Cadth 2015 d2 warren cadth april_14_2015

European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

Cross-Border Collaboration

Can the Lessons Be Learned From the Development and Piloting of the EUnetHTA Rapid Relative Effectiveness Model Serve to Support HTA of Medical Devices Throughout Canada?

CADTH Symposium,Saskatoon, Canada 12-14 April 2015

Simone Warren MScProject Coordinator WP5 EUnetHTA

Brief Introduction EUnetHTA

The HTA Core Model

Work Package 5

Application in HTA of Medical Devices/other medical technologies

Overview

Scope of EUnetHTA’s work

to create an effective and sustainable network for HTA across Europe to help developing reliable, timely, transparent and transferable information

support collaboration between European HTA organisations that brings added value at the European, national and regional level through facilitating efficient use of resources available for HTA

creating a sustainable system of HTA knowledge sharing

promoting good practice in HTA methods and processes.

Participants in EUnetHTA

EUnetHTA Partners and Associates in JA2.

44 Partner organisations designated by Member States

Large number of regional agencies and non-for-profit organisations that produce or contribute to HTA

EUnetHTA Joint Action 2 (2012-2015)Objectives

To achieve a better understanding for the European Commission and Member States of ways to establish a sustainable structure for HTA work in the EU

To produce recommendations regarding the design and management of the future EU HTA cooperation

Total budget: € 9,428,550

To strengthen the practical application of tools and approaches to cross-border HTA collaboration

European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.euEuropean network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

The HTA Core Model

The Domains of the HTA Core Model®

HTA Core Model DOMAINS

1. Health problem and current use of technology

2. Description and technical characteristics

3. Safety

4. Clinical effectiveness

5. Costs and economic evaluation

6. Ethical analysis

7. Organisational aspects

8. Social aspects

9. Legal aspects

Within each domains – several issues

HTA Core Model DOMAINS

1. Health problem and current use of technology

A0001: For which health conditions, and for what purposes is the technology used?

A0002: What is the disease or health condition in the scope of this assessment?

A0003: What are the known risk factors for the disease or health condition?

4. Clinical effectiveness

D0001:What is the expected beneficial effect of the intervention on mortality?

D0020: Does use of the test lead to improved detection of the condition?

European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.euEuropean network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu 9

Joint Rapid Assessments (WP5)

Two definitions are commonly used in the context of a relative effectiveness assessment :

•Relative efficacy can be defined as the extent to which an intervention does more good than harm, under ideal circumstances, compared with one or more alternative interventions.

•Relative effectiveness can be defined as the extent to which an intervention does more good than harm compared with one or more alternative interventions for achieving the desired results when provided under the usual circumstances of health care practice

Definition of Relative Effectiveness Assessment (REA)

Tools for Strand B

Procedure manual that describes Strand B process

Assessment template provides

guidance for reporting

Guidelines provide

methodo-logical

guidance

provides working

framework through a

set of research

questions*

*+ checklist for ethical, organisational, social and legal issues

Submission File template

that is submitted by manufacturer

+ consideration of other Core Model

applications

Rapid HTA Core Model

Rapid timeframe as assessment characteristics are adapted to national reimbursement context – timely information

Similar set of information within the four domains and European

countries – shareable/ transferable information

A compact and easy-to-read format – useful information

Cross-border collaboration, quality assurance – reliable and transparent information

Main output- Rapid REA

No Recommendations!

