November 23, 2022

1. pCPA and Time to Patient
November 23, 2022

2. Hot Topics Expert Webinar Series
www.cancertaintyforall.ca/ 2
pCPA and provincial listings | Wednesday Nov. 23, 2022 @1pm Eastern
Why timelines for public reimbursement of cancer medicines are getting longer and how this impacts patients
To register, please visit www.cancertaintyforall.ca/hot_topics
Funding algorithms | Tuesday Dec. 13, 2022 @1pm Eastern
What goes into decisions on what medicines patients can access across different lines of treatments?
QALYs | Tuesday Jan. 24, 2023 @1pm Eastern
How arbitrary decisions on cost-effectiveness impact patients’ access to some novel cancer treatments
Surrogate endpoints | Tuesday Feb. 21, 2024 @1pm Eastern
Are drug review processes flexible enough to expedite patients’ access to new cancer medicines?

3. Long and sequential
process before
patients can access
new cancer medicines
www.cancertaintyforall.ca/ 3

4. www.cancertaintyforall.ca/ 4
Potential life-years lost due to process delays and inefficiencies
Source: Potential Life‐Years Lost: The Impact of the Cancer Drug Regulatory and Funding Process in Canada (Sep. 2019)
https://pubmed.ncbi.nlm.nih.gov/31506392/
Overall survival life-years lost from efficacy to HTA Overall survival life-years lost from efficacy to funding
Lung Cancer Breast Cancer Colorectal Cancer

5. CanCertainty Advocacy Campaign
www.cancertaintyforall.ca/ 5

6. Today’s panel
www.cancertaintyforall.ca/ 6
Dr. Judith Glennie
President
J.L. Glennie Consulting Inc.
Barry Stein
President & CEO
Colorectal Cancer Canada
Speakers Moderator
Bill Dempster
CEO
3Sixty Public Affairs
Robert Bick
Consultant
(and CanCertainty
Campaign Co-Lead)

7. www.cancertaintyforall.ca/ 7
Send in your questions!
• We will address your
questions in the last 20
minutes of the webinar
• Click on the “Chat” panel /
button any time to submit
your questions
• If it is addressed to one of
the panelists in particular,
please say who

8. Context: pCPA Strategic Revitalization
• In 2019 the pCPA engaged a consultant for
an in-depth assessment of the organization
to inform its revitalization including its:
- role, scope, mandate,
- capacity, governance and accountability
- staffing structure
- negotiation timelines & decision-making
processes,
- transparency, and key performance indicator
(KPI) measurement processes
www.cancertaintyforall.ca/ 8

9. pCPA – Strategic Revitalization
• pCPA’s Governing Council has decided to (initially)
move forward with work in three key areas:
www.cancertaintyforall.ca/ 9
- Governance and Organizational Structure
- Strategic Management
- Operational Management

10. pCPA - Governance and Organizational Structure
The consultant considered several governance
options and ultimately recommended that:
the pCPA become a stand-alone organization. A
separate organization would allow the pCPA to
consolidate and centralize its operational authority,
redesign its Office structure, and ensure its
governance and accountability structures are fully
aligned. It would also provide the opportunity to hire
and house dedicated pCPA staff and to better
coordinate the broader organization which includes
allocated staff from jurisdictional drug programs.
www.cancertaintyforall.ca/ 10
pCPA member jurisdictions have accepted the recommendation
in principle and Dominic Tan reports that “This continues to be an
important aspect for the pCPA and work is still ongoing.”

11. Listing Timeframes for Oncology Products:
Canada + Ontario
Why timelines for public reimbursement are getting
longer and how this impacts patients
CanCertainty Webinar
November 23, 2022
Dr. Judith Glennie, President, J.L. Glennie Consulting Inc.
On behalf of:
Ms. Lana Duon, Reimbursement Analyst and Ms. Sherry O’Quinn, Managing Principal, MORSE Consulting Inc.
J. L. Glennie Consulting Inc.
11

12. Background
• Health Canada and both of Canada’s health technology assessment
(HTA) bodies have put significant effort into creating opportunities for
accelerated regulatory and HTA reviews for innovative products.
• The later stages of the reimbursement process – pricing negotiations
and provincial listings – are lagging, resulting in delays in patient
access to new medications.
Glennie JL, Duon L, and O’Quinn S. Assessment of
Listing Timeframes for Oncology Products in Canada.
Provincial Reimbursement Advisor 2022; 25(1): 12-25.
12

13. 0
100
200
300
400
500
600
700
800
900
2018 2019 2020
Days
Min, Average, and Max Time at pCPA (HTA Completion to LOI) by Year
Max Min Average
File prioritization leading to high uncertainty for pCPA timelines
Oncology Listing Timelines (pCPA and LOI to Listing) for Files Completed by pCPA in 2018-2020 13

14. 0
200
400
600
800
1000
1200
2018
2019
2020
2018
2019
2020
2018
2019
2020
2018
2019
2020
2018
2019
2020
2018
2019
2020
2018
2019
2020
2018
2019
2020
2018
2019
2020
2018
2019
2020
2018
2019
2020
QC PEI NFLD NB NS MB SK BC AB ON NIHB
Days
Min, Average, and Max Time-to-List (LOI to Listing) by Jurisdiction & Year
Max Min Average
pCPA prioritization driving improved timelines at the expense of fewer drugs being listed
Oncology Listing Timelines (pCPA and LOI to Listing) for Files Completed by pCPA in 2018-2020 14

