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European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
Apply(ing) theHTA Core Model for Rapid
Assessmentfor national adaptation and
reportingSime Warren, National Health Care Institute of the Netherlands, Diemen, the NetherlandsAnna Nachtnebel, Ludwig Boltzmann Institute for HTA, Vienna, AustriaWP5 - Applying the HTA Core Model for Rapid Assessment for national adaptation andreporting
Third WP2 Face to Face Training Course for EUnetHTA stakeholders, Brussels, 23rd of April2015
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
WP5 Partners Overview
May 8, 2015 2
27 Associated Partners:Austria, Belgium, Croatia,Cyprus, Czech Republic,Denmark, Finland, France,Germany, Hungary, Ireland, Italy,Latvia, Lithuania, Malta,Netherlands, Norway, Poland,Portugal, Slovakia, Slovenia,Spain
Lead Partner: ZIN, the NetherlandsCo-Lead Partner: LBI for HTA, Austria
24 Collaborating Partners:Austria, Belgium, Bulgaria,Denmark, Germany, Italy,Ireland, LuxembourgRussia, Romania, Scotland,Spain, Switzerland, Turkey
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No recommendations!
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Work Package 5 Strand A
Rapid relative effectiveness assessment ofpharmaceuticals
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Topic Selection
Technology under evaluation by Committee for Medicinal Productsfor Human Use (CHMP)
Expression of interest by WP5 SA members based on the CHMP list
Expression of interest to participate by the Market AuthorizationHolder (by letter)
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Tools for Strand A
Proceduremanual thatdescribesStrand Aprocess
Assessmenttemplate thatprovidesguidance forreporting
Guidelinesthat providemethodo-logicalguidance
Model thatprovidesworkingframeworkthrough a setof researchquestions
*+ checklist for ethical, organisational, social and legal issues
Submissionfile templatethat issubmitted bymanufacturer
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agency X
Agency A Agency B
author co-author
agency C agency D agency E agency Gagency F
pool of dedicated reviewers
agency Xagency X
agency X
agency Xagency X
agency Xagency X
agency Xagency X
agency X
MAH (Strand A)/ WP5 members review
Strand A - Processes for Rapid Assessments
1st version of REA
Editorial versionof REA
Final of REA
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Scoping Phase
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1. Expression of interestregarding topic by:
Pharmaceuticalscompany
HTA organisation(WP5 members)
2. Selection ofAuthor/Co-Author/Reviewers(WP5 internal process)
3. Receive draftsubmission file fromMAH
4. Pre-Scoping E-
Meeting
WP5 Strand A - Scoping Phase
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1.
1.
2.
4.
3.
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5. Scoping meetingwith MAH (f-t-f)
6. Feedback fromAuthors on draftsubmission file
7. Receive finalsubmission file
8. Finalisation ofproject planincluding timelines
WP5 Strand A - Scoping Phase
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6.
5.
7.
8.
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WP5 Strand A - Assessment Phase
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WP5 Strand A - Assessment Phase
1. Preparing the firstdraft of the assessmentby the Author and Co-Author (35 days)
2. Review by dedicatedreviewers (10 days)
3. Preparation ofsecond draft of theassessment by authors(15 days)
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2.
1. 3.
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WP5 Strand A - Assessment Phase
4. Editorial review andlayouting (15 days)
5. Consultation phase of allWP5 members and marketauthorization holder (10days)
6. Final version of theassessment (15 days)
7. Publication of final reportand implementation into thenational context
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4. 6.
5.
7.
5.
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First Pilot: Zostavax
Zostavax for the prevention of herpes zosterand post herpetic neuralgia
Pilot team:
o Author: CVZ (NL)
o Co-Author: “A. Gemelli” Teaching Hospital (IT)
o Dedicated reviewers: HAS (FR), GOG (A),MoH Czech Republic, DPA/MFH (M), RIZIV(B), MSSSI (S), Regio Veneto (IT)
Duration: 04/2013- published on the EUnetHTAwebsite on 08/2013
Uptake or use in local/national reports: Austria(twice, 2013), Spain (2013), the Netherlands (2014),possible France (2014)
http://www.eunethta.eu/sites/5026.fedimbo.belgium.be/files/Zostavax_main%20report%20including%20appendices_20130922.pdf
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Second Pilot: Canagliflozin
Canagliflozin for the treatment of type IIdiabetes mellitus
Pilot team:
o Authors: AAZ (Croatia), FIMEA (Finland),Regione Veneto (Italy)
o Dedicated reviewers: HAS, HVB; CAHIAQ;Medical University of Sofia; MoH CzechRep.
