La France dans la coopération européenne

pour l’évaluation des technologies de santé

Dr François MeyerConseiller du Président, HASRare 2017Paris, 21 novembre 2017

01Evaluation des

technologies de santé : coopération européenne

3

Commission de la tranparence (CT)

Haute Autorité de santé

Eva

luat

ion

CHMP (EMA) ou Commission d’évaluation initiale du rapport bénéfice risque (ANSM)

Qualité pharmaceutique et rapport bénéfice/risque

European Commission /ANSMMarketing Authorization

Mise à dispositionContrôle de la publicité

- Etudes post-inscription- Pharmacovigilance, - Risk Management Plans- Etudes complémentaires

Réévaluationpériodique

Tous les 5 ans

Commission d’évaluationéconomique et de santé

publique (CEESP)

MinistèreInscription sur les listes

Assurance maladieTaux de remboursement

Comité économique des produits de santé Prix

Déc

isio

n

Evaluation du médicament: 3 questions essentielles

• Le produit a-t-il suffisamment d’intérêt pour être pris en charge par la solidarité nationale? – Service Médical Rendu (SMR)

• Le produit apporte-t-il un progrès par rapport aux alternatives disponibles?– Valeur ajoutée: Amélioration du

Service Médical Rendu (ASMR)

• Quelle efficience?– Avis d’efficience,

impact budgétaire

4

Négociationdu prix

Inscription au remboursement

Eval

uatio

n m

édic

ale

Eva

luat

ion

méd

ico

écon

omiq

ue

Une évaluation dynamique

5

AVANT l’AMM• Rencontres précoces

• Autres (Accès précoce par ATU)

Au moment de l’AMM:

Avis pour:INSCRIPTION

PRIX

APRES AMM• Réévaluation

• Suivi en vie réelle (« études post inscriptions »)

• Extensions d’indication

Service Evaluation

du Médicamentde la HAS

Commission de la

transparence

+ Experts externes

AVIS de la HAS

Donnéesdisponibles

Dossier industriel

“ ANALYSE ” “ APPRECIATION ”

Littérature Médicale

Ministre

Evaluation des médicaments par la Commission de la transparence (CT)

“ INSCRIPTION ”

CEPS“ PRIX ”

UNCAM“ TAUX ”

6

Service Evaluation

du Médicamentde la HAS

Commission de la

transparence

+ Experts externes

AVIS de la HAS

Donnéesdisponibles

Dossier industriel

“ ANALYSE ” “ APPRECIATION ”

Littérature Médicale

Ministre“ INSCRIPTION ”

CEPS“ PRIX ”

UNCAM“ TAUX ”

7

Champ de la coopération européenne

Service Evaluation

du Médicamentde la HAS

Commission de la

transparence

+ Experts externes

AVIS de la HAS

Donnéesdisponibles

Dossier industriel

“ ANALYSE ” “ APPRECIATION ”

Littérature Médicale

Ministre

Champ de la coopération européenne

“ INSCRIPTION ”

CEPS“ PRIX ”

UNCAM“ TAUX ”

EarlyDialogues

Analyses conjointes

Guides méthodo-logiques

Post-launch

Evidence8

European Network for Health Technology Assessment

EUnetHTA Joint Action 32016 - 2020

Joint Action 3 main activities

10

Early DialoguesScienficAdvice

Joint Assessments

Additional datacollection

Comparative or full HTA / REA

Use

of t

echn

olog

y in

hea

lth

care

Time line of innovation

Collecting evidence in early development.

HTAINDUSTRYREGULATORS

Assessment for market authorization

Collecting post-marketing evidence

AWP5 WP4

BWP5

REA = relative effectiveness assessment

Implication de la HAS dans la coopération européenne

• Membre fondateur de la coopération EUnetHTA (2006)

• Implication dans les deux axes de coopération– Coordination (lead partner) de la thématique sur

l’amélioration des données produites• Rencontres précoces• Études complémentaires (registres et autres)

– Contributeur majeur à la production de rapports communs d’évaluation

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Evaluations communes

• Premier rapport d’évaluation commune EUnetHTA 2017

• Regorafenib dans le cancer hépatique

• HAS auteur principal

• Disponible sur www.eunethta.eu

12

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

Lead Partner: HAS, Co-lead partner: G-BA

Objective of WP5

To help to generate optimal and robust evidence for different stakeholders, bringing benefits for patient access and public health.

