Health technology assessment of medical devices (HTA-MDs) presents unique challenges compared to pharmaceuticals. Total MD expenditure continues to grow in Europe, and countries typically conduct their own HTA-MDs evaluations, with varying institutionalization arrangements. European Union’s (EU’s) HTA Regulation aims to establish collaborative clinical assessments across Member States, potentially expediting the path from EU safety certification of MDs to pricing and reimbursement decisions. This study aims to identify emergent configurations among institutionalizations of HTA-MDs in the EU, European Economic Area (EEA), and European Free Trade Association (EFTA) countries.

Publicly available data were cross-sectionally collected for EU, EEA, and EFTA countries until August 2024 to allow a cross-country analysis of HTA-MDs institutionalizations. Countries were included if they had at least one publicly mandated body for HTA-MDs. Data sources were scientific databases, institutional websites, and HTA bodies’ documentation. A framework of 16 elements, qualitatively describing the institutionalization of HTA-MDs, was developed based on a document review and used as a dataset for agglomerative hierarchical cluster analysis to identify patterns of HTA-MDs institutionalization.

The 21 included countries formed three clusters: Cluster 1 featured regulatory-focused, legally bound HTA-MDs systems with mandatory assessments determining reimbursement decisions; Cluster 2 was characterized by regulatory functions, external expert collaboration, formal prioritization processes, and organized Horizon Scanning; Cluster 3 showed recommendatory functions, nonmandatory assessments, and limited impact on reimbursement decisions.

HTA-MDs institutionalizations could benefit from implementing prioritization processes of evaluations, establishing networks of collaborative assessment centers, and ensuring links between evaluations and reimbursement decisions.

To systematize the information and perspectives shared during the 2024 LATAM policy forum, which explored advancements in horizon scanning and early dialogue processes in the region, by analyzing the main discussion and identifying the main lessons.

This article is based on the discussions and background materials provided during the 1.5 days in-person 2024 Latin American Policy Forum (59 representatives from 11 countries). We gathered and systematized the information shared during the forum, including the results of a pre-forum survey. The Forum agenda included keynote presentations, breakout group activities, and plenary discussions to identify the main lessons and key messages from all different stakeholders’ points of view.

The forum highlighted the growing recognition of the need for structured horizon scanning and early dialogue processes in Latin America. Key barriers were identified, including the absence of clear legal frameworks, limited data availability, and the need for capacity-building. Potential solutions included fostering regional cooperation, improving transparency, and creating pilot programs for early engagement. Engaging patients and the pharmaceutical industry was deemed essential for trust and foster alignment between HTA agencies and regulators.

Horizon scanning and early dialogue represent critical tools for improving health system preparedness and aligning innovation with local needs. Their implementation, however, requires coordinated efforts across multiple stakeholders, enhanced dialogue, and the development of supportive legal and regulatory frameworks.

Life-cycle health technology assessment (HTA) requires an index economic model to establish how estimated cost-effectiveness evolves with emerging evidence. We developed an open-source index economic evaluation of entrectinib, a tumor-agnostic therapy with conditional market authorization. Our objective was to replicate the initial HTA report from publicly available information, aiming to identify key operational and methodological aspects for operationalizing life-cycle decision-making.

We used partitioned survival analysis to determine tumor-agnostic and tumor-specific cost-effectiveness, using publicly available HTA reviews for parameterization. We estimated incremental costs in 2021 Canadian and US dollars (CAD and USD) from a public-payer healthcare perspective, quality-adjusted life years (QALYs), and incremental net monetary benefit (INMB). We assessed the impact of treatment effectiveness, extrapolation assumptions, and next-generation sequencing (NGS) costs.

One-third of the parameters (n = 30) were unavailable in the Canadian reimbursement review and were sourced from international reviews. Tumor-agnostic incremental costs were CAD 68,451 (95 percent confidence interval: 35,466, 92,155) and USD 54,608 (28,294, 73,518), and QALYs were 0.13 (−0.42, 0.42), yielding INMB CAD −55,803 at 100,000/QALY (USD −44,518). Full extrapolation of treatment effectiveness also yielded negative INMB (CAD −66,664). Inclusion of NGS costs diminished the expected value. Heterogeneity was considerable across tumor indications.

