A genuine need or nice to have? Understanding HTA representatives' perspectives on the use of patient preference data.

Objectives: The roles and potential value of patient preference (PP) data in health technology assessment (HTA) remain to be fully realized despite an expanding literature and various efforts to establish their utility. This article reports lessons learned through a series of collaborative workshops with HTA representatives, organized by the Health Technology Assessment International's Patient Preferences Project Subcommittee.

Methods: Five online workshops were conducted between June 2022 and June 2023, seeking to facilitate collaborative learning and reflection on ways that PP data can be integrated into HTA.

Considerations for regulation and evaluation of digital mental health technologies.

Digital mental health technologies (DMHTs) are becoming well established within mental health services and through direct-to-consumer models. Due to their scalable nature, DMHTs may support services to bridge the gap between demand and the available workforce, particularly where existing pathways have long delays or restricted capacity. Challenges and risks associated with DMHTs also need consideration.

Fostering Shared Decision-Making Between Patients and Health Care Professionals in Clinical Practice Guidelines: Protocol for a Project to Develop and Test a Tool for Guideline Developers.

Background: Clinical practice guidelines (CPGs) are designed to assist health care professionals in medical decision-making, but they often lack effective integration of shared decision-making (SDM) principles to reflect patient values and preferences, particularly in the context of preference-sensitive CPG recommendations. To address this shortcoming and foster SDM through CPGs, the integration of patient decision aids (PDAs) into CPGs has been proposed as an important strategy. However, methods for systematically identifying and prioritizing CPG recommendations relevant to SDM and related decision support tools are currently lacking.

Equity, diversity, and inclusion in oncology pharmacy practice: Everyone's business.

Introduction: Equity, Diversity, and Inclusion (EDI) is gaining increased attention within all industries healthcare being no exception. The terminology Equity, Diversity, and Inclusion and its abbreviation EDI gained popularity in the early 2000's when varied socio-political factors prompted many organisations to examine EDI concepts and how to operationalise them. The growing diversity of our society requires cross-cultural inclusive approaches to increase equity and access to services.

How can regulation and reimbursement better accommodate flexible suites of digital health technologies?

Individual digital health devices are increasingly being bundled together as interacting, multicomponent suites, to deliver clinical services (e.g., teleconsultation and ‘hospital-at-home services’).

Digital health technologies need regulation and reimbursement that enable flexible interactions and groupings.

Digital Health Technologies (DHTs) are being applied in a widening range of scenarios in medicine. We describe the emerging phenomenon of the grouping of individual DHTs, with a clinical use case and regulatory approval in their own right, into packages to perform specific clinical tasks in defined settings. Example groupings include suites of devices for remote monitoring, or for smart clinics.

Consolidated Health Economic Evaluation Reporting Standards for Interventions That Use Artificial Intelligence (CHEERS-AI).

Objectives: Economic evaluations (EEs) are commonly used by decision makers to understand the value of health interventions. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS 2022) provide reporting guidelines for EEs. Healthcare systems will increasingly see new interventions that use artificial intelligence (AI) to perform their function.

An operationalization framework for lifecycle health technology assessment: a Health Technology Assessment International Global Policy Forum Task Force report.

Operationalization guidance is needed to support health technology assessment (HTA) bodies considering implementing lifecycle HTA (LC-HTA) approaches. The 2022 Health Technology Assessment International (HTAi) Global Policy Forum (GPF) established a Task Force to develop a position paper on LC-HTA. In its first paper, the Task Force established a definition and framework for LC-HTA in order to tailor it to specific decision problems.

Lifecycle HTA: promising applications and a framework for implementation. An HTAi Global Policy Forum Task Force report.

The 2022 Health Technology Assessment International (HTAi) Global Policy Forum (GPF) established the goal of developing a position statement and framework for lifecycle HTA (LC-HTA), through a Task Force leveraging multi-stakeholder monthly discussions and GPF member input. The Task Force developed a working definition: LC-HTA is a systematic process utilizing sequential HTA activities to inform decision making where the evidence base, the health technology itself, or the context in which it is applied, has a potential to meaningfully change at different points in its LC. Four key scenarios were identified where it was considered that an LC-HTA approach would add sufficient value to HTA bodies and their key stakeholders to justify the additional resource burden.

