The document discusses proposed changes to the Patented Medicine Prices Review Board (PMPRB) and their impact on drug pricing and patient access in Canada. Key changes include the incorporation of economic factors in price determinations and the updating of comparator countries, which could lead to a reduction in drug prices by approximately 25% and result in annual savings. However, there are concerns about potential delays in access to new medicines and barriers for drugs treating rare diseases due to limited stakeholder consultations and lack of patient input mechanisms.

1. 1
How Proposed Changes to the
Patented Medicine Prices Review Board
Could Affect Patients’ Access to Drugs
September 28, 2017

2. 2
Today’s participants
Bill Dempster
CEO – 3Sixty Public Affairs
Moderator
Panelist
Neil Palmer
Founder & Principal Consultant –
PDCI Market Access
Panelist
Wayne Critchley
Senior Associate –
Global Public Affairs
Panelist
John-Peter Bradford
CEO – Life Saving Therapies Network

3. 3
1. Introduction to
PMPRB / proposed
changes
2. Panellists’
perspectives
3. Discussion
What we’ll discuss

4. What is the PMPRB?
• Quasi-judicial federal agency
• Reports to the federal health minister
• Twofold mandate:
regulates prices and reports on trends
• Regulates prices of patented drugs based on:
o independent assessment of treatment’s therapeutic value vs.
alternatives
o prices for same medications in other countries, which currently
include France, Germany, Italy, Sweden, Switzerland, the United
Kingdom and the United States (i.e., the basket of reference
countries or PMRB7)
4

5. Proposed changes to the PMPRB
• Patented Medicines Regulations key
changes:
o Addition of economic factors for PMPRB
excessive price determinations:
- Pharmacoeconomic analysis
- Size of market
- Canadian GDP
o Updating the list of comparator countries
- Remove U.S. and Switzerland
- Add Australia, Belgium, Norway, Japan,
Netherlands, South Korea & Spain
o Requirements to report rebates to the
PMPRB
5
Source: PMPRB’s strategic plan

6. Evolution and key dates
May 16, 2017
Consultation
document released
– opportunity to
provide written
input until
Jun. 28, 2017
Fall 2017
Draft regulations
will be published in
Canada Gazette I
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 II
75-day
consultation period
End of 2018
Health Canada
aiming to conclude
the regulatory
amendment process
by this time
Strategic Plan
Dec. 2015
PMPRB
Guidelines
Jun. 2016
Nov-Dec 2017
GUIDELINES
discussions
and consultations
to occur at the
same time
NEW
Health
Minister
Ginette
Petitpas Taylor
6

7. PMPRB REFORM:
IMPACT FOR PATIENTS?
September 28, 2017
Wayne Critchley

8. 8
Minister of Health: Prime Minister’s Mandate Letter
“…Improve access to necessary prescription
medications”
• “joining with provincial and territorial
governments to buy drugs in bulk”
• “reducing the cost Canadian governments
pay for these drugs”
• “making them more affordable for
Canadians”
• “exploring the need for a national formulary”

9. 9
Health minister vows to
save Canadians
'billions' on drug prices
January, 2017
… will bring prices in
“line to what we are
seeing in countries like
New Zealand”

10. 10
PMPRB Reform –
Statements from Former Minister Philpott
PMRPB reform is a precursor to any potential
Pharmacare plan: we don’t want to “lock in extremely
high-price medications” – April 13, 2016
May 16, 2017 Speech:
• Announced proposed PMPRB reforms and
consultation process
• Canada has the 3rd highest drug prices & the 2nd
highest per capita pharmaceutical spending in the
OECD
• Proposed changes would lower prices in range of
25%
• Would bring annual savings of $3.5 billion
Other announcements in May 16 speech:
• Work with provinces on a “National Formulary”
• System alignment – Health Canada and CADTH
• Promised announcement on pCPA

11. 11
Government's Regulatory Proposals –
Some Potential Impacts
• Duplication of HTA reviews
• 25% reduction in overall list
prices
• Impact on pCPA and
PLAs????
• Lower prices for private
insurers
• Impact on government
innovation policies and
biopharmaceutical investment
• Delayed launch of innovative
drugs in Canada

12. 12
SOME KEY ISSUES
CONSULTATIONS
• No multi-
stakeholder
consultations
• Written
submissions only
• Limited meetings
LIMITED LINK TO
PUBLIC PAYERS
• PMPRB has no
engagement in
HC/CADTH/pCPA
processes
• Potential for
conflict between
agencies
SPECIAL ISSUES
FOR PATIENT
GROUPS
• Potential delays in
access
• New barriers for
drugs for rare
diseases
• PMPRB has no
patient input
mechanisms

13. 13
Contact:
Wayne Critchley
Senior Associate, HLS
Tel: 613-783-3449
wcritchley@globalpublic.com
Global Public Affairs: Contact Information
Ottawa
50 O’Connor Street, Suite 901
Ottawa, ON K1P 6L2
Telephone: 1 (613) 782-2336
Toronto
595 Bay Street, Suite 401
Toronto, ON M5G 2C2
Telephone: 1 (416) 597-3485
Edmonton
10060 Jasper Avenue, Suite
2020
Edmonton, AB T5J 3R8
Telephone: 1 (780) 665-4946
Calgary
633-6th Avenue SW, Suite
1000
Calgary, AB T2P 2Y5
Telephone: 1 (403) 264-3800
Vancouver
355 Burrard Street, Suite
570
Vancouver, BC V6C 2G8
Telephone: 1 (604) 362-2522

