The pCODR process is designed to bring consistency and clarity to the assessment of cancer drugs by reviewing clinical evidence, cost-effectiveness, and patient perspectives, and using this information to make recommendations to Canada's provinces and territories (except Quebec) in guiding their drug funding decisions. Interested in learning more?

1. When pCODR says
“no,” then what?
Thursday, April 30th, 2020
13:00-14:00
Presented by Ryan Clarke,
founder of Advocacy Solutions

2. When pCODR says “no,”
then what?
Ryan Clarke, LL.B.
ryan@advocacysolutions.ca
(416) 919-9532

3. Overview
• Broad overview of drug approval and reimbursement
processes
• Closer look at the pCODR process
• Closer look at the pCPA process
• Patterns between pCODR recommendations and pCPA
outcomes
– Methodology, findings and conclusions of CCSN research into
pCODR recommendations from 2019
• What can you do if pCODR says “no”
• What should you do if pCODR says “yes” (given COVID-19)
• Q&A

4. Canadian Drug Approval & Reimbursement Processes

5. Regulatory Review & Reimbursement Processes
• Public drug formularies are impacted by federal, provincial and national
policies
• Manufacturer submits to Health Canada for approval
• The Canadian Agency for Drugs and Technologies in Health (CADTH)
operates two pan-Canadian drug review processes:
– Common Drug Review (CDR) reviews new drugs (non-oncology) and makes
reimbursement recommendations (with the exception of Quebec)
– pan-Canadian Oncology Drug Review (pCODR), which deals specifically with cancer
drugs and makes reimbursement recommendations (with the exception of Quebec)
• The pan-Canadian Pharmaceutical Alliance (pCPA) conducts joint
federal/provincial/territorial negotiations for brand name drugs in Canada
• Provinces also review new drugs and make the final reimbursement
decisions through product listing agreements

6. pan-Canadian Oncology Drug Review
• As the review process within CADTH specifically for oncology drugs, pCODR
issues positive or negative funding recommendations
• Recommendations are made by the pan-Canadian Oncology Drug Review
(pCODR) Expert Review Committee (pERC) based on:
– clinical evidence
– cost-effectiveness
– patient perspectives
• Information is then used to make recommendations to Canada's provinces
and territories (except Quebec) in guiding their cancer drug funding
decisions
• pCODR takes into account evidence from a number of sources, including
patient groups, drug manufacturers, clinician-based tumour groups, and
the pCODR Provincial Advisory Group
• Patient/clinician input processes for pCODR allows for written input at two
points: prior to pERC review and after pERC initial recommendation is issued
6

8. • Established in August 2010, the pan-Canadian Pharmaceutical
Alliance (pCPA) conducts joint provincial/territorial negotiations
for brand name drugs in Canada
• The pCPA member jurisdictions include public drug plan and/or
cancer agency participation from: British Columbia, Alberta,
Saskatchewan, Manitoba, Ontario, Québec, New Brunswick,
Nova Scotia, Prince Edward Island, Newfoundland & Labrador,
Yukon, Northwest Territories, Nunavut, Non-Insured Health
Benefits (NIHB), Correctional Services of Canada (CSC) and
Veterans Affairs Canada (VAC)
• All brand name drugs coming forward for funding through
pCODR and CDR are considered for negotiation through the
pCPA

9. • The pCPA’s mandate is to enhance patient access to clinically
relevant and cost-effective drug treatment options
• It serves this mandate by conducting collective, expert-informed,
negotiations for drugs
• Through the combined negotiating power of drug plans across
multiple provinces and territories, the pCPA objectives are to:
– increase access to clinically effective and cost-effective drug
treatment options
– achieve consistent and lower drug costs for participating
jurisdictions
– reduce duplication of effort and improve use of resources
– improve consistency of decisions among participating
jurisdictions

10. pCPA – Negotiation Process
Divided into four distinct phases:
• Initiation - once a recommendation is
published by CADTH and/or INESSS for a
new drug, pCPA issues an
acknowledgment letter to the
manufacturer advising them that the
drug is now under consideration for
negotiation by pCPA
• Consideration - pCPA considers whether
it will enter into a negotiation for a drug
while also gathering additional
information or clarification as required -
once this phase is completed, pCPA will
issue a letter to the manufacturer
identifying whether pCPA will engage in
negotiations (Engagement Letter), place
a hold on the consideration phase, or
close the file and not negotiate

11. pCPA – Negotiation Process
Divided into four distinct phases
(continued)
• Negotiation – lead jurisdiction(s) is
assigned and aims to finalize
negotiations within 90 business days
from the Engagement Letter
• Completion - pCPA process is
considered complete once the
negotiation has resulted in mutually
agreed upon terms and a fully
executed letter of agreement (LOI),
or, if mutually agreed upon terms are
not reached, pCPA has issued a close
letter to the manufacturer, indicating
that the negotiation is closed

12. pCPA Status Lists*
Under consideration for negotiation (16 – 9 oncology)
Active negotiations (20 – 5 oncology)
Negotiations that were not pursued (75)
• With LOI (316)
• With no LOI (53)
Completed negotiations (369)
Product currently on hold (0)
*Status lists maintained by pCPA (as May 5th)

14. Research - Overview
• With a number of medications coming out of
CADTH in which negotiations were not
pursued or, if initiated, were not successfully
concluded, CCSN engaged Eastlake Research
Group to examine whether the rate of
positive pCODR recommendations changed
recently and, if so, to evaluate any potential
reasons
• All pCODR recommendations for 2019 were
reviewed and a comparison drawn between
those issued before July 1, 2019 and those
issued after that date
• Overall finding – 88% of recommendations
before July 1, 2019 were positive; only 50%
of recommendations post that date were
positive

