Development of a framework for the generation and use of Real-World Evidence for cancer drug funding.
The CanREValue Collaboration hosted a webinar on November 6, 2019 to introduce their preliminary framework and to outline the Stakeholder Feedback process. The slide deck that was presented, along with a recording can be accessed from the CanREValue website.
The purpose of the CanReValue Collaboration is to develop a framework for Canadian provinces to generate and use real-world evidence (RWE) for cancer drug funding decisions in a consistent and integrated manner.
The membership of this collaboration includes a range of stakeholders including: Health Canada, PMPRB, CAPCA, Provincial Cancer Agencies, HTA, Ministries of Health, pCPA, patients, and family members, CPAC, and researchers.
The membership has created five working groups (Planning and Drug Selection, RWE Data, RWE Methods, RWE Reassessment and Uptake & RWE Engagement) who are responsible for developing the framework. The preliminary framework was presented at the webinar, along with a brief update on the findings from each working group
The preliminary framework is as follows:
Source: CanREValue Stakeholder Consultation Webinar. November 6, 2019. Available at: https://cc-arcc.ca/canrevalue-kt/#toggle-id-4
A series of consultations is planned, beginning with release of 3 interim reports developed by the working groups which will be released beginning with the first on November 11, 2019 and continuing through to mid-January. All stakeholders are encouraged to provide written feedback. The reports can be accessed in the following ways:
- Register for the CanREValue mailing list (canREvalue@cc-arcc.ca)
- Visit the CanREValue website (https://cc-arcc.ca/canrevalue-kt)
Feedback can be provided in written form within 1 month after release of each draft report. Feedback will be considered, collated and shared publicly, along with and an updated report.
Summary of Working Group Activities
1) Planning & Drug Selection Working Group (Chair: Scott Gavura)
Purpose: To develop criteria to identify potential drug candidates for real world evaluation and establish provincial infrastructure for RWE.
The working group members have developed a topic identification process which they applied to identify 3 potential candidate drugs for RWE evaluation. They have also consulted with experts regarding prioritization process development, and this work is still underway.
The topic identification process has three potential triggers of RWE questions:
- Uncertainties in the clinical benefit and/or alignment with patient values.
- Uncertainties in value for money or feasibility of adoption of the drug.
- The uncertainties identified in triggers 1 & 2 are not expected to be resolved by evidence from future planned studies.
The screening and prioritization process is still under development and members will develop a multi-criteria decision analysis-based rating tool for prioritizing RWE questions. Two sets of criteria are being considered: the importance of the uncertainty identified and the likelihood of resolving the uncertainty identified using administrative data.
Interim Policy Report – Section 1 Release: Anticipated Early December
2) Data Working Group (Chair: Dr. Claire de Oliveira)
Purpose: To identify strategies to access data across provinces and harmonize data elements relevant for RWE studies.
Data experts from ten provinces were iteratively consulted to complete an asset review. A survey was circulated to identify the main data custodians in each province and the available databases held by each jurisdiction. They requested information on
- Data elements held in databases, including whether the data elements were available and linkable, and any limitations in coverage and/or completeness; and
- Each province’s capability to conduct a real-world study on different outcomes of interest such as effectiveness, safety & toxicity, budget impact and PROs/QOL.
Interim Data Report Release: November 11, 2019
3) Method Working Group (Chair: Dr. Jeffrey Hoch)
Purpose: To assess the appropriate methodology and make recommendations for the methods to evaluate RWD.
The group has adopted an outcome focused approach and will concentrate on methods to evaluate different outcomes (survival analysis). They are working with an international team to consider different methods and determine what recommendations can be made.
The general categories of methods include multivariable based regression, propensity score related analysis, instrumental variable methods and other.
They are currently writing a paper describing the options they are considering. Subsequently, they will write a second paper that will test the methods outlined in the first paper and identify challenges.
Interim Method Report Release: Mid-January 2020
4) Reassessment and Uptake Working Group (Co-Chairs: Erica Craig & Brent Fraser)
Purpose: To develop strategies for implementing RWE results for HTA reassessment and policy making decisions.
The working group members have developed a draft reassessment process which was evaluated through the performance of a mock reassessment session.
In the preliminary process that was outlined, reassessment can be initiated by a province, industry or CADTH. This would then trigger a review and recommendation from the Committee. One early finding from the evaluation was the need to revise the recommendation categories. This work is still underway
Interim Policy Report Section 2 Release: Early December 2019
5) RWE Engagement Working Group (Chair: Dr. Bill Evans)
Purpose: To ensure appropriate input from key stakeholders cross jurisdictionally, at all steps of the framework development.
This working group aims to seek input from the public and all stakeholders on the preliminary framework process through a series of interim reports (release dates summarized above).
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