Collaborative Demonstration Project in the Province of Québec for the Operationalization of Value-Based Agreement: Moving From a Vision to Implementation

OBJECTIVES: The coverage of innovative therapies has always presented complexities and challenges. Today, it is particularly frustrating for patients, prescribers, policymakers, payers, and producers (5Ps), especially when it comes to high-cost medications. The revolutionary concept of gene therapy, which aims to cure or treat diseases by altering genes, has moved from theory to practice with the first U.S. approvals in 2017. Currently, nearly 400 gene therapies are in clinical development. The pressing question now is: how will we reimburse these groundbreaking drugs? How can we balance the triple aim?

Over the past decade, there has been a growing recognition of the need to modernize reimbursement strategies, shifting towards value-based agreements (VBAs). Despite this awareness, there is still a significant lack of infrastructure to effectively implement these agreements.

METHODS: In June 2024, a showcase project will be launched in the province of Quebec in collaboration with the 5Ps. The project's objective is to initiate a comprehensive discussion on the operationalization of VBAs, including implementation mechanisms and favorable conditions, as well as share insights to optimize future VBAs.

The showcase will be an inclusive process, ensuring transparency in data collection and decision-making related to VBAs. Three working groups will be established to oversee and implement the project: Strategic, Steering, and Tactical committees.

The project will be divided into two phases. Phase 1 will establish collaboration and governance frameworks, developing project scenarios and methodologies, identifying initial therapeutic indications, and crafting an implementation strategy. Phase 2 will involve conducting the demonstration project, capturing real-world data (RWD) and applying real-world evidence (RWE) for the VBAs. This project aims to pave the way for sustainable and effective VBAs in the future.

RESULTS: The first insights of this project will be shared during the North American ISPOR conference in Montreal (May 2025).

CONCLUSIONS: NA