A systematic review of economic evaluations of pharmacological treatments for active tuberculosis.

Objectives: The continuing spread of tuberculosis (TB) worldwide, especially drug-resistant TB, poses a major challenge to healthcare systems globally. Addressing this requires appraising the cost effectiveness of existing pharmacological interventions against TB to identify key drivers of cost effectiveness and value and guide pharmaceutical innovation and novel drug regimen development.

Methods: Studies were identified from a search of six database: MEDLINE MEDLINE-In Process, MEDLINE Epub Ahead of Print, EMBASE, Cochrane Database of Systematic Reviews, and Econlit in July 2022.

Methods for Including Adverse Events in Economic Evaluations: Suggestions for Improvement.

Objective: Inclusion of relevant effectiveness and safety outcomes in economic evaluation of health technologies is required to aid efficient healthcare decisions. Our objective was to identify the key issues related to the inclusion of adverse events (AEs) in economic evaluation and explore perspectives for good practice recommendations to handle these issues.

Methods: We focused on the frequently encountered methodological issues related to the integration of AEs in economic evaluations of health technologies.

A Systematic Literature Review of Gaps and Challenges in Value Assessment of Biosimilars: An ISPOR Special Interest Group Report.

Objectives: This study aims to provide an overview of the gaps and challenges in the value assessment of biosimilars and to identify potential approaches to address them.

Methods: A multidisciplinary, international team of biosimilar experts identified gaps and challenges. A systematic review was conducted of the peer-reviewed literature in PubMed, EMBASE, Web of Science Core Collection, EBSCOhost Business Source Complete; and of the gray literature.

An evaluation of managed access agreements in England based on stakeholder experience.

Objectives: The objective of this research was to evaluate managed access policy in England, drawing upon the expertise of a range of stakeholders involved in its implementation.

Methods: Seven focus groups were conducted with payer and health technology assessment representatives, clinicians, and representatives from industry and patient/carer organizations within England. Transcripts were analyzed using framework analysis to identify stakeholders' views on the successes and challenges of managed access policy.

Perspectives on Patient-Reported Outcome Data After Treatment Discontinuation in Cancer Clinical Trials.

Objectives: Patient-reported outcome (PRO) data are critical in understanding treatments from the patient perspective in cancer clinical trials. The potential benefits and methodological approaches to the collection of PRO data after treatment discontinuation (eg, because of progressive disease or unacceptable drug toxicity) are less clear. The purpose of this article is to describe the Food and Drug Administration's Oncology Center of Excellence and the Critical Path Institute cosponsored 2-hour virtual roundtable, held in 2020, to discuss this specific issue.

Recommendations to overcome barriers to the use of artificial intelligence-driven evidence in health technology assessment.

Background: Artificial intelligence (AI) has attracted much attention because of its enormous potential in healthcare, but uptake has been slow. There are substantial barriers that challenge health technology assessment (HTA) professionals to use AI-generated evidence for decision-making from large real-world databases (e.g.

Remote care through telehealth for people with inflammatory bowel disease.

Background: People with inflammatory bowel disease (IBD) require intensive follow-up with frequent consultations after diagnosis. IBD telehealth management includes consulting by phone, instant messenger, video, text message, or web-based services. Telehealth can be beneficial for people with IBD, but may have its own set of challenges.

Methods for living guidelines: early guidance based on practical experience. Paper 4: search methods and approaches for living guidelines.

Objectives: To describe the key features of a continual evidence surveillance process that can be implemented for living guidelines and to outline the considerations and trade-offs in adopting different approaches.

Study Design And Setting: Members of the Australian Living Evidence Consortium (ALEC), National Institute of Health and Care Excellence (NICE), and the US GRADE Network (USGN) shared their practical experiences of and approaches to establishing surveillance systems for living guidelines. We identified several common components of evidence surveillance and listed the key features and considerations for each component drawn from case studies, highlighting differences with standard guidelines.

Institutionalizing health technology assessment in Egypt: Situational analysis and roadmap.

To conduct a situational analysis with the aim to inform future health technology assessment efforts (HTA) in Egypt. The Egyptian government has set universal health coverage as a 2030 target. Several agencies have been created in the context of the ongoing healthcare reform.