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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
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
Patient Engagement in HTA Drug Review Process
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
Patient Engagement in HTA Drug Review Process
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
Patient Engagement in HTA Drug Review Process
5
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
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
Patient Engagement in HTA Drug Review Process
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
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
Patient Engagement in HTA Drug Review Process
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?
Health Technology Assessment
Patient Engagement Navigator:
A New Resource
10
Patient Engagement in HTA Drug Review Process
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?
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?
Patient Engagement in HTA Drug Review Process
13
• 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
Patient Engagement in HTA Drug Review Process
14
HTAPEN Key Activities
Health Technology
Assessment E-Bulletin
hta@canceraction.ca
Patient Engagement in HTA Drug Review Process
15
• 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
Patient Engagement in HTA Drug Review Process
16
Online Resources for Patient Groups
www.ccanceraction.ca
Patient Engagement in HTA Drug Review Process
17
• 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
Patient Engagement in HTA Drug Review Process
18
Guidelines, Procedures and
Templates
https://www.cadth.ca/pcodr
Patient Engagement in HTA Drug Review Process
19
Adam Waiser
HTA Patient Engagement Navigator
(416) 418-5035
hta@canceraction.ca
HTAPEN Contact Information
Patient Engagement in HTA Drug Review Process
20
Thank You and Questions?

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Patient Engagement in HTA Drug Review Process

  • 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
  • 3. Patient Engagement in HTA Drug Review Process 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
  • 4. Patient Engagement in HTA Drug Review Process 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
  • 5. Patient Engagement in HTA Drug Review Process 5 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
  • 7. Patient Engagement in HTA Drug Review Process 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
  • 9. Patient Engagement in HTA Drug Review Process 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
  • 11. Patient Engagement in HTA Drug Review Process 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?
  • 13. Patient Engagement in HTA Drug Review Process 13 • 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
  • 14. Patient Engagement in HTA Drug Review Process 14 HTAPEN Key Activities Health Technology Assessment E-Bulletin hta@canceraction.ca
  • 15. Patient Engagement in HTA Drug Review Process 15 • 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
  • 16. Patient Engagement in HTA Drug Review Process 16 Online Resources for Patient Groups www.ccanceraction.ca
  • 17. Patient Engagement in HTA Drug Review Process 17 • 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
  • 18. Patient Engagement in HTA Drug Review Process 18 Guidelines, Procedures and Templates https://www.cadth.ca/pcodr
  • 19. Patient Engagement in HTA Drug Review Process 19 Adam Waiser HTA Patient Engagement Navigator (416) 418-5035 hta@canceraction.ca HTAPEN Contact Information
  • 20. Patient Engagement in HTA Drug Review Process 20 Thank You and Questions?