stakeholder engagement session_phase ii of the transfer of pcodr to cadth_patient advocacy groups...
TRANSCRIPT
Stakeholder Engagement Session
Phase II of the
Transfer of pCODR to CADTH
Patient Advocacy Groups and Clinicians
February 5, 2015
PresentersDr. Brian O’Rourke
• President and CEO, CADTH
Mr. Scott Livingstone
• Co-Chair, CDR-pCODR Process Steering Committee
• President and CEO, Saskatchewan Cancer Agency
Ms. Judy McPhee
• Co-Chair, CDR-pCODR Process Steering Committee
• Executive Director, Nova Scotia Department of Health and
Wellness
Dr. Chander Sehgal
• Director, CADTH Common Drug Review and Optimal Use
Dr. Mona Sabharwal
• Executive Director, pan-Canadian Oncology Drug Review
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Principles for the meeting
• Open, respectful discussion
• Let’s listen
• Loop back to address outcomes/unanswered questions
Pre-circulated materials
• Agenda
• CDR and pCODR process maps
• CDR Deliberative Framework
• Overview of pCODR Step-by-Step process
• Key themes reported from stakeholder input and feedback
on pCODR transfer to CADTH
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Session objectives
• CADTH is committed to ongoing, two-way communication
with stakeholders
• This consultation continues the dialogue begun in June
2014
• Today, we will:
o Recap the consultation process to date and what we heard
from stakeholders
o Provide an update on our progress and a brief overview of
key priority areas
o Answer questions and discuss key issues about Phase II
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Direction from the Conference of
Deputy Ministers of Health
Transfer pCDOR to CADTH in two phases:
• Phase 1 of the transfer of pCODR to CADTH
• pCODR people, processes, and expertise remain intact as a
program under the governance of CADTH
• Almost complete: website transfer in spring of 2015
• Phase 2 of the transfer of pCODR to CADTH
• Better alignment of the pCODR and CDR evaluation criteria while
taking advantage of the best practices of pCODR and CDR
Of Note: There will still be separate programs for
CDR and pCODR.
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• CDR-pCODR Process Steering Committee• Chair of the CADTH pCODR Advisory Committee (PAC): Scott
Livingstone (Saskatchewan Cancer Agency)
• Chair of the CADTH Drug Policy Advisory Committee (DPAC): Judy McPhee (NS Department of Health and Wellness)
• Representatives from provincial cancer agencies and federal-provincial/territorial drug plans
• Stakeholder feedback• June 9th consultation sessions with patient groups, clinicians,
and industry representatives
• Written feedback received from formal consultation
• Key themes: Separate programs, engagement, timeliness, transparency, collaboration
Process to Guide the CDR-pCODR
Alignment
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• Progress to Date
• Agreement on broad principles for CADTH drug reviews
• Identified major areas for alignment
• Undertook a detailed review of the entire process for CDR and
pCODR to confirm similarities and identify areas requiring
further consultation
• Areas for Alignment
• Recommendation framework
• Review processes
• Stakeholder engagement
• Administrative processes
CDR-pCODR Process Steering Committee
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CADTH Common Drug Review• A pan-Canadian process that provides formulary listing
recommendations to publicly-funded drug plans
• 18 CDR-participating drug plans
• Established in 2003 to reduce duplication across
jurisdictions, maximize the use of limited resources, and
enhance the consistency of drug reviews.
• Listing recommendations are provided by an appointed,
national, expert advisory committee• Canadian Drug Expert Committee (CDEC)
CDR Process Overview
Submission accepted
for review
Review teams established• ≥ 2 clinical reviewers
• 2 economic reviewers
• Project owner (clinical)
• Project owner (economic)
• Project manager
• Information specialist
• ≥ 1 clinical expert
Clinical
Review
Economic
Review
Clinical
Report
Economic
Report
Manufacturer comments
and reviewer responses
Manufacturer’s submission
to CDRReview Process
Patient
Input
All above information used by CDEC
to make recommendations
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How Patient Input is Used in CDR
10
Canadian
patient groups
CADTH review
team
Expert Committee
(CDEC)
18 drug plans
Patient input submissions
Patient input collated,
summarized, used to inform
protocol, and included in report
Patient input presented,
used in deliberations, and
reflected in recommendations
Original input
and summary
sent to CDEC
Reasons and
recommendations
published
Input
shared
Input
shared
Input
shared
Updated March 31, 2011
1. Conduct
Pre-
Submission
Planning
activities
including
getting
input from
PAG and
notifying
Patient
Advocacy
Groups
2. Prepare
& submit
Request
for Drug
Review
4.2
Conduct
Economic
Review
5.
