A drug company has sued the South Carolina Medicaid agency over its use of a commonly prescribed hormone injection that prevents pre-term births.
K-V Pharmaceutical Co., which filed the suit in U.S. District Court last week, wants to stop the state from using 17P in its low-cost, non-brand version.
That type costs $20 per injection, compared with a list price of about $690 for K-V’s version, called Makena, according to the S.C. Medicaid agency. Medicaid is the state and federally funded health insurance program for low-income mothers, children and people with disabilities.
K-V alleges that the state is using “sham restrictions” to deny Makena to Medicaid patients.
“These unlawful actions ... have placed K-V on the verge of financial failure,” the company said in the suit, noting that K-V is “almost entirely dependent upon sales of Makena.”
S.C. Medicaid officials point out that the non-brand preparation mixed by local pharmacists has been proven safe and effective. Tony Keck, director of the S.C. Department of Health and Human Services, called the suit a “perfect example why health care is so expensive in the United States.”
“Forcing our physicians to use Makena so K-V can meet its quarterly profit objectives is not an option for us,” Keck said in a statement.
K-V, which has filed related suits against Georgia and the U.S. Food and Drug Administration, received FDA approval for Makena in March 2011. Medicaid has been covering the pharmacist-compounded version since 2005.
The low-cost version of the injection — shown to prevent pre-term births in women who already have had premature babies — is embraced by a number of physician and other associations, including the S.C. chapter of the American Congress of Obstetrics and Gynecology, the S.C. Hospital Association and the March of Dimes.
Medicaid covered 17P for 231 South Carolina patients in 2011, the agency said. The state allows doctors to request Medicaid approval for the brand-name version if they have a “medically necessary” reason to prescribe it. The agency has received no such requests.
Keck said K-V is attempting to “force doctors to prescribe a drug they don’t want to use at a cost many times more than the current therapy that is working well to reduce prematurity.”
Charles Rittenberg, an obstetrician at MUSC who specializes in pre-term birth prevention, said Tuesday the brand-name version is unnecessarily costly.
“The active ingredient is all that matters,” Rittenberg said. “There is no specific need for Makena. I have never prescribed it. No doctors have ever asked me about it.”
The state characterized the suit as “a last-ditch effort by K-V to avoid bankruptcy after years of management problems,” noting that the company in 2008 and 2009 struggled with a national recall of all products it manufactured, among other legal problems.
Still, K-V said Makena is safer and more effective than compounded preparations that are not required to meet manufacturing guidelines. The FDA tested both versions, releasing its findings in June.
“Although the analysis of this limited sample of compounded (17P) did not identify any major safety problems, approved drug products, such as Makena, provide a greater assurance of safety and effectiveness than do compounded products,” the FDA said in a release.
Reach Renee Dudley at 937-5550.
or on Twitter @renee_dudley.
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