Summer 2020 PMPRB Webinar Series Has the PMPRB removed the obstacles to access in its Guidelines? Thursday, June 25, 2020 12PM - 1PM EDT

1. Has the PMPRB removed the
obstacles to access in its guidelines?
Summer Webinar Series on the PMPRB Changes
June 25, 2020
1

2. • Durhane Wong-Rieger Canadian Organization for Rare Disorders
• Neil Palmer PDCI Market Access
• Stephanie Stavros CF Get Loud Canada
• Jason Field Life Sciences Ontario
• Bennett Lee Sanofi Canada
Today’s panel
2

3. MAY
6
RECAP from our Spring Series of
Webinars
3
APRIL
29
MAY
13
Patients Speak Out
at noon at noon at noon
Drug Launches:
What Influences the Decision
to Deploy New Medicines?
Alternative Approaches to
Innovative Drug Pricing
Rx

4. FOR PMPRB
• Lives matter. Explore impact of pricing policies on patients’ lives and build polices to support drugs
getting to Canadian patients.
• PMPRB should act less like a punitive body and more like a “public good” agency. Collaborate with
patients, clinicians, payers, and other stakeholders to arrive at pricing guidelines that work for all.
• If goal is 20% reduction toward OECD median, as announced, implement new 11-country comparison;
economic factors assessed by CADTH/INESSS as starting point for negotiation; do not set PMPRB
maximum $/QALY
FOR POLICY MAKERS
• This next generation of drug are revolutionary. Ensure that Canada’s pharmaceutical policies, including
pricing policies, will allow Canadians to have access as soon as possible.
• STOP the PMPRB … until all of the proper consultations and considerations have been conducted.
• Expand upon COVID-19 Public-Private partnerships between government and pharmaceutical industry.
Engage Early in development process; Communicate Continuously; Seek Preferred Partner Pricing
CORD’S KEY RECOMMENDATIONS

5. The PMPRB HAS updated its draft guidelines – there have been changes, including higher thresholds
and price reduction “floors,” however, the system continues to be formulaic leading to two questions:
1. If these guidelines come into being, will patients benefit or be harmed?
2. Will the guidelines allow for more holistic strategies and alternative approach as we discussed in
the spring series? (amortization, managed access, outcomes-based agreements)
We have 30 days to develop written input – until July 20, 2020 – and participate in a webinars - CORD
wants to ensure all stakeholders have an opportunity to closely examine how the changes will
actually impact patients, especially regarding timely access to new medicines and clinical trials
The goal of our summer webinar series: understand the PMPRB’s updated draft guidelines, allow an
opportunity for dialogue on the latest changes with officials, and mobilize and coordinate efforts to
communicate our collective input and concerns to all levels of government
CONTEXT FOR PMPRB SUMMER WEBINAR SERIES
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6. 6

7. Overview, Impact and Implications of
PMPRB 2020 Price Reforms
Webinar June 25, 2020
W. Neil Palmer
©2020 PDCI Market Access 7

8. PMPRB Amended Regulations & Draft Guidelines
• PMPRB Amended Regulations published August 2019
• “Draft” Guidelines released November 22, 2019
• Consultation period – comments by February 14, 2020
• PMPRB travelling road show to meet with “stakeholders” beginning
December 2, 2019 in Western Canada
• Industry Technical Briefing Dec 9, 2019
• “Civil Society Forum” ("third sector" of society, distinct from government and
business) Dec 10, 2019 in Ottawa
– Open to patient groups and academics
– Closed to industry
• Policy Forum Q1 2020 (cancelled due to Covid-19)
• June 2020: Coming into force of Regulations deferred to January 2021
• Revised draft Guidelines published June 19, 2020, with 30-day consultation
period
– Final Guidelines – Fall 2020
– Coming into force January 2021
– Likely to be some transition measures
8©2020 PDCI Market Access

9. PMPRB Amendments to Patented Medicines Regulations
(effective as of July 1 2020 January 1 2021)
New Excessive Price Factors
• Cost effectiveness
• Market Size
• Per capita GDP
New Reporting Requirements
• Confidential rebates to provinces and other 3rd party
payers
• PMPRB 11 reference countries
Reductions in Reporting Requirements
• Breakdowns of sales by class of customer no longer
required
• Patented generic drug products need not be reported
unless there is a complaint
9©2020 PDCI Market Access
Changes to PMPRB Reference Countries
PMPRB-7 PMPRB-11

10. New 2020 Draft Guidelines are far more complex
10©2020 PDCI Market Access
2019 2020

11. Summary of draft Guidelines changes: some improvements, many concerns
• Improvements
– Existing medicines maintain current prices subject to Highest Intl Price (PMPRB11)
– “Gap” medicines - no rebated price - but list price set by Median international price of PMPRB-11
– Only new medicines to be categorized and assessed against new economic factors
– Category 1 criteria for new medicines revised (fewer products to fall within Cat 1 criteria)
• Market size threshold raised from $25M to $50M
• High cost threshold raised from 50% to 150% of per capita GDP or from ~$30K to ~$90K per year
• Consideration of clinical benefit reinstated with “Therapeutic Criteria Level”
• Concerns:
– PMPRB Staff can arbitrarily modify price tests and thresholds when products are subject to investigation
– Makeup of PMPRB-11 continues to exclude US, Switzerland
– Relevant indication based on size of patient population (not greatest therapeutic benefit)
– dTCC based on the median (instead of top of class) and comparators to include low priced generics
– Arbitrary reductions of 50% to rebated prices in some cases
– Formulas for pharmacoeconomic and market size adjustments are unclear, complex
– No examples or case studies
– Uncertainty! – particularly for rare disease, specialty and oncology drugs
11©2020 PDCI Market Access

12. Adverse Impact to Patient Access and Patient Support Programs
Despite the changes to the draft Guidelines:
• Uncertainty and threat of low prices will lead to delayed or no launch decisions for innovative drugs in
Canada
• Reduction in industry sponsored clinical trials results in fewer patients gaining early access to new
technologies
• PMPRB’s low price guidelines (combined with provincial policies) jeopardize patient support programs
for expensive and rare disease drugs, including:
– Specialty pharmacy services
– Infusion services (if infused)
– Nurse support and self care training (eg SC injections)
– Reimbursement coordination
– Copay assistance
– Compassionate access for patients with no drug insurance coverage
12©2020 PDCI Market Access

13. Biography
W. Neil Palmer
Neil.Palmer@pdci.ca
www.pdci.ca
Neil is Senior Strategic Adviser and President Emeritus of PDCI Market Access Inc., Canada’s leading pricing and reimbursement consultancy that he
co-founded in 1996. Prior to PDCI, Neil worked with the 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.
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 presented extensively on pharmaceutical pricing and reimbursement issues and is a frequent speaker at
conferences in North America and Europe.
©2020 PDCI Market Access 13

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15. JULY
9
Federal Price Controls and Access
to Medicines Webinar Series
15
JUNE
25
JULY
16
Has the PMPRB removed
the obstacles to access
in its Guidelines?
at noon at 1pm at noon
An invitation for the Board
of the PMPRB to hear
directly from patients
Sharing and comparing
feedback for the
PMPRB Guidelines