Petition to Convert Claritin®, Allegra® and Zyrtec® to OTC Status

5/10/01


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Table of Contents

Petition to Convert Claritin®, Allegra® and Zyrtec® to OTC Status

Why I am here before you today.

History

Status of Petition

Why Did WellPoint Submit the Petition?

PPT Slide

Why Are These Second Generation Antihistamines Prescription Drugs?

Second Generation Antihistamines Meet Requirements for OTC Switch

2nd Generation Antihistamines

Methods

PPT Slide

PPT Slide

Conclusions

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

Conclusions

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

Author: Employee