Elena Parmelli1, Laura Amato2, Andrew D Oxman3, Pablo Alonso-Coello4, Massimo Brunetti5, Jenny Moberg6, Francesco Nonino7, Silvia Pregno5, Carlo Saitto8, Holger J Schünemann9, Marina Davoli10. 1. Department of Epidemiology,Lazio Regional Health Service,ASL Roma 1,Italian Cochrane Centre,Department of Diagnostic,Clinical and Public Health Medicine,University of Modena and Reggio Emiliae.parmelli@deplazio.it. 2. Department of Epidemiology,Lazio Regional Health Service,ASL Roma 1. 3. Centre for Informed Health Choices,Norwegian Institute of Public Health. 4. Iberoamerican Cochrane Center,IIB Sant Pau-CIBERESP;Health Research Methods,Evidence,and Impact (formerly "Clinical Epidemiology and Biostatistics") and of Medicine,McMaster University. 5. Local Health Authority,Modena. 6. Global Health Unit,Norwegian Knowledge Centre for the Health Services. 7. Drug and Devices Evaluation Area,Emilia-Romagna Region,Bologna. 8. Local Health Authority ASL Roma 1,Rome. 9. Departments of Health Research Methods,Evidence,and Impact (formerly "Clinical Epidemiology and Biostatistics") and of Medicine,McMaster University. 10. Department of Epidemiology,Lazio Regional Health Service - ASL Roma 1.
Abstract
OBJECTIVES: Coverage decisions are decisions by third party payers about whether and how much to pay for technologies or services, and under what conditions. Given their complexity, a systematic and transparent approach is needed. The DECIDE (Developing and Evaluating Communication Strategies to Support Informed Decisions and Practice Based on Evidence) Project, a GRADE (Grading of Recommendations Assessment, Development and Evaluation) Working Group initiative funded by the European Union, has developed GRADE Evidence to Decision (EtD) framework for different types of decisions, including coverage ones. METHODS: We used an iterative approach, including brainstorming to generate ideas, consultation with stakeholders, user testing, and pilot testing of the framework. RESULTS: The general structure of the EtD includes formulation of the question, an assessment using twelve criteria, and conclusions. Criteria that are relevant for coverage decisions are similar to those for clinical recommendations from a population perspective. Important differences between the two include the decision-making processes, accountability, and the nature of the judgments that need to be made for some criteria. Although cost-effectiveness is a key consideration when making coverage decisions, it may not be the determining factor. Strength of recommendation is not directly linked to the type of coverage decisions, but when there are important uncertainties, it may be possible to cover an intervention for a subgroup, in the context of research, with price negotiation, or with restrictions. CONCLUSIONS: The EtD provides a systematic and transparent approach for making coverage decisions. It helps ensure consideration of key criteria that determine whether a technology or service should be covered and that judgments are informed by the best available evidence.
OBJECTIVES: Coverage decisions are decisions by third party payers about whether and how much to pay for technologies or services, and under what conditions. Given their complexity, a systematic and transparent approach is needed. The DECIDE (Developing and Evaluating Communication Strategies to Support Informed Decisions and Practice Based on Evidence) Project, a GRADE (Grading of Recommendations Assessment, Development and Evaluation) Working Group initiative funded by the European Union, has developed GRADE Evidence to Decision (EtD) framework for different types of decisions, including coverage ones. METHODS: We used an iterative approach, including brainstorming to generate ideas, consultation with stakeholders, user testing, and pilot testing of the framework. RESULTS: The general structure of the EtD includes formulation of the question, an assessment using twelve criteria, and conclusions. Criteria that are relevant for coverage decisions are similar to those for clinical recommendations from a population perspective. Important differences between the two include the decision-making processes, accountability, and the nature of the judgments that need to be made for some criteria. Although cost-effectiveness is a key consideration when making coverage decisions, it may not be the determining factor. Strength of recommendation is not directly linked to the type of coverage decisions, but when there are important uncertainties, it may be possible to cover an intervention for a subgroup, in the context of research, with price negotiation, or with restrictions. CONCLUSIONS: The EtD provides a systematic and transparent approach for making coverage decisions. It helps ensure consideration of key criteria that determine whether a technology or service should be covered and that judgments are informed by the best available evidence.
