Achievements
Highlights from our year
Our Changing Response to the COVID-19 Pandemic
In 2022, the global pandemic continued to evolve, as did the response from health systems, regulators, and HTA bodies. Advances in vaccines and boosters offered protection and treatments expanded.
During the year, the federal government continued to nationally procure certain drug products. We finalized procedures for reviews of nationally procured pharmaceuticals to support federal, provincial, and territorial decision-making. This was another opportunity for innovation in our work, with a focus on the delivery of implementation advice, where requested, to inform the best use of these products. We delivered implementation advice on:
- tixagevimab and cilgavimab (Evusheld) for preexposure prophylaxis of COVID-19 in adults and adolescents
- tixagevimab and cilgavimab (Evusheld) for mild to moderate COVID-19 in adults and adolescents.
We also collaborated with global and national organizations and scientists to deliver a suite of evidence products on post–COVID-19 condition. This included a report on the state of specialty clinics in Canada, a living rapid scoping review showing where evidence exists and where there are gaps, and an online platform that compiled the latest guidelines and recommendations. We also convened a national roundtable on models of care for long COVID to facilitate connections across jurisdictions.
Supporting Canada’s Response to Monkeypox
The Public Health Agency of Canada first announced 2 confirmed monkeypox (mpox) cases in May 2022. Cases rose over the summer and in July 2022, WHO declared the mpox outbreak a public health emergency of international concern.
The Public Health Agency of Canada asked us to conduct a review to provide advice on the appropriate use of tecovirimat (TPOXX) for the treatment of mpox. Throughout the COVID-19 pandemic, we had conducted several abbreviated reviews. However, the review of tecovirimat for mpox was more challenging given the lack of efficacy evidence within human clinical trials. As a result, we adopted a rigorous, transparent, and flexible approach to produce fit-for-purpose implementation advice that met the strict timelines and unique needs of decision-makers.
Fit-For-Purpose Reimbursement Review Process
In 2022, global trends in the pharmaceutical sector continued to influence us, though our ambition to help advance timely and sustainable access to effective medicines remained constant. We adapted processes and introduced new ways of working to bring greater responsiveness and flexibility to our Drug Reimbursement Review program.
To address gaps that arise when there is no reimbursement recommendation for a drug product, we established a new review pathway. The Non-Sponsored Single Drug Review process allows public drug plans to request a reimbursement review when the manufacturer of a potentially eligible drug chooses not to submit through our sponsored reimbursement review process (for example, a drug for a pediatric condition). The new pathway helps address inconsistency in access for patients and potentially allows public drug plans to realize the clinical and economic benefits of repurposing drugs for use in patient populations where there are unmet medical needs. We also introduced a Streamlined Drug Class Review to deliver timelier recommendations on the appropriate use of drugs in a class or category.
Globally, regulatory authorities are continuing to move to more agile review processes that may consider earlier phases of clinical data and could lead to earlier drug approvals with certain conditions. We are working to keep pace with these developments and ensure that HTA is an enabler, not a barrier, to the appropriate entry and adoption of effective technologies into health care systems. In this context, we initiated a consultation on time-limited drug reimbursement recommendations — a type of recommendation that could increase access to promising treatments when more evidence is needed to address uncertainty.
Delivering Postmarket Evidence on Drugs
In 2022, we were given responsibility for the important work of Canada’s Drug Safety and Effectiveness Network. In the fall, as previously mentioned, we created our Post-Market Drug Evaluation Program and established our CoLab research network to answer questions about drugs that are already available to patients in Canada.
The Post-Market Drug Evaluation Program is an effective way to centralize questions and coordinate the generation of postmarket evidence safety and effectiveness, formulary management, appropriate use, and whether drug products are meeting unmet needs that may have been identified at the market approval and reimbursement phases. We also established the Post-Market Drug Evaluation Advisory Committee, a multidisciplinary group that includes patients and industry, that provides strategic advice to the program and ensures we are responsive to changes in the pharmaceutical environment.
With a dozen active oncology and non-oncology postmarket drug evaluation projects underway, we will be releasing its first set of CoLab reports in the coming year.
Seeking the Voices of Indigenous Health Leaders
We acknowledge the critical need for Indigenous perspectives in the Canadian health care system. In March 2023, we sponsored an Indigenous health leaders meeting on the unceded territory of the Anishinaabe Algonquin Nation, bringing together several Indigenous health leaders from across Canada.
The objective of the gathering was to develop criteria, principles, and process considerations through an Indigenous-led discussion that would guide the prioritization of requests to us with, for, and about Indigenous Peoples.
