cadth medical device and clinical intervention … portfolio...procedures, and systems developed to...

CADTH Medical Device

and Clinical Intervention

Portfolio Information

Session THURSDAY, NOVEMBER 1, 2018

10:00 A.M. TO 12:00 P.M.

Health Technology Management

1. An increased emphasis on implementation support.

2. A shift in focus from assessment at the point of adoption to

evaluation across the life cycle of a drug or health

technology.

3. Strengthened engagement with stakeholders (patients,

clinicians, citizens, industry).

4. An approach that better supports access, appropriate use,

and affordability.

Pre-market

dialogue

Managed

entry

Post-market

surveillance

Managed

exit

Reassessment

Mission CADTH consistently

delivers credible scientific

evidence and management

strategies that enable the

appropriate use of health technologies.

Vision Canada has a world-class

system for assessing and

managing health

technologies to achieve

better outcomes and value for Canadians.

CADTH Values

• Excellence

o CADTH is trustworthy, delivers what it promises, and exceeds

expectations by focusing on impact to drive better health, better

patient experience, and better value for Canadians.

• Responsiveness

o CADTH understands and meets the needs of its customers in a

timely fashion.

• Collaboration

o CADTH creates and nurtures partnerships with those who produce,

acquire, deploy, and use health care technologies to promote their

appropriate use.

• Transparency

o CADTH makes timely and user-friendly information about its

programs, processes, and performance widely available, with a

special emphasis on engaging key stakeholders.

CADTH Strategic Plan 2018-2021

1. Close the gap between evidence,

policy, and practice.

2. Adopt a life-cycle approach to health

technology assessment.

3. Anticipate health system and

technology trends and develop agile

management strategies.

Strategic Issues

1. The pan-Canadian Health Organization

Implementation Steering Group

2. The Advisory Council on the Implementation

of National Pharmacare

3. The Health and Biosciences Economic

Strategy Table

Session Objectives

• CADTH is committed to ongoing, two-way

communication with stakeholders

• Today is an opportunity to learn about:

o CADTH’s Medical Devices and Clinical Interventions

Portfolio

o Recent program and product updates

o Other CADTH initiatives

o Key topics of interest to you during the Open Forum

Presenters

• Brian O’Rourke, President and CEO

• Harindra Wijeysundera, VP, Medical Devices & Clinical

Interventions

• Lesley Dunfield, Director, HTA and Program Development

• Chris Kamel, Director, HTA and Rapid Response

• Tarry Ahuja, Manager, Program Development, RWE Lead

• Michelle Mujoomdar, A/VP, Evidence Standards

Overview of the Agenda

TOPIC LEAD

Welcome and Strategic Update Brian O’Rourke

Medical Device and Clinical Intervention Portfolio a) Overview b) Program and Product Updates

Harindra Wijeysundera Lesley Dunfield Chris Kamel

New Initiatives a) Implementation Support b) Value-Based Procurement c) Real-World Evidence d) Disinvestment/Reassessment e) CAR T-Cell Therapies

Brian O’Rourke Harindra Wijeysundera Tarry Ahuja Lesley Dunfield

Stakeholder Engagement Michelle Mujoomdar Harindra Wijeysundera Brian O’Rourke

Open Forum CADTH Team

Wrap Up Brian O’Rourke

Questions

• Questions of clarification after each

• Open Forum at the end of the session

• In-person:

o Please use a microphone for the benefit of on-

line participants

• On-line:

o Use the question feature on the webinar toolbar

Medical Device and Clinical

Intervention Portfolio a) Overview

b) Program and Product Updates

Medical Device and Clinical Intervention

Portfolio

Outline

a) Health technology assessment (HTA)

• What

• When

• Who

• How

b) Health technology management (HTM)

• Is it different?

WHAT is HTA

• WHO definition

• The systematic evaluation of properties, effects, and/or impacts

of health technology

• Health technology is the application of organized knowledge and

skills in the form of medicines, medical devices, vaccines,

procedures, and systems developed to solve a health problem

and improve quality of life.