Duration: 05/2013 -02/2014
o Delay mostly due to external factors (i.e.delayed decision of CHMP)
Local reports Finland, Croatia, theNetherlands
(Data still being updated)
http://www.eunethta.eu/sites/5026.fedimbo.belgium.be/files/WP5_SA-2_canagliflozin_for_the_treatment_of_diabetes_mellitus.pdf
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Third Pilot: Sorafenib
Sorafenib for the treatment of progressive,locally advanced or metastatic, differentiated(papillary/follicular/Hürthle cell) thyroidcarcinoma refractory to radioactive iodine
Pilot team:
o Authors: AIFA (Italy), INFARMED (Portugal)
˗ Dedicated reviewers: RIZIV (Belgium), FIMEA (Finland), GYEMSZI (Hungary),NCPE (Ireland), Slovakian MoH
Duration: 07/2014 -03/2015
Local reports Awaiting more information
http://www.eunethta.eu/news/joint-assessment-sorafenib-nexavar-and-its-use-treatment-thyroid-carcinoma-0
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Fourth Pilot: Ramucirumab
Ramucirumab in combination with Paclitaxelas second-line treatment for adult patients withadvanced gastric or gastro-oesophagealjunction adenocarcinoma
Pilot team:
o Authors: NOKC (Norway), AAZ (Croatia),
o Dedicated reviewers: Slovak Ministry ofHealth, FIMEA (Finland), GYMSZI(Hungary), A.Gemelli Teaching Hospital(Italy)
Duration: 11/2014 -03/2015
o Pilot met the agreed upon timelines
Local reports Awaiting more information
http://www.eunethta.eu/news/joint-assessment-ramucirumab-cyramza-combination-paclitaxel-second-line-treatment-adult-patient
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Future Pilot Planning
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WorkPackage 5
Strand A
WP5- SA5
AssessmentPhase
WP5-SA6
ScopingPhase
WP5-SA7
Topicselection
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WP5 Strand B –Joint Assessment on ‘other technologies’
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Tools for Strand B
Proceduremanual
thatdescribesStrand Bprocess
Assessmenttemplateprovides
guidance forreporting
Guidelinesprovide
methodo-logical
guidance
providesworking
frameworkthrough a
set ofresearch
questions*
*+ checklist for ethical, organisational, social and legal issues
SubmissionFile template
that issubmitted bymanufacturer
(s)
+ consideration ofother Core Model
applications
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Relevance of topic assessed will determine participation by other membersAND uptake of assessment in local/national context,
No technology specific assessments – class assessments
2 options:
1. Call for collaboration: Authoring agency selects 2 topics out of their ownwork programme – WP5 members are asked to indicate their preference –choice of final topic
Also members are asked if they want to contribute: co-authors, dedicatedreviewers
1. POP- Database: overlap in topics indicate potential partners forcollaboration and also relevance for other countries. Authors can approachagencies directly and ask if collaboration would be feasible
Team Building and Topic selection
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1 authoring agency: responsible for the overall quality of theassments, usually for Effectiveness and Safety Domain and for theSummary
1 – 3 co-authors: assist authoring agency in selection of relevantassessment elements of HTA Core Model for Rapid REA; quality ofassurance of work of author; usually responsible for authoring 1 – 2other domains
Dedicated reviewers: 3 – 6; read first draft of assessment – qualityassurance
Coordination Team: LBI-HTA for managing contact withmanufacturers/Stakeholder Forum(Stakeoholder Advisory Group),overseeing communication/work-flow within pilot team
Team
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Modes of collaboration
agency X
Agency A: authorof all domains
Agency B: co-authorchecks work of author
agency 4
agency 1
agency 3
agency X
agency X
agency Xagency X
agency 5
agency 2
agency X
agency Xagency X
agency Xagency X
Agency C:1-? domains
Agency B:1- ? domains
Agency A:1 - ? domains
Agency D:1 - ? domains
agency 3