The Indigenous Health Leaders meeting represented a first opportunity for us to begin building upon our objective, identified in our reconciliation roadmap, to develop a plan for process changes internal to our work with, for, and about Indigenous Peoples. It was also a first step to listening, learning, and setting forth a strategy for meaningful engagement and partnership-building with Indigenous Peoples, with the goal of influencing and shaping health systems together. In the upcoming year, and led by our Strategic Partner for Indigenous Engagement, we will develop an implementation plan to operationalize the recommendations.
Readying Health Systems for Change
Through our annual Watch List, we distinguished hype from hope about health technologies in precision medicine and identified key issues that may influence their adoption or disrupt the delivery of care. The report underscores that health system fragmentation may lead to challenges in the funding of precision medicine technologies, and new approaches will be needed to help balance the need for evaluation and timely access for patients.
More than 1,000 people from across Canada and around the world registered for our virtual launch event, where a group of experts discussed the implications of these emerging technologies and issues.
Through Horizon Scans, we also delivered future-focused information on other emerging trends and technologies health system leaders need to understand. These included:
- clinical applications of virtual and augmented reality
- robotic surgical systems
- point-of-care tests and other rapid testing technologies
- emerging technologies for early diagnosis of Alzheimer disease
- multicancer early detection technologies and genomic profiling technologies to inform cancer care.
Supporting a Potential Pan-Canadian Formulary
The Government of Canada approached us in July 2021 to develop a recommended framework for creating and managing a potential pan-Canadian prescription drug list, or formulary.
After convening a multidisciplinary advisory panel of experts, we released a report in June 2022 entitled Building Toward a Potential Pan-Canadian Formulary: A Report From the Advisory Panel. The report contains a series of nonbinding recommendations, including 6 guiding principles and a proposed staged approach for developing a formulary. The advisory panel’s final report was submitted to Health Canada and shared with provincial and territorial governments.
To ensure the perspectives of populations made vulnerable by social and/or economic policies, particularly Indigenous Peoples and those who have experienced the historic and ongoing impacts of colonization, were included in developing a potential pan-Canadian formulary, the panel (through us), purposefully sought input from more than 20 organizations that serve these populations.
Real-World Evidence — A Year of Learning by Doing
A key component of our 3-year strategic plan is to be a leader in evidence appraisal and to optimize, where appropriate, the integration of RWE into our work. RWE is evidence about the use, safety, and effectiveness of a drug or other health technology that is based on data from the real-world health care setting.
To optimize its use, we entered a 1-year learning period and initiated several projects and collaborations to bring stakeholders together and learn from each other. Our goals included:
- facilitating multistakeholder dialogue
- examining ways to generate and access real-world data
- engaging in collaborative partnerships
- developing guidance for reporting RWE studies in collaboration with Health Canada and national and international experts.
We established and coordinated the activities of a multistakeholder network for drugs for rare diseases to start collaboratively answering questions about drugs for rare diseases poised to enter the Canadian health system, and to optimize the integration of RWE into regulatory and reimbursement decision-making for drugs for rare diseases. We also:
- piloted the expansion our Scientific Advice program to include advice on RWE in the preregulatory phase
- created an inventory of administrative databases in Canada (including those for rare diseases) to understand whether the databases have the relevant data elements to generate quality decision-grade evidence in a timely manner
- shared learnings related to understanding rare diseases and how to answer questions related to drugs for rare diseases poised to enter the Canadian health system.
Additionally, on behalf of the RWE Steering Committee cochaired by Health Canada and us, we developed draft guidance to inform the use of RWE that may be submitted for consideration by regulatory and reimbursement decision-makers. Throughout the year, we participated in meetings and presentations to communicate the work and launched a public consultation to solicit feedback. More than 50 participants spanning patient groups, industry, data holders, HTA organizations, academic researchers, and private sector consultants responded during an 8-week consultation period.
Increasing Transparency into our Work
Enhancing the understanding and transparency of our work is important to us. To support this commitment, we took several steps forward, including hosting 2 virtual information sessions during the fiscal year. The first event, held in April 2022, provided a forum to discuss priority initiatives and served as the launch of our strategic plan. The second event, held in December 2022, provided an update on our progress, with a focus on pharmaceutical reviews, medical devices and clinical interventions, and initiatives related to RWE.
We also hosted several virtual events designed to inform stakeholders about notable developments and answer questions. These included sessions on the Post-Market Drug Evaluation Program and opportunities to participate in our postmarket research network. A hybrid town hall on Canadian RWE initiatives, hosted in collaboration with the Canadian Association for Population Therapeutics, gathered stakeholders to share updates on ongoing work at Canada's Drug Agency, elsewhere in Canada, and globally.
Additionally, we held a consultation webinar to discuss the process used to develop reporting guidance on RWE and clarify how stakeholders could be involved.