CADTH Drug Portfolio

Information Session Patient Groups and Clinicians

OCTOBER 14, 2015

Welcome

ROBYN OSGOOD

MODERATOR

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

3

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

Principles for the meeting

• Open, respectful discussion

• Let’s listen

• Loop back to address outcomes/unanswered questions

5

Introductory Remarks

DR. BRIAN O’ROURKE

PRESIDENT AND CHIEF EXECUTIVE OFFICER

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

7

CADTH Scientific Advice Program

MICHELLE MUJOOMDAR, PhD.

DIRECTOR, SCIENTIFIC AFFAIRS

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

9

• 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?

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

Eligibility

• New drug products

• Existing drug products with new indications

• Drugs for rare diseases

• Subsequent entry biologics (SEBs)

• Oncology products

12

Types of questions asked

• Patient population

• Comparator

• Outcomes

• Follow-up

• Analyses

• Health Economic-related

13

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

Patient Involvement

15

Two approaches:

1. Information provided by company

2. Patient interview

Potential Benefits

• Early input in drug development process

• Recommendations based on better evidence

• Reduced uncertainty

• Test new development strategies

• Advice in context

16

17

www.cadth.ca/scientificadvice

scientificadvice@cadth.ca

requests@cadth.ca

18

Evolving Patient Involvement

Processes

KEN BOND

DIRECTOR, STRATEGIC INITIATIVES

Opportunities for Input

• Submissions from individual patients and

caregivers

• Therapeutic Review feedback and process

revisions

Enhancing Input and Feedback

Assessments:

• Use of patient group input in CDR

• Letters of appreciation

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

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

24

CADTH Drug Portfolio Updates

BRENT FRASER

VICE-PRESIDENT, PHARMACEUTICAL REVIEWS

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

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

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

32

CDR and Optimal Use of Drugs –

Consultations and Updates

DR. CHANDER SEHGAL

DIRECTOR, CADTH COMMON DRUG REVIEW AND

OPTIMAL USE

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.

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.

Identification of Topics for Therapeutic

Reviews

Topic Identification

CADTH Staff (PDOs, LOs)

Policy Makers, Government

CDEC, CDR

Environmental Scans, Horizon

Scans

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

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

39

CDR/pCODR Alignment –

Consultations and Updates

BRENT FRASER

VICE-PRESIDENT, PHARMACEUTICAL REVIEWS

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)

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

42

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.

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.

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

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

52

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