14. 14September 2017
How Proposed Changes to PMPRB
Could Affect Patient Access to Drugs
September 2017

15. Mechanisms for Price Setting / Reimbursement
15September 2017
Canada France Germany Italy Sweden Switz. UK USA
Additional benefit
(level of
improvement)
   
Clinical Effectiveness        
Internal referencing
(cost comparisons to
similar drugs,
generics, biosimilars)
       *
External referencing
(international price
comparisons)
  *  
Cost effectiveness
(e.g., $/QALY)      
Affordability
(budget impact)        *
Risk Sharing
(product listing
agreements)
  *   *  
Regional decision
making       *
Tiered Formularies 

16. PMPRB: Less Reliance on International Prices?
• PMPRB: “Given that it is standard industry
practice worldwide to insist that public prices
not reflect discounts and rebates, should the
PMPRB generally place less weight on
international public list prices when
determining the non-excessive price ceiling
for a drug?”
• International price referencing began in
Canada in 1987 (PMPRB C-22 amendments
to Patent Act)
• Listing agreements and patient access
schemes make international price
comparisons challenging
– but these exist because of international price
referencing
– transparent pricing would result in a
downward spiral of prices
– even if prices are identical at launch, prices
will inevitably move apart because of
exchange rates
16September 2017

17. Health Canada: Criteria for selecting proposed reference countries
Three main criteria have been used to select the countries:
1. Consumer protection: whether the country has national pricing containment measures in place to protect
consumers from high drug prices;
2. Economic Standing: whether the country has a similar economic standing to Canada, as measured by GDP
per capita; and
3. Pharmaceutical market characteristics: whether the country has similar market characteristics to Canada,
such as population, consumption, revenues and market entry of new products.
17September 2017
Proposed Countries
Source: Health Canada “Protecting Canadians from Excessive Drug Prices: Consulting on Proposed Amendments to the Patented Medicines Regulations”, Ottawa May 2017

18. What is the impact of International Reference Pricing?
• Is there evidence that lower prices delay product
introduction in “low price” countries?
18September 2017

19. Health Canada / PMPRB: Lower prices have no effect on Access to Medicines
19September 2017

20. But for New Medicines…
Foreign Prices are similar or higher than Canada
20September 2017
New med prices the same or higher in most
other countries including Sweden & UK

21. Launch Sequencing is well established…
21September 2017

22. Sample Launch Sequence Analysis
22September 2017

23. Reservation Prices – At what point will products not be available?
• Reservation (or reserve) price is a term referring to a limit on the price of
a good or a service.
– On the demand side, it is the highest price that a buyer is willing to pay;
– On the supply side, it is the lowest price at which a seller is willing to sell a
good or service.
23September 2017

24. International (External) Reference Pricing
24September 2017
Pharmaceutical Reference Pricing in the U.S. Delusion or a soon-to-be Reality? April 2016 Ilkka Anhava Ling Chen Huiyan
Jin Emil Nedev David Spellberg.

25. Biography
25September 2017
W. Neil Palmer
President & Principal Consultant
PDCI Market Access Inc
Neil.Palmer@pdci.ca
www.pdci.ca
Neil Palmer President and Principal Consultant of PDCI Market Access Inc. (PDCI) a leading pricing and
reimbursement consultancy founded in 1996. He leads a senior team of market access professionals with
pricing & reimbursement engagements covering Canada, Europe, and the United States.
Prior to PDCI, Neil worked with the Canadian Patented Medicine Prices Review Board (PMPRB) where his
responsibilities included policy development, overseeing the price review of patented medicines and
conducting economic research. Prior to the PMPRB, he worked with the Health Division of Statistics Canada
where he was responsible for economic and statistical analysis of health care costs and utilization. Neil also
worked with RTI Health Solutions (Research Triangle Park, North Carolina) where he served as global vice
president for pricing and reimbursement. After completing his studies at the University of Western
Ontario, Neil began his career in Montreal with the research group of the Kellogg Centre for Advanced
Studies in Primary Care. He has written extensively on pharmaceutical pricing and reimbursement issues
and is a frequent speaker at conferences in North America and Europe.
In January 2015, Neil was appointed Adjunct Assistant Professor at the University of Southern California
School of Pharmacy graduate program in Health Care Decision Analysis where he lectures on health
technology assessment, pricing and market access from a global perspective.

26. 26
Discussion
CONSULTATIONS
• No multi-
stakeholder
consultations
• Written
submissions only
• Limited meetings
LIMITED LINK TO
PUBLIC PAYERS
• PMPRB has no
engagement in
HC/CADTH/pCPA
processes
• Potential for
conflict between
agencies
SPECIAL ISSUES FOR
PATIENT GROUPS
• Potential delays in
access
• New barriers for
drugs for rare
diseases
• PMPRB has no
patient input
mechanisms

27. 27
Canadian Cancer Survivor Network
Contact Info
Canadian Cancer Survivor Network
1750 Courtwood Crescent, Suite 210
Ottawa, ON K2C 2B5
Telephone: 613-898-1871
E-mail jmanthorne@survivornet.ca or mforrest@survivornet.ca
Website www.survivornet.ca
Twitter: @survivornetca
Facebook: www.facebook.com/CanadianSurvivorNet
Pinterest: http://pinterest.com/survivornetwork/