15. Research - Methods
All pCODR final recommendations issued in 2019 were
reviewed and the following information abstracted:
• Name of drug
• Dates of submission to pCODR and issuance of final
recommendation, and whether the submission preceded
Health Canada’s Notice of Compliance
• Recommendation and any conditions
• The indication, i.e. the type of cancer for which the drug is
indicated
• Whether the cancer is a solid tumour or not
• How the drug is to be used: advanced or metastatic cancer,
relapsed or refractory cancer, adjuvant therapy, after prior
treatments or surgery, in combination with other therapies
(a drug could fit into more than one of these categories)
• The phase of clinical trial(s) whose evidence was reviewed
by pCODR
• Provincial funding status for the drug available from the
pCODR website (since pCODR does not review oncology
drugs for Quebec, this information excluded the funding
status in that province)
pCPA negotiation status relating to the pCODR
recommendations were also recorded

16. 29%
71%
All pCODR Recommendations in 2019
Negative Recommendations (9) Positive Recommendations (22)
12%
88%
Recommendations Issued Prior to July 1, 2019
Negative Recommendations (2) Positive Recommendations (15)
50%50%
Recommendations Issued After July 1, 2019
Negative Recommendations (7) Positive Recommendations (7)

17. Positive Recommendations (Timeline) 22
Negative Recommendations (Timeline) 9

18. 16
66
3
0
2
4
6
8
10
12
14
16
18
Solid Tumors Non-Solid Tumors
Recommendations Recommendations by Tumor Type
Positive
Negative

19. 10
3
2
9
10
5
1
0
1
4
0
2
4
6
8
10
12
Metastatic
Cancers
Relapsed or
Refractory
Cancers
Adjuvant
Therapy
Combination
Therapy
Prior Therapy or
Surgery
Reccomendations Recommendations by Cancer Type*
Positive
Negative
*Drugs may be in more than one category

20. 33%
87%
0% 0%
67%
13%
100% 100%
0%
20%
40%
60%
80%
100%
Phase I/II Phase III Phase IV Undefined
Recommendations by Trial Phase
Positive
Negative

21. Research - Conditions/Reasons

22. 15
1
6
1
7
1
0
2
4
6
8
10
12
14
16
Complete
with LOI
Complete
without
LOI
Active Not
pursued
Unknown
Recomendations
pCPA Status
Positive
Negative

23. Provincial Funding Status
• Highlights (as of March 31st)
– None of the 22 drugs that received a positive
recommendation have been funded in every province
– Only one of the 9 drugs that received a negative
recommendation has been funded in one province –
Adcetris (NHL) in BC
– Of the positive drugs:
• SK has funded the most (8), followed by BC (7), MB (4) and ON (3)
• Three provinces have funded only one (NS/NB/NL)
• Two provinces have funded none (AB/PE)
• Imfinzi (NSCLC) has been funded in the most provinces (5)

24. What Does the Research Tell Us?
• While there is a good probability that a
medication that receives a “yes” from
pCODR will ultimately be issued an LOI (68%
based on the 2019 analysis to date), the
review shows that the percentage of
positive recommendations dropped
significantly in the latter half of the year
• When a medication receives a “no” from
pCODR, there will be issues regarding the
product’s clinical benefit
• It is also highly unlikely that such a drug will
even be invited into pCPA, let alone be
issued an LOI
• And even if the product does receive an LOI,
there is even less likelihood that any
province will ever fund it (1/81)
• But there are avenues that can be pursued

25. When pCODR Says “no”?
• Start early – build relationships and deliver
messaging to other stakeholders, national
review bodies and provincial officials
beginning as early on as possible (i.e. well
before the drug is even submitted to Health
Canada for approval) to set the tone for a
sustained advocacy effort
• Encourage the manufacturer to wait to
submit with Phase III trials
• Encourage the manufacturer to resubmit to
pCODR if additional data may be forthcoming
• Engage pCPA directly to request that the
medication not be unilaterally put on the
“negotiations that were not pursued” list
• If negotiations with pCPA do commence,
engage both the manufacturer and pCPA
directly to encourage them to actively seek a
path towards a LOI

26. When pCODR Says “no”?
• Gather patient/caregiver stories
• Host advocacy training sessions with
supporters
• Establish e-Advocacy hub to facilitate
grassroots engagement at the
provincial level
• Hold virtual advocacy day/week in
key provinces (i.e. meetings)
• Engage in sustained
traditional/social media campaign to
amplify e-Advocacy efforts
• Consider employing other advocacy
tools – i.e. petitions, postcards,
pledges, etc.

27. When pCODR
Says “yes” During COVID-19?
• On March 23rd, pCPA issued the following to manufacturers:

28. When pCODR Says “yes” During COVID-19?
But again, there are avenues that can be pursued:
• Continue to build relationships and deliver messaging to other stakeholders,
pCPA and provincial officials around the importance of timely access to
medications (i.e. teleconferences, virtual meetings)
• Gather patient/caregiver stories
• Host advocacy training sessions with supporters
• Engage in sustained social media campaign, ideally framing your need within
the context of COVID-19
• Consider launching a sustained e-Advocacy campaign targeting pCPA and/or
the provinces (when appropriate)
• Consider planning a virtual advocacy day targeting one or more of the key
provinces
So even a “yes” recommendation during this pandemic will
mean delay, which is never in the best interests of patients

29. Canadian Cancer Survivor Network
Contact Info
1750 Courtwood Crescent, Suite 210
Ottawa, ON K2C 2B5
Telephone / Téléphone : 613-898-1871
E-mail: jmanthorne@survivornet.ca or info@survivornet.ca
Website: www.survivornet.ca
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Facebook: www.facebook.com/CanadianSurvivorNet
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