EXCITE International: Vision, Reality and the Norwegian Connection

September 2018

Leslie Levin MD, FRCP (Lon), FRCPC

Chief Executive and Scientific Officer

EXCITE International

Professor of Medicine University of Toronto

AdoptionChallenges

Three Hurdles in the pathway to adoption1. Regulatory 2. Coverage and payment 3. Market Positioning and Access Strategy

(Diffusion)

The Health Technology Ecosystem

• Innovation thrives in low risk, supportive ecosystems

• Our technology ecosystem is

• FRAGMENTED, UNPREDICTABLE, BLACK HOLE

• HIGH RISK

• NOT NECESSARILY RESPONSIVE TO NEED

• UNDER CONSTANT STRESS – INCREASING DEMANDS AND COSTS

• INNOVATION, UNDER-FUNDED AND HAPHAZARD

• HIGH REJECTION RATES BY PAYERS

• Can’t continue – we are part of one ecosystem:

• Coverage decisions should not occur at the back end

• This is why the not-for-profit corporation, EXCITE International exists

The New Health Ecosystem

• Mega corporations increasingly involved in health services market• Multinationals e.g. Medtronic focused on value-based

outcomes e.g. coronary stent insertions, diabetes • Non-health mega corporations increasingly involved

in care delivery e.g.:• Apple• Uber• Amazon

• Technologies will be more directed to health system needs

• Focus of new trial designs that use existing patient outcomes data sets

• Bundled payments for episodes of care: new technologies evaluated for ability to improve efficiencies in clinical pathways (Next Slide). Fee for service model threatened

MODULE 1: ED

DIAGNOSTICSMODULE 3: ACUTE

RESPIR. FAILURE

MODULE 5: NPPV

MODULE 6: IMV

MODULE 7:

DISCHARGE PLANNING

DEATH

MODULE 7:

DISCHARGE PLANNING

MODULE 9:

WEANING

MODULE 7:

DISCHARGE PLANNING

INDEX EVENT:

PATIENT PRESENTS AT ED

WITH ACUTE

EXACERBATION OF COPD

N = 16,502 (2010/11)

P = 1.0

MODULE 2:

TREATMENT IN ED

MODULE 4: ADMIT FOR

USUAL MEDICAL CARE

CLINICAL

ASSESSMEN

T NODE 1

CLINICAL

ASSESSMEN

T NODE 2

CLINICAL

ASSESSMEN

T NODE 4

P = 0.516

P = 0.031

P = 0.453

P = 0.446

P = 0.554

P = 0.032

P = 0.968

DEATHP = 0.04

MODULE 8:

VAP

MODULE 8:

VAP

P = 0.003

P = 0.744

P = 0.226

P = 0.003

P = 0.997

CLINICAL ASSESSMENT NODE 1

DECISION TO ADMIT / TREAT IN ED

Example of Care Pathway-Decision Analytic Model for COPD Acute Exacerbation (From HQO)

MODULE 3

ACUTE RESPIRATORY FAILURE

HOME

HOME

HOME

Intervention Evidence Measure

NPPV offered as

first line therapy

OHTAC Recommended

% NPPV vs.

IMV

Oxygen therapy OHTAC Recommended

% receiving O2

Bronchodilators % receiving bronchodilator

Risk factorTreat

in ED

Admit

to ward

SaO2 < 90% No Yes

Changes on

chest X-rayNo Present

Arterial pH level ≥ 7.35 < 7.35

Arterial PaO2 ≥ 7 kPa < 7 kPa

Evidence Driving Innovation – the EXCITE Initiative

Regulation TIME

Pre-Market Post-Market(HTA)

Cost Effectiveness (CE)

Systematic review

Effectiveness

Obsolescence

Diffusion

Yes

Unconditional No

• Efficacy Safety

• Value (CE) Affordability

• Ethical & societal

• Post-market conditions

E f f e c t i v e n e s s

Cost Effectiveness

Systematic review

• Efficacy Safety• Value (CE)

Affordability• Ethical & societal• Post-market

conditions

Reimbursement

UPTAKE

What is all the EXCITEment About?

