Pricing

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

Internl Median
Median of 6 European US
4
New Chemical

• First to address a new indication
• About the same as existing
• Efficacy Safety

Internl Median
Median of 6 European US
Therapeutic Class
Highest price in therapeutic class
5
New Chemical

• Substantially better/safer than existing

• First to address a new indication
• About the same as existing

Internl Median
Therapeutic Class
6
Modified Timeline
Trials
Pre-Clinical
Clinical
NOC
First Sale
7
Trials

• Define indication
• Demonstrate superiority over existing
• Identify appropriate (high priced) comparators
• Quantify comparable dosage regimens

e.g. Prevnar
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
Internl 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