15. Ontario listing timelines are highly unpredictable (IV & oral)*
Parameter Average (days) Standard Deviation
(days)
Range (days)
Products with ON listings (n=31)
Overall average time to
complete ON listing
process
137.4 84.1 9-460
• Average time pre-
COVID-19 (n=7)
126.7 35.0 52-153
• Average time post-
COVID-19 (n=24)
140.6 94.1 9-460
Products in ON queue (n=12)
Overall average time in
ON queue (as of
November 27, 2021)
103.1 58.5 44-257
*as of November 27, 2021 15

16. Ontario TTL vs. Other Provinces (examples)*
Product/Indication LOI Date ON Listing Date
(TTL)
SK Listing Date
(TTL)
AB Listing Date
(TTL)
Brentuximab Vedotin
(Stage IV Hodgkin lymphoma; with doxorubicin,
vinblastine, and dacarbazine)
April 28, 2021 November 4, 2021
(190)
August 1, 2021
(95)
July 1, 2021
(64)
Pembrolizumab
(Renal Cell Carcinoma)
December 1, 2020 March 16, 2021
(105)
February 1, 2021
(62)
February 4, 2021
(65)
Gemtuzumab Ozogamicin (Acute Myeloid
Leukemia)
August 12, 2020 November 15, 2021
(460)
November 1, 2020
(81)
Not listed
Palbociclib
(with fulvestrant for HR-positive, HER2-negative
locally advanced or metastatic breast cancer)
April 8, 2020 December 4, 2020
(240)
August 1, 2020
(115)
September 15, 2020
(160)
Crizotinib
(ROS1-positive advanced non-small cell lung
cancer)
March 20, 2020 December 4, 2020
(259)
August 1, 2020
(134)
July 30, 2020
(132)
Bosutinib [RFA]
(Chronic Myeloid Leukemia)
February 19, 2020 September 3, 2020
(197)
February 20, 2020
(1)
July 30, 2020
(152)
Venetoclax
(with rituximab in Chronic Lymphocytic Leukemia)
October 28, 2019 March 16, 2020
(140)
March 1, 2020
(125)
April 10, 2020
(165)
Cabozantinib
(Renal Cell Carcinoma)
November 5, 2019 May 6, 2020
(183)
March 1, 2020
(117)
April 10, 2020
(157)
*as of November 27, 2021 16

17. Ontario Queue vs. Other Provinces (examples)*
Product/Indication LOI date Time in ON queue Listing date in other provinces
Niraparib
(1L ovarian cancer)
August 11, 2021 108 days BC: December 1, 2021
AB: November 1, 2021
QC: September 29, 2021
Entrectinib
(ROS1-positive non-small
cell lung cancer)
July 6, 2021 144 days BC: via BC Cancer Compassionate
program as of May 2021
AB: November 1, 2021
SK: November 1, 2021
QC: August 18, 2021
Gilteritinib
(Relapsed/refractory
acute myeloid leukemia)
March 15, 2021 257 days BC: September 1, 2021
AB: May 1, 2021
SK: July 1, 2021
QC: May 27, 2021
Cabozantinib
(Hepatocellular
carcinoma)
August 24, 2021 95 days AB: November 1, 2021
SK: November 1, 2021
QC: September 29, 2021
*as of November 27, 2021 17

18. Bottom Line
• Significant variability in the timelines for both
pCPA and provincial listing processes – both IV
and oral.
• Ontario case study demonstrates frequent
delays in TTL compared to other jurisdictions.
• No specific, identifiable rationale for delays in
Ontario.
• RESULT: Significant uncertainty for patients,
as they await access to new medications
already recommended by the HTA process.
18

19. Potential
Reasons for
Provincial
Listing Delays
• Implementation considerations not being
addressed prior to LOI
• Need to finalize provincial criteria for use
and/or revise listing criteria for other therapies
• Sequencing considerations and or use in
combination with another drug
• Availability of funding for new companion
diagnostics and/or change to timing of testing
in the patient journey
• Planning work to ensure smooth integration
into health system
• Policy considerations not being addressed in
advance (e.g., inpatient vs. outpatient funding)
• Budget impact – need for additional approvals, etc.
19

20. Need for a shift in focus, from addressing administrative needs to
meeting patient needs
Closing Comments
20

21. www.cancertaintyforall.ca/ 21
Discussion

22. NEXT WEBINAR
www.cancertaintyforall.ca/ 22
Robert Bick
Consultant
(and CanCertainty
Campaign Co-Lead)
Funding algorithms | Tuesday Dec. 13, 2022 @1pm Eastern
What goes into decisions on what medicines patients can
access across different lines of treatments?
Alex Chambers
Manager – National Oncology Policy
Novartis
Howard Lim
Medical Oncologist
BC Cancer Agency

23. Coalition Members
www.cancertaintyforall.ca/ 23