Avandia has taken another hit on the chin, as two large pharmacy benefit managers announced that they would be dropping the controversial diabetes drug from their value-based prescription drug formularies as of January 1, 2008 because of safety concerns. The decision by HealthTrans Pharmacy and Prime Therapeutics to stop covering Avandia will do little to help sales of the drug, which have gone downhill since it was associated with an increased risk of heart attack in May.
Avandia’s heart attack link came to light when an analysis of 42 clinical trails published by the Cleveland Clinic in May showed that patients taking the drug had a 43% higher risk of having a heart attack. Just last month, the Food & Drug Administration (FDA) announced the addition of a long-awaited black box warning for Avandia’s increased risk of heart attacks. However, many patient advocates and FDA critics thought the black box warning was a weak response to Avandia’s safety issues, and have called on GlaxoSmithKline, the maker of Avandia, and the FDA to pull the drug from the market.
In announcing their decisions, both HealthTrans and Prime Therapeutics said that the safety issues surrounding Avandia where the main reasons for the drug’s removal from their formularies. “Our first concern is the safety of individuals taking medications included in our value-based formulary,” Ryan Haynes, R.Ph., director of clinical services for HealthTrans said in a press release. “Our P&T committee analyzed available data and weighed the benefits with the potential risks and determined that Avandia presents a greater risk for adverse events than benefits at this time.”
HealthTrans and Prime Therapeutics are just the latest healthcare providers to move to limit access to Avandia since issues surrounding its safety came to light. In October, the Department of Veterans Affairs (VA) announced that it was removing Avandia from its prescription drug formulary because of its heart attack risks. The VA said that it would still make Avandia available for patients who were already taking it and wanted to continue. But the decision means that patients not currently prescribed Avandia will not be able to get it through the VA in the future. Prior to its announcement, the VA accounted for about 8% of Avandia sales.
In late November, the American Diabetes Association announced that it was updating its “consensus statement” on the use of oral diabetes medications in light of the increased heart attack risks linked to some diabetes medicines, such as Avandia. The new consensus statement reads in part: “New information suggests additional hazards associated with the use of either thiazolidedione, and rosiglitazone (Avandia) in particular may result in an increased frequency of myocardial infarctions. . . We therefore recommend greater caution in using thiazolidediones, especially in patients at risk of, or with, congestive heart failure.” The American Diabetes Association is one of the most influential diabetes groups in the US, and its recommendations carry a lot of weight with doctors.
Avandia was once GlaxoSmithKline’s second-biggest selling drug, with worldwide revenue of $3.2 billion in 2006, but sales have plunged since May, with US sales down 48 percent in the third quarter from a year ago.