French perspective on the

European collaboration on HTA

Dr François Meyer, MD CADTH SYMPOSIUM APRIL 2014

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

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From HTA to pricing and reimbursement

Chefs de projet HAS

Commission CNEDiMTS

CT

Review of

available data

ASSESSMENT APPRAISAL

Dossier

from

Company

Literature

Economic Committee

Ministry of Health

NHI funds

Decision

on P&R

Demande

d’étude

Avis HAS

H T A

4

Areas for cooperation / harmonisation

HAS internal assessors

HAS

Committee

Review of

available data

ASSESSMENT APPRAISAL

Dossier

from

Company

Literature

Decicion makers on reimburse-ment and

Price

Decision

on P&R

Request for

additional

data

collection

Early

Dialogue

Core HTA

information

Assessment

HAS Guidance

Additional

data

collection

Methodo-

logical

Guidelines

Template

for data

sub-

mission

Two types of collaborative actions

Cooperation on HTA production

Objectives Actions

• Avoid duplication of work

• Increase consistency

• Increase transparency

• Joint assessment reports / Core HTA

information

• Template for companies to submit

data

• Methodological guidelines

5

Improvement of quality of data produced in primary research

Objectives Actions

• Improvement of the developmet

plans of new technologies

• Improvement of the additional data

collection (to reduce uncertainty

ater initial assessment)

• Early Dialogues

• Disease specific guidelines

• Definition of common core protocols

for additionnal data collection

Cooperation on HTA production:

Common assessments

Drugs (published)

Zostavax®, Herpes zoster vaccine

Invokana®, canagliflozin, oral antidiabetic

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Medical Devices – Procedures (published)

By-pass duodéno-jéjunal sans chirurgie (Endobarrier®)

Renal denervation systems for resistant hypertension

Medical Devices – Procedures (ongoing)

Balloon Eustachian tuboplasty for the treatment of Eustachian tube

obstruction

Biodegradable stents for benign gastrointestinal pathology

Cooperation on HTA production:

Methodological guidelines

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9 Guidelines published: • Criteria for choice of most appropriate comparator(s)

• Methods of comparison: direct and indirect comparisons

• Endpoints used for REA of pharmaceuticals:

– Clinical endpoints

– Surrogate endpoints

– Composite endpoints

– Health-related quality of life

– Safety

• Levels of evidence:

– Internal validity

– Applicability

New Guidelines under development – Economic evaluation

– Personalised Medicine

– Medical Devices

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Ex: Choice of endpoints for relative

effectiveness assessment (REA)

Primary endpoint: – Main symptom/sign of a disease

– Valid measure of clinical benefit

• Hard endpoint (mortality, MI, stroke)

• Surrogate (HbA1c, BP, HIV viral load)

– Relevant

– Responsive to change

Depends on: – Target population

– Characteristics of disease

– Core symptom/sign

– Intended claim

– Valid measure of clinical benefit

– “Hierarchy of endpoints in a trial (primary, co-primary, secondary, exploratory)

Choice of endpoints for relative

effectiveness assessment (REA)

• Trial still to be powered on primary endpoint

• Other endpoints (e.g. clinical events related to

the disease or its treatment, HRQoL)

– systematically assessed in comparison to an

adequate comparator(s) in parallel to the primary

endpoint ;

– Relevance and hierarchy of the different endpoints

will depend on the objective of REA, on the disease

itself and the aim of treatment investigated ;

Guidelines are tested through the production of

common assessment reports (core HTA) and early

dialogues.

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Improvement of quality of data

produced in primary research (1)

1. Initial data production

Disease specific guidelines

• Ongoing: Osteoarthritis

• Public consultation: Q4 2014

• Includes pharmaceuticals, medical devices

Early dialogues

• Company presents its development plans and ask

questions to HTA bodies to check whether the choices

made are appropriate (choice of comparator, endpoint,

population…)

• Confidential

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Improvement of quality of data

produced in primary research (2)

2. Additional data collection

– Request made by HTA bodies at the time of initial

evalution to reduce uncertainty for a new technology

• Already achieved :

IT system and database to communicate between

HTA bodies

Criteria to select technologies for which there is a

need for additional data collection

• Ongoing

Position papers on how to best define the research question

and how to chose the appropriate method for ADC

Common core protocols

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

13

WP4Testing

collaborative production

of HTA information

WP5Applying the HTA

Core Model for Rapid

Assessment

WP6Information

Management Infrastructure and Services

(IMIS)

WP7Methodology development and evidence

generation

WP8Maintenance of HTA Core Model

infrastructure

WP1Coordination &

Sustainablenetwork

Implementation

WP2Dissemination & Capacity Building

WP3Evaluation &

Data Collectionon cost-

effectiveness

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

13

WP4Testing

collaborative production

of HTA information

WP5Applying the HTA

Core Model for Rapid

Assessment

WP6Information

Management Infrastructure and Services

(IMIS)

WP7Methodology development and evidence

generation

WP8Maintenance of HTA Core Model

infrastructure

WP1Coordination &

Sustainablenetwork

Implementation

WP2Dissemination & Capacity Building

WP3Evaluation &

Data Collectionon cost-

effectiveness

EarlyDialogues

Diseasespecific

guideline

AdditionalEvidence

Generation

Methodo-logical

guidelines

Template for industry

HTA core model

14

Areas for cooperation / harmonisation

HAS internal assessors

HAS

Committee

Review of

available data

ASSESSMENT APPRAISAL

Dossier

from

Company

Literature

Decicion makers on reimburse-ment and

Price

Decision

on P&R

Request for

additional

data

collection

Early

Dialogue

Core HTA

information

Assessment

HAS Guidance

Additional

data

collection

Methodo-

logical

Guidelines

Template

for data

sub-

mission