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How to use HTA for decisionmaking?Stakeholder involvement
EUnetHTA Training Course for StakeholdersRome, 29 Oct 2014
Anna Nachtnebel LBI-HTA, AustriaTove Ringerike, NOKC, Norway
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Session outline
2
1. How to use HTA for decision making:Learning outcome: Understand how HTA assessments (EUnetHTA pilots) can beused for decision making, its usefulness and its limits.
14:00 – 14:30 Presentations
• Introduction to Rapid Assessments of other technologies
• Renal Denervation Assessment - Case Example
• Different forms of usage of pilots
14:30 -16:00 Group work
2. Stakeholder involvementLearning outcome: Provide patients and providers with tools and knowledge tofacilitate participation in the HTA process
16:00 – 16:10 Presentation
• Overview on current stakeholder involvement in
Strand B
16:10 – 16:50 Plenary
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How to use HTA for decision-making
3
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To test the capacity of national/local HTA bodies tocollaboratively produce pilot rapid assessments
To test the application (transportation) of thosecollaboratively produced assessments in the national/localcontext
Adaptation of the “HTA Core Model for Rapid RelativeEffectiveness”
Work Package 5 - Objectives
April 25, 2013 4
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• Associated partners – AP (27 partners)• ZIN (Netherlands); LP
• LBI-HTA (Austria); Co-LP
• HVB (Austria); active, Strand A + B
• BIQG/GÖG (Austria); less active, Strand A +(B)
• KCE (Belgium); less active, Strand B
• MoH (Cyprus); less active, Strand A
• MoH (Czech Republic); less active, Strand A +B
• AAZ (Croatia); active, Strand A +B
• CR.DK (Denmark); active, Strand B
• FIMEA (Finland); active, Strand A
• THL (Finland); active, Strand B
• HAS (France); active, Strand A +B
• IQWIG (Germany); less active Strand A +B
• GYEMSZI (Hungary); less active, Strand A +B
• HIQA (Ireland); active, Strand B
• Agenas (Italy); active, Strand B
• Regione Veneto (Italy); active, Strand A +B
• AIFA (Italy); active, Strand A
• NHS (Latvia); less active, Strand A +B
• VASPVT (Lithuania); active, Strand A +B
• MFH (Malta); less active, Strand A +B
• NOKC (Norway); active, Strand A +B
• AHTAPol (Poland); less active, Strand A +B
• INFARMED (Portugal); active, Strand A
• Ministry of Health of the Slovak Republic (Slovakia); active,
Strand A +B
• NIPH (Slovenia); less active, Strand B
• ISCIII (Spain); active, Strand B
• Collaborating partners – CP (24 partners)• Donau Universität Krems (Austria); less active, Strand B
• RIZIV (Belgium); less active, Strand A +B
• Medical University of Sofia (Bulgaria); active, Strand A +B
• KORA (Denmark); less active, Strand A
• Interdisciplinary Centre for Health Technology Assessment (HTA)
and Public Health, University of Erlangen-Nuremberg, National
BMBF-Cluster of Excellence ‚Medical Technologies - Medical
Valley EMN’ (Germany); active, Strand B
• NCPE (Ireland); less active, Strand A
• CMSS Luxembourg)
• Laziosanità (Italy); active, Strand B
• University Hospital “A. Gemelli” (Italy); active, Strand A +B
• NCHTA (Russia); less active, Strand A +B
• Healthcare Improvement Scotland (Scotland); less active, Strand
A +B
• AETSA (Spain); less active, Strand A
• DGCF MSSSI (Spain); less active, Strand A
• Basque Office for HTA (Spain); less active, Strand B
• CAHIAQ (Spain); less active, Strand A
• Avalia-t (Spain); active, Strand B
• Swiss Federal Office for Public Health (Switzerland); Strand A +B
• SAGEM HTA (Turkey)
• KDTD (Turkey); less active
• CHIF (Croatia); active, Strand A
• SMCA (Lithuania); less active
• SAGEM (Turkey); less active, Strand A + B
• CMSS (Luxembourg); less active
• NCPRMP (Romania); less active
• SESCS (Spain)
• Tubitak (Turkey)
WP5 Members
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Strand B
Tools
*+ checklist for ethical, organisational, social and legal issues
Rapidassessments
Model thatprovidesframeworkthrough a set ofresearchquestions, butalso otherapplications..
Guidelines thatprovidemethodologicalguidance
Assessmenttemplate thatprovides guidancefor reporting
Procedure manualthat describesprocess of StrandB
Insert picture oftable of contentof zostavax?
+ Other Core ModelApplications
Reliable, timely, transparent,transferable HTA information
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HTA Core Model for Rapid REA – assessmentelements
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1. POP database: overlaps in topics listed at POP?
