Provider Notice issued 05/09/2011

​Coverage of Progesterone Therapy to Reduce the Risk of Preterm Birth

This notice updates the department's policy regarding coverage of progesterone therapy. The American College of Obstetricians and Gynecologists (ACOG) recommends use of progesterone to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. The department covers the following formulations of progesterone: Injectable, oral, vaginal suppository, and vaginal gel. ACOG does not recommend a specific formulation. The department will reimburse providers for progesterone therapy during weeks 16 through 36 of the pregnancy.

After the commercially-available injectable product was removed from the market in 2000, injectable 17α-hydroxyprogesterone caproate (17P) was only available through compounding pharmacies. A commercially-available injectable 17P product is again on the market. This product, Makena, was originally priced at $1,584 per weekly dose. The price has been reduced to 728.64, which is still significantly higher than the $40.00 per dose maximum price for the compounded injectable 17P. Therefore, the department has determined that the oral and vaginal suppository progesterone formulations will be the preferred products, and Makena will require prior approval. Patients must use a four week trial of the oral formulation and a four week trial of the vaginal suppository formulation before Makena will be approved. If a patient cannot tolerate the oral or vaginal suppository formulations, the department will approve Makena.

In the event a provider determines that there is a medical need for a particular variation of the injectable product for a particular patient, requiring the product to be compounded for that patient, the department will continue to cover compounded injectable 17P as a preferred product.

Makena will not be billable through the pharmacy system; it will only be reimbursed when purchased and billed by the administering or ordering prescriber. Compounded 17P, as well as the oral, vaginal suppository, and vaginal gel formulations of progesterone, may be billed through the pharmacy system. The oral and vaginal suppository progesterone formulations do not require prior approval. The vaginal gel will continue to require prior approval.

Effective March 1, 2011, the department raised its maximum allowable rate for injectable 17P to $40.00 per 250mg. injection. This is the rate for either compounded injectable 17P or Makena. As a reminder, providers should bill their usual and customary charge and the department will reimburse the lesser of $40.00 or the provider's charges.

If a provider determines that a patient must use Makena rather than the preferred formulations, the provider can request prior authorization either by fax at 217-524-7264 or 217-524-0404; or by calling the Drug Prior Approval Hotline at 1-800-252-8942.

Questions regarding this notice may be directed to the Bureau of Pharmacy Services at 1-877-782-5565, option 7.

Theresa A. Eagleson, Administrator

Division of Medical Programs