la france dans la coopération européenne pour l’évaluation ... · technologies de santé ......
TRANSCRIPT
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
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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
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Négociationdu prix
Inscription au remboursement
Eval
uatio
n m
édic
ale
Eva
luat
ion
méd
ico
écon
omiq
ue
Une évaluation dynamique
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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 ”
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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 ”
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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
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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
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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)
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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
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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
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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
