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1. Navigating the path towards successful implementation of the EU HTA Regulation: key takeaways from the 2023 Spring Convention of the European Access Academy

Author

Brinkhuis, Francine, Julian, Elaine, van den Ham, Hendrika, Gianfrate, Fabrizio, Strammiello, Valentina, Berntgen, Michael, Pavlovic, Mira, Mol, Peter, Wasem, Jürgen, Van Dyck, Walter, Cardone, Antonella, Dierks, Christian, Schiel, Anja, Bernardini, Renato, Solà-Morales, Oriol, Ruof, Jörg, and Goettsch, Wim

Published
2024
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3. Current state-of-the-art and gaps in platform trials: 10 things you should know, insights from EU-PEARL

Author

Sánchez-Montalva, Adrian, Estevez, Ana Belén, Sánchez, Àlex, Sanjuan, Anna, Sena, Elena, Granados, Emma, Arévalo de Andrés, Esther, Nuñez, Fátima, Arteaga, Gara, Fuentes Ruiz, Gabriela Perez, Fernández, Guillermo, Rivera-Esteban, Jesus, Comella, Joan, Ramos-Quiroga, Josep Antoni, Genescà, Joan, Espinosa, Juan, Pericàs, Juan Manuel, Murcia, Lada, Cash-Gibson, Lucinda, de Valles Silvosa, Maria, Barroso de Sousa, María Fernanda, Sánchez-Maroto Carrizo, Olga, Ibañez-Jiménez, Pol, Augustin, Salvador, Perez-Hoyos, Santiago, Rodríguez-Navarro, Sarai, Muñoz-Martínez, Sergio, Serres, Silvia, Kalko, Susana, Michon, Amelie, Ussi, Anton, Lydall, Ben, van de Ketterij, Edwin, Quiles, Ignacio, Carapina, Tamara, Kumaus, Constantin, Ramazanova, Dariga, Meyer, Elias Laurin, Koenig, Franz, Roig, Marta Bofill, Brunner, Martin, Posch, Martin, Krotka, Pavla, Zehetmayer, Sonja, Carton, Charlotte, Legius, Eric, Begum, Amina, Pariante, Carmine, Worrell, Courtney, Lombardo, Giulia, Sforzini, Luca, Brown, Mollie, Gullet, Nancy, Amasi-Hartoonian, Nare, Ferner, Rosalie, Kose, Melisa, Spitaleri, Andrea, Ghodousi, Arash, Di Serio, Clelia, Cirillo, Daniela, Cugnata, Federica, Saluzzo, Francesca, Benedetti, Francesco, Scarale, Maria Giovanna, Zini, Michela, Rancoita, Paola Maria, Alagna, Riccardo, Poletti, Sara, Dhaenens, Britt, Van Der Lei, Johan, de Steenwinkel, Jurriaan, Moinat, Maxim, Oostenbrink, Rianne, Hoogendijk, Witte, Hölscher, Michael, Heinrich, Norbert, Otte, Christian, Potratz, Cornelia, Zocholl, Dario, Kulakova, Eugenia, Tacke, Frank, Brasanac, Jelena, Leubner, Jonas, Krajewska, Maja, Freitag, Michaela Maria, Gold, Stefan, Zoller, Thomas, Chae, Woo Ri, Daniel, Christel, Kara, Leila, Vaterkowski, Morgan, Griffon, Nicolas, Wolkenstein, Pierre, Pais, Raluca, Ratziu, Vlad, Voets, David, Maes, Christophe, Kalra, Dipak, Thienpoint, Geert, Deckerck, Jens, Lea, Nathan, Singleton, Peter, Viele, Kert, Jacko, Peter, Berry, Scott, Parke, Tom, Aydin, Burç, Kubiak, Christine, Demotes, Jacques, Ueda, Keiko, Matei, Mihaela, Contrino, Sergio, Röhl, Claas, Cordero, Estefania, Greenhalgh, Fiona, Jarke, Hannes, Angelova, Juliana, Boudes, Mathieu, Dressler, Stephan, Strammiello, Valentina, Anstee, Quentin, Gutierrez-Ibarluzea, Iñaki, Otte, Maximilian, Heimbach, Natalie, Hofner, Benjamin, Burgwinkel, Cora, Kaestel, Hue, Hees, Katharina, Nguyen, Quynh, Prieto-Alhambra, Daniel, Tan, Eng Hooi (Cheryl), Raviglione, Mario, de Colombani, Pierpaolo, Villa, Simone, Maron, Eduard, Evans, Gareth, Savitz, Adam J., Van Dessel, Ann, Duca, Anna, Kaminski, Anne, Wouters, Bie, Porter, Brandon, Charron, Catherine, Spiertz, Cecile, Zizzamia, Christopher, Millar, Daniel, Hasselbaink, Danny, Orr, David, Kesters, Divya, Hubin, Ellen, Davies, Emma, Didden, Eva-Maria, Guz, Gabriela, Verstraete, Evelyn, Mao, Gary, Capuano, George, Martynowicz, Heddie, De Smedt, Heidi, Larsson, Ingela, Bruegelmans, Ines, Coste, Isabelle, Gonzalez Moreno, Jesus Maria, Niewczas, Julia, Xu, Jiajun, Rombouts, Karin, Woo, Katherine, Wuyts, Kathleen, Hersh, Kathryn, Oldenburg, Khrista, Zhang, Lingjiao, Schmidt, Mark, Szuch, Mark, Todorovic, Marija, Mangelaars, Maartje, Grewal, Melissa, Sandor, Molli, Di Prospero, Nick, Van Houten, Pamela, Minnick, Pansy, Bastos, Polyana, Patrizi, Robert, Morello, Salvatore, De Wilde, Severijn, Sun, Tao, Kline, Timothy, de Marez, Tine, Mielke, Tobias, Reijns, Tom, Popova, Vanina, Flossbach, Yanina, Tymofyeyev, Yevgen, De Groote, Zeger, Sverdlov, Alex, Bobirca, Alexandra, Krause, Annekatrin, Bobrica, Catalin, Heintz, Daniela, Magirr, Dominic, Glimm, Ekkehard, Baffert, Fabienne, Castiglione, Federica, Caruso, Franca, Patalano, Francesco, Bretz, Frank, Heimann, Guenter, Carbarns, Ian, Rodríguez, Ignacio, Ratescu, Ioana, Hampson, Lisa, Pedrosa, Marcos, Hark, Mareile, Mesenbrink, Peter, Penna, Sabina Hernandez, Bergues-Lang, Sarah, Baltes-Engler, Susanne, Arsiwala, Tasneem, Mondragon, Valeria Jordan, Guo, Hua, Da Costa, Jose Leite, Burman, Carl-Fredrik, Kirk, George, Aaes-Jørgensen, Anders, Dirach, Jorgen, Kjær, Mette Skalshøi, Martin, Alexandra, Hristov, Diyan, Rousseaux, Florent, Hittel, Norbert, Dornheim, Robert, Evans, Daniel, Sykes, Nick, Couvert, Camille, Leuven, Catherine, Notelet, Loïc, Gidh-Jain, Madhavi, Jouannin, Mathieu, Ammour, Nadir, Pierre, Suzanne, Haufe, Volker, Dong, Yingwen, Dubanchet, Catherine, de Préville, Nathalie, Baltauss, Tania, Jian, Zhu, Shnider, Sara, Bar-El, Tal, Bakker, Annette, Nievo, Marco, Iloeje, Uche, Conradie, Almari, Auffarrth, Ece, Lombard, Leandra, Benhayoun, Majda, Olugbosi, Morounfolu, Seidel, Stephanie S., Gumí, Berta, Guzmán, Claudia García, Molero, Eva, Pairó, Gisela, Machin, Núria, Cardelús, Raimon, Ramasastry, Saira, Pelzer, Saskia, Kremer, Andreas, Lindfors, Erno, Lynch, Chris, Spiertz, Cécile, Machín, Núria, and Pericàs, Juan M.

