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Postlaunch evidence generation practices among health technology assessment bodies in Europe

Published online by Cambridge University Press:  19 April 2022

Janet Puñal-Riobóo ,
Leonor Varela-Lema Open the ORCID record for Leonor Varela-Lema [Opens in a new window] ,
Chantal Guilhaume ,
Margaret Galbraith Open the ORCID record for Margaret Galbraith [Opens in a new window] ,
Chantal Bélorgey ,
Maria José Faraldo  and
Amélie Meillassoux
Janet Puñal-Riobóo
Affiliation:
Galician Health Knowledge Agency (AVALIA-T, ACIS), Santiago de Compostela, Spain
Leonor Varela-Lema*
Affiliation:
Preventive Medicine and Public Health Department, University of Santiago de Compostela, Santiago de Compostela, Spain
Chantal Guilhaume
Affiliation:
Haute Autorité de Santé (HAS), Saint-Denis, France
Margaret Galbraith
Affiliation:
Haute Autorité de Santé (HAS), Saint-Denis, France
Chantal Bélorgey
Affiliation:
Haute Autorité de Santé (HAS), Saint-Denis, France
Maria José Faraldo
Affiliation:
Galician Health Knowledge Agency (AVALIA-T, ACIS), Santiago de Compostela, Spain
Amélie Meillassoux
Affiliation:
Haute Autorité de Santé (HAS), Saint-Denis, France
*
*Author for correspondence: Leonor Varela-Lema, E-mail: leonor.varela@usc.es
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Abstract

Objectives

The term Postlaunch Evidence Generation (PLEG) refers to evidence generated after the launch or licensing of a health technology. The aim of this paper is to provide an overview of the implementation of these practices in the European Union in order to explore cross-border cooperation opportunities.

Methods

In December 2019, a survey composed of nine closed-ended questions with multiple choice answers about the PLEG practices in each country was sent to all twenty-five dedicated work package (WP5B) partners of the European Network of Health Technology Assessment (EUnetHTA) Joint Action 3. In addition to the survey, the national practices were discussed during a face-to-face meeting with WP5B partners.

Results

Twelve Health TechnologyAssessment (HTA) bodies completed the survey. Of these, eleven reported procedures in place for official requests for PLEGs in their remit. In the large majority of cases, the requests are made at the time of the assessment/appraisal. Several agencies participate in the definition of the scope of the PLEG or review of its protocol. Data collection and analysis mainly lie with companies for pharmaceuticals, whereas it is more the responsibility of the HTA bodies for medical devices. Only one agency owns the data and is able to exchange them without asking permission.

Conclusions

Most agencies recommend European collaboration on PLEG commence once the evidence gaps have been defined or during the production of the HTA report in the case of European joint assessment.

Keywords

EUnetHTA partnersPLEG practiceEvidence gapsHealth technology assessment
Type
Article Commentary
Information
International Journal of Technology Assessment in Health Care , Volume 38 , Issue 1 , 2022 , e33
Copyright
© The Author(s), 2022. Published by Cambridge University Press

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Footnotes

The authors would like to acknowledge Annette Abraham (G-BA), Antje Behring (G-BA), Rimma Berenstein (G-BA), Susanne Brueck (G-BA), Agnese Cangini (AIFA), Anna Cavazzana (Veneto/CRUF), Mariane Cossito (Infarmed), Judith Fernandez (HAS), Emmanuelle Fouteau (HAS), Irena Guzina (HAS), Wim Goettsch (ZIN), Brad Groves (NICE), Hanna-Mari Jauhonen (Fimea), Piia Rannanheimo (Fimea), Krystyna Hviding (NOMA), Matthias Menig (SNHTA), Goedele Van-Hassten (SNHTA), Marija Svajda (HZJZ), Entela Xoxi (UCSC GEMELLI), and Johan Pontén (TLV).

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