The Canadian Cancer Survivor Network is pleased to offer a webinar titled “Health Canada calls for new tools to control drug prices: what will it mean for patients?”. This webinar will summarize the various pharmaceutical pricing reforms recently announced by federal health minister Dr. Jane Philpott and examine their potential effects on patient access to new innovations.

1. 1
Health Canada calls for
new tools to control drug prices:
What will it mean for patients?
June 8, 2017

2. 2
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

3. 3
1. CONTEXT: HOW WE GOT HERE

4. 4
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

5. 5
Federal health minister’s pharmaceutical priorities:
affordability, accessibility, and appropriateness

6. 6
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

7. 7
2. PRICE REGULATION REFORMS

8. 8
Evolution of PMPRB’s modernization
Dec. 15, 2015 May 16, 2017
Jun. 24, 2016
Consultation
Opportunity
Submissions due
Jun. 28, 2017

9. 9
Drug Development
Health Canada
Review
Patented Medicine
Prices Review Board
Patient Access
Late 1980’s:
PMPRB was the
only organization
reviewing drug
prices

10. 10
Drug Development
Health Canada
Review
Patented Medicine
Prices Review Board
Health Technology
Assessment
Hospitals
Patient Access
Private Drug PlansPublic Drug Plans
Today:
dozens of
organizations that
review drug prices

11. 11
3. PMPRB 101: HOW IT WORKS
P PM R B

12. 12
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

13. 13
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

14. 14
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

15. 15
Pricing Regulation - Enforcement
• Investigations
• Non-compliance options
– Board orders
– Voluntary compliance
undertakings (VCUs)
• Federal court

16. 16
4. PROPOSED CHANGES

17. 17
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?

18. 18
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

19. 19
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?”

20. 20
4. New reporting requirements
• Requirements to provide pharmacoeconomic
analyses
The paper asks:
Is the information relevant, sufficient
and available?

21. 21
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?

22. 22
5. CONSULTATION TIMELINE
?
?
? ?
?

23. 23
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

24. 24
Economic factors
Proposed
changes
Reporting
rebates
Consultations
/engagement
Drivers for
proposed changes
Timely access to
new medicines
Affordability
Access to clinical
trials
Comparator
countries

25. William (Bill) Dempster
wdempster@3sixtypublicaffairs.com
613.800.8344 (direct)
613.614.0283 (mobile)
Gerry Jeffcott
gjeffcott@3sixtypublicaffairs.com
613.851.1602 (mobile)

26. 26
Canadian Cancer Survivor Network
Contact Info
Canadian Cancer Survivor Network
1750 Courtwood Crescent, Suite 210
Ottawa, ON K2C 2B5
Telephone / Téléphone : 613-898-1871
E-mail jmanthorne@survivornet.ca or mforrest@survivornet.ca
Web site www.survivornet.ca
Blog: http://jackiemanthornescancerblog.blogspot.com/
Twitter: @survivornetca
Facebook: www.facebook.com/CanadianSurvivorNet
Pinterest: http://pinterest.com/survivornetwork/