This document discusses patient engagement in the health technology assessment (HTA) drug review process in Canada. It provides an overview of the different organizations involved in drug regulation and funding, and explains the value of incorporating patient input and perspectives into the HTA process. A key point is the Health Technology Assessment Patient Engagement Navigator (HTAPEN) project, which aims to promote and support patient involvement in HTA drug reviews through activities like workshops, online resources, and acting as a liaison between patient groups and the review process. The document outlines the goals and activities of the HTAPEN project in engaging patients in the assessment of new cancer drugs by regulatory bodies like CADTH's pCODR program.

1. Patient Engagement in
HTA Drug Review Process
Helen Mai, CADTH
Adam Waiser, HTAPEN, Canadian Cancer Action Network
Canadian Expert Patients in Health Technology Conference
November 7-8, 2016

2. Patient Engagement in HTA Drug Review Process
2
• Understanding Health Technology
Assessment (HTA)
• Value of Patient Input and Feedback in HTA
process
• Collaborative Projects - Capacity Building
of Patient Engagement & Involvement in
Cancer Drug Reviews
Objectives

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3
Drug Access—Who Does What
Health Canada
Regulator
(Effect &
safety)
CDR
(CADTH)
pCODR
(CADTH)
Quebec
(INESSS)
HTA
(Assess
value)
Pan Canadian Pharmaceutical
Alliance (pCPA)
Price
negotiator
F/P/T Ministries of Health and
Cancer Agencies
Decision
maker/
funder

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4
• Regulator: How confident can we be that
results are real?
• HTA: How confident can we be in the
magnitude of that benefit and what is its
value?
Understanding evidence for regulatory review
vs health technology assessment

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Provincial Advisory
Group
Submitter
Patient Advocacy
Group
Registered Clinician
Review Team
Registered Clinician
Provincial Advisory
Group
Patient Advocacy
Group
pERC
Submitter
INPUT
SUBMISSION
REVIEW
DELIBERATIONS
FEEDBACK
Initial
Recommendation
Final
Recommendation
CADTH’s pan-Canadian Oncology Drug Review

6. Expert Committees (CDEC, pERC)
Presented, used in
deliberations & reflected
in recommendations
Who Uses Patient Input?
CADTH Review Team
Used to inform protocol
& report
Public Drug Plans
Shared with plans and
shared at www.cadth.ca
Patient Engagement in HTA Drug Review Process

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7
pCODR Expert Review Committee’s (pERC) Deliberative
Framework
Clinical Benefit
• Effectiveness
• Safety
• Burden of Illness
• Need
Patient Values
• Alignment with values
Economic
Evaluation
• Cost effectiveness
Adoption and
Feasibility
• Economic feasibility (BIA)
• Organizational feasibility

8. Patient Engagement in HTA Drug Review Process
Patient input to CDR & pCODR
Single
44%
2 to 4
31%
5 to 10
15%
11+
10%
137 patient groups
submitted to
CDR & pCODR
532 patient input
submissions
June 2010 – June 2016
Many groups responded to
multiple calls for patient
input

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9
• HTA recommendations will ultimately affect
patients for whom the technology is intended
• Only patients and their family/caregivers have:
 day-to-day lived experience with the disease or
condition
 direct experience with currently available
treatments (if applicable) and possibly
experience with the technology being reviewed
• Patients and their caregivers can provide their
perspectives on the most important considerations
and outcomes for a new technology
Why Does Patient Input Matter in HTA?

10. Health Technology Assessment
Patient Engagement Navigator:
A New Resource
10

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11
• The Health Technology Assessment Patient
Engagement Navigator (HTAPEN) project is a
collaboration of the Canadian Cancer Action
Network (CCAN) and CADTH
• The HTAPEN project is funded by the Canadian
Partnership Against Cancer, with in-kind
funding provided by CADTH and CCAN, to
develop, identify and support opportunities for
patient and caregiver involvement with the
pCODR program
How Can We Promote Patient Participation in
Canadian HTA Drug Reviews?

12. Patient Engagement in HTA Drug Review Process
12
A live resource to support and further enhance cancer patient
community involvement in the assessment of new cancer drugs.
Key activities of the HTAPEN project:
• Promote patient awareness of pCODR and their role in the
HTA process.
• Work directly with patient groups to identify and collect
data as well as to prepare the submissions.
• Expand the breadth and improve the quality of resources
available to patients.
What is a HTA Patient Engagement Navigator?

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• Targeted outreach to patient groups after a
call for patient input has been announced
• Presentations to organizations and events
about the HTAPEN project
• Workshop for Patient Groups: Role of
Health Technology Assessment in Cancer
Drug Funding Decisions
• Act as a go-between for patient groups to
help them connect with the pCODR process
HTAPEN Key Activities

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HTAPEN Key Activities
Health Technology
Assessment E-Bulletin
hta@canceraction.ca

15. Patient Engagement in HTA Drug Review Process
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• Provide support that is geared to the specific
needs of a patient group
• Provide advice to help groups find patients
with relevant experience
• Help patient groups develop survey questions
and strategies
• Review previous submissions for ways to
improve in the future
• Provide opportunity for feedback and dialogue
on patient evidence submission
HTAPEN Key Activities

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Online Resources for Patient Groups
www.ccanceraction.ca

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• A Guide for Patient Advocacy Groups:
How to provide patient and caregiver input for
a pCODR drug review
• Online CCAN/pCODR narrated presentations
Online Resources for Patient Groups

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Guidelines, Procedures and
Templates
https://www.cadth.ca/pcodr

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Adam Waiser
HTA Patient Engagement Navigator
(416) 418-5035
hta@canceraction.ca
HTAPEN Contact Information

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20
Thank You and Questions?