• Excellence in Clinical Innovation and Technical Evaluation

• EXCITE

• Evaluate technologies early to satisfy regulators and payers through single pre-market studies that reduce risk of rejection by payers

• EXCITE International

• Evaluate in many countries to avoid multiple studies that satisfy all regulators and payers

• Accelerate:

• global reach

• access by patients

• Encourage innovation• Stakeholder partnerships:

innovation to adoption• EI partner, participant in

ETR, protocol development and clinical trials

• Facilitate adoption using EI data

• Develop ETR, Protocols and Clinical Trials with multi-stakeholder input from member countries : drive early adoption globally

• Promote excellence • Contribute to global issues

that affect local interests

Local EXCITE (Hub) EXCITE International (EI)

EXCITE International (EI)

• World-leading policymakers, payers/ health systems, innovation thinkers have joined forces through EXCITE International: incorporated not for profit March 2016

• Game-changing with 3 main offerings:

- Early Technology Review provides strategic direction

- Common protocol meets expectations of key stakeholders internationally through early single studies

- Clinical trials by EXCITE partners expedites global reach

• Built on excellence in each country, respecting independence, uniqueness, needs, governance and decision making

• International excellence selected and shared

- Forums to share perspectives, expertise and ideas

Clinical Trials (Kaiser, CROs ? Mayo)CORE (Yale Medical School), BaimInstitute (Harvard)Blue Cross Blue Shield, Kaiser, Aetna, CMSFDAMDIC (NEST)Industry:

AdvaMedMDMA

ECRI (Human factors)

US UK

N

EUROPE

Netherland

Nordic

(France, Spain)

Canada

IDEAL (Surgical quality)Govt. Office of Life SciencesGovt. NHSNICE Academic Health Science NetworksIndustry: Association of British Healthcare IndustriesBoard representative

MaRS EXCITE & 4 Academic Methodology Centers with 24 Research HospitalsGlobal eHealth (Human Factors)Ontario Ministry of Health Industry (MEDEC) OHTACHealth Canada

NorwayNorway Health TechGovernmentNordic Proof Clinical TrialsInnovation NorwayBoard representativeNetherlandsRadBoud UMC

EU Clinical trials networkEarly HTA and decision analysisPatient engagement

GovernmentFrance and SpainMedpass (Early development)10

EI Coalition

Norway and EXCITE International (EI)

• Partership commenced in 2016 resulted in MOU with Norway HealthTech (Kathrine Myhre)

• Appointment of Carl Gilhuus-Moe to EI Board August 2018

• Creating a broad-based EXCITE Norway, “owned and operated” by Norway, aligned to EI at every level; may broaden partnership and include other Nordic countries

• Norwegian companies are leading internationally in understanding and using EI offerings

• Plea: do not relapse or entrench post market HTA which creates an adversarial relationships, stifles innovation and may not be in the patients’ best interests

Secretariat

CEO and CSO Les Levin

Secretary Treasurer Dan Wright

International

Scientific

Collaboration

Chair Bryan Luce

Executive Board:Rick Kuntz (Chair) Sir Bruce

Keogh Anne KolbeSean Tunis. Ilse Treurnicht

Carl Gilhuus-Moe Richard Ivey Les Levin Mark Leahey, NL rep

Advisory BoardChair Anne Kolbe

Hubs:US, UK, Canada,

Norway Netherlands

• Clinical trials • Develop local

partnerships with industry, regulators, payers, KOLs, academia, patients

Payers’ Advisory

CommitteeChair Naomi

Aronson

Patients Included Initiative

Lead Lucien Engelen

EI: Governance

IndustryAdvisoryCommitteeChair Rick Kuntz

• Anne Kolbe Chair New Zealand• William Charnetski Health Ministry

Ontario, Canada• MDIC US• Brian O’Rourke CADTH Canada• David Boudreau Health Canada • Chris Henshall Consultatnt, UK• Jo Carol Hiatt Kaiser Permanente US• Joe Gatewood VP AdvaMed US• Louis Jacques Consultant: Past

Medical Director, CMS US• Mark Leahey CEO Medical Devices

Manufacturers Assoc US• Murray Sheldon FDA US• Naomi Aronson, Chair Payers’

Advisory Committee & ED Clinical Evaluation, Innovation and Policy BCBS US

• Neil Fraser CEO Medtronic, Canada

• TBA Office of Life Sciences UK• Andrew Davies Assoc British

Healthcare Industries UK• Rafi Hoffstein CEO MaRS Innovation

Canada• Shirlee Sharkey Health System

Canada• Trent Haywood Chief Medical Officer,

BCBS Association US• Yves Verbovan MedTech Europe

Belgium• Shaihira Bhimani, Director MaRS

EXCITE Canada;• Netherlands TBA• Bryan Luce, Chair SC; President

Evidera USA• Kathrine Myhre CEO HealthTech

Norway

EI Advisory Council

Who is on the Payer Advisory

Committee?