Authors: Rob B M De Vries; Michelle Angrish; Patience Browne; Jan Brozek; Andrew A Rooney; Daniele S Wikoff; Paul Whaley; Stephen W Edwards; Rebecca L Morgan; Ingrid L Druwe; Sebastian Hoffmann; Thomas Hartung; Kristina Thayer; Marc T Avey; Brandiese E J Beverly; Maicon Falavigna; Catherine Gibbons; Katy Goyak; Andrew Kraft; Fernando Nampo; Amir Qaseem; Meg Sears; Jasvinder A Singh; Catherine Willett; Erin Y Yost; Holger Schünemann; Katya Tsaioun Journal: ALTEX Date: 2021-04-08 Impact factor: 6.250
Authors: Jenny Moberg; Andrew D Oxman; Sarah Rosenbaum; Holger J Schünemann; Gordon Guyatt; Signe Flottorp; Claire Glenton; Simon Lewin; Angela Morelli; Gabriel Rada; Pablo Alonso-Coello Journal: Health Res Policy Syst Date: 2018-05-29
Authors: Sarah E Rosenbaum; Jenny Moberg; Claire Glenton; Holger J Schünemann; Simon Lewin; Elie Akl; Reem A Mustafa; Angela Morelli; Joshua P Vogel; Pablo Alonso-Coello; Gabriel Rada; Juan Vásquez; Elena Parmelli; A Metin Gülmezoglu; Signe A Flottorp; Andrew D Oxman Journal: Glob Chall Date: 2018-01-10
Authors: J Jean Bousquet; Holger J Schünemann; Alkis Togias; Marina Erhola; Peter W Hellings; Torsten Zuberbier; Ioana Agache; Ignacio J Ansotegui; Josep M Anto; Claus Bachert; Sven Becker; Martin Bedolla-Barajas; Michael Bewick; Sinthia Bosnic-Anticevich; Isabelle Bosse; Louis P Boulet; Jean Marc Bourrez; Guy Brusselle; Niels Chavannes; Elisio Costa; Alvaro A Cruz; Wienczyslawa Czarlewski; Wytske J Fokkens; Joao A Fonseca; Mina Gaga; Tari Haahtela; Maddalena Illario; Ludger Klimek; Piotr Kuna; Violeta Kvedariene; L T T Le; Desiree Larenas-Linnemann; Daniel Laune; Olga M Lourenço; Enrica Menditto; Joaquin Mullol; Yashitaka Okamoto; Nikos Papadopoulos; Nhân Pham-Thi; Robert Picard; Hilary Pinnock; Nicolas Roche; Regina E Roller-Wirnsberger; Christine Rolland; Boleslaw Samolinski; Aziz Sheikh; Sanna Toppila-Salmi; Ioanna Tsiligianni; Arunas Valiulis; Erkka Valovirta; Tuula Vasankari; Maria-Teresa Ventura; Samantha Walker; Sian Williams; Cezmi A Akdis; Isabella Annesi-Maesano; Sylvie Arnavielhe; Xavier Basagana; Eric Bateman; Anna Bedbrook; K S Bennoor; Samuel Benveniste; Karl C Bergmann; Slawomir Bialek; Nils Billo; Carsten Bindslev-Jensen; Leif Bjermer; Hubert Blain; Mateo Bonini; Philippe Bonniaud; Jacques Bouchard; Vitalis Briedis; Christofer E Brightling; Jan Brozek; Roland Buhl; Roland Buonaiuto; Giorgo W Canonica; Victoria Cardona; Ana M Carriazo; Warner Carr; Christine Cartier; Thomas Casale; Lorenzo Cecchi; Alfonso M Cepeda Sarabia; Eka Chkhartishvili; Derek K Chu; Cemal Cingi; Elaine Colgan; Jaime Correia de Sousa; Anne Lise Courbis; Adnan Custovic; Biljana Cvetkosvki; Gennaro D'Amato; Jane da Silva; Carina Dantas; Dejand Dokic; Yves Dauvilliers; Antoni Dedeu; Giulia De Feo; Philippe Devillier; Stefania Di Capua; Marc Dykewickz; Ruta Dubakiene; Motohiro Ebisawa; Yaya El-Gamal; Esben Eller; Regina Emuzyte; John Farrell; Antjie Fink-Wagner; Alessandro