EUnetHTA JA3. an update and future initiatives. Wim Goettsch. Director EUnetHTA JA3 Directorate. Brussel, February 15, 2018

Transcription

1 EUnetHTA JA3 an update and future initiatives Wim Gettsch Directr EUnetHTA JA3 Directrate Brussel, February 15, 2018

2 Outline Update n WP activities Interactin with stakehlders/ema Future perspectives/develpments in EUnetHTA Reginal initiatives Twards a permanent mdel Eurpean netwrk fr Health Technlgy Assessment JA

3 Summary f Activities in EUnetHTA JA3 WP4 Jint Prductin T prduce rapid REA n pharmaceuticals and ther technlgies; T prvide a system fr tpic selectin and priritizatin, e.g. hrizn scanning. WP5 Evidence Generatin T cnduct Early Dialgues (jint HTA r parallel/jint with regulatrs); T cperate n additinal pst-launch data cllectin t be used in varius cntexts (such as MEAs, CED). WP6 Quality Management T prvide quality management fr EUnetHTA jint prducts; T further develp methdlgies and tls fr jint wrk if necessary. WP7 Natinal implementatin and impact T facilitate the reuse and implementatin f jint prducts at the natinal/lcal level; T measure the impact f jint wrk in cllabratin with ther wrk packages. WP1 Crdinatin WP2 Disseminatin WP3 Evaluatin Eurpean netwrk fr Health Technlgy Assessment JA

4 WP4 Status Jint and Cllabrative Assessments Other technlgies planned 2 CA nging 2 JA 5 CA published 4 CA 13 Pharma technlgies published 3 JA 3 Eurpean netwrk fr Health Technlgy Assessment JA

5 Future relevant activities fr WP4 Changes t the pharma JA Simplify the prductin prcess (n draft submissin file, fcus n PICO) Adapt EUnetHTA JA templates (readability), simplify prcess Mre actively cntacting manufacturers n prducts f interest fr HTA bdies Wrking grup fr Tpic Identificatin, Selectin and Priritisatin (TISP) Bth n pharma and nn-pharma activities Als links t hrizn scanning activities Additinal activities n Medical devices EUnetHTA Task Frce n HTA and medical device regulatin (first meeting May 29) Interactin with reginal initiatives (discussed later) Eurpean netwrk fr Health Technlgy Assessment JA

6 WP5A - Early Dialgues Status since JA3 start 3x withdrawn 1 phthalmlgy 1 nclgy 1 vaccine 20 Letters f Intent 8 Onclgy 2 Neurlgy 2 Immun-inflammatin 1 Ophthalmlgy 1 Vaccine 1 Metablic disrder 1 infectius disease 2 Hematlgy 7x individual PCI (~2-3 HTABs) 4 nclgy 1 neurlgy 1Immuninflammatin 1 infectius disease 4 Cmpleted 10x EDWP 3 multi-hta EDs + 7 PCC 4 nclgy 1 neurlgy 1 metablic disrder 2 Hematlgy 1 infectius disease 1 immun-inflammatin 4 Cmpleted Eurpean netwrk fr Health Technlgy Assessment JA

7 WP5B: Pst Launch Evidence Generatin (PLEG) B1- PLEG Pilts: Disease specific pilts : Tw nging: tw qualificatin f registries, in cllabratin with EMA Prduct-specific pilts: Calls fr pilts n drugs abut t be launched (tw tpics prpsed by AIFA and TLV) Calls fr pilts n medical devices expected in March B2 - Quality standards tl t evaluate registries Secnd draft f the tl currently tested by three HTA bdies (AQuAS, avaliat, INFARMED) Third draft f the tl tgether with first draft f the Visin paper fr independently accrediting r assuring registers: expected March 2018 Eurpean netwrk fr Health Technlgy Assessment JA

