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
:1. Introduction
2. Approach
2.1. Study Context
2.2. Simulation Exercise Format
3. Findings
3.1. Generalizability of Real-World Evidence Is Perceived as a Strength
3.2. Trust in Real-World Evidence Pertaining to Patient Value Depends on the Source of the Real-World Data
3.3. Establishing a Cost-Effectiveness Threshold
3.4. Collecting Relevant Evidence to Inform Reassessment
3.5. Patient Engagement
3.6. Modifying Recommendation Categories
3.7. Accounting for Context and Changing Landscape
3.8. A Priori Study Plan
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
Appendix A. Case Study (Abridged)
Appendix A.1. Background
Appendix A.2. Mock Reassessment
- Remain at status quo
- ⚬
- The provided evidence confirmed the effectiveness, safety, and cost-effectiveness. There is no need to change the current reimbursement recommendation.
- ⚬
- The provided evidence was insufficient to address an important question of effectiveness, safety, or cost-effectiveness. More data are required.
- Revisit funding criteria or pricing
- ⚬
- Based on the new evidence, funding criteria need to be revised (i.e., broader or narrower indication)
- ⚬
- Based on the new evidence reviewed, the cost effectiveness of the drug has changed. Jurisdictions should evaluate whether existing pricing arrangements reflect the revised cost effectiveness.
- Do not continue to fund/delist
- ⚬
- Based on the new evidence, the committee concluded that there was at least one better alternative treatment available.
- ⚬
- Based on the new evidence, the committee concluded that there was a potential safety concern.
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Representative | Sample Size |
---|---|
Health Canada representatives | N = 2 |
PMPRB representatives | N = 2 |
pCPA representatives | N = 2 |
Clinicians—Medical Oncologists | N = 7 |
CADTH/INESSS Staff | N = 5 |
pERC Committee members (Current or Previous) | N = 6 |
Public Drug Plan Administrators | N = 8 |
Patient representatives | N = 2 |
Academics | N = 6 |
Agenda | Content |
---|---|
Proposed reassessment process | Introduce the proposed reassessment process |
Case-study: bevacizumab for metastatic colorectal cancer | Clinical Evidence: RWE on overall survival and safety data |
Economic evidence: RWE on average cost per patient over time and the incremental cost-effectiveness ratio (ICER) | |
Patient value evidence Patient-reported symptoms and experiences from published literature | |
Implementation and Sustainability evidence RWE on budget impact | |
Breakout Group Discussion | Deliberate new evidence on the funded drug Issue a reassessment recommendation Critique the reassessment process |
Group discussion | Debrief |
Evidence Categories | Elements |
---|---|
Clinical evidence | Performance status Dose delays and dose intensity Long-term toxicity Sub-groups that may benefit less from treatments |
Patient values | Patient experiences and expectations Patient-reported outcomes Caregiver inputs Quality of Life (QoL) collected using validated tools |
Economic evidence | Quality adjusted life years Utility values ICER using confidential prices |
Implementation & Feasibility | Disease-specific treatment maps to describe current treatment sequencing and how sequencing might change dependent of the outcome of the reassessment Resource reallocation: where would the resources be reallocated from? |
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Share and Cite
Dai, W.F.; Craig, E.; Fraser, B.; Chambers, A.; Mai, H.; Brown, M.B.; Earle, C.C.; Evans, W.K.; Geirnaert, M.; Taylor, M.; et al. 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. Curr. Oncol. 2021, 28, 4645-4654. https://doi.org/10.3390/curroncol28060392
Dai WF, Craig E, Fraser B, Chambers A, Mai H, Brown MB, Earle CC, Evans WK, Geirnaert M, Taylor M, et al. 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. Current Oncology. 2021; 28(6):4645-4654. https://doi.org/10.3390/curroncol28060392
Chicago/Turabian StyleDai, Wei Fang, Erica Craig, Brent Fraser, Alex Chambers, Helen Mai, M. Bryson Brown, Craig C. Earle, William K. Evans, Marc Geirnaert, Marianne Taylor, and et al. 2021. "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" Current Oncology 28, no. 6: 4645-4654. https://doi.org/10.3390/curroncol28060392