28 April 2017

The European Patients’ Academy (EUPATI)

HTA involvement

What this presentation covers:

Why EUPATI?

What is EUPATI?

What has EUPATI delivered?

EUPATI and HTA guidance

Health research & policy is changing at a fast pace

Innovation transforms the lives of patients with serious, lifelong conditions: Molecular targets/pathways Genome sequencing, Translational research Personalized medicine

• Small trial populations • Biomarkers, companion diagnostics

Need for post-marketing data Health Technology Assessment,

QoL, endpoints, comparators BUT long term pressure on health budgets

– here to stay

Window of opportunity trial design relationship

between researchers, regulators, industry, patients

3

Public

Research Ethics Committees

Competent authorities

Policy makers /Research Policy

HTA agencies & committees

Research subject

Info provider

Advisor

Reviewer

Co-researcher

Driving force

Clinical Research

Patients have a key role in all aspects of health-related research

Trial protocol design, informed consent, ethical

review, marketing authorization, value

assessment, health policy

Patient involvement in practice within the R&D life cycle Source: Geissler, Ryll, Leto, Uhlenhopp – www.eupati.eu

Source: Geissler, Ryll, Uhlenhopp, Leto (2016): www.eupati.eu

Public

Research Ethics Committees

Competent authorities

Policy makers /Research Policy

HTA agencies & committees

Research subject

Info provider

Advisor

Reviewer

Co-researcher

Driving force

Clinical Research

Patients have a key role in all aspects of health-related research

Trial protocol design, informed consent, ethical

review, marketing authorization, value

assessment, health policy

EUPATI: Paradigm shift in empowering patients on medicines R&D

Launched Feb 2012 as a public private partnership, 33 consortium members, Funded by Innovative Medicines Initiative

has developed and disseminate objective, credible, correct and up-to-date public knowledge about medicines R&D

is building competencies & expert capacity among patients and the public,

has been a game changer and driver of patient engagement in R&D

Continues as a permanent educational programme

EUPATI Patient Experts Training Course -- for expert patients

EUPATI is developing education targeted at different levels

EUPATI Educational Toolbox -- for patient advocates

EUPATI Internet Library -- for the health-interested public

English French German Spanish Polish Italian Russian (Rumanian) (Portuguese)

English

1.Discovery of Medicines

2.Pre-clinical Development

3.Clinical Development

4.Clinical Trials 5.Regulatory

Affairs, Drug Safety, Pharmaco-vigilance

6.Health Technology Assessment

The EUPATI Patient Expert Training Course

The EUPATI National Platforms

18+ EUPATI National Platforms

EUPATI National Platforms... bring all stakeholders together in countries address educational needs in R&D disseminate EUPATI’s training material to patient

organisations

National platforms set up in AT, FR, DE, IE, IT, LU, MT, PL, ES, CH, UK, DK, SK, PT Additional platform initiatives ongoing NO, GR, RO, SRB, SE

What are ENPs doing?

ENP social media campaigns

ENP learning webinars

ENP workshops & conferences

ENP MoUs with partners ENPs on the TV

ENPs in the papers

The EUPATI Guidances on the interaction of patients with regulators, HTA bodies,

industry and ethics committees

EUPATI Guidances for patient involvement and interaction – Why?

Patients & patient organisations to be involved more widely • include early & post-approval stages,

not confined to clinical development Overarching guidance on meaningful and ethical interaction

is missing in many areas, especially in R&D, causing insecurity • Existing codes/regulations hold mostly legal & ethical content,

i.e. collaboration, communication, funding -- do not cover patient involvement in R&D

• e.g. EFPIA, EATG code, PCWP framework, ECAB, EMA framework, HTAi

Language needs to be more directive towards patient involvement • Clear default statement that collaboration is allowed unless

expressly forbidden

EUPATI Guidances to support the interaction with patient organisations in R&D

EUPATI has developed guidances for the interaction of patient organisations with stakeholders in industry-led R&D in HTA bodies in regulatory processes in ethics committees Available for download at EUPATI.eu > Resources > Guidances

Guidance on interaction between patients and HTA bodies

Definition of terms Definition of rationale Reference to frames and examples used Basic tenets:

• Relevance • Fairness • Equity • Legitimacy • Capacity building

Practical guidance for HTA bodies on what to do and how Practical guidance for POs on what to do and how

This is what we want to see happen

This is what we offer in exchange

Two simple basic principles!

Scientific involvement and policy work must go together

If you could learn it, I can learn it, too

Please be in touch! tamas@eupati.eu