8 WP 6 - Quality management, guidance and tls Eurpean netwrk fr Health Technlgy Assessment JA

9 The EUnetHTA Cmpanin Guide - status Eurpean netwrk fr Health Technlgy Assessment JA

10 WP 7 Status f activities Activity Due date Status Activity 1: Research and analysis Activity 2: Case studies Activity 3: Technical t supprt develpment f the mdel f HTA cperatin Activity 4: Implementatin Netwrk Final reprt Nv 17 (deliverable) Onging thrughut JA3 Delayed t accunt fr publicatin f the EC prpsal fr a regulatin n HTA Implementatin reprts t be published May 2018, Nv 2018, May 2019, Nv 2019 Final reprt is publically available n the EUnetHTA website Year 1 case studies published in the activity 1 reprt Year 2 case studies t take place in April and May s as t include discussin f the EC prpsal fr a regulatin n HTA 4 cuntries have vlunteered fr year 2 Activity t be initiated fllwing liaisn with WP1 Data cllectin prcedures t gather experiences f using the EUnetHTA assessments in place The first implementatin reprt will include: a baseline t measure assessment use in JA3 first implementatin data frm JA3 assessments Eurpean netwrk fr Health Technlgy Assessment JA

11 Future wrk Onging cllectin and publicatin f data (quantitative and qualitative) abut use f the JA3 EUnetHTA assessments; Cllabrative wrk with WP6B amng HTA users abut incrprating EUnetHTA tls and guidelines in their natinal prcedures; Develp resurces and run activities t supprt implementatin f EUnetHTA utputs; Supprt the develpment f the mdel f HTA cperatin. Eurpean netwrk fr Health Technlgy Assessment JA

12 WP1 Output and Milestnes in 2017 Participatin, Cntributin and Crdinatin Reprting Prducts and Services Publicatin Increased Technical and Netwrk Capabilities Eurpean netwrk fr Health Technlgy Assessment

13 Assembly and Frum, HTA Synergy, EUnetHTA-EFPIA Technical Meeting, EUnetHTA-EMA bilaterals, Executive Bard/Prject Management Grup Face-t- Face, invlvement and cntributin t Eurpean-wide sympsiums and rganizatins Submissin f Interim Technical and Financial Reprt (81 partner rganisatins and institutins) EUnetHTA-EMA Parallel Cnsultatin Prcess (Early Dialgues) and cntinued prductin f REAs Internal mnthly summaries and quarterly EUnetHTA magazine; interview and publicatin pieces in jurnals and web New Intranet infrastructure (400+ users): develpment f Prject Management Tl (PMT), Advanced Address Bk (AAB); 30% increase in scial media base; launch f rebuilt website is imminent Eurpean netwrk fr Health Technlgy Assessment 13

14 WP2 activities Invlvement in cmmunicatin activities Disseminatin registry Training: Training Strategy A virtual classrm with training materials fr partners A Welcme Package fr newcmers Stakehlder Invlvement activities Overall Stakehlder Invlvement SOP Stakehlder Registry Eurpean netwrk fr Health Technlgy Assessment 14

15 Eurpean netwrk fr Health Technlgy Assessment JA

16 Prgress Stakehlder invlvement in JA3 (I) Crss-WP task grup n invlvement patient and cnsumers started fall 2017 Supprt invlvement in WP4 and WP5 activities Meeting F2F January 2018 Experiences with invlvement shared and cllected and prpsal t mve n Crss-WP task grup n invlvement healthcare prviders will be initiated in 2018 Supprt invlvement in WP4 and WP5 activities Interactins with pharma industry n WP4 and WP5 Link t Heads f Agency meeting in May 2017 Technical meeting with EFPIA in December 2017 Experiences are shared and prpsals t imprve were discussed Individual MAH interactin in REAs Eurpean netwrk fr Health Technlgy Assessment JA

17 Prgress Stakehlder invlvement in JA3 (II) Interactin with MedTech industry Individual MAH interactin in REAs Planning a technical meeting with MedTech Industry in 2018 Interactin with payers will be intensified Based n sme early interactins in a meeting with EMA in September Meetings ging t be planned t identify prgress activities and identify gaps t prgress n Invlvement in EUnetHTA Frum 2017 Active cntributin f stakehlders in different panels n invlvement as such, hrizn scanning and tpic selectin and rle f additinal data cllectin Eurpean netwrk fr Health Technlgy Assessment JA

