The document discusses discordance between recommendations from the pan-Canadian Oncology Drug Review (pERC) and provincial funding decisions for cancer drugs in Canada. It presents results from a survey of provincial drug funding decision-makers that identified several potential reasons for discordance, including differences in priorities, clinical evidence, and budget constraints between the levels. Challenges to alignment included issues with clinical trial evidence as well as pressure to expand access, while suggested solutions centered on strengthening consensus around treatment pathways and priorities nationally.

1. Allan Grill, MD, CCFP, MPH
Family Physician Member, pERC
Mona Sabharwal, BScPhm, Pharm. D., R.Ph.,
Executive Director, pCODR
Nianda Penner, BSc(Pharm), R.Ph.,
Knowledge Management, pCODR
CADTH Symposium, Concurrent Session B1
Monday, April 13, 2015

2. Disclaimer
• I have no financial conflicts of interest to declare
• I receive a per diem remuneration for work
associated with CED and pERC membership
• The opinions expressed in this presentation
reflect the presenters own personal experiences
with Health Technology Assessment and public
drug policy, and do not represent the opinions of
other pERC members, pCODR, CADTH, the
Ontario Public Drug Programs, Cancer Care
Ontario, or the Ontario Ministry of Health and
Long-Term Care

3. 3
• To review the discordance rates associated with pERC
recommendations and provincial cancer drug funding
decisions
• To outline the potential reasons for discordance in the
context of Health Technology Assessment (HTA)
• To present the results of a national survey among drug
funding decision makers outlining the challenges and
potential solutions towards enhancing alignment for
Canada’s national cancer drug review process
OBJECTIVES

4. 4
• pCODR/CADTH Overview:
§ Health Technology Assessment
§ National, evidence-based cancer drug review process
§ Consistency & clarity via Deliberative Framework à legitimacy
§ Process should guide provinces in drug-funding decision making
Background

5. 5
Background
• pERC recommendations are meant to:
§ Achieve best possible health outcomes
§ Contribute to health system sustainability
§ Promote equity across provinces
• Is there discordance between recommendations and
decisions?

6. 6
• A state of disagreement and disharmony
What is Discordance?

7. 7
As of December 31, 2014, pERC had issued 39 final
recommendations:
• 7 (18%) positive recommendations
• 24 (61%) conditional recommendations
• 8 (21%) negative recommendations
pERC Final Recommendations
18%
61%
21%
Positive
Recommendation
Conditional
Recommendation
Negative
Recommendation

8. 8
Of the funding decisions made, percentage of those funding decisions
that are in concordance with the pERC recommendations:
Rate of Concordance
75
80
85
90
95
100
BC
AB
SK
MB
ON
NB
NS
PEI
NL
%

9. 9
pERC Recommendations to Fund
1. Pazopanib (Votrient) for
metastatic renal cell
carcinoma [Jan 20, 2012]
2. Bendamustine hydrochloride
(Treanda) for NHL [Dec 14,
2012]
3. Axitinib (Inlyta) for
metastatic renal cell
carcinoma [Apr 11, 2013]
4. Bortezomib (Velcade) for
multiple myeloma, pre-
ASCT [Apr 11, 2013]
5. Pazopanib (Votrient)
resubmissions for
metastatic renal cell
carcinoma [Sep 16, 2013]
6. Afatinib (Giotrif) for non-
small cell lung cancer [May
20, 2014]
7. Arsenic trioxide (Trisenox)
for Acute Promyelocytic
Leukemia [Mar 5, 2014]
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
1 2 3 4 5 6 7
Provincial Funding as of December 31, 2014
Funded Under Negotiation with Manufacturer
Under Provincial Consideration Not Funded

10. 10
pERC Recommendations to Not Fund
1. Pazopanib (Votrient) for soft
tissue sarcoma [Dec 14,
2012]
2. Bendamustine hydrochloride
(Treanda) for CLL [Dec 14,
2012]
3. Bortezomib (Velcade) for
multiple myeloma, post-
ASCT [Apr 11, 2013]
4. Lapatinib (Tykerb) for
breast cancer [Jul 22, 2013
5. Regorafenib (stivarga) for
metastatic colorectal
cancer [Dec 2, 2013]
6. Cetuximab (Erbitux0 for
metastatic colorectal
cancer [Jan 27, 2014]
7. Aflibercept (Zaltrap) for
metastatic colorectal
cancer [Sep 22, 2014]
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
1 2 3 4 5 6 7
Provincial Funding as of December 31, 2014
Funded Under Negotiation with Manufacturer
Under Provincial Consideration Not Funded

11. 11
pERC Recommendations to Fund on Conditions
0
10
20
30
40
50
60
70
80
90
100
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
Provincial
Funding
as
of
December
31,
2014
Funded
Under
NegoMaMon
with
Manufacturer
Under
Provincial
ConsideraMon
Not
Funded