Membership

• Naomi Aronson Chair (BCBS Association)

• Jo Carol Hiatt (Kaiser Permanente)

• Robert McDonough (Aetna)

• Ed Pezalla (Aetna)

• Alan Rosenberg (Anthem)

• Tamara Tyrek Jensen (CMS)

• Bill Charnetski (Ontario Ministry of Health)

• Nina Pinwill NHS UK

• Pall Jonsson NICE UK

• Ministry of Health Netherlands (TBD)

• Ministry of Health Norway (TBD)

What are the Payer

Advisory CommitteeObjectives?

• Advises EI Board on selecting technologies

• Early advice to industry on relevance to Payers at proof-of-concept stage (ETR)

• Input into protocol development to meet expectations for coverage

• Share high level decision processes

• Drive innovation pipeline based on health system needs

• NB: PAC is advisory. Cannot recommend funding

PROPRIETARY & CONFIDENTIAL 16

• Bryan Luce - Chair; Immediate past CSO, PCORI USA• Peter McCulloch, Prof Surgery; Fellow Trinity College Oxford Univ and John Radcliffe

Hospital, Oxford. Head of IDEAL, UK• Naomi Aronson - Executive Director of Clinical Evaluation, Innovation, and Policy,

Blue Cross and Blue Shield Association USA• Rod Taylor - Prof Health Services Research, University of Exeter, UK• Peter Juni - Director Applied Health Research Centre Li Ka-Shing Institute; Prof Med

Univ Toronto Canada• Amit Oza – Director, Cancer Clinical Trials PMH, Prof Medicine, Uiv Toronto Canada• Joseph Ross - Center for Outcomes Research and Evaluation, Assoc Prof Med, Yale

School of Medicine USA• Mike Argentieri, ECRI – Usabiity/Human Factors USA• Danica Marinac-Dabic – Director Division of Epidemiology (FDA) USA• Elise Berliner – Director, Technology Assessment Program (AHRQ) USA• Maroeska Rovers, Evidence Synthesis RadBoud/MedValue Netherlands • Joe Caffazio, UHN – Director Global e-Health (Usability) Canada• Fiona Miller – Qualitative/ Patient preference Univ Toronto Canada• Gheorghe Doros - Professor Biostatistics, Boston University USA• Rachel Fleurence MDIC (NEST Program) USA• PCORnet TBA USA• Jason Connor – President, ConfluenceStat USA• Per Olav Norwegian Knowledge Centre for Health Norway

EI Scientific Collaboration (SC)

EI: EARLY Technology Review

• Framework defines expectations of Company, EI and Panel

• Key stakeholder advice:• Ecosystem e.g comparators, target population, deployment • Benchmarking and downstream effects on costs and events:

defining magnitude of effect required to meet cost effective thresholds and/or savings

• Barriers/facilitators to coverage, adoption, diffusion• High level advice on proof of concept & clinical trial design

• Company engages with Regulators to establish requirements

• Company involved throughout the 16 week process

• Strictly confidential to EI: company may release

• Direct interaction with investors encouraged

17

CompanyEarlyTech

Review

1

Application

Protocol

2

SC with GMRC:End-users Payers/Health systems Patients RegulatorsEarly HTA; & econ analysisPatient outcomes dataUsability

Clinical Trial

3

Radboud (NL)NOCRI (U.K.)Baim Institute (U.S.)MaRS EXCITE (Canada)Nordic Proof MedPass (EU)

EI BoardInformed by PAC &

SC

Comparative Effectiveness

(Data from trial)

4

Global adoption through EXCITE

partners

5

EI Algorithm

InvestorsAcceleratorsMultinational

Proof of Concept

EXCITE International – the Value-Add

• Work together as international partners to anticipate and deal with changing realities

• Accelerate, and decrease cost and uncertainty of the pathway from innovation to adoption through front-ended harmonized approach

• Input and adoption through independent platforms across multiple countries

• No other organization can bring this strength through direct engagement with the largest health systems, payers, regulators, and credibility globally

• EI is the only organization with a membership strong enough to anticipate, impact and change the ecosystem