• A multidisciplinary process to evaluate the social, economic,

organizational, and ethical issues of a health intervention or

health technology.

• The main purpose is to inform policy decision-making.

HTA — Who?

• HTA bodies

• NICE

• ICER

• CADTH

• Hospital-based units

• Hospital value analysis committees

• Central difference is that HTA bodies conduct

evaluation of a class of devices, while hospital-based

value analysis is done at the product level.

Device

Rapid Response 279

Environmental and Horizon Scans

Environmental Scan – Report 4

Horizon Scan – Bulletin 12

Horizon Scan – Newsletter 2

Horizon Scan – Roundup 2


Health Technology Assessment 2

Optimal Use 2

HTA — When

• Canada is a federal system that is highly decentralized

• Regulatory approval to enter the marketplace is conducted federally by Health Canada

• based on a reasonable ratio of efficacy and safety

• special access/compassionate use

• Once in the market place, funding for medical devices is determined and provided at the provincial/territorial level

• Single third-party payer

• Administration of health care delivery is done regionally within provinces

HEALTH CANADA Federal role

Funding Decisions: Health Technology Assessment Provincial role

How?

• Common misconception

• HTA is equivalent to a regulatory decision with just the

addition of costs.

How?

• Multi-Criteria Deliberative Framework:

• Relevance and unmet need

• Benefits

• Harms

• Patient perspective

• Economic impact

• Implementation

• Legal

• Ethical

• Environmental impact

How?

• CADTH synthesizes evidence

• External expert committee makes independent

recommendations

• HTERP

HTA — How?

• The recommendation is based on a proposition of:

How?

• EVIDENCE PACKAGE that includes comparative evidence

on:

• Relevance and unmet need

• Benefits

• Harms

• Patient perspective

• Economic impact

• Implementation

• Legal

• Ethical

• Environmental impact

HTA Limitations

• Passive

• Not timely !!!

• Makes less relevant

• Evidence is based on early phase of learning curve

• Evidence base may not reflect real-world performance


Horizon Scanning

HTA/ Optimal Use Products

Implementation Support Inform Procurement

Re-assessment/ disinvestment

• Life-cycle approach

• Active

• Informs topics upstream • Tailored review

• “Fit for purpose”

• Deconstructed and

distributed across Pan-

Canadian Collaborative

• Informs implementation

downstream

RAPID RESPONSE SERVICE

Opportunities

• Greater alignment of regulatory and adoption process

• Use special access as an input for topic selection

• Initiate earlier reimbursement assessments

• Challenges is quality of evidence

• Need for reassessments

• ? Conditional approval

• Implementation

• Regional hubs

• Informing value-based procurement

• Reassessment/Disinvestment

Medical Device and Clinical

Intervention Portfolio a) Overview

b) Program and Product Updates

Additional Analyses Accelerated Methods

Rapid Response HTA/OU

Assessment Products

Rapid Response: Products

Rapid Response: Customers

• Federal government

• Provincial governments

• Regional health authorities

• Hospitals

Rapid Response: Process (Summary

With Critical Appraisal)

Receive Request

Topic Refinement

(PICOS) Literature Search

Screening and Study Selection (Titles and

Abstracts)

Retrieve Full Text Screening and Study Selection (Full Text

Review)

Synthesis (Narrative) Internal Review

Publication and Dissemination

Follow-Up With Customer

Fast Facts

• Approximately 300 reports per year

• Over 4,000 reports since program inception

• Up to 75% on medical device topics

Future Growth

• New products

• Professional societies

• Choosing Wisely Canada

Additional Analyses Accelerated Methods

Rapid Response HTA/OU

Assessment Products

Health Technology Assessment

Effectiveness Review Economic Analysis

Ethics

Implementation Environmental

Impact

Legal Qualitative Review

Optimal Use

• HTA with recommendations

• Policy and practice decisions

• Inform appropriate use

• Recommendations developed by an expert

committee

• Knowledge mobilization

Health Technology Expert Review

Panel (HTERP)

