EUnetHTA approach in the Spanish HTA Network · European network for Health Technology Assessment |...

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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, 28-29 th May 2015

Transcript of EUnetHTA approach in the Spanish HTA Network · European network for Health Technology Assessment |...

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

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Thank you