European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu
EUnetHTA approach
in the Spanish HTA Network
Marisa López-García, Avalia-t
Teresa Molina-López, AETSA
Copenhagen, 28-29th
May 2015
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The Spanish Network of Agencies for HTA has been created in 2012 by
consensus of the Interterritorial Council of the National Healthcare System
The network is regulated by law (Royal Decree 200/2012 assigned the
coordination of the Network to DG of Public Health, Quality and Innovation &
Ministerial Order SS1833/2013, regulates the Council of the Network)
It is based on mutual recognition among the agencies
The collaboration has been in place since 2006 (Framework: NHS Quality
Plan)
It is in a continuous process of quality improvement.
SPANISH NETWORK OF AGENCIES FOR HTA AND SERVICES
OF THE NATIONAL HEALTH SYSTEM
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The Technical Secretariat is held by the Deputy Directorate of Quality
and Cohesion (SMoH)
The network is made up of 8 agencies
lAETS. HTA Agency-Health Institute Carlos III (ISCIII)
lOSTEBA. Basque Office for Health Technology Assessment
lAVALIA-T. Galician Agency for Health Technology Assessment
lCAHIAQ. Catalan Agency for Health Information, Assessment and Quality
lAETSA. Andalusian Agency for Health Technology Assessment
lSESCS. Evaluation and Planning Unit - Directorate of the Canary Islands Health Service
lIACS. The Aragon Health Sciences Institute
lUETS. Health Technology Assessment Unit, Madrid.
Who makes up the network?
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The Ministry of Health (SMoH) defines the basic
portfolio of the NHS with the agreement of the 17 Regional
Governments
Network´s HTA reports are used to support national
decision making
At the national level, decision making is done by the
Interterritorial Council
Any relevant technology that is to be incorporated into
the portfolio of services of the NHS must be assessed by
one of the agencies
HTA Reports are mandatory but not binding
Spain has a high level of decentralization in policy
making
A complementary regional framework could also be
implemented to specify an additional regional portfolio
The Decision-Making Process and the HTA Tool in Spain
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A.Who can request HTA reports?
lThe Ministry of Health (SMoH) and Regional
Healthcare Services
lEvery request must be carried out using a
structured form and documented in order to
sustain the appropriateness of the request
The Spanish Network´s Annual Working Plan (I)
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B. Prioritization
The process of identification and prioritization is undertaken yearly by the
SMoH and all of the Regional Healthcare Services
The annual working plan of the Network is approved by the Interterritorial
Council of the SMoH that allocates a specific budget
The timetable is defined by the SMoH who sets timeliness
The type of report is agreed upon with the agencies‘ advice
The Spanish Network´s Annual Working Plan (II)
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JA2 EunetHTA involvement: majority of agencies have collaborated
voluntarily without funding: (Osteba, Avalia-t, AQUAS, AETSA, UETS) and
one with funding (ISCIIII)
SMoh: Financial support for international activities
Spanish Network and JA2 EUnetHTA
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National Uptake within the
Spanish HTA Network
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Strategy Lines
Methodological Guidelines
National Adaptation of Joint Assessment
Learning/training
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Methodological Guidelines (I)
•Since 2006: Shared methodological guidelines
Topics identification, selection and establishing priorities
Search strategies: locating and selecting studies
Quality assessment of studies in HTA
Collecting data, analyzing and presenting results
Quality control of HTA production
Emerging HT/ Horizon Scanning
Tools to provide support in decision–making on the introduction of new
technologies in hospitals: GANT, GEN, GINF guidelines
Patient guidelines
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Methodological Guidelines (II)
•At National level In 2014 2015 Spanish Network for HTA Work Plan:
Process Guideline for HTA (ongoing)
Objective: ▲To update methods and processes ▲ Framework:
•Methodological EUnetHTA Guidelines (9)
•National Adaptation, Reuse of JW and cooperation (POP-DB)
•CORE-MODEL adoption
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Methodological Guidelines (III)
Process Guideline for HTA (ongoing)
Coordinator group: Avalia-t and AETSA Working group: UETS-ISCIII, Osteba, AQuas, SCETS, IACS, UETS Madrid
The guide will cover the following topics:
Procedure
Ontology
Main methodological aspects
Reporting structure
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Methodological Guidelines (IV)
•At Regional level Guideline for efficacy and safety
data synthesis for new drugs
(AETSA)
Based on Methodological
EUnetHTA Guidelines (9)
EUnetHTA Core-Model:
REA for pharmaceuticals
Incorporating National
Adaptation and Reuse of JW
http://goo.gl/qv9HRm
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National Adaptation (NA) of Joint Assessment (I)
NA in HTA Process
Agreement with Network Board about: relevancy and timing
Procedure: EUnetHTA toolkit Methodology section in the report: explicit declaration about the strategy of NA
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•Piloting NA 1: Balloon Eustachian Tuboplasty for the treatment of Eustachian tube dysfunction
Adoption (AETSA)
National Adaptation (NA) of Joint Assessment (II)
http://goo.gl/C5l4Yq
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•Piloting NA 2: Duodenal-Jejunal bypass sleeve for the treatment of
obesity with or without type II diabetes mellitus Adaptation (ISCIII)
National Adaptation (NA) of Joint Assessment (II)
http://gesdoc.isciii.es/gesdoccontroller?action=download&id=29/09/2014-ef80379f51
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National Adaptation (NA) of Joint Assessment (III)
Piloting NA 3: Canaglifozin.
Used as reference in Therapeutic Positioning Report (Discussion)
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• JA 1: Renal Denervation Collaboration in EunetHTA JA to update national HTA Report
Direct use to reinforce the decision making process
National Adaptation (NA) of Joint Assessment (IV)
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• JA 2: Biodegradable stents (BVS) for the treatment of
refractory or recurrent benign oesophageal stenosis
(ongoing)
ISCIII, AETSA
National Adoption (NA) of Joint Assessment (V)
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EUnetHTA Tools (Database and Guidelines): Capacity building
EUnetHTA activities face-to face training courses (Brussels,
Paris...)
Training activities Internal activities in every agency
Learning/training (I)
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Learning/training (III)
Annual Internal Spanish HTA Network
Workshop
September 2015: Seville National Uptake:
Final discussion Guideline for HTA
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Facilitators and barriers for
national uptake
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1. Alignment of identification and
priority processes are essential for a
right timing of assessment
•Spanish HTA Network Project (2015): – Adaptation of a prioritization regional tool PriTec (Avalia-t) to be used at National Level – Integration of Horizon Scanning Activities:
•Osteba, Avalia-t, AETSA
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2. Common Methodology
Procedures are necessary
•Process Guideline for HTA (ongoing)
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3. Development of capacity building in
EUnetHTA tools and procedures must be in the
strategy of the Agencies
•Annual Internal Spanish
Network Workshop - September 2015: Seville