DHH Issues Update to Medicaid Providers on Makena

Wednesday, April 27, 2011  |  Contact: Lisa R. Faust; (225) 342-7913 or (225) 252-3579 (cell)

BATON ROUGE -- DHH Secretary Bruce D. Greenstein and Medicaid Medical Director Dr. Rodney Wise issued the following update to Medicaid providers today regarding the hormone progesterone, commonly known as 17P, which, despite its proven effectiveness in dramatically reducing the risk of a repeat premature birth, has recently been priced at a rate that may keep it out of reach for many Louisiana mothers.

Copy of DHH's letter to Louisiana Medicaid medical providers:

Dear Health Care Providers,

Several months ago, as part of our Birth Outcomes Project, the Louisiana Department of Health and Hospitals authorized Medicaid coverage of the compounded drug 17 alpha-OH Progesterone Caproate (or 17P) for use in Medicaid-covered pregnant women at a high risk of preterm birth. According to most recent data, 15.4 percent of Louisiana babies are born premature-more than double the national average of 7.6 percent.  We also know that the average preterm birth costs the Louisiana Medicaid program $33,433 in the first year of life-compared to only $3,671 for a term birth. The use of 17P has been shown to reduce the instance of repeat preterm births in women carrying a single child by 30 to 40 percent. Considering that our state Medicaid program is on track to cover over 70 percent of the births in this state this year, we recognize Medicaid's unique position to address these alarming statistics.

However, a few months ago, the Food and Drug Administration (FDA) approved an application by KV Pharmaceutical to produce a commercially manufactured version of the drug, named Makena. Currently, we reimburse $20 per dose of 17P in its generic form, which is safely compounded by pharmacists across Louisiana. Upon FDA's approval, KV Pharmaceutical announced pricing of $1,500 per dose and issued cease-and-desist letters to pharmacies compounding the generic form of the drug. KV Pharmaceutical responded to the subsequent outcry by reducing the price of Makena to $690 per dose, but even at this price, it remains out of reach for state Medicaid programs and the women they cover.

As we have been watching this situation very closely, we wanted to share with you the latest news on 17P and Makena and information on where our program stands today.  Following the release of the discounted price, KV Pharmaceuticals announced a 23 percent Medicaid rebate and a patient assistance program. Even with the price reduction and the 23 percent rebate, Makena will cost more than $530 per dose. Additionally, the KV Pharmaceutical patient assistance program only benefits women who do not have coverage of any kind, making Medicaid recipients ineligible.

At the urging of professionals like yourselves, the FDA announced it does not intend to prohibit pharmacies from compounding 17P unless the drugs are "unsafe, of substandard quality, or are not being compounded in accordance with appropriate standards for compounding sterile products." This is good news for Louisiana women. Medicaid will continue to cover the average costs of the compounded version of the drug, and we urge medical professionals to use it in their patients for whom it is indicated.

DHH's Birth Outcomes Project represents a commitment from the department to improve our outcomes, but we will only be successful with the engagement of physicians, expecting moms and all payers. We encourage you to stay engaged in this issue, and we commit to continue fighting any effort to take this life-saving treatment out of reach of vulnerable families. Please feel free to contact us if you have any questions or additional concerns.

Sincerely,

Bruce D. Greenstein                                                              Rodney Wise, M.D.
Secretary                                                                              Medicaid Medical Director

The Louisiana Department of Health and Hospitals strives to protect and promote health statewide and to ensure access to medical, preventive and rehabilitative services for all state citiznes. To learn more about DHH, visit http://www.dhh.louisiana.gov. For up-to-date health information, news and emergency updates, follow DHH's blog, Twitter account and Facebook.

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