Table of Contents
Petition to Convert Claritin®, Allegra® and Zyrtec®to OTC Status
Why I am here before you today.
Status of Petition
Why Did WellPoint Submit the Petition?
Why Are These Second Generation Antihistamines Prescription Drugs?
Second Generation Antihistamines Meet Requirements for OTC Switch
2nd Generation Antihistamines
Cost-Effectiveness of Converting Non-Sedating Antihistamines from Rx to OTC Status
Base Case Results
ICER Sensitivity Analysis:Percent Drop in Non-Sedating Price After OTC Conversion
ICER Sensitivity Analysis:Percent of Patients Treated by MD
Precedent for an FDA Initiated OTC Switch
OTC Status of Second Generation Antihistamines is in the Public Interest
Example: Draft Labeling - Loratadine OTC
WellPoint’s Request for the Advisory Committee, FDA and the Industry