2
2. Call for collaboration: authoring agency selectsrelevant topics out of its own work programme –notification/inquiry to Strand B members
Topic selection
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2 Collaboration models for pilotsso far…
WP5 member
Agency A: authorof all domains
Agency B: co-authorchecks work of author
Dedicatedreviewer 4
Dedicatedreviewer 1
Dedicatedreviewer 3
WP5 memberWP5 member
WP5 memberWP5 member
Dedicatedreviewer 5
Dedicatedreviewer 2
WP5 member
WP5 memberWP5 member
WP5 memberWP5 member
WP5 member
Agency C:1-? domains
Agency B:1- ? domains
Agency A:1 - ? domains
Agency D:1 - ? domains
Dedicatedreviewer 3
Dedicatedreviewer 1
Dedicatedreviewer 2
Dedicatedreviewer 5
Dedicatedreviewer 4
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Assessments
June 19, 2015 12
˗ 2 Published:
• Duodenal-jejunal bypass sleeve for the treatment ofobesity with or without Type II Diabetes mellitus:published August 2013
• Renal denervation systems for treatment-resistanthypertension: published December 2013
˗ 3 Ongoing:
• Balloon Eustachian tuboplasty for the treatment ofEustachian tube dysfunction: external review, plannedpublication December 2014
• Biodegradable stents for benign refractory esophagealstenosis: postponed – RCT in publication
• Implantable devices for the treatment of mitral valveregurgitation (TBC)
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Tove Ringerike, Norwegian Knowledge Centre for the Health Services (NOKC)
EUnetHTA JA2 WP5 – Strand B:Renal Denervation Assessment Case Example
October 29, 2014
Tove Ringerike for the RDN pilot team
A1
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Slide 13
A1 We could change the colors in my part of the presentation to "EunetHTA" colors, might look nicer. Do you know how to switch colors?Author; 1/10/2014
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• Joint production by:
• Public Health and QualityImprovement, Central DenmarkRegion (CFK), Denmark
• Galician Health TechnologyAssessment (Avalia-t), Spain
• Norwegian Knowledge Centre for theHealth Services (NOKC), Norway
• Coordinating team WP5B: LBI-HTA,Austria
Renal denervation systems for treatment-resistant hypertension
http://www.eunethta.eu/outputs/second-pilot-rapid-assessment-renal-denervation-systems-treatment-resistant-hypertension
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What is renal denervation?
Source: http://www.renaldenervationworld.org/
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In a HTA perspective, it is important that we choose the most relevantoutcomes, especially patient centered outcomes
Use methodological guidelines (http://www.eunethta.eu/eunethta-guidelines)
What do you need to know before making adesicion?
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Project plan
Final assessment
Feed-back and peer-review
˗ Dedicated reviewers
˗ Other WP5 members
˗ Public consultation /Stakeholders
˗ Medical editing
Process
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RDN suggested by NOKC, based on clinicalinterest/commission in Norway (winter 2012-2013)
The technology was in use in clinical trials, but not yetwidely used in clinical practice
A perfect time for doing the assessment?
Why we chose to assess RDN
A2
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Slide 19
A2 Delete? Depend on what you cover in your slide on topic selection/POP database.Author; 1/10/2014
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• The initial plan was to assess the Simplicity device fromMedtronic
• However, feedback from other companies encouragedus to assess more than one device
One could ask if it was necessary to do a class review?
Plan A: Single technology assessmentPlan B: Multiple technolgy assessment
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Identified systems
A3
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Slide 21
A3 I will not draw any attention to the fact that we actually include information on devices without CE mark. But it is something we easily could
have added as exclusion criteria. So much easier to know these things in hindsight.Author; 1/10/2014
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Depend on:
˗ Maturity/developmental status of the technology
˗ Issues to be adressed in that domain
˗ Topic
˗ Resources
They may differ between projects and sections!
Description of the methods used is included in eachdomain.
Selection of methods used:
A4
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Slide 22
A4 Delete? Not relevant for the audience group?Author; 1/10/2014
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Search in electronic databases for published trials and inclinical trial registries for ongoing trials
For safety we included all prospective trials
For clinical effectiveness we only included prospective trialswith a control group
What we did
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Safety (3 RCT, 3 non-RCT, 16 case series) -> 13 studiesreported procedure-related complications, mostly of mild tomoderate nature.
Clinical effectiveness (3 RCT, 1 controlled trial) -> no/verylimited data on hard endpoints or long-term effects. Limiteddata suggests decrease in blood pressure.
Several ongoing or planned studies
What we found
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• We identified several ongoing studies.
It is important to assess the willingness to wait foradditional data versus the need to make a decision?
How to handle ongoing studies?
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So in plain language we did not find any alarmingcause for concerns about safety, but are not quitesure if the technology will actually perform well onpatient centered outcomes like mortality andcardiovascular events
What we conclude
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SYMPLICITY HTN-3, failed to meet its primary efficacyendpoint. The trial met its primary safety endpoint
Covidien to Exit OneShot™ Renal DenervationProgram This voluntary action is primarily in response toslower than expected development of the renal denervationmarket.
What has happened after publication of thepilot REA (dec 2013)
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Questions?
June 19, 2015 28
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National reports: Spain,Austria, Denmark …?
Directly used for decisionmaking
Link on Homepages
Others: reusage in other WP5pilot assessment, publicationin peer reviewed journal
Uptake of Assessments
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• Could you/would you use the assessment
directly for deriving a decision? If so, why? If not,
why not?
• Which decision would you derive based on the
information provided in the assessment?
Explain why.
Group work
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Stakeholder involvement
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Compilation of final project plan
• Stakeholder Advisory Group & Stakeholder Forum: informed aboutupcoming public consultation of project plan, inquiry to suggest externalmedical experts, patients representatives, identification of manufacturers
• Manufacturer(s): informed about upcoming public consultation of projectplan, to submit evidence/information on reimbursement status, submissionfile, scoping meeting(?)
• Patients: scoping - selection of relevant outcomes, comparators, draftproject plan
• Medical experts: scoping - selection of relevant outcomes, comparators,draft project plan
• Public: draft project plan
Stakeholder involvement - Scoping Phase
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Production of final assessment
Manufacturer(s), patients, medical experts: opportunityto comment on second draft of assessment, comments &answers publicly available
Further involvement
Update of HTA Core Model for Rapid REA
Stakeholder involvement - Assessment Phase
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Where do you think stakeholder involvement ismost relevant?
Could you think of other ways of stakeholderinvolvement?
Should there be criteria for selecting stakeholders?
Plenary session
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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