Published
2024
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6. Current state-of-the-art and gaps in platform trials: 10 things you should know, insights from EU-PEARL

Author

Koenig, Franz, primary, Spiertz, Cécile, additional, Millar, Daniel, additional, Rodríguez-Navarro, Sarai, additional, Machín, Núria, additional, Van Dessel, Ann, additional, Genescà, Joan, additional, Pericàs, Juan M., additional, Posch, Martin, additional, Sánchez-Montalva, Adrian, additional, Estevez, Ana Belén, additional, Sánchez, Àlex, additional, Sanjuan, Anna, additional, Sena, Elena, additional, Granados, Emma, additional, Arévalo de Andrés, Esther, additional, Nuñez, Fátima, additional, Arteaga, Gara, additional, Fuentes Ruiz, Gabriela Perez, additional, Fernández, Guillermo, additional, Rivera-Esteban, Jesus, additional, Comella, Joan, additional, Ramos-Quiroga, Josep Antoni, additional, Espinosa, Juan, additional, Pericàs, Juan Manuel, additional, Murcia, Lada, additional, Cash-Gibson, Lucinda, additional, de Valles Silvosa, Maria, additional, Barroso de Sousa, María Fernanda, additional, Sánchez-Maroto Carrizo, Olga, additional, Ibañez-Jiménez, Pol, additional, Augustin, Salvador, additional, Perez-Hoyos, Santiago, additional, Muñoz-Martínez, Sergio, additional, Serres, Silvia, additional, Kalko, Susana, additional, Michon, Amelie, additional, Ussi, Anton, additional, Lydall, Ben, additional, van de Ketterij, Edwin, additional, Quiles, Ignacio, additional, Carapina, Tamara, additional, Kumaus, Constantin, additional, Ramazanova, Dariga, additional, Meyer, Elias Laurin, additional, Koenig, Franz, additional, Roig, Marta Bofill, additional, Brunner, Martin, additional, Krotka, Pavla, additional, Zehetmayer, Sonja, additional, Carton, Charlotte, additional, Legius, Eric, additional, Begum, Amina, additional, Pariante, Carmine, additional, Worrell, Courtney, additional, Lombardo, Giulia, additional, Sforzini, Luca, additional, Brown, Mollie, additional, Gullet, Nancy, additional, Amasi-Hartoonian, Nare, additional, Ferner, Rosalie, additional, Kose, Melisa, additional, Spitaleri, Andrea, additional, Ghodousi, Arash, additional, Di Serio, Clelia, additional, Cirillo, Daniela, additional, Cugnata, Federica, additional, Saluzzo, Francesca, additional, Benedetti, Francesco, additional, Scarale, Maria Giovanna, additional, Zini, Michela, additional, Rancoita, Paola Maria, additional, Alagna, Riccardo, additional, Poletti, Sara, additional, Dhaenens, Britt, additional, Van Der Lei, Johan, additional, de Steenwinkel, Jurriaan, additional, Moinat, Maxim, additional, Oostenbrink, Rianne, additional, Hoogendijk, Witte, additional, Hölscher, Michael, additional, Heinrich, Norbert, additional, Otte, Christian, additional, Potratz, Cornelia, additional, Zocholl, Dario, additional, Kulakova, Eugenia, additional, Tacke, Frank, additional, Brasanac, Jelena, additional, Leubner, Jonas, additional, Krajewska, Maja, additional, Freitag, Michaela Maria, additional, Gold, Stefan, additional, Zoller, Thomas, additional, Chae, Woo Ri, additional, Daniel, Christel, additional, Kara, Leila, additional, Vaterkowski, Morgan, additional, Griffon, Nicolas, additional, Wolkenstein, Pierre, additional, Pais, Raluca, additional, Ratziu, Vlad, additional, Voets, David, additional, Maes, Christophe, additional, Kalra, Dipak, additional, Thienpoint, Geert, additional, Deckerck, Jens, additional, Lea, Nathan, additional, Singleton, Peter, additional, Viele, Kert, additional, Jacko, Peter, additional, Berry, Scott, additional, Parke, Tom, additional, Aydin, Burç, additional, Kubiak, Christine, additional, Demotes, Jacques, additional, Ueda, Keiko, additional, Matei, Mihaela, additional, Contrino, Sergio, additional, Röhl, Claas, additional, Cordero, Estefania, additional, Greenhalgh, Fiona, additional, Jarke, Hannes, additional, Angelova, Juliana, additional, Boudes, Mathieu, additional, Dressler, Stephan, additional, Strammiello, Valentina, additional, Anstee, Quentin, additional, Gutierrez-Ibarluzea, Iñaki, additional, Otte, Maximilian, additional, Heimbach, Natalie, additional, Hofner, Benjamin, additional, Burgwinkel, Cora, additional, Kaestel, Hue, additional, Hees, Katharina, additional, Nguyen, Quynh, additional, Prieto-Alhambra, Daniel, additional, Tan, Eng