Statistical Impact on Managed Care Negotiations: Level of Follow-Up and Relevant Endpoints

• Activity Number: 595
• Type: Contributed
• Date/Time: Wednesday, August 4, 2010 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Gary A. Cline*+
• Companies: ICON plc
• Keywords: managed ; ITT ; endpoint ; follow-up ; relevant ; tier

Abstract

Some managed care organizations are reviewing established marketed drugs under more stringent guidelines than used by the FDA. Clinical trials conducted 5-10 years ago may be expected to adhere to managed care guidelines created within the last 1-2 years. Tier 2 drugs may be classified as tier 3 or off formulary due to the new reviews. A review by a managed care organization resulted in a lack of coverage for an established marketed drug due to a lower than desired level of follow-up for the ITT population and a perceived lack of clinical relevance for the primary endpoint. An expanded set of statistical analyses that addressed the more stringent criteria resulted in a reinstatement of tier 2 coverage and ~$50MM net outside sales per year. The additional analyses included increasing the number of patients, focusing on relevant endpoints, and conducting a series of robustness analyses.