Local OB/GYNs Urge Medicaid to Reconsider Coverage for Preterm Labor Drug

RICHMOND, VA, July 10, 2011

The Department of Medical Assistance Services (DMAS), the agency that administers Medicaid, has taken a strict interpretation of a Virginia statute regarding the compounding of a drug that can prevent preterm labor. Dr. Kay Stout of Richmond-based Virginia Women's Center remarked that "when there is the option for patients with Virginia Medicaid to receive this drug for $2,000 per pregnancy, why is it required that they receive the drug at $13,800 per pregnancy?"

In February of this year, the U.S. Food and Drug Administration gave Ther-Rx/KV Pharmaceutical exclusive rights to sell Makena , a branded version of progesterone which has been proven to help prevent preterm labor. Prior to Makena , the drug had been compounded by pharmacies for $10 or $20 a dose. Makena was priced at $1,500 per dose, an exorbitant cost considering a patient could receive as many as 20 doses during her pregnancy. In response to outraged medical societies and many obstetrician gynecologists, including the maternal-fetal medicine specialists at Virginia Women's Center, Ther-Rx/KV Pharmaceutical revisited their pricing structure and now sells Makena at $690 per dose. The U.S. Food and Drug Administration also informed compounding pharmacies that they were not required to "cease and desist" as they had been told by Ther-Rx/KV Pharmaceutical and that there would be no penalty for continuing to sell the compounded version of the drug.

In April, DMAS informed medical providers in the state of Virginia that due to a Virginia statute which regulates the practice of compounding, DMAS will only provide coverage for Makena . Not only will Virginia's taxpayers be burdened by this, but also Virginia's medical providers as they are now required to bear the costs of Makena up front.

Medical providers who choose to prescribe Makena to patients with Medicaid are required to purchase Makena for $3,450 per five dose vial and then provide an actual invoice after each dose is administered in order to be reimbursed for the cost of the drug. Because the potential always exists for injections to be overdrawn, the providers run the risk of losing $690 with each five dose vial that they purchase. By adhering to this procedure, medical providers also run the risk that doses could expire, not to mention the additional administrative work that is involved.

In an age where government, providers and patients alike are challenged with the goal of reducing health care costs, Virginia Women's Center providers urge DMAS to reconsider this strict adherence to Virginia statute in the case of Makena to ensure that all patients, no matter their insurance, are able to receive this beneficial drug in the most cost-effective way possible.

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