Hooi (Cheryl), additional, Raviglione, Mario, additional, de Colombani, Pierpaolo, additional, Villa, Simone, additional, Maron, Eduard, additional, Evans, Gareth, additional, Savitz, Adam J., additional, Duca, Anna, additional, Kaminski, Anne, additional, Wouters, Bie, additional, Porter, Brandon, additional, Charron, Catherine, additional, Spiertz, Cecile, additional, Zizzamia, Christopher, additional, Hasselbaink, Danny, additional, Orr, David, additional, Kesters, Divya, additional, Hubin, Ellen, additional, Davies, Emma, additional, Didden, Eva-Maria, additional, Guz, Gabriela, additional, Verstraete, Evelyn, additional, Mao, Gary, additional, Capuano, George, additional, Martynowicz, Heddie, additional, De Smedt, Heidi, additional, Larsson, Ingela, additional, Bruegelmans, Ines, additional, Coste, Isabelle, additional, Gonzalez Moreno, Jesus Maria, additional, Niewczas, Julia, additional, Xu, Jiajun, additional, Rombouts, Karin, additional, Woo, Katherine, additional, Wuyts, Kathleen, additional, Hersh, Kathryn, additional, Oldenburg, Khrista, additional, Zhang, Lingjiao, additional, Schmidt, Mark, additional, Szuch, Mark, additional, Todorovic, Marija, additional, Mangelaars, Maartje, additional, Grewal, Melissa, additional, Sandor, Molli, additional, Di Prospero, Nick, additional, Van Houten, Pamela, additional, Minnick, Pansy, additional, Bastos, Polyana, additional, Patrizi, Robert, additional, Morello, Salvatore, additional, De Wilde, Severijn, additional, Sun, Tao, additional, Kline, Timothy, additional, de Marez, Tine, additional, Mielke, Tobias, additional, Reijns, Tom, additional, Popova, Vanina, additional, Flossbach, Yanina, additional, Tymofyeyev, Yevgen, additional, De Groote, Zeger, additional, Sverdlov, Alex, additional, Bobirca, Alexandra, additional, Krause, Annekatrin, additional, Bobrica, Catalin, additional, Heintz, Daniela, additional, Magirr, Dominic, additional, Glimm, Ekkehard, additional, Baffert, Fabienne, additional, Castiglione, Federica, additional, Caruso, Franca, additional, Patalano, Francesco, additional, Bretz, Frank, additional, Heimann, Guenter, additional, Carbarns, Ian, additional, Rodríguez, Ignacio, additional, Ratescu, Ioana, additional, Hampson, Lisa, additional, Pedrosa, Marcos, additional, Hark, Mareile, additional, Mesenbrink, Peter, additional, Penna, Sabina Hernandez, additional, Bergues-Lang, Sarah, additional, Baltes-Engler, Susanne, additional, Arsiwala, Tasneem, additional, Mondragon, Valeria Jordan, additional, Guo, Hua, additional, Da Costa, Jose Leite, additional, Burman, Carl-Fredrik, additional, Kirk, George, additional, Aaes-Jørgensen, Anders, additional, Dirach, Jorgen, additional, Kjær, Mette Skalshøi, additional, Martin, Alexandra, additional, Hristov, Diyan, additional, Rousseaux, Florent, additional, Hittel, Norbert, additional, Dornheim, Robert, additional, Evans, Daniel, additional, Sykes, Nick, additional, Couvert, Camille, additional, Leuven, Catherine, additional, Notelet, Loïc, additional, Gidh-Jain, Madhavi, additional, Jouannin, Mathieu, additional, Ammour, Nadir, additional, Pierre, Suzanne, additional, Haufe, Volker, additional, Dong, Yingwen, additional, Dubanchet, Catherine, additional, de Préville, Nathalie, additional, Baltauss, Tania, additional, Jian, Zhu, additional, Shnider, Sara, additional, Bar-El, Tal, additional, Bakker, Annette, additional, Nievo, Marco, additional, Iloeje, Uche, additional, Conradie, Almari, additional, Auffarrth, Ece, additional, Lombard, Leandra, additional, Benhayoun, Majda, additional, Olugbosi, Morounfolu, additional, Seidel, Stephanie S., additional, Gumí, Berta, additional, Guzmán, Claudia García, additional, Molero, Eva, additional, Pairó, Gisela, additional, Machin, Núria, additional, Cardelús, Raimon, additional, Ramasastry, Saira, additional, Pelzer, Saskia, additional, Kremer, Andreas, additional, Lindfors, Erno, additional, and Lynch, Chris, additional

