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Is It Time to Commit to a Process to Re-Evaluate Oncology Drugs? A Descriptive Analysis of Systemic Therapies for
Sandeep Sehdev1, Alexandra Chambers2
1Division of Medical Oncology, Department of Medicine, The Ottawa Hospital Cancer Centre and The University of Ottawa, Ottawa, ON K1N 6N5, Canada.
Abstract:
We undertook an analysis of the Canadian Agency for Drugs and Technologies in Health (CADTH)'s health technology assessments (HTAs) of systemic therapies for solid tumour indications to determine if a mechanism to re-evaluate HTA decisions is needed based on the level of certainty supporting the original recommendation. To measure the certainty in the evidence, we analysed if: (1) overall survival (OS) was the primary endpoint in the pivotal trial, (2) median OS was available at the time of the recommendation, and (3) the expert review committee explicitly identified gaps in the evidence. There were 96 drugs approved by Health Canada that met our eligibility criteria between 1 January 2017 and 31 October 2021. Median OS was not estimable at the time of the recommendation in 57% of the positive recommendations, and the uncertainty in the magnitude of clinical benefit was identified by the expert review committee in 21% of the positive recommendations. There is uncertainty at the time of the HTA recommendation for many drugs, and thus a need to implement a process to re-evaluate drugs in Canada to allow patients timely access to promising therapies while ensuring long-term value of therapies to patients and the healthcare system.
Insights
Many cancer drug recommendations lack sufficient evidence, particularly regarding overall survival (OS). This highlights the need for a re-evaluation process to ensure timely patient access to effective therapies and long-term healthcare value.
Area of Science:
- Health Technology Assessment
- Oncology
- Evidence-Based Medicine
Background:
- Canadian Agency for Drugs and Technologies in Health (CADTH) provides health technology assessments (HTAs) for drug reimbursement.
- HTAs guide decisions on the adoption and funding of new health technologies.
- Evaluating the certainty of evidence in HTA recommendations is crucial for patient access and healthcare system value.
Purpose of the Study:
- To determine if a mechanism to re-evaluate CADTH HTA decisions for systemic therapies in solid tumours is needed.
- To assess the certainty of evidence supporting original HTA recommendations based on specific criteria.
Main Methods:
- Analysis of CADTH HTAs for systemic therapies for solid tumours approved by Health Canada between January 2017 and October 2021.
- Evaluation criteria included: (1) overall survival (OS) as primary endpoint, (2) availability of median OS, and (3) explicit identification of evidence gaps by the expert review committee.
Main Results:
- 96 drugs met the eligibility criteria.
- Median OS was not estimable at the time of recommendation in 57% of positive recommendations.
- Uncertainty in clinical benefit magnitude was identified in 21% of positive recommendations.
Conclusions:
- Significant uncertainty exists in the evidence supporting many HTA recommendations for cancer therapies.
- A re-evaluation process for HTA decisions is necessary in Canada.
- Implementing such a process can facilitate timely patient access to promising therapies while ensuring long-term healthcare system value.
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