Pricing & the Patented Medicine Prices Review Board Joan M c Cormick Price Regulatory Consulting Brogan Inc.

Factors Affecting Drug Pricing Value Provincial buying power Competition US PMPRB

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

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

Substantially better/safer than existing First to address a new indication About the same as existing New Chemical Intern’l Median Therapeuti c Class

Modified Timeline Pre-ClinicalClinicalNOCFirst Sale Trials

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

Modified Timeline Pre-ClinicalClinicalNOCFirst Sale Trials Monograph

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

Modified Timeline Pre-ClinicalClinicalNOCFirst Sale Trials Monograph Intern’l Prices

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

2003 PMPRB Annual Report

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