Published
2024
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7. Role of Patient Organisations

Author

Bedlington, Nicola, Geissler, Jan, Houyez, François, Lightbourne, Alison, Maskens, Deborah, Strammiello, Valentina, Facey, Karen M., editor, Ploug Hansen, Helle, editor, and Single, Ann N.V., editor

Published
2017
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8. Uncertainty management in regulatory and health technology assessment decision-making on drugs: guidance of the HTAi-DIA Working Group

Author

Hogervorst, Milou Amber, Vreman, Rick, Heikkinen, Inkatuuli, Bagchi, Indranil, Gutierrez-Ibarluzea, Inaki, Ryll, Bettina, Eichler, Hans-Georg, Petelos, Elena, Tunis, Sean, Sapede, Claudine, Goettsch, Wim, Janssens, Rosanne, Huys, Isabelle, Barbier, Liese, DeJean, Deirdre, Strammiello, Valentina, Lingri, Dimitra, Goodall, Melinda, Papadaki, Magdalini, Toussi, Massoud, Voulgaraki, Despina, Mitan, Ania, Oortwijn, Wija, Hogervorst, Milou Amber, Vreman, Rick, Heikkinen, Inkatuuli, Bagchi, Indranil, Gutierrez-Ibarluzea, Inaki, Ryll, Bettina, Eichler, Hans-Georg, Petelos, Elena, Tunis, Sean, Sapede, Claudine, Goettsch, Wim, Janssens, Rosanne, Huys, Isabelle, Barbier, Liese, DeJean, Deirdre, Strammiello, Valentina, Lingri, Dimitra, Goodall, Melinda, Papadaki, Magdalini, Toussi, Massoud, Voulgaraki, Despina, Mitan, Ania, and Oortwijn, Wija