Endpoints used for REA of pharmaceuticals

1. Clinical endpoints

2. Composite endpoints

3. Surrogate endpoints

4. Safety

5. Health-related quality of life

Comparators and comparisons

6. Criteria for the choice of the most appropriate comparator(s)

7. Direct and indirect comparison

Levels of evidence

8. Internal validity

9. Applicability of evidence in the context of a relative effectiveness assessment

Link to the guidelines

http://www.eunethta.eu/outputs/methodological-guideline-rea-pharmaceuticals-clinical-endpoints

9 Methodological Guidelines for Rapid REA

Pilot team:

•1 – 3 (co)authors

•3 – 6 dedicated reviewing agencies

•Coordination Team

•EUnetHTA members

Stakeholders:

•Manufacturers: evidence, reimbursement status, project plan, assessment, submission file

•Patient/Consumer representatives: project plan, assessment

•Medical experts: project plan, assessment

•Stakeholder Advisory Group/Stakeholder Forum: project plan

•Public: project plan

Production of assessments

1 authoring agency: responsible for the overall quality of the assments, usually for Effectiveness and Safety Domain and for the Summary

1 – 3 co-authors: assist authoring agency in selection of relevant assessment elements of HTA Core Model for Rapid REA; quality of assurance of work of author; usually responsible for authoring 1 – 2 other domains

Dedicated reviewers: 3 – 6; read first draft of assessment – quality assurance

Coordination Team: LBI-HTA for managing contact with manufacturers/Stakeholder Forum(Stakeoholder Advisory Group), overseeing communication/work-flow within pilot team

Team Building and Topic selection

Relevance of topic assessed will determine participation by other members AND uptake of assessment in local/national context,

No technology specific assessments – class assessments

2 options:

1. Call for collaboration: Authoring agency selects 2 topics out of their own work programme – WP5 members are asked to indicate their preference – choice of final topic

Also members are asked if they want to contribute: co-authors, dedicated reviewers

2. POP- Database: overlap in topics indicate potential partners for collaboration and also relevance for other countries. Authors can approach agencies directly and ask if collaboration would be feasible

Team Building and Topic selection

Modes of collaboration

agency X

Agency A: author of all domains

Agency B: co-author checks work of author

agency 4

agency 1

agency 3

agency X

agency Xagency X

agency 5

agency 2

agency X

agency Xagency X

Agency C:1-? domains

Agency B: 1- ? domains

Agency A: 1 - ? domains

Agency D: 1 - ? domains

agency 3

agency 1 agency 2

agency 5agency 4

Authors and co-authors

Dedicated reviewers

WP5 Members Review

European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu 20

Duodenal-jejunal bypass sleeve for the treatment of obesity with or without type II Diabetes mellitus

Renal denervation for treatment resistant hypertension

Balloon Eustachian Tuboplasty for the treatment of Eustachian tube dsyfunction

Biodegradable stents for benign refractory esophageal stenosis

Implantable devices for the treatment of mitral valve regurgitation

Duration January 2013 – August 2013

April 2013 – December 2013

April 2014 – February 2015

April 2014 – August 2015

October 2014 – September 2015

Pilot team agencies, n

8 8 5 5 9

(Co-)Authoring HTA bodies

LBI-HTA (Austria)AAZ (Croatia)

NOKC (Norway) Avalia-t (Spain)CFK (Denmark)

FinOHTA/THL HIQA (Ireland)

ISCIII (Spain)SAGEM (Turkey)

Agenas (Italy)AAZ (Croatia)MoH (Slovakia)

Dedicated reviewing HTA bodies

GYMEZSI (Hungary)HIQA (Ireland)HVB (Austria)ISCIII (Spain)NOKC (Norway)Charles University Prague (Czech Republic)

HIS (UK)FinOHTA/THL (Finland)AHTAPol (Poland)GYMEZSI (Hungary)IQWiG (Germany)

GYMEZSI (Hungary)HVB (Austria)AHTAPol (Poland)

VASPVT (Lithuania)Slovak Ministry of Health (Slovakia)LBI-HTA (Austria)

HAS (France)BIQG/GÖG (Austria)AETSA (Spain)AAZ (Croatia)HIQA (Ireland)HIS (Scottland)

Compiling a Rapid REA - Scoping phase

Main output: final Project Plan including information on:

