About this Webinar: This session will provide participants with an overview of what is involved in getting a new cancer treatment reviewed and approved in Canada. The webinar will feature representatives from 3Sixty Public Affairs, who will detail the key steps required to provide patient access to a new treatment option. The journey begins with a Health Canada review of safety, efficacy and quality. That is followed by comparative cost and effectiveness evaluations and the establishmentof a place in therapy by health technology assessment (HTA) agencies. After the HTA recommendations are issued, then the national pricing negotiation process takes place, followed by reimbursement decision-making at the jurisdictional level. During all that, new products also must pass through a national price review. Patients and stakeholders have some opportunities to provide input at various points in the process. All that and more will be covered during the presentation. Afterward, the presenters will lead an interactive question and answer session that will permit audience members to explore these processes further.

1. EXPLORING THE CANCER
TREATMENT REIMBURSEMENT
JOURNEY IN CANADA
March 23, 2023
with Bill Dempster
& Gerry Jeffcott

2. What we will discuss…
1. Overview of the Canadian
Medication Approval Process
2. Opportunities and Issues
3. Discussion and Q & A
2

3. 1. Overview of the Canadian
Medication Approval Process
3

4. Sequential process leads to long reimbursement timelines
4
Provincial
listing
(variable)
pCPA
negotiation
process
(Avg 8 months)
Possibility of parallel reviews
Average time it takes to
complete pCPA negotiation
process
Average time Health
Canada takes to review a
medicine
Average time CADTH review
process takes for cancer
medicines following Health
Canada’s approval
CADTH
review process
(Avg 7 months)
CADTH source: IQVIA, Provincial Reimbursement Advisor, Vol. 24, Issue 3 (August 2021), p. 60;
pCPA wait time source: CADTH review reports: https://cadth.ca/reimbursement-review-reports and pCPA brand name drugs negotiations status: https://www.pcpacanada.ca/negotiations
Health Canada
review
(6-12 months)
Average time it takes for
provinces to add product
to their formularies
following pCPA deal

5. Reimbursement review timeframes - oncology
5
Source: Innovative Medicines Canada, Canadian public insurance plans and delays in patient access to innovative medicines, Dec. 2021:
https://innovativemedicines.ca/resources/all-resources/canadian-public-insurance-plans-and-delays-in-patient-access-to-innovative-medicines

6. The reimbursement
journey for new
cancer therapies in
Canada
• Several steps to manage after Health
Canada approval – mostly conducted
sequentially
• Private plans are generally faster and
more generous with reimbursement
than public plans (but that is converging)
6
© 2023 3SIXTY PUBLIC AFFAIRS INC. ALL RIGHTS RESERVED.

7. Health Canada review
7
Ad hoc input when
requested by Health
Canada
• Health Canada responsible for protecting Canadians’
health and well-being
• Regulatory reviews ensure medicines are safe,
effective and of high quality; cost / price not
considered
• Success comes in the form of a Notice of Compliance
(NoC) / Notice of Compliance with conditions (NoC/c):
• For products that are not yet approved, Health
Canada administers the Special Access Programme
• Post-marketing surveillance is also a key role for
Health Canada

8. Patented Medicine Prices
Review Board
• Federal regulatory agency
• PMPRB’s mandate is to ensures that prices for
patented medicines sold in Canada are not
“excessive”
• Determines the maximum (factory-gate) prices
that can be charged in Canada for patented
medications
• Also regulates the level of price increase
manufacturers may take on an annual basis
• Currently undergoing significant change /
reforms
8
No formal input –
although can engage on
policy / guidelines

9. Health Technology Assessment
9
• Canada’s health technology
assessment agency
• Reimbursement reviews offer
public payers non-binding,
scientifically-based, expert
recommendations addressing
whether a medication should be
publicly reimbursed and under
what circumstances
• Reviews typically prompted by
manufacturer submissions, but
opportunity exists for clinician or
public payer-driven submissions
• Formal, multi-step review process examining
clinical and economic data leads to
recommendations
• Recommendations developed for oncology-
specific expert review committee which
follows a deliberative review framework
• Recommendations forwarded to participating
public drug plans and cancer agencies for
listing decisions
Formal patient and
clinician input
opportunities!
• Plays the same role in Quebec that CADTH
provides to the rest of the country
• Review processes are similar, but not
identical