Abstract

ObjectivesUncertainty is a fundamental component of decision making regarding access to and pricing and reimbursement of drugs. The context-specific interpretation and mitigation of uncertainty remain major challenges for decision makers. Following the 2021 HTAi Global Policy Forum, a cross-sectoral, interdisciplinary HTAi-DIA Working Group (WG) was initiated to develop guidance to support stakeholder deliberation on the systematic identification and mitigation of uncertainties in the regulatory-HTA interface. MethodsSix online discussions among WG members (Dec 2021-Sep 2022) who examined the output of a scoping review, two literature-based case studies and a survey; application of the initial guidance to a real-world case study; and two international conference panel discussions. ResultsThe WG identified key concepts, clustered into twelve building blocks that were collectively perceived to define uncertainty: "unavailable," "inaccurate," "conflicting," "not understandable," "random variation," "information," "prediction," "impact," "risk," "relevance," "context," and "judgment." These were converted into a checklist to explain and define whether any issue constitutes a decision-relevant uncertainty. A taxonomy of domains in which uncertainty may exist within the regulatory-HTA interface was developed to facilitate categorization. The real-world case study was used to demonstrate how the guidance may facilitate deliberation between stakeholders and where additional guidance development may be needed. ConclusionsThe systematic approach taken for the identification of uncertainties in this guidance has the potential to facilitate understanding of uncertainty and its management across different stakeholders involved in drug development and evaluation. This can improve consistency and transparency throughout decision processes. To further support uncertainty management, linkage to suitable mitigation strategies is necessary.

Published
2023

9. Uncertainty management in regulatory and health technology assessment decision-making on drugs: guidance of the HTAi-DIA Working Group

Author

Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, PECP - Centre for Pharmaceutical Policy and Regulation, Hogervorst, Milou Amber, Vreman, Rick, Heikkinen, Inkatuuli, Bagchi, Indranil, Gutierrez-Ibarluzea, Inaki, Ryll, Bettina, Eichler, Hans-Georg, Petelos, Elena, Tunis, Sean, Sapede, Claudine, Goettsch, Wim, Janssens, Rosanne, Huys, Isabelle, Barbier, Liese, DeJean, Deirdre, Strammiello, Valentina, Lingri, Dimitra, Goodall, Melinda, Papadaki, Magdalini, Toussi, Massoud, Voulgaraki, Despina, Mitan, Ania, Oortwijn, Wija, Afd Pharmacoepi & Clinical Pharmacology, Pharmacoepidemiology and Clinical Pharmacology, PECP - Centre for Pharmaceutical Policy and Regulation, Hogervorst, Milou Amber, Vreman, Rick, Heikkinen, Inkatuuli, Bagchi, Indranil, Gutierrez-Ibarluzea, Inaki, Ryll, Bettina, Eichler, Hans-Georg, Petelos, Elena, Tunis, Sean, Sapede, Claudine, Goettsch, Wim, Janssens, Rosanne, Huys, Isabelle, Barbier, Liese, DeJean, Deirdre, Strammiello, Valentina, Lingri, Dimitra, Goodall, Melinda, Papadaki, Magdalini, Toussi, Massoud, Voulgaraki, Despina, Mitan, Ania, and Oortwijn, Wija

Published
2023

10. PP60 Enhancing Patient Empowerment: European Capacity Building Initiative And Curriculum Development In Health Technology Assessment Training.

Author

Muehler, Milena, Siebert, Silke, Schnell-Inderst, Petra, Roßmann, Sonja, Puntscher, Sibylle, Planinschitz, Tanja, Hallsson, Lára R., Houÿez, François, Delaye, Julien, Strammiello, Valentina, and Siebert, Uwe

