not-yet-known not-yet-known not-yet-known unknown THE PHARMACEUTICAL INNOVATIVENESS INDEX: SUPPORTING VALUE-BASED ECONOMIC REGULATION OF INNOVATIVE MEDICINES

Le résumé fourni par la source

not-yet-known not-yet-known not-yet-known unknown Background: The pricing regulation of new medicines must balance financial sustainability with access to innovation. Value-Based Pricing (VBP) strategies aim to align drug prices with their clinical and social impact. The Pharmaceutical Innovativeness Index (PII) is a proposed tool to assess the degree of innovativeness of medicines with the potential to support pricing decisions within economic regulation frameworks. Methods: An exploratory study was conducted using a focus group with experts in health economics and pharmaceutical regulation. Participants evaluated the applicability of the PII in drug pricing and discussed key domains relevant to the pricing of pharmaceutical innovations. Based on the focus group results, a pricing model was developed to integrate the PII and other critical criteria into the decision-making process. Two case studies were used to assess the feasibility of implementing the proposed model. Results: Participants rated Added Therapeutic Value (ATV) and Unmet Therapeutic Need (UTN) as the most relevant domains in determining innovativeness. Methodological Quality (MQ) and Study Design (SD) were also considered important to reduce bias in the evaluation process. The PII scores showed good alignment with expert perceptions in the case studies. The proposed model incorporates international practices and includes additional criteria such as safety and incremental innovation. Conclusion: The proposed pricing model provides a structured approach to assess and reward innovative technologies. The PII demonstrated potential to enhance transparency, consistency, and regulatory efficiency in drug pricing decisions in Brazil, though regulatory adjustments would be required for implementation.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.