that helps to offset the federal and state costs of most outpatient prescription drugs dispensed to Medicaid patients. All 50 states and the District of Columbia cover prescription drugs under the Medicaid Drug Rebate Program.

"We believe that women ought to have the option to treat conditions that truly impact them, and Diclegis is the only FDA-approved Pregnancy Category A treatment for NVP," said Gilbert Godin, Chief Executive Officer, Duchesnay USA. "It has been Duchesnay USA's critical focus to make Diclegis, affordable, accessible and broadly available. With Medicaid eligibility, we can help ensure that women of all backgrounds can access this one-of-a-kind safe and effective therapy."