CADTH Drug Portfolio Information Session Portfolio Sessio… · • Feb 2015: CDR & pCODR...
Transcript of CADTH Drug Portfolio Information Session Portfolio Sessio… · • Feb 2015: CDR & pCODR...
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CADTH Drug Portfolio
Information Session Patient Groups and Clinicians
OCTOBER 14, 2015
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Welcome
ROBYN OSGOOD
MODERATOR
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Presenters
• Dr. Brian O’Rourke President and Chief Executive Officer, CADTH
• Mr. Brent Fraser Vice-President, Pharmaceutical Reviews, CADTH
• Dr. Chander Sehgal
Director, CADTH Common Drug Review and Optimal Use
• Dr. Mona Sabharwal Executive Director, CADTH pan-Canadian Oncology Drug Review
• Dr. Michelle Mujoomdar
Director, Scientific Affairs, CADTH
• Mr. Ken Bond
Director, Strategic Initiatives, CADTH
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Overview of the Agenda
TOPIC LEAD
Welcome Robyn Osgood
Introductory Remarks Brian O’Rourke
CADTH Scientific Advice Program Michelle Mujoomdar
Evolving Patient Engagement Processes Ken Bond
CADTH Drug Portfolio Updates Brent Fraser
pCODR Consultations and Updates Mona Sabharwal
CDR and Optimal Use Consultations and Updates
Chander Sehgal
CDR/pCODR Alignment – Consultations and Updates
Brent Fraser
Open Forum Robyn Osgood
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Principles for the meeting
• Open, respectful discussion
• Let’s listen
• Loop back to address outcomes/unanswered questions
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Introductory Remarks
DR. BRIAN O’ROURKE
PRESIDENT AND CHIEF EXECUTIVE OFFICER
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Session Objectives
1. Outline and hear your thoughts on the CADTH Scientific
Advice Program and Patient Engagement Strategy
2. Provide program updates from the CADTH drug portfolio
3. Provide an update and answer your questions on CDR-
pCODR alignment activities, including progress to date and
key priority areas
4. Answer questions and discuss key issues
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CADTH Scientific Advice Program
MICHELLE MUJOOMDAR, PhD.
DIRECTOR, SCIENTIFIC AFFAIRS
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About the CADTH Scientific Advice
Program
• Voluntary, fee-for-service consultation for pharmaceutical
companies
• Advice on early drug development plans from a health
technology assessment (HTA) perspective
• Advice at an early point in the drug development process
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• Industry interest (requests since 2008)
• CADTH Pilot
• Comparable International Programs:
• NICE (UK)
• EUnetHTA (Europe)
• AIFA(Italian Medicines Agency)
• G-BA (Germany)
• EMA-HTA Joint Advice
Why Scientific Advice at CADTH?
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Development of a CADTH Program
Guiding Principles
• Voluntary
• Non-binding
• Fee-for-service based on cost recovery
• Will not detract or divert resources from other CADTH
programs
Our Approach to Developing the Program
• Engagement with Industry
• Learn from existing programs at leading HTA agencies
• Adapt and build on the strengths of CADTH
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Eligibility
• New drug products
• Existing drug products with new indications
• Drugs for rare diseases
• Subsequent entry biologics (SEBs)
• Oncology products
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Types of questions asked
• Patient population
• Comparator
• Outcomes
• Follow-up
• Analyses
• Health Economic-related
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Features of a Scientific Advice
program
General
• Face-to-face meeting with open, candid exchange
• Written record of advice
• Value in experts attending meeting; all participants must
be knowledgeable
Nature of the advice
• Relevant, timely, constructive, and actionable with a
specific point of view provided
• Balance between covering all issue and discussing key
issues in depth
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Patient Involvement
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Two approaches:
1. Information provided by company
2. Patient interview
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Potential Benefits
• Early input in drug development process
• Recommendations based on better evidence
• Reduced uncertainty
• Test new development strategies
• Advice in context
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Evolving Patient Involvement
Processes
KEN BOND
DIRECTOR, STRATEGIC INITIATIVES
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Opportunities for Input
• Submissions from individual patients and
caregivers
• Therapeutic Review feedback and process
revisions
