Concerned about Adverse Events HealthTrans Removes Avandia

-Reuters

12/06/2007 - HealthTrans Pharmacy and Therapeutics (P&T) Committee recommended removal of Avandia(R) (rosiglitazone) from its value-based formulary effective Jan. 1 due to concerns surfacing in clinical data in recent months. The P&T Committee also recommended moving ACTOS(R) (pioglitazone) to the third tier of the formulary and to continue monitoring clinical data for both products. This class of drugs is under scrutiny by the Federal Food and Drug Administration (FDA) because of increased adverse cardiac events reported in some type-2 diabetic patients taking either of the medications.

The FDA has issued a "black box" warning for Avandia and is continuing to monitor clinical data for both Avandia and ACTOS as they are in the same category of medication. The committee noted that the FDA has recommended that patients taking these medications, especially those who are known to have underlying heart disease or who are at high risk for heart attack, should talk to their doctor about this information as they evaluate available treatment options for their type-2 diabetes. "Our first concern is the safety of individuals taking medications included in our value-based formulary," said Ryan Haynes, R.Ph., director of clinical services for HealthTrans. "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." In addition to Avandia, other products containing the medication rosiglitazone including Avandamet(R) and Avandaryl(R) were also recommended for removal from the value-based formulary. Other products containing the medication pioglitazone including, ACTOplus met(TM) and Duetact(TM) were recommended to be moved to the third tier of the formulary, Haynes noted. "Our P&T committee, which is comprised of independent physicians, pharmacists, and nurses, is committed to always doing what is best for the patient," said Jack McClurg, CEO of HealthTrans. "This means they have to make some tough decisions about discontinuing drugs that they have determined present significant risks.

We have the flexibility in our system to assist our clients in implementing the recommended strategies while effecting smooth transitions for those members affected by these changes." About HealthTrans HealthTrans, pharmacy benefits administrator, provides employers, third party administrators, brokers, consultants, managed care organizations (MCOs), and other payers with the tools and clinical expertise to more efficiently manage pharmacy benefit programs. HealthTrans' solutions use Web-enabled applications that provide clients with the increased flexibility to manage pharmacy network administration, benefits administration, claims processing, financial reporting, mail order/90 day at retail programs, as well as manufacturers' rebate processing and reporting. HealthTrans has always offered a transparent business model that aligns our goals with those of our clients through full-disclosure and a value-based formulary model that focuses on the lowest overall net drug spend to help them lower pharmacy costs