Plenaries

PLENARY ONE

The Role of HTA in Achieving and Progressing Universal Health Coverage

Universal Health Coverage (UHC) has been acknowledged as a priority goal of many health systems, with the recognition that UHC improves the health of a population and reduces health inequalities. Furthermore, there is general consensus that healthier populations are more productive, take less sick leave and demand less healthcare services resulting in economic benefits on a long-term basis. The importance of achieving UHC is reflected in the consistent calls by the World Health Organization (WHO) for member states to implement systems that promote access to quality health care and provide households with the needed protection from the catastrophic consequences of out-of-pocket (OOP) health-related payments. Progress towards UHC is a continuous process that changes in responses to shifting demographic, epidemiological and technological trends, as well as a population’s expectations.

HTA is recognized as an important approach in setting benefits packages for UHC and in answering other key questions that policy makers are left to grapple with after the commitment to UHC is made. HTA can address central issues: what services should be made available, and under what conditions? In the context of fixed and restricted budgets, where it is necessary to prioritize, should more (priority) services be included? Should coverage of existing (priority) services be expanded or excluded? Should co-payments of existing (priority) services be reduced? When making these decisions, social, legal ethical, and socio-economic issues need to be addressed in a meaningful deliberative manner to enhance public accountability.

The need to perform HTA is higher where resources are limited. For example, in countries with a fragile economic state, HTA can be used to define basic benefit packages; emergency kits and for disaster planning. For low-income countries with low levels of UHC, HTA can be used to define essential medicines and other interventions packages (including vaccinations, prevention and some treatments), for middle-income countries with medium UHC, HTA can then be used to define extensions to benefits packages including treatment of (non-communicable) diseases and for specific populations. For high-income countries with a high level of UHC, HTA can be used to define full-benefits packages (including home care, palliative care and diagnostic services and innovative technologies) and to reassess or disinvest from services.

There are also many hurdles to be overcome in relation to healthcare and human resource capacity and access to health services. These relate to scope of services, quality, cost, and governance of a specific context. HTA is an effective tool to unravel/unveil these barriers by answering questions about a health technology or service, in terms of availability, accessibility, equity, and affordability in that specific context. However, HTA is not the only solution to achieving and progressing UHC in any health system. HTA should be considered as one part of the complex health ecosystem within a political system with local customs, cultural and environmental issues always being considered when prioritizing services.

Based on the above description, the plenary session will consist of:

 

PLENARY TWO

How to Adapt HTA to Address Technologies that are ‘Disrupting’ Health Systems

There are an increasing number of emerging innovations that have a high potential to be “disruptive.” That is, technologies that are representing fundamentally, and possibly unexpected, new modes of clinical practice or service improvement that will disrupt or overturn the traditional methods and practices in health systems. They include but are not limited to potentially curative therapies such as, gene therapies, somatic-cell therapies, and tissue-engineered therapies. Examples include Chimeric Antigen Receptor (CAR) T-cell therapies, gene editing using Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR), preventative therapy for Alzheimer’s Disease and genetic diagnostic tests.

It is often challenging to adequately estimate the value of these disruptive technologies using current HTA frameworks and methodologies. As these typically ‘one-shot,’ expensive treatments will most likely be compared to a lifetime of existing treatments, the traditional HTA paradigms will be tested. This may include increased safety concerns (certainty of treatment effect and potential for adverse events); assessing and paying for value, and appropriate incorporation of ethical, legal, social, and patient/consumer issues and concerns. A number of policy issues may impact current HTA frameworks and methodologies in considering these technologies, such as: global differences in regulatory, patenting and pricing mechanisms; the manufacturing and subsequent organization of service delivery; and balance of risk versus access to innovative technologies (particularly in the context of a sustainable health system providing Universal Health Coverage).

Recognizing the large number of disruptive technologies under development, consideration needs to be given to whether current HTA frameworks are appropriate for the evaluation of these potentially ground-breaking technologies. Critical assessment of the current HTA frameworks with regards to the specific characteristics of these technologies and continued dialogue will be key to ensuring appropriate market access and for informing coverage decisions.

This plenary session aims to gain insights and generate discussion on the following areas:

 

PLENARY THREE

Incoming Tides and What it Means for HTA; the Rise of Real-World Evidence, ‘Big Data’, and Artificial Intelligence.

In the last few years, real-world evidence (RWE), ‘big data’, and Artificial Intelligence (AI) have been rapidly increasing in terms of prevalence and applications. The following definitions can be considered:

The rise in these data collection and analysis modalities is already impacting health care delivery and subsequently HTA, with the potential to reshape health care practice around the world. However, these increased possibilities also bring a number of challenges. The quality and acceptability of the data being collected, the governance and accountability surrounding the data (including consent for data collection and usage) and transference of data securely across stakeholder groups are all key issues. Principles on how and when RWE, big data, and AI can be used to inform decision-making (both at the clinical level and also in the context of HTA) all need to be deliberated and openly discussed.

Applications of AI, based on big data, are already being used for assisting clinical decision making, radiological and pathological analysis, early prediction, monitoring of health risks, and health insurance fraud detection. The possible increase in predictive accuracy is a result of potentially complex algorithms that can sometimes appear to be “black boxes”; it is important that comprehensive evaluations and input from all stakeholders (particularly from the viewpoint of patients and citizens) is undertaken. AI is also being integrated into HTA conduct (including, but not limited to, horizon scanning and systematic literature searches). As a result, the HTA community need to urgently consider how this will affect clinical and HTA workforces, and how to effectively collaborate with technology developers and platforms. It is also imperative that preparation for the influx of big data, RWE, and AI continues; including a deeper understanding of the potential ‘disruption’ to sustainable health systems.

Given the breadth of the full topic, the plenary session will focus on AI including: