ATLANTA (CN) - Georgia is violating Medicaid laws by failing to cover Makena, the only drug approved to treat preterm births, a federal judge ruled.
Makena is a progesterone-based drug designed to reduce the risk of premature birth in women pregnant with a single baby who have had a prior preterm birth. After the Food and Drug Administration approved the treatment in early 2011, KV Pharmaceutical charged $1,500 for Makena, while a compounded version was available for $20 a week. KV Pharma lowered the price to $690 in April 2011, but it continued to face protests from patient and doctor groups.
Though the Medicaid Act requires states to cover Makena for its FDA-approved indications, KV Pharma claimed that some states favored a compounded version of the drug over Makena and imposed unlawful restrictions on its product.
It filed federal complaints over the restrictions in Georgia and South Carolina.
In the Georgia case, the drugmaker insisted that Makena is theoretically a "covered outpatient drug." And yet, the Georgia Department of Community Health (DCH) restricted access to Makena by asking physicians to document the "medical necessity" of prescribing it over CHC, short for compounded hydroxyprogesterone caproate.
KV Pharma also sued the FDA in July for allowing compounding pharmacies to offer the lower-cost version of the drug, which contains the same active ingredients, but does not undergo the approval process.
The Northern District of Georgia refused to stay KV Pharma's lawsuit against the state pending the outcome of its action against the FDA, noting that the resolution of that lawsuit is irrelevant to the Georgia case.
U.S. District Judge Charles Pannell ruled that KV Pharma is likely to prove that Georgia Medicaid is breaking the law by failing to cover Makena.
"Because the court finds that the FDA drug approval process means something, the defendants' current policy favoring CHC over Makena is the opposite of what it should be," Pannell wrote. "As a result of the upside-down policy, the FDA-approved drug is not covered."
KV Pharma proved that the loss of revenue from Makena sales had contributed to its financial difficulties, including its filing for bankruptcy earlier this month, the court found.
Though Georgia may pay more for Makena, it will not suffer irreparable damages, and patients will benefit from an FDA-approved drug, the ruling states.
Pannell granted a preliminary injunction to KV Pharma, finding that Makena's Medicaid coverage would not disserve public interest.
"The parties agree that it is in the public interest to prevent preterm births," the ruling states. "Requiring the defendants to take steps to do so by utilizing the only FDA-approved drug as opposed to non-approved CHC, even at a higher cost, advances this public interest."
Makena is a progesterone-based drug designed to reduce the risk of premature birth in women pregnant with a single baby who have had a prior preterm birth. After the Food and Drug Administration approved the treatment in early 2011, KV Pharmaceutical charged $1,500 for Makena, while a compounded version was available for $20 a week. KV Pharma lowered the price to $690 in April 2011, but it continued to face protests from patient and doctor groups.
Though the Medicaid Act requires states to cover Makena for its FDA-approved indications, KV Pharma claimed that some states favored a compounded version of the drug over Makena and imposed unlawful restrictions on its product.
It filed federal complaints over the restrictions in Georgia and South Carolina.
In the Georgia case, the drugmaker insisted that Makena is theoretically a "covered outpatient drug." And yet, the Georgia Department of Community Health (DCH) restricted access to Makena by asking physicians to document the "medical necessity" of prescribing it over CHC, short for compounded hydroxyprogesterone caproate.
KV Pharma also sued the FDA in July for allowing compounding pharmacies to offer the lower-cost version of the drug, which contains the same active ingredients, but does not undergo the approval process.
The Northern District of Georgia refused to stay KV Pharma's lawsuit against the state pending the outcome of its action against the FDA, noting that the resolution of that lawsuit is irrelevant to the Georgia case.
U.S. District Judge Charles Pannell ruled that KV Pharma is likely to prove that Georgia Medicaid is breaking the law by failing to cover Makena.
"Because the court finds that the FDA drug approval process means something, the defendants' current policy favoring CHC over Makena is the opposite of what it should be," Pannell wrote. "As a result of the upside-down policy, the FDA-approved drug is not covered."
KV Pharma proved that the loss of revenue from Makena sales had contributed to its financial difficulties, including its filing for bankruptcy earlier this month, the court found.
Though Georgia may pay more for Makena, it will not suffer irreparable damages, and patients will benefit from an FDA-approved drug, the ruling states.
Pannell granted a preliminary injunction to KV Pharma, finding that Makena's Medicaid coverage would not disserve public interest.
"The parties agree that it is in the public interest to prevent preterm births," the ruling states. "Requiring the defendants to take steps to do so by utilizing the only FDA-approved drug as opposed to non-approved CHC, even at a higher cost, advances this public interest."
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