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Health Canada calls for new tools to control drug prices: What will it mean for patients?
June 8, 2017
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1. Context: How We Got Here
2. Price Regulation Reforms
3. PMPRB 101: How it Works
4. Proposed Changes
5. Consultation Timeline
6. Qs & As – Discussion
What we’ll discuss
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1. CONTEXT: HOW WE GOT HERE
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Drug plan budget growth
International price
comparisons
Rationale for reforms on pharma prices
Medication spending growth
Total drug expenditure compared to
other countries
Growing number of medicines with high per-patient
prices
Step towards national
pharmacare (first – bring prices down)
R&D spending levels in Canada
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Federal health minister’s pharmaceutical priorities: affordability, accessibility, and appropriateness
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Proposed reform package
May 16, 2017 – accessibility, affordability and appropriateness of prescription drugs:
National Formulary
• Changes to the pricing framework of the Patented Medicine Prices Review Board
• Development of a national formulary
• More resources for the pan-Canadian Pharmaceutical Alliance
• An aligned and parallel system for regulatory and HTA reviews
• e-Prescribing
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2. PRICE REGULATION REFORMS
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Evolution of PMPRB’s modernization
Dec. 15, 2015 May 16, 2017
Jun. 24, 2016
Consultation Opportunity
Submissions due Jun. 28, 2017
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Drug Development
Health Canada Review
Patented Medicine Prices Review Board
Patient Access
Late 1980’s: PMPRB was the
only organization reviewing drug
prices
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Drug Development
Health Canada Review
Patented Medicine Prices Review Board
Health Technology Assessment
Hospitals
Patient Access
Private Drug Plans Public Drug Plans
Today: dozens of
organizations that review drug prices
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3. PMPRB 101: HOW IT WORKS
P P M R B
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What is the PMPRB?
• Quasi-judicial federal agency • Regulates medication prices while they are under patent • Reports to the federal health minister • Twofold mandate
– Regulatory – Ensures that prices charged by patentees for patented medicines sold in Canada are not “excessive”
– Reporting – Tracks pricing trends related to all medicines and the research and development spending of patentees
• Classifies medicines based on level of therapeutic improvement
• Ex-factory price regulated – not consumer price • PMPRB approval of price not required before sale
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Pricing regulation – PMPRB Tests
International Comparisons
(7 comparator countries)
FRANCE UK
GERMANY ITALY
SWEDEN USA
SWITZERLAND
Level of
Clinical
Improvement
Price Test All Patented
Medicines
Breakthrough Median International Price
Prices of patented medicines can never exceed the International Maximum Price (i.e., the highest price among the PMPRB7 comparator countries
Substantial improvement
Higher of the Therapeutic Class Comparison (TCC) and the International Median
Moderate improvement
Midpoint of the Therapeutic Class Comparison and International Median (but not lower than the TCC)
No or little improvement
Therapeutic Class Comparison or Reasonable Relationship Test
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Pricing regulation – monitoring by PMPRB
• Price can never be higher than highest international price
• Maximum allowable price set at launch
• Annual price increases limited to inflation
• Regular reporting requirements by manufacturers
• Four market segments - retail, distributor, pharmacy and hospital
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Pricing Regulation - Enforcement
• Investigations
• Non-compliance options
– Board orders
– Voluntary compliance undertakings (VCUs)
• Federal court
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4. PROPOSED CHANGES
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1. Proposed New Factors
• Pharmacoeconomic (P/E) evaluations
• Potential pre-determined threshold levels / QALYs
• Size of the potential market
• Per capita GDP
The paper asks: • Are the proposed new factors important
considerations? • What other factors could be included and how should
they be used?
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2. List of Comparator Countries
The paper asks: • Other countries? • Criteria?
Current list: Proposed list (May 2017):
FRANCE UK
GERMANY ITALY
SWEDEN USA
SWITZERLAND
FRANCE UK
GERMANY ITALY
SWEDEN AUSTRALIA
BELGIUM
JAPAN
NORWAY
S. KOREA
NETHERLANDS SPAIN
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3. Patented generics
• Elimination of active monitoring of patented generics
The paper asks: “Should generic medicines covered by patents only report to PMPRB based on a complaint?”
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4. New reporting requirements
• Requirements to provide pharmacoeconomic analyses
The paper asks: Is the information relevant, sufficient and available?
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5. Requirements to report tebates
• Submission of discount/rebate information by patentees
The paper asks: Is there any reason why such disclosures should not be required?
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5. CONSULTATION TIMELINE
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Implementation Timeline
May 16
Consultation document released – open for stakeholder
input until June 28, 2017
Fall 2017
Draft regulations will be published in
Canada Gazette Part-1 along with regulatory
impact analysis statement (RIAS)
2018
Review of comments/input on draft regulations and development of final
regulations to be published in Canada
Gazette Part-2
75-day consultation period
End of 2018
Minister Philpott hopes to conclude the regulatory amendment
process by this time
…2019
Revisions to Guidelines – Operational Issues
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Economic factors
Proposed changes
Reporting rebates
Consultations /engagement
Drivers for proposed changes
Timely access to new medicines
Affordability
Access to clinical trials
Comparator countries
William (Bill) Dempster [email protected]
613.800.8344 (direct)
613.614.0283 (mobile)
Gerry Jeffcott [email protected]
613.851.1602 (mobile)
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Canadian Cancer Survivor Network Contact Info
Canadian Cancer Survivor Network
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