10. Reimbursement review process
10
Overview of CADTH’s Reimbursement Review Processes

11. pan-Canadian Pharmaceutical Alliance
11
• National, multi-jurisdictional
negotiations (all provinces, territories
and the federal government)
• One jurisdiction negotiates on behalf of
all – or the office of the pCPA can lead
negotiations
• If negotiations are successful, separate
agreements are completed with each
interested jurisdiction
No formal
opportunity for
stakeholder input

12. Public formularies and hospitals
12
Public Formularies
• Secure confidential agreements between innovative
manufacturers and public drug benefit programs to
facilitate improved access (rebates or other criteria)
• They vary significantly in terms of structure with the
common factor being the pCPA to inform which
products are reimbursed by the plan on a formulary
• Some conduct additional HTA reviews
• All maintain special / exceptional access programs to
consider case-by-case coverage for prescribed meds not
listed, but needed for a specific patient
• All offer catastrophic prescription coverage (e.g.,
Trillium) or universal income-adjusted plans (BC)
Hospitals
• Medications administered in Canadian hospitals
to eligible residents are fully funded by the public
health care system (medicare)
• Reimbursement decision are typically made at
the regional local level
Various opportunities
for stakeholder input

13. Private payers
13
• Plans offered by employers, associations and other
groups, but provided by health benefit providers
such as SunLife, Blue Cross or Canada Life
• Coverage offered is often based on standardized
plan templates, but customization is common
• Typically provide much faster access to a broader
range of medicines than public plans
• Increasingly plans are adopting plan design tools to
manage those costs relying on annual and lifetime
caps, managed formularies, prior authorization
schemes and HTA reviews before listing
Patient access programs and
Access Navigators!

14. 14
2. Opportunities and Issues

15. Other access pathways
15
• Specialized provincial funding programs
• Hospital foundation funding
• Patient enrollment in clinical trials
• Health Canada’s Special Access Programme
• Manufacturer-funded compassionate access
programs and patient support programs

16. CADTH recommended price reductions for
oncology medicines, 2020
16
Source: Macdonald-Laurier Institute’s More than a dose of collaboration (Jun. 2021)
https://macdonaldlaurier.ca/files/pdf/20210525_More_than_a_dose_of_collaboration_Rawson_Adams_PAPER_FWeb.pdf?mc_cid=44923e3a19&mc_eid=UNIQID
78% of oncology
medicines required
50% to 100% price
reduction based on
CADTH reviews

17. Number of Health Canada and HTA submissions lower and
more delayed than in the United States
17
“The reason for discordance
between [US accelerated
approval] and [Health Canada and
HTA] submission is multifactorial
and may include the uncertainty
around comparative clinical
benefits.”
Source: Canadian Regulatory and Health Technology Assessment for Malignant Hematology and Oncology
Indications Compared With the US Food and Drug Administration Accelerated Approval Program
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2782983
• Since August 2019, of 31 medicines that
have been approved for cancer-related
indications by FDA, 13 have not been
submitted to Health Canada
Source: https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-
new-therapeutic-biological-products/novel-drug-approvals-2021
https://www.canada.ca/en/health-canada/services/drug-health-product-review-
approval/submissions-under-review.html
https://www.fraserinstitute.org/studies/timely-access-to-new-
pharmaceuticals-in-canada-the-united-states-and-the-european-union

18. Other issues related to the HTA processes
and pCPA
18
• Alignment of CADTH’s oncology and non-oncology process
• New organization structure (EVP)
• Collaboration between CADTH & INESSS
• Real World Evidence
• Funding algorithms, diagnostics, etc.
• pCPA/PMPRB at global tables on negotiations
• pCPA incorporated as its own separate not-for-profit
corporation

19. Discussion and Q&A
19

20. 20

21. Canadian Cancer Survivor Network
Contact Information
jmanthorne@survivornet.ca
mforrest@survivornet.ca
Website: survivornet.ca
Twitter: @survivornetca
Facebook: facebook.com/CanadianSurvivorNet
Pinterest: pinterest.ca/survivornetwork
21
Canadian Cancer Survivor Network
1750 Courtwood Crescent, Suite 210
Ottawa, ON K2C 2B5
613 898-1871