Abstract

Introduction: The new Regulation (EU) 2021/2282 on health technology assessment (HTAR) highlights the increasing importance of patient perspectives, emphasizing their crucial role in HTA. The European Capacity Building for Patients (EUCAPA) project aims to empower patients for active involvement in HTA. EUCAPA focuses on equipping patients with capacities through the development of HTA training, including introductory, fast-track, and extended training programs. Methods: Within the EU-funded EU4Health program, the EUCAPA consortium was tasked with capacity building for patients and patient representatives. Training programs were developed using a coproduction approach, integrating patient representatives' perspectives into both curriculum development and the design of training sessions. This innovative approach involved close collaboration between patient representatives and HTA scientists, jointly shaping the program content. The curriculum was designed to incorporate the heterogeneous medical and cultural backgrounds and varying levels of prior knowledge among participants, recognizing diverse experiences that individuals bring to the training. To enhance accessibility, a blended learning approach with offline, virtual, and in-person parts was adopted. Results: The training comprised introductory (two hours), fast-track (eight hours), and extended (four days) training sessions. Training modules include competencies such as a profound understanding of HTA processes and key principles, domains, impact of HTA, outcome measurements, and study designs to raise awareness, promote, and enhance patient engagement as foreseen in the HTAR. The training modules focus on empowering patients to advocate for their rights and communities and to contribute meaningfully to comprehensive treatment evaluation. Specifically, modules on communication and personal skills, patient involvement, and engagement at both national and European levels underscore promotion of patient empowerment. Training sessions can be accessed online (EUCAPA.eu). Conclusions: The training development within the EUCAPA project addresses the evolving landscape of joint HTA by emphasizing the significance of patient perspectives, fostering core competencies, and responding to the increasing demand for active patient involvement and advocacy at both national and supranational levels. [ABSTRACT FROM AUTHOR]

Published
2025
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11. Uncertainty management in regulatory and health technology assessment decision-making on drugs: guidance of the HTAi-DIA Working Group

Author

Hogervorst, Milou Amber, primary, Vreman, Rick, additional, Heikkinen, Inkatuuli, additional, Bagchi, Indranil, additional, Gutierrez-Ibarluzea, Inaki, additional, Ryll, Bettina, additional, Eichler, Hans-Georg, additional, Petelos, Elena, additional, Tunis, Sean, additional, Sapede, Claudine, additional, Goettsch, Wim, additional, Janssens, Rosanne, additional, Huys, Isabelle, additional, Barbier, Liese, additional, DeJean, Deirdre, additional, Strammiello, Valentina, additional, Lingri, Dimitra, additional, Goodall, Melinda, additional, Papadaki, Magdalini, additional, Toussi, Massoud, additional, Voulgaraki, Despina, additional, Mitan, Ania, additional, and Oortwijn, Wija, additional

Published
2023
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12. Designing and Implementing Deliberative Processes for Health Technology Assessment: A Good Practices Report of a Joint HTAi/ISPOR Task Force

Author

Oortwijn, W.J., Husereau, Don, Abelson, Julia, Barasa, Edwine, Bayani, Diana Dana, Santos, Vania Canuto, Strammiello, Valentina, Teerawattananon, Yot, Oortwijn, W.J., Husereau, Don, Abelson, Julia, Barasa, Edwine, Bayani, Diana Dana, Santos, Vania Canuto, Strammiello, Valentina, and Teerawattananon, Yot

Abstract

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Published
2022

13. Designing and Implementing Deliberative Processes for Health Technology Assessment: A Good Practices Report of a Joint HTAi/ISPOR Task Force

Author

Oortwijn, Wija, primary, Husereau, Don, additional, Abelson, Julia, additional, Barasa, Edwine, additional, Bayani, Diana (Dana), additional, Santos, Vania Canuto, additional, Culyer, Anthony, additional, Facey, Karen, additional, Grainger, David, additional, Kieslich, Katharina, additional, Ollendorf, Daniel, additional, Pichon-Riviere, Andrés, additional, Sandman, Lars, additional, Strammiello, Valentina, additional, and Teerawattananon, Yot, additional

Published
2022
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16. Self-management interventions for adults living with Chronic Obstructive Pulmonary Disease (COPD) : The development of a Core Outcome Set for COMPAR-EU project

Author

Camus-García, Estela, González-González, Ana Isabel, Heijmans, Monique, Niño de Guzmán, Ena, Valli, Claudia, Beltran, Jessica, Pardo-Hernandez, Hector, Ninov, Lyudmil, Strammiello, Valentina, Immonen, Kaisa, Mavridis, Dimitris, Ballester, Marta, Suñol, Rosa, Orrego, Carola, Camus-García, Estela, González-González, Ana Isabel, Heijmans, Monique, Niño de Guzmán, Ena, Valli, Claudia, Beltran, Jessica, Pardo-Hernandez, Hector, Ninov, Lyudmil, Strammiello, Valentina, Immonen, Kaisa, Mavridis, Dimitris, Ballester, Marta, Suñol, Rosa, and Orrego, Carola

