Pricing &Pricing &the Patented Medicine the Patented Medicine Prices Review BoardPrices Review Board

Joan MJoan MccCormickCormick

Price Regulatory ConsultingPrice Regulatory Consulting

Brogan Inc.Brogan Inc.

Factors Affecting Drug PricingFactors Affecting Drug Pricing

• Value

• Provincial buying power

• Competition

• US

• PMPRB

New ChemicalNew Chemical

• First to address a new indicationIntern’lMedian

Median of 6 European & US

New ChemicalNew Chemical

• First to address a new indication

• About the same as existing– Efficacy & Safety

Intern’lMedian

Therapeutic 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 ChemicalNew Chemical

Intern’lMedian

Therapeutic Class

Modified TimelineModified Timeline

Pre-Clinical Clinical NOC First Sale

Trials

TrialsTrials

• Define indication

• Demonstrate superiority over existing

• Identify appropriate (high priced) comparators

• Quantify comparable dosage regimens

e.g. Fosamaxvs

Calcitonin

e.g. Prevnar

Modified TimelineModified Timeline

Pre-Clinical Clinical NOC First Sale

Trials Monograph

MonographMonograph

• 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 TimelineModified Timeline

Pre-Clinical Clinical NOC First Sale

Trials Monograph Intern’l Prices

International PricesInternational Prices

• International Median– Substantial improvement

– Breakthrough

– Unofficial tests for Board

• International Maximum– Price cap for ALL drugs

– Throughout patent life

e.g. StarnocViread

2003 PMPRB Annual Report

PricingPricing

• Advanced planning pays off– International prices

– Monograph

– Trials

• Requires interdepartmental co-operation

….PMPRB is only one factor