Summarize
& Review
with pERC
6. Prepare &
Publicly
Post Initial
Recomm,
Post
Reviews
8. Summarize
& Review with
pERC
3.1 Screen
Submission
and Initiate
Review
Process
End‡
Ind
us
try/
Tu
mo
ur
Gro
up
pC
OD
R *
Variable 5 business days 70-90 business days 12 business days 10 business days 20 business days
7.1 Get
Feedback
from
Submitter
(and impacted
manufacturer)
7.3 Get
Feedback
from Patient
Advocacy
Group
7.2 Get
Feedback
from PAG
Pa
tie
nt
Ad
vo
ca
cy
Gro
up
s
9. Prepare &
Publicly Post
Final
Recomm &
Post Input
12 business days
*Includes pCODR Secretariat, Clinical
Guidance Panel, Economic Guidance Panel,
pCODR Expert Review Committee (pERC)
and Provincial Advisory Group (PAG)
4.1.1/4.2.2
Clarify info
with
Submitter
during
review
4.1
Conduct
Clinical
Review
3.2 Collect
Patient
Advocacy
Group
Input
Estimated
99 – 149
business days
7.4
Eligible for
Early
Conversion?
No Yes
‡Next steps could include
Recommendation implementation,
Procedural Review or Resubmission
pCODR Review Process
© 2015 pan-Canadian Oncology Drug Review11
Key Similarities of CADTH Drug Review
Processes
• Encourage patient input
• Have clinician inputs for understanding the clinical context
• Work with deliberative processes and committees to develop
recommendations
• Commit to making recommendations that are usable and ready
for implementation by participating agencies and drug plans
• Offer various mechanisms to involve the federal, provincial, and
territorial partners
• Allow for public and detailed tracking of milestones of each
submission
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1. Moving forward with decisions based on
previous consultation and feedback.
2. New topics open for consultation.
3. Other decisions related to CDR and pCODR.
Implementing Phase II of the pCODR
Transfer to CADTH
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• Adoption of common guiding principles for CADTH drug review programs• Creation of common Guiding Principles from pCODR
guiding principleso Accountable governance, collaborative and representative,
efficient and effective, ethical
• Consolidating pCODR guiding principles with the core corporate values of CADTHo Evidence-based, committed to excellence, continuous
evaluation
• Agreement that there will be a common recommendation framework for CDR and pCODR• Specific wording still under discussion
• Likely a hybrid between the 4 recommendation categories for CDR and the 3 categories for pCODR
Decisions Informed by Stakeholders
14
• Under Review Processes
• Posting of initial recommendations
• Under Stakeholder Engagement
• Exploring more open expert review
committees
• Exploring individual patient/caregiver input
New Topics Open for Consultation
15
1. Patient input to CADTH reviews will continue to be an essential component of the process• Confirmed in new CADTH Strategic Plan 2015-2018
o “Embrace evolving successes in patient engagement practices in health technology assessment”
2. Lengthening the mandatory notification period for pending submissions by manufacturers• Time frame for notification period still to be confirmed
3. Industry application fees for pCODR submissions will be implemented on April 1st, 2015• For all drugs submitted to pCODR with a NOC date on or after
April 1st, 2015
• Will permit an increase in the number of drugs reviewed
Other Decisions Related to CDR and
pCODR
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Key areas to seek input from
stakeholders
1. Explore ways to further enhance transparency of the drug review process, such as, examining more open expert review committee meetings
• What do you understand ‘open meeting’ to mean?
• How do we do this and ensure equity? For example, it may be difficult for some groups to attend in-person.
• What impact on timelines would you be prepared to tolerate?
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Key areas to seek input from
stakeholders
2. Explore the inclusion of individual patient/caregiver input
• Explore approaches to obtain those perspectives when there is no patient group or related patient group representing patients for the particular disease/tumour for which a drug under review is indicated
• In what ways other than through template submissions (e.g., individual interviews, focus groups), might the information from these perspectives be effectively gathered?
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Key areas to seek input from
stakeholders
3. Examining the pros and cons of posting initial recommendations
• Posting initial recommendations provides all stakeholders with the opportunity to comment. It also lengthens the overall time of the review process.
• How much time is needed to respond to an initial recommendation?
• Do you accept the potential timeline impact on the review process overall?
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We want to hear from you
• Summary of today’s discussion will be publicly posted
• Opportunity for additional feedback
Email us at:
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cadth.ca/photoblog [email protected]
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