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

Petition to Convert Claritin®, Allegra® and Zyrtec® to OTC Status. Robert Seidman, PharmD, MPH Chief Pharmacy Officer WellPoint Health Networks. FDA Pulmonary and OTC Advisory Committee Meeting May 11, 2001. Why I am here before you today. . History.

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

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  1. Petition to Convert Claritin®, Allegra® and Zyrtec®to OTC Status Robert Seidman, PharmD, MPH Chief Pharmacy Officer WellPoint Health Networks FDA Pulmonary and OTC Advisory Committee Meeting May 11, 2001

  2. Why I am here before you today.

  3. History • Blue Cross of California, a subsidiary of WellPoint Health Networks • Filed a Citizen Petition with FDA on July 22, 1998 under 21 CFR 10.30 • Requesting that 2nd generation antihistamines and antihistamine/decongestant combinations be switched to over-the-counter status • Claritin®, Claritin-D® • Allegra®, Allegra-D® • Zyrtec®

  4. Status of Petition • No FDA decision • Petition pending for almost 3 years • January 1999 • FDA letter from Dr. Woodcock • Petition presents complex issues • FDA needs more time to evaluate • June 2000 • FDA hearing to review Rx to OTC process • May 2001 • FDA hearing to discuss the WellPoint petition

  5. Why Did WellPoint Submit the Petition? • Patients are seeking greater ownership and control over their healthcare; • Prefer to self-medicate where appropriate and feasible; • More convenient for patients; • Patients can decide when they need to use antihistamines and antihistamine/decongestant combinations; • Already over 100 different antihistamines and antihistamine/decongestant combinations OTC; and • Rising cost of Rx drugs is making it difficult to provide an affordable, broad-based prescription benefit.

  6. Recognition of the Problem Antihistamines (Oral) Percent Increase in Sales, 1993-1998 612% Antidepressants Cholesterol Reducers Anti-ulcerants 240% 194% 71%

  7. Why Are These Second Generation Antihistamines Prescription Drugs? • Durham-Humphrey Amendment to Federal Food, Drug and Cosmetic Act (1951) A drug is expected to be made available without a prescription if, by following the labeling, consumers can use it safely and effectively without professional guidance.

  8. Second Generation Antihistamines Meet Requirements for OTC Switch Answer - Yes • Can the condition be adequately self diagnosed? • Can the condition be successfully self-treated? • Is the self-treatment product safe and effective for consumer use, under conditions of actual use? Answer - Yes Answer - Yes

  9. 2nd Generation Antihistamines • Effective for relieving symptoms • Runny nose, sneezing, itching of the nose or throat and itchy, watery eyes • Less side effects than 1st generation antihistamines currently available OTC • Less sedation (drowsiness) • Less anticholinergic effects (dizziness, blurred vision, dry mouth, etc.)

  10. Evidence Report:Efficacy and Toxicity of Selected 1st and 2nd Generation Antihistamines Methods Jack Kern, Pharm.D. Assistant Professor of Clinical Pharmacy University of Southern California School of Pharmacy • Literature • Identify all RCTs with selected antihistamines (reference librarian) • Reject/accept references • Screen titles, abstracts and references • Build evidence tables • Significant factors! • Build shrinkage plots (statistician) • Discussion and understanding

  11. Meta-Analysis Summary of Global Efficacy

  12. Meta-Analysis Summary of Sedation

  13. Conclusions • The quality of these studies is high • 2nd generation antihistamines are as effective as the 1st generation products • 2nd generation antihistamines are saferthan the 1st generation products

  14. Cost-Effectiveness of Converting Non-Sedating Antihistamines from Rx to OTC Status • Decision-analytic model • Perspective: Societal • Period: One year • Cohort: Adult population in the U.S. • Comparison: Prescription loratadine vs. over-the-counter loratadine • Impact: Effects of sedation on motor vehicle accidents • Output: Incremental cost per quality-adjusted life year Michael B. Nichol, Ph.D., Patrick Sullivan, Ph.D. (cand.) University of Southern California School of Pharmacy

  15. Base Case Results • The Incremental Cost-Effectiveness Ratio (ICER) for the base case analysis is a savings of more than $62,000 per quality-adjusted life year • Using the same base case values, an alternative estimate produced a savings of more than $98,000 per life year saved

  16. ICER Sensitivity Analysis:Percent Drop in Non-Sedating Price After OTC Conversion Cost/QALY Base Case 66% Drop $50K/QALY breakeven point: 27.5% drop Percent

  17. ICER Sensitivity Analysis:Percent of Patients Treated by MD Cost/QALY Base Case: 12% Treated by MD Base Case: 12% Treated by MD Percent

  18. Conclusions • Preliminary evidence suggests that converting non-sedating antihistamines to over-the-counter status would be cost-saving to society as a result of reductions in motor vehicle accidents • Additional factors should be incorporated into a final model: • Inappropriate treatment with OTC non-sedating antihistamines • Modeling effect of OTC availability on price and demand • Refining incremental QALY improvements due to availability of non-sedating antihistamine • Impact on workplace productivity

  19. Precedent for an FDA Initiated OTC Switch • FDA initiated the OTC switch of Alupent® (metaproterenol) inhaler in 1982 • FDA did not seek input from an expert advisory panel or the public before permitting the drug to be marketed as an OTC drug product • FDA received comments and public criticism from physicians who felt they should have been consulted prior to the switch • FDA reiterated that it believed Alupent® to be safe for OTC use, but switched the drug back to Rx status

  20. OTC Status of Second Generation Antihistamines is in the Public Interest • The products meet all requirements for OTC status • Long history of OTC marketing around the world • Drugs are effective and safe • Lower incidence of side effects than existing OTC antihistamine products • Switching the products to OTC status will make safer products accessible to the public

  21. Example: Draft Labeling - Loratadine OTC INDICATIONS: For the temporary relief of sneezing, itchy, watery eyes, itching of the nose or throat and runny nose due to hay fever or other upper respiratory allergies. DIRECTIONS: ADULTS AND CHILDREN 6 YEARS AND OVER One tablet once daily. Do not exceed recommended dosage. Prolonged usage should only be on the advice of a physician. WARNINGS: If you are pregnant or nursing a baby seek the advice of a health care professional before using this product. KEEP THIS AND ALL OTHER DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

  22. WellPoint’s Request for the Advisory Committee, FDA and the Industry • Advisory Committee • Vote today to recommend OTC status • FDA • Act swiftly to switch the products to OTC status • Industry • Work with the Agency to make these safe and effective second generation antihistamines readily available to the U.S. public

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