Informing Real-Time Decisions with Post-Market Drug Evidence

It’s been 1 year since CADTH launched the Post-Market Drug Evaluation (PMDE) Program to provide decision-makers with evidence about drugs that have been approved and are already in use by people in Canada. With the PMDE program, CADTH is enhancing how we evaluate drugs across their life cycle and advancing efforts to incorporate real-world evidence into our assessments.

CADTH’s post-market evidence is playing a key role in decision-making about drugs to treat COVID-19.

During the pandemic, the Public Health Agency of Canada (PHAC) procured and distributed drugs for COVID-19 to give people in Canada equitable and timely access to emerging treatments. However, to inform future discussions about the use of these products, PHAC needed evidence from the PMDE program to understand how the drugs work in the real world. In other words, are these drugs still safe, working as intended, and being used appropriately? Post-market data are especially critical to answering these questions, considering that the COVID-19 virus keeps evolving and historical clinical data may have limited applicability.

Working with researchers in CADTH’s CoLab Network (a group of experts in applied research, methodology, and data analysis), CADTH delivered a suite of systematic reviews that evaluate the growing body of evidence, including real-world data, for Paxlovid, Remdesivir, and Tocilizumab. This work synthesized evidence from clinical trials, utilization data, and observational studies to help identify patients most likely to benefit from treatment.

Informing Future Reimbursement Decisions

In anticipation of the eventual transition of a centralized national procurement process for COVID-19 drugs to the federal, provincial, and territorial publicly funded drug programs, CADTH met with manufacturers to discuss submissions that would help support ongoing access to these products. Given the comprehensiveness and timeliness of the CoLab-generated post-market evidence, CADTH will also use the Paxlovid systematic review in the reimbursement review of this product that is currently underway. By leveraging this work, we are accelerating the review, maximizing efficiencies, and considering the most relevant data. The review includes 2 randomized-controlled trials and 27 observational studies because of an ever-changing patient population and continuous mutations of the COVID-19 virus.

The systematic review, conducted by the team at the Alberta Drug and Technology Evaluation Consortium, will be an important component of the clinical evidence that the Canadian Drug Expert Committee considers. The committee is scheduled to review Paxlovid during its December 2023 meeting. CADTH anticipates posting a draft recommendation for stakeholder feedback in January 2024 and, potentially, a final reimbursement recommendation in February 2024. 

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