December 19, 2012 — KV Pharmaceutical, a St. Louis-based distributor of a drug to prevent premature labor, has sued several state Medicaid officials for restricting the treatment's availability and coverage, the Texas Tribune's "Texas Weekly" reports (Ramshaw, "Texas Weekly," Texas Tribune, 12/18).
FDA approved the drug -- Makena, a synthetic form of the hormone progesterone -- in February 2011 for the reduction of the risk of certain preterm births. Previously, because no commercial product was available, compounding pharmacies dispensed synthetic progesterone for about $10 to $20 per shot.
KV listed the price of Makena at $1,500 and sent letters to compounding pharmacies warning them of potential FDA action if they continued to produce the treatment. However, FDA refused to take enforcement action against the compounding pharmacies (Women's Health Policy Report, 3/31/2011).
KV has filed lawsuits in Georgia, Illinois and South Carolina to compel the states' Medicaid programs to offer and pay for Makena. A federal judge ruled that Georgia's Medicaid program must offer the coverage, while Illinois' Department of Healthcare and Family Services settled its case. In September, a federal judge threw out KV's claims that FDA had not blocked drug compounders from producing a low-cost version of Makena.
Potential Litigation in Texas
Texas might be the next state KV sues for restricting Medicaid coverage of Makena, according to "Texas Weekly." The company disputes Texas' Medicaid policy, which covers the drug for low-income pregnant women only if there is no compounding pharmacy within 50 miles of their doctor's office and none that will deliver. The company also says that it has made Texas' Medicaid program a "fair and compelling supplemental rebate offer" to decrease the drug's price to "well below $300" per injection.
KV says it has not heard from Texas officials since an in-person meeting in August, despite a national meningitis outbreak this fall that was linked to a compounding center. Scott Goedeke, a senior vice president at KV, said, "We don't want high-risk pregnant moms to be the next patient group tragically affected by a problem with a compounded drug when an FDA-approved one is sitting on the shelf ready to ship."
Texas Health and Human Services Commission spokesperson Stephanie Goodman said that an FDA review of samples of the compounded drug from several pharmacies "found no safety concerns" and that the state has not received any complaints regarding the treatment. Goodman said the state will not expand coverage of Makena unless FDA takes action to limit the compounded version ("Texas Weekly," Texas Tribune, 12/18).
Debra Ness, publisher & president, National Partnership
Andrea Friedman, associate editor & director of reproductive health programs, National Partnership
Marya Torrez, associate editor & senior reproductive health policy counsel, National Partnership
Melissa Safford, associate editor & policy advocate for reproductive health, National Partnership
Perry Sacks, assistant editor & health program associate, National Partnership
Cindy Romero, assistant editor & communications assistant, National Partnership
Justyn Ware, editor
Amanda Wolfe, editor-in-chief
Heather Drost, Hanna Jaquith, Marcelle Maginnis, Ashley Marchand and Michelle Stuckey, staff writers
Tucker Ball, director of new media, National Partnership