Considerations for Developing a Reassessment Process: Report from the Canadian Real-World Evidence for Value of Cancer Drugs (CanREValue) Collaboration’s Reassessment and Uptake Working Group

Abstract

The Canadian Real-world Evidence for Value in Cancer Drugs (CanREValue) Collaboration was established to develop a framework for generating and using real-world evidence (RWE) to inform the reassessment of cancer drugs following initial health technology assessment (HTA). The Reassessment and Uptake Working Group (RWG) is one of the five established CanREValue Working Groups. The RWG aims to develop considerations for incorporating RWE for HTA reassessment and strategies for using RWE to reassess drug funding decisions. Between February 2018 and December 2019, the RWG attended four teleconferences (with follow-up surveys) and two in-person meetings to discuss recommendations for the development of a reassessment process and potential barriers and facilitators. Modified Delphi methods were used to gather input. A draft report of recommendations (to December 2018) was shared for public consultation (December 2019 to January 2020). Initial considerations for developing a reassessment process were proposed. Specifically, reassessment can be initiated by diverse stakeholders, including decision makers from public drug plans or industry stakeholders. The reassessment process should be modelled after existing deliberation and recommendation frameworks used by HTA agencies. Proposed reassessment outcome categories include maintaining status quo, revisiting funding criteria, renegotiating price, or disinvesting. Overall, these initial considerations will serve as the basis for future advancements by the Collaboration.

Cost‐effectiveness of second‐line ipilimumab for metastatic melanoma: A real‐world population‐based cohort study of resource utilization

“…Therefore, this study illustrates the importance of life‐cycle reassessment of cost‐effectiveness based on RWE to verify whether the initial trial‐based predictions translate into real‐world settings, 36 particularly when costs are high and benefit is uncertain. Furthermore, in cases where the real‐world cost‐effectiveness is underestimated by the initial prediction, these findings may provide valuable evidence to support price renegotiations as well as the capacity for revising existing drug funding decisions 37,38 …”

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 .…”

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

“…As part of the overall objective to develop a framework for the generation and use of RWE to inform cancer drug funding decisions [ 11 ], the CanREValue collaboration established the RWE Reassessment and Uptake Working Group (Reassessment WG). The Reassessment WG has since developed a proposed reassessment process that uses RWE [ 12 ]. Modelled after the existing initial assessment process used at the Canadian Agency for Drugs and Technologies in Health (CADTH) [ 13 ], the Reassessment WG recommended that a reassessment submission file, with new evidence on a funded cancer drug, be reviewed and evaluated by a multidisciplinary committee.…”

“…Modelled after the existing initial assessment process used at the Canadian Agency for Drugs and Technologies in Health (CADTH) [ 13 ], the Reassessment WG recommended that a reassessment submission file, with new evidence on a funded cancer drug, be reviewed and evaluated by a multidisciplinary committee. After deliberating on the new evidence, the committee would issue one of three recommendations: maintain status quo, revisit funding criteria or pricing, or do not continue funding/consider disinvestment strategies [ 12 ].…”