February 22, 2005 Medicaid Program Implements Patient Safeguards Against Potentially Dangerous Drugs

BATON ROUGE, Feb 22, 2005 - In light of recent news reports that the pain-relieving drugs Celebrex and Bextra might increase risk for heart attacks and strokes, the Department of Health is placing safeguards in the Medicaid Pharmacy Program to ensure these drugs are prescribed with caution.

Dr. Fred Cerise, secretary of the state Department of Health and Hospitals, will issue a letter to prescribing practitioners and pharmacists within the LDH Medicaid program March 1 informing them of the new policy regarding these drugs, which are part of a class of non-steroidal, anti-inflammatory drugs known as Cox-2 inhibitors.

The letter states that because of possible health risks associated with the use of Cox-2 inhibitors, effective March 15, Medicaid will fill these prescriptions only for recipients who demonstrate a medical need for these medications over an alternative pain reliever such as ibuprofen.

“This is an aggressive, responsible approach to patient safety that will ensure better health outcomes for our Medicaid recipients,” Cerise said.

The Cox-2 inhibitor class also includes the drug Vioxx, which was pulled from the market in September 2004 after studies associated the drug with cardiovascular problems. Celebrex and Bextra could result in similar health risks. The Louisiana Medicaid Drug Utilization Review Board, which provides direction on clinical appropriateness of medications to the Medicaid Pharmacy Program, suggested the state adopt this policy in light of recent reports about these possible adverse events.

“A ‘New England Journal of Medicine’ report showed our Medicaid recipients are prescribed these newer and more costly drugs at a higher rate than 46 other states,” said Medicaid Medical Director Dr. Roxane Townsend, who also provides consultation to the Drug Utilization Review Board. “This is often because of aggressive marketing for these drugs, not because of genuine medical needs for our patients. In many cases, an older and perhaps safer pain reliever would be just as effective and would not pose such a serious risk.”

Kaiser Permanente, the nation’s largest, nonprofit HMO, banned dispensing of Bextra because of safety concerns.

The Food and Drug Administration recently convened an oversight panel to study the regulation and distribution of these medications after reports of the cardiovascular health risks. Although that panel did not recommend pulling Celebrex and Bextra from the market, it did advise placing warning labels on these medications; including more patient information when prescribing; placing restrictions on which patients can and should receive these drugs; and possibly banning direct advertising of these drugs.

Under the new prescribing policy, Medicaid patients could not have prescriptions for these drugs filled without the prescribing practitioner documenting medical justification for using Celebrex or Bextra instead of another pain reliever. Since Cox-2 inhibitors are meant to treat pain without causing damage to the stomach lining, patients with a history of stomach problems, or elderly patients at-risk for stomach problems, are the types of patients appropriately prescribed these medications. For those without such a history, a different medication would be prescribed in place of Celebrex or Bextra.

Physicians will have to indicate approved diagnosis codes for these exemptions for approval and payment of a Cox-2 inhibitor claim.

“This move is an example of the type of work we hope to achieve in our health care reform efforts,” Cerise said. “It is a win-win situation because it promotes patient safety and responsible prescribing, and, like many quality improvement initiatives, it saves costs, since Cox-2 inhibitors are three times more expensive than other pain-relieving drugs. We hope to find and implement more measures such as this one in our Medicaid program.”

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