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Enhancing Input and Feedback
Assessments:
• Use of patient group input in CDR
• Letters of appreciation
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Medical Devices and Procedures
• Explicit consideration of patient values and
preferences
• Systematic review of patient preferences and
values
• Patient interviews to validate key outcomes
• Patient groups to comment on draft report and
recommendations
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Collaboration and Outreach
• Patient Community Liaison Forum webpage
www.cadth.ca/cadth-patient-community-liaison-
forum
• HTAi Patient and Citizen Involvement Interest
Group Meeting October 18-20
• CADTH 2016 Symposium
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CADTH Drug Portfolio Updates
BRENT FRASER
VICE-PRESIDENT, PHARMACEUTICAL REVIEWS
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Timeframes
• April 2014: pCODR transfer to CADTH
• June 2014: CDR Stakeholder information sessions
• Feb 2015: CDR & pCODR Stakeholder engagement sessions
• Feb-Sept 2015
o Written stakeholder feedback opportunity
o CADTH’s establishes the CDR-pCODR alignment working group to identify
areas for alignment and prepare procedural changes
o Ongoing consultation with participating jurisdictions (drug plans and cancer
agencies)
• Sept-Oct 2015:
o CADTH drug portfolio information session
o Stakeholder consultations of key alignment initiatives
o Identification of additional procedural and process items for alignment
between the CDR and pCODR programs
• January – March 2016: Implementation of the procedural decisions made
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pCODR Consultations and Updates
DR. MONA SABHARWAL
EXECUTIVE DIRECTOR, CADTH PAN-CANADIAN
ONCOLOGY DRUG REVIEW
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Patient Engagement & Collaboration
New Initiative:
• Expanding the CADTH Drug Review Process to Receive Patient
Input Submissions From Individual Patients and Caregivers
Collaboration Projects (2015):
• Illustrating key components of the existing “Guide for Patient
Advocacy Groups” through two narrated slide decks
• Cancer Drug Pipeline Information for Patient Advocacy Groups
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Proposal:
• Develop a mechanism that will increase opportunities for
clinicians to participate in the CADTH pCODR process
Objectives:
• Provide value-added contextual information for Clinical Guidance
Panel and pERC
• Enable cancer specialists to provide input on value of a particular
drug and its place in therapy
• Solicit values of broad clinician community
• Continue to foster relationships with the clinician community
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Consultation on Enhance Clinician
Engagement
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Ind
ustr
y/
Tu
mo
ur
Gro
up
p
CO
DR
*
Pati
en
t A
dv
ocacy
Gro
up
s
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‡
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)
7.3a Get
Feedback
from Patient
Advocacy
Group
7.2 Get Feedback from
PAG
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
3.2a 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 3.2b Collect
Regsitered
Clinician
Input
7.3b Get
Feedback
from
Registered
Clinician
Proposed Approach for Clinician
Engagement
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CDR and Optimal Use of Drugs –
Consultations and Updates
DR. CHANDER SEHGAL
DIRECTOR, CADTH COMMON DRUG REVIEW AND
OPTIMAL USE
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Revised voluntary withdrawal process
• CADTH has recently seen an increase in the number of
submissions that are withdrawn by manufacturers during the
embargo period.
• In order to be accountable to stakeholders, CADTH has a public
responsibility to communicate the outcomes of drug reviews that
were considered by CDEC.
• CADTH plans to revise the CDR Procedure by only permitting
withdrawal of a submission up until 4:00 p.m. EST five business
days before CDEC is scheduled to deliberate.
• This procedural change would be effective for all submissions
targeting the Jan 2016 CDEC meeting or later.
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CADTH responses to manufacturer comments
• To increase the transparency of the CDR process, CADTH plans to
revise the CDR Procedure and provide manufacturers with the
CDR review team’s responses to their comments regarding the
draft CDR review reports.
• This would be effective for all submissions and resubmissions
targeting the January 2016 CDEC meeting or later.
• Responses will be provided seven business days prior to the
CDEC meeting
• The responses will be provided for information only and
manufacturers should not contact CADTH regarding the content of
the response document.
