Drugs price and reimbursement regulation: comparators, endpoints and role of the cost-effectiveness

Authors

  • Claudio Jommi SDA Bocconi, Milano - Italy https://orcid.org/0000-0002-2862-2990
  • Giovanni Apolone Fondazione IRCCS Istituto Nazionale dei Tumori, Milano - Italy https://orcid.org/0000-0001-5179-104X
  • Giovanna Scroccaro Regione Veneto, Venezia - Italy https://orcid.org/0000-0002-6438-8521
  • Valentina Acciai Ipsen, Milano - Italy
  • Antonio Addis Dipartimento Epidemiologia del Servizio Sanitario Regionale - Regione Lazio, Roma - Italy
  • Andrea Ardizzoni Università degli Studi di Bologna, Azienda Ospedaliero-Universitaria di Bologna IRCCS - Policlinico S. Orsola-Malpighi, Bologna - Italy
  • Renato Bernardini Università degli Studi di Catania, Catania - Italy https://orcid.org/0000-0002-4765-0663
  • Alberto Bortolami Rete Oncologica del Veneto, Istituto Oncologico Veneto IRCCS, Padova - Italy
  • Alessia Brigido Ipsen, Milano - Italy https://orcid.org/0000-0002-9600-3884
  • Giuliano Buzzetti Dephaforum, Milano - Italy https://orcid.org/0000-0002-4197-9871
  • Pier Luigi Canonico Università del Piemonte Orientale, Novara - Italy
  • Francesca Caprari Alexion Pharma, Milano - Italy
  • Stefano Centanni Università degli Studi di Milano, ASST – Santi Paolo e Carlo, Milano - Italy
  • Chiara Cernetti Beigene, Milano - Italy https://orcid.org/0000-0002-4457-6605
  • Americo Cicchetti Università Cattolica del Sacro Cuore, Roma - Italy
  • Giorgio Corsico Amgen, Milano - Italy
  • Francesco Damele Sanofi, Milano - Italy
  • Filippo De Braud Università degli Studi di Milano, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano - Italy https://orcid.org/0000-0003-0103-730X
  • Sara Manurita BMS, Roma - Italy
  • Francesco Saverio Mennini Università degli Studi di Roma "Tor Vergata", Roma - Italy https://orcid.org/0000-0002-4738-5505
  • Irene Olivi CSL Behring, Milano - Italy
  • Federica Parretta Abbvie, Roma - Italy
  • Lara Pippo CSL Behring, Milano - Italy
  • Stefania Pulimeno Teva, Milano - Italy
  • Massimo Riccaboni IMT School for Advanced Studies, Lucca - Italy
  • Giuseppe Rossi ASST Spedali Civili di Brescia, Brescia - Italy https://orcid.org/0000-0001-8377-2898
  • Cecilia Saleri AstraZeneca, Milano - Italy https://orcid.org/0000-0001-8888-5242
  • Alessandra Sinibaldi Galápagos Biopharma Italy, Milano - Italy https://orcid.org/0000-0001-7622-6207
  • Federico Spandonaro Università Telematica San Raffaele, Roma - Italy https://orcid.org/0000-0003-1388-2850
  • Cristian Stefenoni Pfizer, Roma - Italy
  • Elena Visentin Galápagos Biopharma Italy, Milano - Italy
  • Pierluigi Viale Università degli Studi di Bologna, Azienda Ospedaliero-Universitaria di Bologna IRCCS - Policlinico S. Orsola-Malpighi, Bologna - Italy
  • Giuseppina Zapparelli BMS, Roma - Italy
  • Patrizia Popoli Istituto Superiore di Sanità, Roma - Italy

DOI:

https://doi.org/10.33393/grhta.2022.2475

Keywords:

Comparators, Cost-effectiveness, Endpoints, 648 List, Price and reimbursement

Abstract

This document illustrates the results of a discussion of two multi-disciplinary expert panels on pricing and reimbursement of medicines. Experts work in different organizations. The discussion focused on comparator(s), endpoint(s), negotiation of prices of new medicines and/or indications to include in the List 648, as well as the role of cost-effectiveness in the price and reimbursement negotiation. The debate took place during the fourth edition of the Seminari di Mogliano, organized on the 30th of September/1st of October, 2021.

