Building a National Reassessment Process for Oncology Drugs: Lessons Learned by the Canadian Real-World Evidence for Value of Cancer Drugs (CanREValue) Collaboration through a Simulated Reassessment Exercise

Abstract

The CanREValue Collaboration established the Reassessment & Uptake Working Group to develop a preliminary process to reassess funded cancer drugs in Canada. A simulated exercise was conducted to evaluate the proposed reassessment process using a real-world case. We invited 32 attendees including representatives from Health Canada and Health Technology Assessment (HTA) agencies, along with payers, clinicians, academics, and patient representatives. A case was developed using a real-world study on a publicly funded cancer drug. In facilitated group sessions, participants were asked to deliberate upon the evidence presented in the case to issue reassessment recommendations. Several themes were identified through the deliberation discussions. While the generalizability of real-world evidence (RWE) is perceived as a strength, trust in the RWE depends largely on the source of the real-world data. The attendees suggested several improvements to the proposed reassessment process including evidence requirement for reassessment, recommendation categories, and a priori study protocols. This exercise generated important insights on the evidence required for conducting reassessment and considerations for improvements of the proposed reassessment process. Building upon lessons from this exercise, future work would continue to refine the reassessment process as part of the overall CanREValue framework.

Real-world data: A systematic literature review on the barriers, challenges, and opportunities associated with their inclusion in the health technology assessment process

“…This from another perspective could pose challenges in the pursuit of standardizing the integration of RWD across institutions. The qualitative study by Dai et al (2021) [42] evaluated a proposed re-evaluation process for cancer drugs in Canada. The study emphasized the importance of reliable RWE, challenges in establishing an incremental cost-effectiveness ratio (ICER) for reassessments, and the importance of rigorous evaluation criteria in the re-evaluation process for cancer drugs.…”

“…These initiatives aim to enhance the consistency and quality of MD assessment processes across European HTA organizations. Dai et al (2021) [42] evaluated the proposed re-evaluation process for cancer medicines in Canada, focusing on the use of RWD and indicated that stakeholders expressed confidence in the results, citing the availability of RWE on clinical benefit and cost-effectiveness from various Canadian provinces. The study recommended involving patients in the reassessment process and leveraging RWE for studying rare cancers and targeted therapies.…”

Cost-effectiveness Analysis of Pertuzumab With Trastuzumab in Patients With Metastatic Breast Cancer

“…Our study also suggests the feasibility of conducting economic evaluations using patient-level data that are routinely collected in Ontario. The lessons learned from this study will be important for the larger work of the CanREValue Collaboration or other initiatives that aim to develop frameworks for the reassessment of publicly funded drugs as part of life-cycle health technology management . With the increasing costs of new drugs, life-cycle health technology management with reassessment allows decision-makers to consider alternative funding approaches, such as conditional approval contingent on collection of data or performance-based agreement .…”

Engaging Patients in the Canadian Real-World Evidence for Value in Cancer Drugs (CanREValue) Initiative: Processes and Lessons Learned

“…To solicit feedback, the core team posted the WG reports on the Canadian Centre for Applied Research and Cancer Control (ARCC)/CanREValue website ( ) and reached out to the CanREValue mailing list, requesting that respondents review the reports and answer three survey questions [ 1 , 3 ]: What barriers and opportunities do you see to the implementation of the proposed framework? ; What benefits/opportunities are there for your organization if the proposed framework for the reassessment of funded drugs is implemented?…”