1. The team

2. Timelines

3. Methods/Scope:

PICO Table

Planned methodology

Data extraction table

Assessment elements and research questions

Scoping Phase

PICO Table

4 Domains:

1. Health Problem and Current Use of the Technology

2. Description and Technical Characteristics of the Technology

3. Clinical Effectiveness

4. Safety

Each domain consists of several issues (=generic research questions)

Authors go through these issues and decide whether it is relevant for their assessment

Ethical, organisational, social and legal issues covered in checklist

Selecting relevant assessment elements

Selecting Assessment elements – formulating research questions

After selection of relevant issues:

1. Authors translate generic questions into research question (and they provide answers to these research questions during the production phase)

2. Submission file template with the generic questions selected are send to manufactures which provide answers to these questions

Core Model for Rapid REA

Submission File TemplateContext – WP7 SG4

• EUnetHTA developed a submission template that includes the evidence requirements from European reimbursement organisations and reflects the HTA Core Model to support the production of core HTA information and rapid assessments

• Data extraction of national evidence requirements

• Categorisation of information according to a framework

April 15, 2023 27

Submission File template

• The template follows the 4 Core Model domains

• Development of a series of modules for each domain (related to CM topic); each module has a group of questions/headings (related to AE issues, clarifications or HTA methodology)

• Link to WP5 assessments – piloting

• Serves as a tool for national agencies

• Meant to standardise processes across Europe and therefore support manufacturers

• Could be used to support national reimbursement processes in Europe, will ideally be used by all European countries for reimbursement

April 15, 2023 28

Application in HTA of Medical Devices/other medical technologies

Challenges & solutions 1

Topic selection: determines relevance for and thus uptake by members

indication-specific, not technology-specific

authors provide a rationale for topic selection

mini-prioritisation: authors suggest two potential topics out, members asked to rank them

Scope: CE mark often broad indication – different than that suggested by manufacturer(s), guidelines,…

- Scoping meetings with manufacturer helpful to better characterise, eg. target population, comparison to “Instructions of Use”

- Public consultation of draft project plan

- Involvement of medical experts early on

Timing of assessment: at what stage of life-cycle of technology, in absence of a clear point of market entry throughout Europe

CE mark as selection criterion

topic selected out of work-programme of authors

Unsolved:

assessment too early with no comparative evidence; lack of comparative studies as “stopping rule”?

too late and already widely used in practice?

updates of assessments?

Quality assurance: participation of HTA agencies (in WP5 51 partners) with different backgrounds, expertise, experiences, methods

first authors responsible for overall quality of assessments

several quality assurance mechanisms in place: internal review, external review, involvement of stakeholders

Unsolved:

Selection criteria for different roles?? differentiation between „experienced“ and „less experienced“ agencies/individuals?

Methods: differences in methods for HTA production between HTA institutes, HTA Core Model for Rapid REA redundant, prone to inconsistencies

10 EUnetHTA Guidelines currently published

more in development (e.g. for literature search, non-randomised trials, etc)

Update of HTA Core Model for Rapid REA (ongoing)

Unsolved:

How to grade the overall strentgh of evidence – GRADE?

Timelines: „rapid“ ~ 6 months, but so far ~ 8 months were needed, even more time needed with piloting the submission file template for medical devices

Unsolved:

routine use of submission file template in future collaborations? First experiences positive from both sides (authors and manufacturers)

timely identification of ALL relevant manufacturer(s)/CE marked products: inquiry about competitors amongst manufacturers, stakeholder advisory group, medical experts…

logistics of scoping meetings with several manufacturers

Conclusion There are a lot of unique challenges to the assessments of MDs, different

from that of pharmaceuticals.

Europe and Canada face some similar challenges, such as scoping and timelines

However, the HTA Core Model and the joint pilot assessments are showing promise in addressing these challenges and we are hopeful for further improvements and developments as we progress beyond the pilot stage and into a more sustainable system of joint rapid HTA.

Challenges addressed by EUnetHTA:

Standardisation

Collaboration: complex but possible!

Any questions?

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