agency 1 agency 2
agency 5agency 4
Authors and co-authors
Dedicated reviewers
WP5
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Pilot team:
1 – 3 (co)authors
3 – 6 dedicated reviewing agencies
Coordination Team
EUnetHTA members
Stakeholders:
Manufacturers: evidence, reimbursement status, project plan, assessment,submission file
Patient/Consumer representatives: project plan, assessment
Medical experts: project plan, assessment
Stakeholder Advisory Group/Stakeholder Forum: project plan
Public: project plan
Production of assessments
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Scoping Phase
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Assessment Phase
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Published Joint Assessments
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Duodenal-jejunalbypass sleeve for thetreatment of obesitywith or without type IIDiabetes mellitus
Renal denervation fortreatment resistanthypertension
Balloon EustachianTuboplasty for thetreatment ofEustachian tubedsyfunction
Duration January 2013 – August2013
April 2013 – December2013
April 2014 – February2015
Pilot team agencies, n 8 8 5
(Co-)Authoring HTAbodies
LBI-HTA (Austria)AAZ (Croatia)
NOKC (Norway) Avalia-t(Spain)CFK (Denmark)
FinOHTA/THLHIQA (Ireland)
Dedicated reviewing HTAbodies
GYMEZSI (Hungary)HIQA (Ireland)HVB (Austria)ISCIII (Spain)NOKC (Norway)Charles UniversityPrague (Czech Republic)
HIS (UK)FinOHTA/THL (Finland)AHTAPol (Poland)GYMEZSI (Hungary)IQWiG (Germany)
GYMEZSI (Hungary)HVB (Austria)AHTAPol (Poland)
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Ongoing Joint Assessment
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Biodegradable stentsfor benign refractoryesophageal stenosis
Implantable devices for
the treatment of mitral
valve regurgitation
Mechanical thrombectomy
in acute ischaemic stroke
Duration April 2014 – August2015
October 2014 – September
2015
April 2015 – December 2015
(TBC)
Pilot team agencies, n 5 9 7
(Co-)Authoring HTAbodies
ISCIII (Spain)SAGEM (Turkey)
Agenas (Italy)
AAZ (Croatia)
MoH (Slovakia)
HIQA (Ireland)
Interdisciplinary Centre for
HTA and Public Health
University of Erlangen-
Nürnberg (Germany)
Dedicated reviewing HTAbodies
VASPVT (Lithuania)Slovak Ministry ofHealth (Slovakia)LBI-HTA (Austria)
HAS (France)
BIQG/GÖG (Austria)
AETSA (Spain)
AAZ (Croatia)
HIQA (Ireland)
HIS (Scottland)
CFK (Denmark)
LBI-HTA (Austria)
HAS (France)
HIS (Scotland)
A. Gemelli Hospital (Italy)
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National adaptation…?
May 8, 2015 31
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WP3 Survey results – Has your organisationused HTA information?
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WP3 Survey results – Purpose of use
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WP3 Survey results – Have you planned touse HTA information
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LBI produced local report based onEUnetHTA Zostavax (November2013)
Assessment
• Translation to German
• Adapation to LBI format
• Tables directly copied fromEnglish EUnetHTA assessment
• Shorter Version
• Adaptation with context specificAustrian data on e.g.epidemiology, costs
Examples for national adaptation ofAssessments
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ISCIII produced local reportbased on EUnetHTAEndobarrier assessment(September 2014)
• Translation to Spanish
• Adaptation to ISCIII format
• English summary
• Update of literature search
Examples of national adaptation
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Could you/would you use the assessment
directly for deriving a decision? If so, why? If not,
why not, which further information would you still
need?
Which decision would YOU derive based on the
information provided in the assessment?
Group work
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Thank you!
This presentation arises from the EUnetHTA
Joint Action 2 which has received fundingfrom the European Union, in the framework ofthe Health Programme