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Health technology assessments (HTAs) of vaccines typically focus on the direct health benefits to individuals and healthcare systems. COVID-19 highlighted the widespread societal impact of infectious diseases and the value of vaccines in averting adverse clinical consequences and in maintaining or resuming social and economic activities. Using COVID-19 as a case study, this research work aimed to set forth a conceptual framework capturing the broader value elements of vaccines and to identify appropriate methods to quantify value elements not routinely considered in HTAs. A two-step approach was adopted, combining a targeted literature review and three rounds of expert elicitation based on a modified Delphi method, leading to a conceptual framework of 30 value elements related to broader health effects, societal and economic impact, public finances, and uncertainty value. When applying the framework to COVID-19 vaccines in post-pandemic settings, 13 value elements were consensually rated highly important by the experts for consideration in HTAs. The experts reviewed over 10 methods that could be leveraged to quantify broader value elements and provided technical forward-looking recommendations. Limitations of the framework and the identified methods were discussed. This study supplements ongoing efforts aimed towards a broader recognition of the full societal value of vaccines. [ABSTRACT FROM AUTHOR]

Objectives: The aim of this study was to explore definitions of value and the use of budget impact and affordability considerations in health technology assessment (HTA) in the Asia region, particularly in relation to high cost technologies. Methods: Issues were debated by senior representatives from HTA and payer systems in Asian countries, delegates from industry, and invited experts at the 2016 meeting of the HTAi Asia Policy Forum (HAPF). A premeeting survey was used to gather data on how value is assessed and budget impact calculations are used within current processes, as well as current approaches to managing affordability. Results: All systems consider health benefit to be the key component of value. There is little consensus around "wider" elements of value that should be included. All systems use budget impact in decision making, although meeting attendees noted the challenges in making accurate estimates. The most common strategies used to address affordability concerns to date have been: restricting coverage, for example, to patients who are likely to get the highest value; discounts; and revenue caps. It was noted that these "solutions" may have unintended consequences of creating inequitable access to therapies and failing to provide adequate rewards for innovation. Conclusions: Decision makers, HTA agencies, and industry need to continue to work together to find mutually agreeable solutions to ensure that patients continue to get equitable access to effective therapies at costs that can be afforded throughout the Asia region. [ABSTRACT FROM AUTHOR]

Pharmaceutical manufacturers, regulators, patients, providers, and payers all have a shared interest in improving health outcomes for patients with cancer. Each plays an important role in helping to achieve this common goal. Pharmaceutical manufacturers seek to develop new medicines that are supported by robust and clinically meaningful evidence of their safety, efficacy, and effectiveness. Regulators authorize these medicines based on evaluations of their safety and efficacy. Patients and providers together make treatment decisions and desire access to the most effective treatment options. Payers appraise new medicines with the goal of ensuring access to those medicines that constitute efficient uses of healthcare expenditure. Profits generated from the sale of the medicines provide a return to the manufacturer, which helps to drive continued research and development in an effort to improve patient health outcomes and societal well-being. Many payers have initiated health technology assessment (HTA) activities to inform decision making in light of the rising costs of health care. Given the financial constraints imposed as a result of the global economic crisis, HTAs are likely to become increasingly important as payers seek value for money solutions to major health problems. Successful collaboration and aligning incentives across stakeholders is critical to ensuring that patients are able to access the most effective medicines. [ABSTRACT FROM AUTHOR]

There is strong evidence that individuals and the public assign relatively greater value to health gains from relatively more severe health states. This preference is increasingly reflected in health technology assessment, with some consideration of severity incorporated by health technology assessment bodies in, among others, The Netherlands, England and Wales, Norway, Sweden, and the United States. If a societal "severity premium" is to be considered fairly and consistently, we argue that a more explicit and quantitative approach is needed. We highlight drawbacks of categorical approaches, especially discontinuities between severity categories that arguably violate concepts of vertical equity, and argue that a more continuous approach to understanding severity is needed. We also note challenges to more explicit approaches, including implications of a lower threshold for less severe conditions and the relative complexity of calculating a continuous severity adjustment. [ABSTRACT FROM AUTHOR]

Abstract: Background: Personalized medicine technologies can improve individual health by delivering the right dose of the right drug to the right patient at the right time but create challenges in deciding which technologies offer sufficient value to justify widespread diffusion. Personalized medicine technologies, however, do not neatly fit into existing health technology assessment and reimbursement processes. Objectives: In this article, the Personalized Medicine Special Interest Group of the International Society for Pharmacoeconomics and Outcomes Research evaluated key development and reimbursement considerations from the payer and manufacturer perspectives. Methods: Five key areas in which health economics and outcomes research best practices could be developed to improve value assessment, reimbursement, and patient access decisions for personalized medicine have been identified. Results: These areas are as follows: 1 research prioritization and early value assessment, 2 best practices for clinical evidence development, 3 best practices for health economic assessment, 4 addressing health technology assessment challenges, and 5 new incentive and reimbursement approaches for personalized medicine. Conclusions: Key gaps in health economics and outcomes research best practices, decision standards, and value assessment processes are also discussed, along with next steps for evolving health economics and outcomes research practices in personalized medicine. [Copyright &y& Elsevier]