Louisiana Medicaid restricts Celebrex, Bextra prescription

While the Ministry of Health in New Zealand has concluded that the risks of Cox-2 drugs like Vioxx, Celebrex, and Bextra outweigh their benefits, a FDA panel has recommended that despite such a high level of risks, these drugs should stay on the market with black-box warnings. This is a result of highly confusing research available at this time regarding the safety of these drugs and this poses several challenges to healthcare providers. For instance, Kaiser Permanente has banned Bextra till more data is available on its safety.

In a few weeks it will be known what decision the FDA takes but other decision-makers are trying to play it safe due to ongoing Vioxx, Bextra, and Celebrex litigation. In light of recent news reports that the pain-relieving drugs Celebrex and Bextra might increase risk for heart attacks and strokes, the Louisiana (United States) Department of Health and Hospitals is placing safeguards in the Medicaid Pharmacy Program to ensure these drugs are prescribed only with caution. (Related article: Vioxx sales may resume in the US)

Dr. Fred Cerise, secretary of the state Department of Health and Hospitals, will issue a letter to prescribing practitioners and pharmacists within the DHH Medicaid program March 1 informing them of the new policy regarding these drugs. 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. 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. (Related article: European Union drug authority bans, restricts Cox-2 drugs)

“This is an aggressive, responsible approach to patient safety that will ensure better health outcomes for our Medicaid recipients,” Cerise said. “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.” (Related article: Hundreds of millions of dollars spent on direct-to-consumer advertising for Vioxx, Celebrex, and Bextra by Merck and Pfizer)

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.

Such action by Louisiana may prompt other similar agencies and HMO's to place restrictions on prescription of Cox-2 drugs, particularly after overwhelming evidence that for vast majority of patients, Cox-2 drugs do not provide any additional benefits than Aleve does but could cause significant damage to the heart.

Recommended article: Merck and Pfizer fought a Coke-Pepsi style marketing battle over Vioxx, Celebrex, and Bextra

Useful links:

Louisiana Department of Health and Hospitals

Medicaid