The two panels agreed on a general need to enhance interaction among the different stakeholders, in the early assessment and negotiation phases, and to increase the transparency/reproducibility of the decisions taken. The experts have also emphasized the need (i) to improve clarity in the evaluation of additional therapeutic value and the place in therapy with respect to comparators and how comparators are identified; (ii) to create work groups to identify the most appropriate endpoint(s), for each therapeutic area and level of unmet needs; (iii) to provide for a systematic use of cost-effectiveness when an added therapeutic value is delivered by a new medicine. With regard to the 648 List, the experts advocated for an overall reorganization of the current rules governing the special uses of drugs.

References

Decreto Ministeriale 2 agosto 2019. Criteri e modalità con cui l'Agenzia italiana del farmaco determina, mediante negoziazione, i prezzi dei farmaci rimborsati dal Servizio sanitario nazionale. GU Serie Generale n.185 del 24-07-2020. Online https://www.gazzettaufficiale.it/eli/id/2020/07/24/20A03810/sg. Accessed June, 10, 2022.

AIFA. Linee-Guida per la compilazione del dossier a supporto della domanda di rimborsabilità e prezzo di un medicinale. Versione 1.0, 2020. Online https://www.aifa.gov.it/documents/20142/1283800/Linee_guida_dossier_domanda_rimborsabilita.pdf. Accessed June, 10, 2022.

AIFA. Report tecnico-scientifici per specialità medicinale. Online https://www.aifa.gov.it/report-tecnico-scientifici. Accessed June, 10, 2022.

HAS (Haute Autorité de Santé). Authorisation for early access to medicinal products: HAS assessment doctrine. Online https://www.has-sante.fr/upload/docs/application/pdf/2021-08/authorisation_for_early_access_to_medicinal_products_has_assessment_doctrine.pdf. Accessed June, 10, 2022.

AIFA. Accesso precoce al farmaco e uso off-label. Online https://www.aifa.gov.it/accesso-precoce-uso-off-label. Accessed June, 10, 2022.

Newton M, Scott K, Troein P. VP. EFPIA Patients W.A.I.T. Indicator 2021 Survey (April 2022). Online https://www.efpia.eu/media/636821/efpia-patients-wait-indicator-final.pdf. Accessed June, 10, 2022.

Husereau D, Drummond M, Augustovski F, et al. Consolidated Health Economic Evaluation Reporting Standards (CHEERS) 2022 Explanation and Elaboration: A Report of the ISPOR CHEERS II Good Practices Task Force. Value Health. 2022;25(1):10-31. https://doi.org/10.1016/j.jval.2021.10.008 PMID:35031088 DOI: https://doi.org/10.1016/j.jval.2021.10.008

Published

2022-09-28

How to Cite

1.
Jommi C, Apolone G, Scroccaro G, Acciai V, Addis A, Ardizzoni A, Bernardini R, Bortolami A, Brigido A, Buzzetti G, Canonico PL, Caprari F, Centanni S, Cernetti C, Cicchetti A, Corsico G, Damele F, De Braud F, Manurita S, Mennini FS, Olivi I, Parretta F, Pippo L, Pulimeno S, Riccaboni M, Rossi G, Saleri C, Sinibaldi A, Spandonaro F, Stefenoni C, Visentin E, Viale P, Zapparelli G, Popoli P. Drugs price and reimbursement regulation: comparators, endpoints and role of the cost-effectiveness. Grhta [Internet]. 2022 Sep. 28 [cited 2022 Dec. 6];9(1):99-104. Available from: https://journals.aboutscience.eu/index.php/grhta/article/view/2475

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