This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.
Abstract Details
Activity Number:
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595
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Type:
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Contributed
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Date/Time:
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Wednesday, August 4, 2010 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract - #306547 |
Title:
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Statistical Impact on Managed Care Negotiations: Level of Follow-Up and Relevant Endpoints
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Author(s):
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Gary A. Cline*+
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Companies:
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ICON plc
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Address:
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1700 Pennbrook Pkwy, North Wales, PA, 19454,
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Keywords:
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managed ;
ITT ;
endpoint ;
follow-up ;
relevant ;
tier
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Abstract:
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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.
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Authors who are presenting talks have a * after their name.
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