Virginia Department of Medical Assistance Will Only Provide Coverage for Makena™

Virginia Women’s Center released a statement last week about Makena™ a branded version of progesterone.  Progesterone has been shown to help reduce the risk of preterm birth for some women.  Progesterone treatment has been available two ways.  One is compounding – a prescription is mixed to meet the specific needs of a patient.  Compounding pharmacies are less common than those where you pick up a mass produced prescription.  The other option is Makena™.  But for those in Virginia who are under the Medicaid umbrella the more expensive Makena™ option is the only choice for Medicaid patients and their care providers.

Virginia Women’s Center – “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.

According to Vital Statistics 27% of Virginia births are covered by Medicaid.  Besides the cost of the treatment why does this matter?  A preterm birth is a birth before 37 weeks of gestation.  Preterm babies are at a higher risk for complications and long term disabilities and their health care costs can be 10 times higher than a healthy baby costing society about $26 billion in care, education and loss of productivity.  Preterm birth is the number 1 killer of newborns.

Preterm by maternal age - Sources •National Center for Health Statistics, final natality data. • Retrieved July 12, 2011, from www.marchofdimes.com/peristats.

• National Center for Health Statistics, final natality data. •Retrieved July 12, 2011, from www.marchofdimes.com/peristats.

Preterm rates by county:-  (In 2008 11.3% of live births in VA were preterm)

Chesterfield 12%
Goochland 13.3%
Hanover 13.4%
Henrico 14.6%
Richmond 13.2%

You can learn more about preterm birth and progesterone treatment at March of Dimes site or by contacting our local March of Dimes -Virginia
10128-A West Broad Street
Glen Allen, VA  23060Phone: (804) 968-4120E-mail: [email protected]

Information for this article compiled from March of Dimes, Virginia Department of Health and The Kaiser Family Foundation statehealthfacts.org.