Patient and Healthcare Professional Involvement in EUnetHTA - - PowerPoint PPT Presentation

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Sep 17, 2023 139 likes •292 views

Patient and Healthcare Professional Involvement in EUnetHTA Activities Michelle Mujoomdar, PhD - Senior Scientific Officer EUnetHTA JA3 directorate, Zorginstituut Nederland PCWP/HCPWP Joint Meeting EMA 27 June 2017 European network for

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European network for Health Technology Assessment | JA3 2016-2020 | www.eunethta.eu

Patient and Healthcare Professional Involvement in EUnetHTA Activities

Michelle Mujoomdar, PhD - Senior Scientific Officer EUnetHTA JA3 directorate, Zorginstituut Nederland PCWP/HCPWP Joint Meeting EMA – 27 June 2017

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European network for Health Technology Assessment | JA3 2016-2020 | www.eunethta.eu

Project Coordinator: The Dutch National Health Care Institute (ZIN)

EUnetHTA JA3 Participants

81 partners consisting of national, regional and non-for- profit agencies that produce or contribute to HTA

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European network for Health Technology Assessment | JA3 2016-2020 | www.eunethta.eu

Organisational and Governance Structure

DG SANTE and CHAFEA

WP2 Dissemination WP3 Evaluation WP4 Joint Production WP5 Evidence Generation WP6 Quality Management WP7 Implementation

Lead: AETS-ISCIII Lead: TLV Lead: NIPHNO Co-lead: LBI ZIN Lead: HAS Co-lead: GBA Lead: IQWiG Co-lead: KCE Lead: NICE Co-lead: Agenas

WP1 Network Coordination - Dutch Health Care Institute Executive Board

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European network for Health Technology Assessment | JA3 2016-2020 | www.eunethta.eu

WP4 Joint Production

To produce rapid REA on other technologies and on pharmaceuticals
To provide a system for topic selection and prioritization

WP5 Evidence Generation

To conduct Early Dialogues (joint HTA or parallel/joint with regulators)
To link additional data collection to on-going activities

WP6 Quality Management

To provide quality management for EUnetHTA joint products
To further develop methodologies and tools for joint work if necessary

Summary of select activities in JA3

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European network for Health Technology Assessment | JA3 2016-2020 | www.eunethta.eu

WP4 Joint Production

To produce rapid REA on other technologies and on pharmaceuticals
To provide a system for topic selection and prioritization

WP5 Evidence Generation

To conduct Early Dialogues (joint HTA or parallel/joint with regulators)
To link additional data collection to on-going activities

WP6 Quality Management

To provide quality management for EUnetHTA joint products
To further develop methodologies and tools for joint work if necessary

Summary of select activities in JA3

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European network for Health Technology Assessment | JA3 2016-2020 | www.eunethta.eu

WP4 – Joint Production

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European network for Health Technology Assessment | JA3 2016-2020 | www.eunethta.eu

Planning for Patient Involvement in WP4 – Joint Production

Patient involvement was a focused discussion at the F2F meeting

for WP4 in Sept 2016

Objectives were:

– to discuss how we can better involve patients in the production process of EUnetHTA assessments. – to enhance the impact of patients’ perspectives in EUnetHTA’s assessments. – to share experiences so we can define a concrete proposal for future work.

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European network for Health Technology Assessment | JA3 2016-2020 | www.eunethta.eu

Patient Involvement in WP4 – Joint Production

Variable experience with involving patients with WP4 partners
Patients were involved in several phases of the HTA process –

scoping, review of the assessment report, and decision-making

The methods used varied between agencies

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European network for Health Technology Assessment | JA3 2016-2020 | www.eunethta.eu

Patients preferred over representatives
In some cases (e.g. screening or health priority setting) healthy citizens

should be involved

Local, regional, and national patients are preferred over supranational
Patients should be reimbursed – if possible – for their time giving input.
Disclosure of material and immaterial benefits – along with and COI is

required

Methods to involve patients should be appropriate and validated; results

transparent and open to public access.

Patient Involvement in WP4 – Joint Production

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European network for Health Technology Assessment | JA3 2016-2020 | www.eunethta.eu

Patient & HCP Involvement in WP4 – Joint Production

General agreement that involving patients and HCP during the scoping

phase is particularily helpful – To ensure inclusion of patient relevant outcomes – To consider QoL, ethical, and social issues – To better understand the clinical condition, care pathway, and current treatments available – To understand what constitutes a clinically meaningful difference

General agreement that choice of method will depend on the topic and
activity. Method needs to be fit-for-purpose.

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European network for Health Technology Assessment | JA3 2016-2020 | www.eunethta.eu

WP5 – Evidence generation

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European network for Health Technology Assessment | JA3 2016-2020 | www.eunethta.eu

Build on experiences and lessons from Shaping European Early Dialogues

(SEED) project

Consider new and different ways of involving patients – e.g, approaches used

by other HTA agencies

For Parallel Consultation with EMA, explore opportunities to coordinate

approaches for patient involvement

Respective role of European networks of associations and national associations

should be clarified

Some (limited) budget available for patient and expert involvement

Patient Involvement in Early Dialogues - Preliminary Thoughts

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European network for Health Technology Assessment | JA3 2016-2020 | www.eunethta.eu

Challenges

Limited experience with

pharmaceutical joint REAS in JA3

Aligning HTA process –

respecting national policies

Same applies to

collaboration with EMA

European-level versus national
rganisations
Limited resources
To learn how PCWP and

HCPWP engages with EMA

Strategic and operational
Areas of focus for work plans
Areas of overlap / synergy

with EUnetHTA or EUnetHTA/EMA joint work plan

Opportunities

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European network for Health Technology Assessment | JA3 2016-2020 | www.eunethta.eu

Patient and Healthcare Professional Involvement in EUnetHTA Activities

Project Coordinator: The Dutch National Health Care Institute (ZIN)

EUnetHTA JA3 Participants

81 partners consisting of national, regional and non-for- profit agencies that produce or contribute to HTA

Organisational and Governance Structure

WP4 Joint Production

WP5 Evidence Generation

WP6 Quality Management

Summary of select activities in JA3

WP4 Joint Production

WP5 Evidence Generation

WP6 Quality Management

Summary of select activities in JA3

WP4 – Joint Production

Planning for Patient Involvement in WP4 – Joint Production

for WP4 in Sept 2016

– to discuss how we can better involve patients in the production process of EUnetHTA assessments. – to enhance the impact of patients’ perspectives in EUnetHTA’s assessments. – to share experiences so we can define a concrete proposal for future work.

Patient Involvement in WP4 – Joint Production

scoping, review of the assessment report, and decision-making

should be involved

required

transparent and open to public access.

Patient Involvement in WP4 – Joint Production

Patient & HCP Involvement in WP4 – Joint Production

phase is particularily helpful – To ensure inclusion of patient relevant outcomes – To consider QoL, ethical, and social issues – To better understand the clinical condition, care pathway, and current treatments available – To understand what constitutes a clinically meaningful difference

WP5 – Evidence generation

(SEED) project

by other HTA agencies

approaches for patient involvement

should be clarified

Patient Involvement in Early Dialogues - Preliminary Thoughts

Challenges

pharmaceutical joint REAS in JA3

respecting national policies

collaboration with EMA

HCPWP engages with EMA

with EUnetHTA or EUnetHTA/EMA joint work plan

Opportunities

Thank you

Email: MMujoomdar@zinl.nl Twitter: @M_Mujoomdar