Fiocchi; Jean F Fontaine; Bilun Gemicioğlu; Peter Schmid-Grendelmeir; Amiran Gamkrelidze; Judith Garcia-Aymerich; Maximiliano Gomez; Sandra González Diaz; Maia Gotua; Nick A Guldemond; Maria-Antonieta Guzmán; Jawad Hajjam; John O'B Hourihane; Marc Humbert; Guido Iaccarino; Despo Ierodiakonou; Maddalena Illario; Juan C Ivancevich; Guy Joos; Ki-Suck Jung; Marek Jutel; Igor Kaidashev; Omer Kalayci; Przemyslaw Kardas; Thomas Keil; Mussa Khaitov; Nikolai Khaltaev; Jorg Kleine-Tebbe; Marek L Kowalski; Vicky Kritikos; Inger Kull; Lisa Leonardini; Philip Lieberman; Brian Lipworth; Karin C Lodrup Carlsen; Claudia C Loureiro; Renaud Louis; Alpana Mair; Gert Marien; Bassam Mahboub; Joao Malva; Patrick Manning; Esteban De Manuel Keenoy; Gailen D Marshall; Mohamed R Masjedi; Jorge F Maspero; Eve Mathieu-Dupas; Poalo M Matricardi; Eric Melén; Elisabete Melo-Gomes; Eli O Meltzer; Enrica Menditto; Jacques Mercier; Neven Miculinic; Florin Mihaltan; Branislava Milenkovic; Giuliana Moda; Maria-Dolores Mogica-Martinez; Yousser Mohammad; Steve Montefort; Ricardo Monti; Mario Morais-Almeida; Ralf Mösges; Lars Münter; Antonella Muraro; Ruth Murray; Robert Naclerio; Luigi Napoli; Leila Namazova-Baranova; Hugo Neffen; Kristoff Nekam; Angelo Neou; Enrico Novellino; Dieudonné Nyembue; Robin O'Hehir; Ken Ohta; Kimi Okubo; Gabrielle Onorato; Solange Ouedraogo; Isabella Pali-Schöll; Susanna Palkonen; Peter Panzner; Hae-Sim Park; Jean-Louis Pépin; Ana-Maria Pereira; Oliver Pfaar; Ema Paulino; Jim Phillips; Robert Picard; Davor Plavec; Ted A Popov; Fabienne Portejoie; David Price; Emmanuel P Prokopakis; Benoit Pugin; Filip Raciborski; Rojin Rajabian-Söderlund; Sietze Reitsma; Xavier Rodo; Antonino Romano; Nelson Rosario; Menahenm Rottem; Dermot Ryan; Johanna Salimäki; Mario M Sanchez-Borges; Juan-Carlos Sisul; Dirceu Solé; David Somekh; Talant Sooronbaev; Milan Sova; Otto Spranger; Cristina Stellato; Rafael Stelmach; Charlotte Suppli Ulrik; Michel Thibaudon; Teresa To; Ana Todo-Bom; Peter V Tomazic; Antonio A Valero; Rudolph Valenta; Marylin Valentin-Rostan; Rianne van der Kleij; Olivier Vandenplas; Giorgio Vezzani; Frédéric Viart; Giovanni Viegi; Dana Wallace; Martin Wagenmann; De Y Wang; Susan Waserman; Magnus Wickman; Dennis M Williams; Gary Wong; Piotr Wroczynski; Panayiotis K Yiallouros; Arzu Yorgancioglu; Osman M Yusuf; Heahter J Zar; Stéphane Zeng; Mario Zernotti; Luo Zhang; Nan S Zhong; Mihaela Zidarn Journal: Clin Transl Allergy Date: 2019-09-09 Impact factor: 5.871
Authors: Thomas Piggott; Miranda Langendam; Elena Parmelli; Jan Adolfsson; Elie A Akl; David Armstrong; Jeffrey Braithwaite; Romina Brignardello-Petersen; Jan Brozek; Jolanta Gore-Booth; Markus Follmann; Zbigniew Leś; Joerg J Meerpohl; Luciana Neamţiu; Monika Nothacker; Amir Qaseem; Paolo Giorgi Rossi; Zuleika Saz-Parkinson; Philip van der Wees; Holger J Schünemann Journal: BMC Health Serv Res Date: 2021-02-24 Impact factor: 2.655