Health Technology Assessment aims to support timely decision making about access to promising innovative treatments for patients in a way that is thorough and rigorous. However, with the pace and scale of technological development, it has been argued that traditional approaches to primary and secondary evidence production and review may be hindering the innovation process and delaying access to care.  

In addition, as new pathways to technology access are introduced; novel data sources and new forms of primary evidence are emerging. These new quantitative and qualitative forms of evidence challenge the established approaches to technology assessment. The recent COVID-19 pandemic has highlighted how evidence generation and use needs to adapt in response to conditions of high uncertainty and urgency with large, well-designed randomised trials that provide precise answers being completed in a matter of months rather than years.  

Approval processes have also accelerated and adapted so that patients can benefit from effective medicines quickly. The use of Real-World Evidence (RWE) has recently taken centre stage with its proposed applications ranging from establishing comparative effectiveness of technologies to post-marketing surveillance of newly approved technologies. However, debates are still ongoing regarding how to ensure the quality of the data collected, the appropriate analysis techniques and approaches to combining these data with evidence from trials in advanced evidence synthesis frameworks.  

We have reached a point where innovative methods and evidence standards for the assessment of technologies will now be required. Debate is needed around the ethical considerations related to decisions and recommendations based on limited and, increasingly, highly uncertain evidence. And discussion of the role of clinical guidelines and their synergy and integration with HTA to support patient access to potentially beneficial innovations in a timely way is required.  

The life cycle, from invention to disinvestment, of any health technology is complex and relies on many different processes, professionals and organizations to facilitate and oversee delivery of technology benefits to patients and healthcare systems. A patient’s access to any technology is influenced by those working on research and development, manufacture and distribution, marketing approval, regulation, distribution, uptake, post-market evaluation and eventually disinvestment. With so many stakeholders engaged in the life cycle of a health technology, our shared primary goal of access to value-based patient care can get lost along the way.  

Inviting patients to be in the driving seat across the technology life cycle has become a hot topic. Today, in many countries’ patients are at the forefront of research funding evaluation committee considerations for clinical trials, for example. Patients are also engaged in meaningful ways through working to standardize clinical study outcomes and critique clinical trial designs.We see patients actively integrated as research partners in priority setting, data and real world evidence generation, within the process of deliberating policy recommendations, and more.  

Yet, while there has been much progress overall, globally, we see considerable diversity in patient engagement practices within HTA bodies.Some agencies are starting to build more active engagement into their practices, and some still considering whether or not there are sufficient resources to support engagement, and indeed a patient, and payer willingness to work better together. As a global community we can share lessons learned from members who have long standing mechanisms for meaningful patient and citizen engagement, and hear from members who are newer to patient engagement to dicuss the possibilities and challenges with a fresh perspective.  

In addition to geographical diversity, stakeholder perspectives vary in their perception and expectations around patient engagement. Emerging research allows us to take a deeper dive into the science of participation as we begin to understand how best to partner with patients and other stakeholders in active and meaningful ways. Moreover, not only do we need to continually review and improve our methods for patient engagement as part of traditional day-to-day HTA but we need to ensure that we openly, effectively and pre-emptively integrate patients into the heart of all health technology innovation as HTA itself becomes more complex.    

Based on the theme description above this plenary will consist of: