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Pricing & the Patented Medicine Prices Review Board

Dive into the complexities of drug pricing, from the impact of regulatory boards to the strategies for setting prices based on international comparisons. Explore the factors affecting drug pricing, such as value, competition, and provincial buying power. Learn about the role of the PMPRB and the nuances of pricing new chemicals and therapeutic classes. Gain insights into pricing strategies, clinical trials, and international price comparisons in the pharmaceutical industry.

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Pricing & the Patented Medicine Prices Review Board

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  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

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