� Initial evidence generation: Early dialoguesWP 5 Strand A

� Post-launch evidence generation (PLEG) WP5 Strand B

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EUnetHTA Work Package 5 on Evidence Generation

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

Gathers HTA bodies with important experience in EDsAND important commitment to participate in EUnetHTA EDs

EDWP members are HTA bodies experienced in collaborative EDs:˗ With adequate expertise and availability˗ With commitment to participate˗ With appropriate budget

Countries represented: • France Germany England Italy Netherlands+Belgium

Hungary

Early Dialogue Working Party (EDWP)

14

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

SimultaneousrequesttoEMAandEUnetHTA

ParallelConsultation

Multi-HTAEarlyDialogue

EUnetHTAmulti-HTAprocedure

EMASAprocedure

EMA/EUnetHTAParallelConsultation

Procedure

RequesttoEMA RequesttoEUnetHTA

Rencontres précoces: Trois possibilités

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

Données complémentairesNeed to collectmore data in the post-marketing

phase?

Definition of the research question

Choice of data sources and methodology

Quality of registries Standardised tool to assess registry quality JA3

Documents availablewww.w.eunetha.eu

1

2

3

1 2 3

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

• EUnetHTAwillNOTorganise and/orfinancethedatacollection system(registryorother)

• RequestsforPLEGaremadeatnational level(partofthenational decisionprocess).EUnetHTAhasnoremittoprovideabinding recommendation onPLEG

• EUnetHTAcanpreparenational decisiononPLEGby‒ Proposing acommon research questionorminimumdataset‒ Giving advice onmethodology (ifregistry used,assessing its

quality forHTApurposes)• Aim:reducedifferencesbetweennationalrequestsregarding

noncontext-specific information‒ ondisease specific registries:onedone,onestarting,with EMA‒ onspecific drugs:candidatestobe chosen before end2017

Post Launch Evidence Generation Pilots

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02Vers une coopération

européenne pérenne ?

…

2016

InceptionImpactAssessment

Scientific & technical

Strategy

Sustainability

Joint production

Early dialogues & Real world data generation

Quality Management

SUSTAINABLE EU

COOPERATIONON HTA

National implementation

and impact

Studies to Support the impactassessment

EU cooperation HTASTATE OF PLAY

Public consultation

Impact assessment

Strategy for EU Cooperation

on HTAReflection Paper on synergies

between regulatory and HTA issues

2020

…

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Ø Low uptake of joint work ⇒ duplication of work by HTAbodies and industry

Ø Differences in the procedural framework and administrativecapacities of Member States ⇒ consistency of assessments andbusiness predictability

Ø Differences in national methodologies ⇒ consistency ofassessments and business predictability

Ø No sustainability of current cooperation model ⇒ return oninvestment, capacity building

STATE OF PLAY

Shortcomings of current EU cooperation on HTA

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EU initiative on HTA - Policy options*

Option 1 Option 2 Option 3 Option 4 Option 5

Status quo –voluntary cooperation

Long-term voluntary cooperation (beyond 2020)

Cooperation through the collection, sharing and use of common tools and data

Cooperation on production of joint REA (relative effectiveness assessments) reports

Cooperation on production of joint Full HTA reports (REA+Non-clinical: economic, ethical, legal, etc.)

Non-legislative Legislative

Policy optionsInception impact assessment

Scope Coordination/secretariat

Funding mechanism

+ Issues to be addressed

21

INITIATIVE

PROCESShttps://ec.europa.eu/health/technology_assessment/eu_cooperation_en

- Inception impact assessment - Published on 15 September 2016

- Public consultation - Online consultation – closed on January 2017- Meetings with EUnetHTA JA3/stakeholders

- Studies to support the impact assessment process

- Impact assessment – ongoing 2017

- EU Initiative – planned end 2017

EU cooperation HTA

Merci de votre attention!http://www.has-sante.fr

f.meyer@has-sante.fr

@HAS_sante@FrancoisMeyerFM