Global & Regional Health Technology Assessment (Sep 2022)

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

  • Claudio Jommi,
  • Giovanni Apolone,
  • Giovanna Scroccaro,
  • Valentina Acciai,
  • Antonio Addis,
  • Andrea Ardizzoni,
  • Renato Bernardini,
  • Alberto Bortolami,
  • Alessia Brigido,
  • Giuliano Buzzetti,
  • Pier Luigi Canonico,
  • Francesca Caprari,
  • Stefano Centanni,
  • Chiara Cernetti,
  • Americo Cicchetti,
  • Giorgio Corsico,
  • Francesco Damele,
  • Filippo De Braud,
  • Sara Manurita,
  • Francesco Saverio Mennini,
  • Irene Olivi,
  • Federica Parretta,
  • Lara Pippo,
  • Stefania Pulimeno,
  • Massimo Riccaboni,
  • Giuseppe Rossi,
  • Cecilia Saleri,
  • Alessandra Sinibaldi,
  • Federico Spandonaro,
  • Cristian Stefenoni,
  • Elena Visentin,
  • Pierluigi Viale,
  • Giuseppina Zapparelli,
  • Patrizia Popoli

DOI
https://doi.org/10.33393/grhta.2022.2475
Journal volume & issue
Vol. 9, no. 1

Abstract

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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.

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