Abstract

A large body of evidence suggests that self-management interventions (SMIs) may improve outcomes in chronic obstructive pulmonary disease (COPD). However, accurate comparisons of the relative effectiveness of SMIs are challenging, partly due to heterogeneity of outcomes across trials and uncertainty about the importance of these outcomes for patients. We aimed to develop a core set of patient-relevant outcomes (COS) for SMIs trials to enhance comparability of interventions and ensure person-centred care. We undertook an innovative approach consisting of four interlinked stages: i) Development of an initial catalogue of outcomes from previous EU-funded projects and/or published studies, ii) Scoping review of reviews on patients and caregivers' perspectives to identify outcomes of interest, iii) Two-round Delphi online survey with patients and patient representatives to rate the importance of outcomes, and iv) Face-to-face consensus workshop with patients, patient representatives, health professionals and researchers to develop the COS. From an initial list of 79 potential outcomes, 16 were included in the COS plus one supplementary outcome relevant to all participants. These were related to patient and caregiver knowledge/competence, self-efficacy, patient activation, self-monitoring, adherence, smoking cessation, COPD symptoms, physical activity, sleep quality, caregiver quality of life, activities of daily living, coping with the disease, participation and decision-making, emergency room visits/admissions and cost effectiveness. The development of the COPD COS for the evaluation of SMIs will increase consistency in the measurement and reporting of outcomes across trials. It will also contribute to more personalized health care and more informed health decisions in clinical practice as patients' preferences regarding COPD outcomes are more systematically included.

Published
2021

17. Self-management interventions for adults living with Chronic Obstructive Pulmonary Disease (COPD): The development of a Core Outcome Set for COMPAR-EU project

Author

Camus-García, Estela, primary, González-González, Ana Isabel, additional, Heijmans, Monique, additional, Niño de Guzmán, Ena, additional, Valli, Claudia, additional, Beltran, Jessica, additional, Pardo-Hernández, Hector, additional, Ninov, Lyudmil, additional, Strammiello, Valentina, additional, Immonen, Kaisa, additional, Mavridis, Dimitris, additional, Ballester, Marta, additional, Suñol, Rosa, additional, and Orrego, Carola, additional

Published
2021
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18. The fourth edition of the European Network for Health Technology Assessment Forum: highlights and outcomes

Author

Tafuri, Giovanni, primary, Bélorgey, Chantal, additional, Favaretti, Carlo, additional, Frénoy, Edith, additional, Giorgio, Flora, additional, Guardian, Marcus, additional, Hebborn, Ansgar, additional, Houÿez, François, additional, Imbert, Jessica, additional, Lacombe, Denis, additional, Garcia, Jordi Llinares, additional, Garrett, Zoe, additional, Petelos, Elena, additional, Saeterdal, Ingvil, additional, Schuurman, Ad, additional, Skjöldebrand, Anna Lefevre, additional, Strammiello, Valentina, additional, Widmer, Daniel, additional, Willemsen, Anne, additional, and Hedberg, Niklas, additional

Published
2020
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21. Designing and Implementing Deliberative Processes for Health Technology Assessment: A Good Practices Report of a Joint HTAi/ISPOR Task Force.

Author

Oortwijn, Wija, Husereau, Don, Abelson, Julia, Barasa, Edwine, Bayani, Diana, Santos, Vania Canuto, Culyer, Anthony, Facey, Karen, Grainger, David, Kieslich, Katharina, Ollendorf, Daniel, Pichon-Riviere, Andrés, Sandman, Lars, Strammiello, Valentina, and Teerawattananon, Yot

Abstract

Objectives: Deliberative processes for health technology assessment (HTA) are intended to facilitate participatory decision making, using discussion and open dialogue between stakeholders. Increasing attention is being given to deliberative processes, but guidance is lacking for those who wish to design or use them. Health Technology Assessment International (HTAi) and ISPOR—The Professional Society for Health Economics and Outcomes Research initiated a joint Task Force to address this gap. Methods: The joint Task Force consisted of fifteen members with different backgrounds, perspectives, and expertise relevant to the field. It developed guidance and a checklist for deliberative processes for HTA. The guidance builds upon the few, existing initiatives in the field, as well as input from the HTA community following an established consultation plan. In addition, the guidance was subject to two rounds of peer review. Results: A deliberative process for HTA consists of procedures, activities, and events that support the informed and critical examination of an issue and the weighing of arguments and evidence to guide a subsequent decision. Guidance and an accompanying checklist are provided for (i) developing the governance and structure of an HTA program and (ii) informing how the various stages of an HTA process might be managed using deliberation. Conclusions: The guidance and the checklist contain a series of questions, grouped by six phases of a model deliberative process. They are offered as practical tools for those wishing to establish or improve deliberative processes for HTA that are fit for local contexts. The tools can also be used for independent scrutiny of deliberative processes. [ABSTRACT FROM AUTHOR]

Published
2021
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22. Health-care improvements in a financially constrained environment

Author

Ekman, Inger, primary, Busse, Reinhard, additional, van Ginneken, Ewout, additional, Van Hoof, Chris, additional, van Ittersum, Linde, additional, Klink, Ab, additional, Kremer, Jan A, additional, Miraldo, Marisa, additional, Olauson, Anders, additional, De Raedt, Walter, additional, Rosen-Zvi, Michal, additional, Strammiello, Valentina, additional, Törnell, Jan, additional, and Swedberg, Karl, additional

Published
2016
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23. Avoiding Error and Finding the Right Balance in European Health Technology Assessments: Insights Generated by the European Access Academy.