• 7 core members

• Chair

• Public member

• Ethicist

• Health economist

• Three health care practitioners

• Up to 5 expert members

HTERP Deliberative Framework

Clinical Context/ Need

Benefits and Harms Economic Impact

Ethics

Implementation

Environmental Impact

Legal Patient Perspectives

TOPIC IDENTIFICATION

HTERP Rapid

Response

Proactive Scoping (PDO)

Horizon Scanning

Priority Lists

Media Decision-Makers

Health Canada

Liaison Officers

Partners

PCC Industry Web

• Call for Topics

• Social Media

Prioritization

• Mandate

• Assess appropriateness

• Conduct scoping

• Prioritization (quarterly)

• Topics under consideration on cadth.ca

Horizon Scanning

Horizon Scanning

• Informs HTA development

• Preparedness

• Overviews

• Early assessments

Environmental Scanning

• Standalone reports or HTA-linked

• Snapshot of current context or practice

across Canadian jurisdictions and beyond

• Methods: literature review, survey,

consultations

Future Initiatives

• Tailored, custom HTA

• Horizon scanning expansion

• Collaborative projects

• Care pathways

New Initiatives a) Implementation Support

b) Value-Based Procurement

c) Real-World Evidence

d) Disinvestment/Reassessment

e) CAR T-Cell Therapies

What is Real-World

Evidence (RWE)?

What is RWE?

Real-world evidence (RWE) is evidence derived from the analysis and/or synthesis of real-world data (RWD).

RWD is an overarching term for data that are not collected in the context of conventional randomised controlled trials (RCTs).

What is RWE?

• Randomized controlled trials (RCTs) have been the gold standard

• Patients are quite homogenous • Data collected are closely controlled and monitored • High internal validity, low external validity

* adapted from www.nehi.net

What is RWE?

• Data comes from various non-RCT sources • Patients are quite heterogeneous • Data collected from real-world practice settings • Low internal validity, high external validity

* adapted from www.nehi.net

CADTH and RWE

CADTH and RWE

• CADTH currently uses RWD/RWE in different applications

• Different sources of evidence will be used to inform different

policy/research questions

• Follow the hierarchy of evidence — RWE will not replace RCTs

• RWE will be used with the product life-cyle approach

• RWE will continue to be used and developed for both drugs and devices

RWE Summit

Defining “Decision-Grade” Real-World Evidence

and its Role in the Canadian Context:

A Design Sprint

October 21, 2018, in Toronto, Ontario

RWE Summit

• Multi-stakeholder RWE workshop held at CAPT meeting (Oct. 2018)

• Organizing partners included: CADTH, Health Canada, IHE, CAPT

• Participants included: Academia, researchers, clinicians, patient

representatives, payers, data providers, and industry

• Used a design sprint model to make the meeting actionable

RWE Summit

• The objectives of the workshop were:

o to identify the value and applications of RWE in supporting

pharmaceutical regulatory and reimbursement decision-making

o to identify the conditions upon which RWE will be considered of

sufficient quality to inform decision-making.

RWE Summit

• Participants worked on two case studies with discussion period

• Meeting summary currently being drafted (Nov/Dec 2018)

Next Steps

Next Steps

• CADTH is currently drafting an RWE Action Plan

• Consultation and collaboration with Health Canada to generate an

RWE Framework document in spring 2019

• Several touch points for consultation and stakeholder feedback during

the process

New Initiatives a) Implementation Support

b) Value-Based Procurement

c) Real-World Evidence

d) Disinvestment/Reassessment

e) CAR T-Cell Therapies

Overview

• CAR T-cell therapy overview

• Medical devices portfolio

• Health Technology Expert Review Panel (HTERP)