12. 12
• So we know there is some discordance.
• What are the potential reasons for discordance between
pERC and the provinces ?
• Do challenges exist that undermine pERC’s impact on
policy-makers leading to discordance?
• Can these challenges be overcome?
More Questions

13. 13
• Hypothesized reasons for discordance
§ pERC member/HTA perspective
• Designed an on-line survey
• Survey issued to participating provincial ministries of health and
cancer agencies
• Survey period March 4, 2015 to April 1, 2015
• 4 questions: Multiple choice + Free text
§ Choose answers based on our developed hypotheses
§ List challenges that limit the effectiveness of HTA processes
§ List solutions that enhance alignment between pERC
recommendations and provincial drug funding decisions
• Anonymity respected
• 100% response rate
Methods

14. 14
1. If your province has made or is to make a decision to
fund a drug where the recommendation from the HTA
review is to not fund, what are the reasons for funding?
Survey Responses
54.5
36.4
63.6
27.3
Comparators
in
trial
not
funded
by
province
Comparators
in
trial
not
relevant
to
pracMce
PoliMcal
pressure
High
tumour
group
priority
%
%
%
%

15. 15
Other Reasons for decision to fund where the
recommendation from the HTA review is not to fund:
• Rarity of cancer
§ Low probability of future clinical trials
• Exceptional access – patient sub-groups (e.g. no other treatment
options)
• Risk-sharing agreement/pay for performance agreement
§ If no patient benefit, then no cost to the province
• “Under consideration” may mean compassionate case-by-case
funding
Survey Responses

16. 16
2. If your province has made or is to make a decision to
not fund a drug where the recommendation from the HTA
review is to fund (with or without conditions), what are
the reasons for not funding?
Survey Responses
9.1%
18.2%
63.6%
27.3%
90.9%
Disagreement
with
the
economic
review
Disagreement
with
the
clinical
review
Drug
was
not
a
priority
for
local
tumour
group
PaMent
populaMon/disease
not
treated
in
province
Budget
constraint
%
%
%
%
%

17. 17
Other Reasons for decision not to fund where the
recommendation from the HTA review is to fund:
• Multiple choices/lines of therapy already exist (no therapeutic gap)
• Budget impact analysis (not always clear for every province in pERC
review)
• Provincial budgets do not align with the HTA process, particularly in
a fiscally constrained year
• Unsuccessful negotiation with manufacturers
• Uncertainty – may require additional information
Survey Responses

18. 18
3. If your province makes a funding decision to fund a drug
prior to completion of the HTA review, what would be the
reason(s)?
Survey Responses
%
%
%
%
42.9%
57.1%
28.6%
Local
tumour
group
priority
PoliMcal
pressure
High
disease
burden
in
the
province
%
%
%
%
%
%

19. 19
Other reasons for funding prior to HTA recommendation:
• Evidence shows survival advantage
§ Ethical challenge not to fund
• Pressure re: patient access to clinical trials
• Overwhelming clinical need
• Expanded eligibilities not mentioned in pERC review
§ other lines of therapy, indication creep
Survey Responses

20. 20
Challenges and barriers that may limit evidence-based
recommendations:
• Quality of clinical trails (design, outcomes measures)
• Standard of care in other jurisdictions (e.g. comparators not available in
Canada)
• Re-interpretation of evidence not being studied in a clinical trial
(tumour groups)
• Trial population not generalizable (e.g. too wide vs. too narrow)
• Technology constraints (f/u trial protocols may be easier to follow in
some jurisdictions)
• Too much dependence on manufacturer for submissions
• Would prefer more tumour group submissions but resources scarce
• pERC’s adherence to evidence-based patient eligibility criteria
• Provinces feel pressure to expand eligibility due to demands
Survey Responses

21. 21
Potential solutions to enhance alignment of funding
decisions with HTA recommendations:
• Pan Canadian Pricing Alliance
• Quicker response from pCODR
• More tumour group input on priorities
• pERC to be more clear on prioritization with each recommendation
• National Drug Program
• PAG should be more aligned due to their involvement in the pERC
process
• Funding decisions may suggest otherwise
• Wording of same decisions varies province to province
• Strengthen national consensus on treatment pathways and add to
pERC’s clinical review
Survey Responses

22. 22
• Some discordance should be expected regarding HTA
recommendations
§ Majority associated with conditional recommendations
• Overlap exists between HTA challenges and solutions
§ Trade-off between being too strict and too lenient (e.g. eligibility
criteria)
§ Trade-off between evidence-based framework vs. local interests
• Discordance may lead to a lack of consistency in decision making
• Discordance may lead to a lack of transparency
• Uncertainty requires more data, and priorities could be shifted to
achieve this
• Consider HTA committee performance review to enhance
accountability
Take Home Messages

23. Thank you
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