Author

Julian E, Belleman T, Garcia MJ, Rutten-van Mölken M, Doeswijk R, Giuliani R, Wörmann BJ, Widmer D, Tilleul P, Casado Arroyo R, Strammiello V, Morgan K, Guardian M, Ermisch M, Bernardini R, Gianfrate F, Capri S, Uyl-de Groot CA, Pavlovic M, and Ruof J

Abstract

Background: We examined four potential challenges for the implementation of the European Union (EU) Regulation 2021/2282 on Health Technology Assessment (EU HTAR): interaction with the European Medicines Agency (EMA), expert input, the interface of European health technology assessment (EU HTA) joint procedures with those within Member States, and the management of conflict of interest. This research aims to explore how to address these challenges in a balanced manner and prioritise key actions for effective collaboration in the context of the EU HTA., Methods: The methodology included a pre-convention survey among relevant stakeholders as well as working groups and the plenary ranking of discussion outcomes at the European Access Academy (EAA) Spring Convention 2024., Results: In the survey, 65.5% of respondents indicated that experts are currently not sufficiently included in the upcoming joint scientific consultations and clinical assessments; only 37.9% suggested that the EU HTA joint procedures would accelerate national appraisal decision-making, and 58.6% believed that the principles of 'transparency' and 'competency' are balanced in the EU HTA position on conflict of interest. The top priority action points identified in the working groups were the involvement of the best available expertise, the early and inclusive involvement of experts, strengthened early scientific dialogue, and the fostering of the political willingness/financial support of EU Member States to increase capacities., Conclusions: The key topics identified were an approach to conflict of interest that balances transparency obligations and the need for expertise, strengthens the involvement of clinical and patient experts, intensifies early interaction between the EMA and EU HTA, and increases the involvement of the EU Member States., Competing Interests: Conflicts of InterestJ.R. and E.J. as EAA Secretariat received an unrestricted grant from Abbvie, AstraZeneca, Bayer, Novartis, Pfizer, Roche, and Sanofi that partially funded this research. Neither the content of this work nor the conclusions drawn and presented in this manuscript were influenced by the sponsoring companies. M.J.G. is an employee of and holds shares in F. Hoffmann-La Roche, Ltd., (© 2025 by the authors.)

Published
2025
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24. Stakeholder perspectives on the current status and potential barriers of patient involvement in health technology assessment (HTA) across Europe.

Author

Holtorf AP, Bertelsen N, Jarke H, Dutarte M, Scalabrini S, and Strammiello V

Subjects
Europe, Humans, Stakeholder Participation, Surveys and Questionnaires, Technology Assessment, Biomedical organization & administration, Patient Participation
Abstract

Background: There are wide variations in the practices of patient involvement in health technology assessment (HTA) in Europe. The field is lacking a consensus on good practices, leading to divergent processes, methods, and evaluation of patient involvement. To identify potential good practice approaches and current gaps, a structured online survey was conducted among HTA stakeholders, including HTA practitioners, patient stakeholders, industry representatives, and others who had experienced patient involvement in HTA., Methods: The questionnaire was co-created by HTA experts, patient stakeholders, and industry representatives and disseminated between 29 April and 14 September 2022., Results: Responses (n = 168) were submitted from thirty-two European countries by HTA practitioners (n = 33), patient stakeholders (n = 75), industry stakeholders (n = 42), providers (n = 5), academics (n = 7), and others (n = 6). The responses indicated that " allowing access to treatments that have demonstrated value" is the principle rationale for conducting HTA. In terms of the importance of patient involvement, there was consensus across stakeholder groups that " patients have insights and information [that] no other stakeholder has " and that patient involvement is important " to inform HTA which evidence is most patient-relevant ". Shortcomings were identified in the lack of systematic and transparent processes, an unsatisfactory level of information and guidance, and minimal communication and collaboration., Conclusions: The diverse stakeholders who responded highlighted the need for improving specific aspects of patient involvement practices, including better guidance and information, a more consistent flow of communication between the HTA body and participating patient stakeholders, and the need to develop and implement a consensus on good practices.

Published
2024
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