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Identification of Topics for Therapeutic
Reviews
Topic Identification
CADTH Staff (PDOs, LOs)
Policy Makers, Government
CDEC, CDR
Environmental Scans, Horizon
Scans
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Patient Input
• Pilot process initiated in 2012 (MS Therapeutic Review) –
until August 2015
• Reasons for seeking Patient Input for CDR Submissions
and Therapeutic Reviews:
o Share lived experience
o Identify unmet needs of existing therapy
o Identify treatment outcomes of greatest importance
o Ask for patient input early to ensure the above are
considered during the project development
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Stakeholder Engagement
Therapeutic Review Process Stakeholders
Patient Groups Public Health Care
Providers Industry Jurisdictions
Project Scoping
Topic
Identification/Refinement
Specialist
experts
Proposed Project Scope
Active Research Phase
List of Included Studies
Draft Science Report (clinical
and economic)
Recommendations Phase
Draft Recommendations Report
CDEC Committee Membership
Knowledge Mobilization Phase
Knowledge Mobilization Tools
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CDR/pCODR Alignment –
Consultations and Updates
BRENT FRASER
VICE-PRESIDENT, PHARMACEUTICAL REVIEWS
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Key Principles
• ‘Alignment’ does not imply ‘identical’
• Build on best practices of both programs
• Customer and Stakeholder engagement key in informing
decisions
• Final decision made by CADTH after considering
stakeholder feedback and internal factors (e.g. impact of the
changes on budget, resourcing and timelines)
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Summary of Written Feedback on
CDR-pCODR alignment (May 2015)
1. Exploring possibility of enhancing transparency of the drug review
process (e.g., examining more open expert review committee meetings)
• Different views of what an ‘open meeting’ means; this ranges from
observing to full participation
• Majority are supportive of the ability to attend CDEC/pERC meeting to have
better insight of the deliberation process, and having a two-step process
(i.e., open meeting and in-camera session for deliberation)
• One submitter noted that alternative approaches to achieve greater
transparency could include:
a) a midpoint meeting
b) sharing of the reviewer comments on the manufacturer response to
clinical and PE Reports, and
c) publication of the draft recommendation for stakeholder comment
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Summary of Written Feedback on CDR-
pCODR alignment (May 2015)
2. Explore the inclusion of individual patient or caregiver input
• Different approaches were submitted for individual patient submissions
• Some suggested no new formal process should be required
o May be done through the current template process or by other
specialized surveys or focused groups, facilitated by CADTH, developed
to reflect and accommodate possible special needs of patient
populations
• Other suggestion:
o Designate CADTH staff person, the two patient PERC representatives
and the patient Navigator position to gather and synthesize this
information
• Opposing view:
o CADTH should not conduct interviews or focus groups, as this would be
seen as counter to the purpose of having the patient input not influenced
by the assessor
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Summary of Written Feedback on
CDR-pCODR alignment (May 2015)
3. Explore pros and cons of mid-point review meeting
• Full support with having a mid-point or checkpoint meeting
4. Explore pros and cons of posting initial recommendations
• Majority support with posting initial recommendation
o One submitter stated that the initial recommendation should not
be posted publicly, but rather released only to process
participants and kept under embargo until the release of the final
recommendation
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Summary of Written Feedback on
CDR-pCODR alignment (May 2015)
5. Other comments
• support CADTH’s adoption of pCODR guiding principles
• support the concept that both CDR and pCODR use the same
recommendation nomenclature
• support CADTH adopting pCODR deliberative framework for both review
processes
• support having a process for additional clinician engagement
• support performance metrics reporting and tracking the uptake of pCODR
recommendations by participating plans, and that this should be done in the
similar fashion for CDR
• support the inclusion of procedural review mechanism for the CDR process,
modelled largely on the pCODR option
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Mandatory Advanced Notification
• CADTH is proposing to establish a mandatory advance
notification period of 180 calendar days for all pending
submissions and resubmissions to CDR and pCODR.
• The applicant would also be required to provide a follow-up
confirmation of the anticipated filing date one month before that
date, at which time there would be public notification
• The key objectives of having advance notification:
o improve forecasting of the quantity and type of CDR and
pCODR applications to be filed.
o help with resource planning, including clinical expert
recruitment, and budgeting for both programs.
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Disclosure of submitted prices
• CADTH has encountered a variety of issues concerning
different interpretations by pharmaceutical manufacturers
when the “submitted price” for a drug is filed as a
confidential price for review through CDR or pCODR.
• These situations have led to confusion between individual
manufacturers and CADTH jurisdictional customers.
• CADTH is proposing that all applicants be required to
agree to the disclosure of the submitted price.
• This revision would enhance transparency for both the
CDR and pCODR processes.
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CDEC and pERC Recommendation
Framework
Current Recommendation Categories
CDR recommendations pCODR recommendations
Four recommendation categories:
• List
• List with clinical criteria and/or
conditions
• Do not list at the submitted price
• Do not list
Three recommendation categories:
• Recommend to fund
• Recommend to fund with conditions
• Do not recommend funding
Proposed recommendation framework for CDR and pCODR:
1. Reimburse
2. Reimburse with clinical criteria and/or conditions
3. Do not reimburse
Detailed context provided in the consultation document posted on CADTH
website on October 9th
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Future Topics for Alignment
• Posting embargoed CDEC recommendations
o This occurs in the pCODR process but not in the CDR
process.
• Procedural review
• Collaborative space
o This is currently being used in the pCODR process but not in
the CDR process.
• Touch point meeting during an ongoing review
• Open CDEC and pERC meetings
• Other topics?
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2016 CADTH Symposium
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