Pricing & the Patented Medicine Prices Review Board

1. Pricing &the Patented Medicine Prices Review Board Joan McCormick Price Regulatory Consulting Brogan Inc.

2. Factors Affecting Drug Pricing • Value • Provincial buying power • Competition • US • PMPRB

3. New Chemical • First to address a new indication Intern’l Median Median of 6 European & US

4. New Chemical • First to address a new indication • About the same as existing • Efficacy & Safety Intern’l Median Median of 6 European & US Therapeutic Class Highest price in therapeutic class

5. New Chemical • First to address a new indication • About the same as existing • Substantially better/safer than existing Intern’l Median Therapeutic Class

6. Modified Timeline Trials Pre-Clinical Clinical NOC First Sale

7. Trials e.g. Prevnar • Define indication • Demonstrate superiority over existing • Identify appropriate (high priced) comparators • Quantify comparable dosage regimens e.g. Fosamax vs Calcitonin

8. Modified Timeline Trials Monograph Pre-Clinical Clinical NOC First Sale

9. Monograph 2 indications or 1 at first sale? • Wording of indication: • Primary indication • Breakthrough indication • Class for comparison • Wording of dosage regimen • Critical in therapeutic class comparison • Maximum normal recommended dosage

10. Modified Timeline Trials Monograph Intern’l Prices Pre-Clinical Clinical NOC First Sale

11. International Prices • International Median • Substantial improvement • Breakthrough • Unofficial tests for Board • International Maximum • Price cap for ALL drugs • Throughout patent life e.g. Starnoc Viread

12. 2003 PMPRB Annual Report

13. Pricing • Advanced planning pays off • International prices • Monograph • Trials • Requires interdepartmental co-operation ….PMPRB is only one factor