18 Eurpean netwrk fr Health Technlgy Assessment JA

19 EUnetHTA-EMA wrkplan early dialgue / scientific advice (WP5A) infrmatin exchange at market entry (WP4): the exchange f infrmatin n the CHMP pinin pst-authrisatin data generatin (WP5B): pst-licensing evidence generatin tls, such as patient registries, EMA and EUnetHTA will als further cllabrate in a number f areas including: cncepts f unmet medical need and therapeutic innvatin in view f pssible synergies; understanding the cnceptual similarities and differences between the significant benefit f rphan medicines versus their added therapeutic value. Structured thrugh bi-annual meetings BUT ALSO INTERACTION WITH Medical Devices Regulatr (DG Grw)! On methdlgies and guidance, starting with meeting May 29 Eurpean netwrk fr Health Technlgy Assessment JA

20 Intrductin: reginal activities (Pharma) 1) FINOSE (Finland, Nrway, Sweden) 2) Valleta (Cyprus, Greece, Italy, Malta, Prtugal, Spain, Slvenia, Cratia, France (bserver)) 3) BeneluxA (Austria, Belgium, Luxemburg, Netherlands) 4) Visegrad +2 (Czech Repubic, Hungary, Pland, Slvakia + Cratia, Lithuania) Cllabrative apprach t gathering infrmatin Hrizn Scanning Mutual recgnitin; Jint HTA HTA Best practices, registries, plicy dilemmas Infrmatin sharing Hrizn Scan interpretatin; Infrmatin exchange; Input fr Jint Negtiatins Specific infrmatin sharing Jint negtiatins Eurpean netwrk fr Health Technlgy Assessment JA

21 Pssibilities fr cllabratin with reginal cllabratin n Pharma FINOSE Valletta BeneluxA Visegrad+2 Hrizn scanning ? Jint HTA REA REA REA -? CEA CEA CEA -? Infrmatin sharing ? Jint Price Negtatins Reginal initiatives may als supprt EUnetHTA by fitting EUnetHTA and natinal systems, identify tpics f interest and increase industry interest t participate in EUnetHTA jint REAs by ffering clear pathways t natinal decisin Eurpean netwrk fr Health Technlgy Assessment JA

22 Specific activities planned with reginal initiatives n Pharma Actins frm WP4 LP and CLP Pharma + WP1 LP: Being invlved in meetings with reginal netwrks Meetings with FINOSE; Meetings and sharing wrkplans n HTA with BeneluxA; Wrking n cntacts with the ther initiatives; In clse cllabratin with the EC. Hw EUnetHTA may supprt in HTA activities f reginal initiatives: Prject management f the jint clinical assessments (clinical evaluatin) including quality management f the prcess incl. methdlgical guidelines, the use f tls and templates and methds fr patient invlvement EUnetHTA WP4 budget Eurpean netwrk fr Health Technlgy Assessment JA

23 Cnclusins EUnetHTA JA3 has prgressed in activities Majr achievements in terms f rganisatin but als cllabratin with EMA (fr instance the early dialgues); Jint assessments f REA bth fr pharmaceuticals and ther technlgies are starting ff, implementatin is grwing; It is imprtant that the current mmentum regarding the jint REA bth n pharma and ther technlgies will be kept! Discussin will start n the develpment f EUnetHTA JA3 activities until 2020 in relatin t the future permanent mdel Deliverable in EUnetHTA JA3 GA is t supprt the develpment f permanent EU cperatin n HTA (WP1 deliverable) Stepwise apprach starting with cnstructive discussins in the EUnetHTA Executive Bard with input f the Eurpean Cmmissin n the future scenari as described in the EC prpsal Linked t the prgress f plitical discussins n the current prpsal f the EC. Taking n bard experiences and views f the stakehlders Eurpean netwrk fr Health Technlgy Assessment JA

24 Thank yu Any questins? Eurpean netwrk fr Health Technlgy Assessment JA