Stakeholder Engagement Session

Phase II of the

Transfer of pCODR to CADTH

Pharmaceutical Manufacturers, Associations, and Consultants

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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OVERVIEW OF CDR AND pCODR

PROCESSES

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

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 Review10

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

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• Under Review Processes

• Posting of initial recommendations

• Mid-point review meeting

• Under Stakeholder Engagement

• Exploring more open expert review committees

New Topics Open for Consultation

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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 ensure confidentiality?

• What impact on timelines would you be prepared to tolerate?

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Key areas to seek input from

stakeholders

2. Examining the pros and cons of mid-point review

meeting (e.g., Checkpoint)

• What are your company’s objectives for check point

meetings?

• Are there other ways to achieve those objectives, in particular

to consider the potential timing of such meetings and

timelines impact on the process?

• If no, why not and if yes, what might those be?

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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 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:

requests@cadth.ca

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