• Assessment process for CAR T-cell therapies

CAR T-Cell Therapy — Overview

Medical Devices

• Medical devices

• Diagnostic tests

• Surgical procedures

• Dental procedures

• Medical procedures

• Clinical interventions

Optimal Use Components



Patient Perspectives Ethics

Implementation

Legal

HTERP Deliberative Framework



Patient Perspectives Ethics

Implementation

Environmental Impact

Legal

Submitting Input

https://drugreviewsadmin.cadth.ca/Landing/Register/Register.

aspx?token=CART

https://drugreviewsadmin.cadth.ca/Landing/Register/Register.aspx?token=CART

https://drugreviewsadmin.cadth.ca/Landing/Register/Register.aspx?token=CART

Stakeholder Engagement a) Patients and Patient Groups

b) Clinicians and Clinical Societies

c) Industry

Overview

Where we can go: “Listening Exercise” with patient groups, committee members, and CADTH directors

Where we are now: Mapped with CADTH Patient Engagement Framework

Guiding us there: Patient and Community Advisory Group

Why Engage Patients

HTAi Patient & Citizen Involvement Interest Group www. htai.org

• Relevance

• Fairness

• Equity

• Legitimacy

• Capacity building

Why Engage Patients

• Patients actively contribute their insights to the Common

Drug Review, pan-Canadian Oncology Drug Review,

Optimal Use and Scientific Advice programs.

• Rapid Response and Optimal Use reports may include an

analysis of published literature on patient perspectives.

Relevance Patients have knowledge, perspectives, and experiences that are unique and contribute to essential evidence for HTA.


Why Engage Patients

• Patients can comment on proposed process changes,

participate in evaluations of CADTH, and contribute to

strategic direction.

• Comment on draft pERC recommendations and Optimal

Use recommendations produced by CDEC and HTERP.

Fairness Patients have the same rights to contribute to the HTA process as other stakeholders and have access to processes that enable effective engagement.


Why Engage Patients

• Patients, families, and communities can offer insights on the

diversity of needs across Canada.

• CADTH deliberative frameworks include multiple

perspectives.

Equity Patient involvement contributes to equity by seeking to understand the diverse needs of patients with a particular health issue, balanced against the requirements of a health system that seeks to distribute resources fairly among all users.


Why Engage Patients

• Groups provide input to CDR and pCODR and identify

patients with specific expertise to contribute to Scientific

Advice, Optimal Use, Environmental and Horizon Scans.

• Recommendations publicly detail how patient perspectives

were considered to reach conclusions.

Legitimacy Patient involvement facilitates those affected by the HTA recommendations to participate in the HTA; contributing to the transparency, accountability, and credibility of the decision-making process.


Why Engage Patients

• Travel awards to CADTH symposium.

• Dedicated patient engagement team.

Capacity Building Patient involvement processes address barriers to involving patients in HTA and build capacity for patients and HTA organizations to work together.


Listening Exercise

Patient Community

Liaison Forum

9 CADTH directors

4 patient and public committee members from pERC, CDEC, and HTERP

21 patient groups involved with CADTH

How can we greater involve

patients, patient groups, and

communities in our work?

We Heard: Greater Involvement

• Meaningful, respectful engagement

• Need for greater diversity of voices

• Greater interaction with expert committees and CADTH

researchers

• Involvement in CADTH governance

• Input and engagement measured to demonstrate impact

• From Patient Community Liaison Forum — involvement in

process design

• Mixed views on capacity for involvement in re-assessment

We Heard: To Be Supported

• Travel awards to CADTH symposium much appreciated

• Clear guidance on what is helpful or seen as biased

• Awareness raising of CADTH and role for patient

perspectives in assessments

• Help preparing / refining patient input

Our Guide: Advisory Group

• Advise CADTH across all programs

• Patient and community — broader than disease-specific

• Lived experience highlighted as essential

• Selected by nominations to meet core competencies

• Agreement that diversity of perspective, accountability to

the community represented, and transparency (financial

and meeting competencies) are important

• Nominations open around end of year, running into early

2019

Stakeholder Engagement a) Patients and Patient Groups

b) Clinicians and Clinical Societies

c) Industry

Open Forum

Wrap Up

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