We developed an open-source index economic evaluation to operationalize life-cycle HTA for a conditionally authorized tumor-agnostic therapy. Our findings outline key operational and methodological considerations necessary for the development of index economic models that support life-cycle HTA, offering insights into their potential integration into regular HTA and policy decision-making processes.

Health economic evaluations are important for healthcare resource allocation. Reviews of health economic evaluations for medical devices have highlighted concerns about the quality of these studies. The complexity of medical devices, including learning curve effects, organizational impact, dynamic pricing, low evidence, and incremental innovation presents unique challenges compared with pharmaceuticals. To support developing a methodological quality assessment instrument for medical device economic evaluations, we conducted a systematic review to identify and evaluate existing economic evaluation quality assessment instruments for suitability in medical device evaluations.

A comprehensive search of databases (MEDLINE, EMBASE, EconLit, CINAHL, and Web of Science) and grey literature was conducted. Two reviewers screened titles and abstracts. Full-text, peer-reviewed primary studies introducing original instruments were included. Only methodological quality assessment instruments were considered for data extraction. Each item was assessed for its suitability in evaluating medical device economic evaluations and inclusion of medical device-specific features.

The search identified 4203 citations and 77 grey literature sources. Fifteen results underwent full-text assessment, with five relevant instruments identified. A previous systematic review identified 10 additional instruments, which we also considered. Of these 25 articles, 13 were included in the review. These instruments lack specificity for medical devices, particularly in addressing features like learning curve effects, organizational impact, and incremental innovation. Instruments should include items specific to these unique characteristics.

Existing instruments contain general items related to health economic evaluation studies, highlighting the need for an instrument specifically tailored to evaluate the methodological quality of medical device economic evaluation studies.

Globally, several health technology assessment (HTA) agencies have started to incorporate environmental considerations into their assessments, given healthcare systems’ substantial environmental footprint. In Canada, two HTA agencies, the Canadian Drug Agency and the Institut national d’excellence en santé et en services sociaux, have announced measures to help mitigate healthcare’s contribution to climate change. Our aim was to review reports from both agencies to identify those incorporating environmental considerations.

We retrieved reports published between 1 May 2023 and 1 December 2024 by the two agencies.

We identifed 202 reports, of which eleven were included. These reports covered diverse technologies, with greenhouse gas emissions and waste production being the most frequently considered environmental dimensions. Parallel evaluation was the predominant method for integrating environmental considerations. We believe that the limited number of reports included may reflect the challenges of incorporating such considerations into HTAs.

By addressing these challenges, HTA agencies could play a pivotal role in guiding decisions that align with environmental goals.

The aim of this study is to develop a patient-level model for type 2 diabetes mellitus (T2DM) progression that can estimate the cost-effectiveness of T2DM interventions from prevention to management.

We developed an individual-level microsimulation model, the Institute of Health Economics Diabetes Model (IHE-DM), that simulates: (i) T2DM progression from normal glucose tolerance (NGT) to T2DM, (ii) the occurrence and timing of eight comorbidities and death, and (iii) the correlated progression of risk factors over time. We report model validation and use a case study to investigate the cost-effectiveness of a hypothetical T2DM prevention program.

The internal validation indicated excellent performance with mean absolute differences between the predicted and observed values for all endpoints of less than 1 percent. External validation results were mixed. The model under-predicted cumulative T2DM incidence in the first 8 years, predicted well from years eight through eleven, and over-predicted from years twelve through fifteen. Our case study estimated an incremental net monetary benefit of CAD 2,701 (USD 2,289) (95% Uncertainty Interval: CAD 1,316 to 4,000 [USD 1,115 to 3,390]) over the 15-year time horizon.

Prominent T2DM models focus on patients with diagnosed T2DM whereas our model simulates progression from NGT to T2DM and incorporates important correlations in the progression of risk factors. These adaptations allow us to evaluate preventative interventions and better capture the long-term impacts, filling an important gap in the evidence base. Our model can be used to inform future funding decisions for T2DM interventions across the care continuum.

To explore the view of nonlayperson committee members on the added value of a discrete choice experiment (DCE) instrument to measure patient and committee member preferences for a health intervention.

Nine semistructured interviews were conducted with voting members from two types of advisory committees in Quebec, Canada: one from the Ministry of Health and Social Services, and eight from the Health Technology Assessment (HTA) agency. The DCE instrument, administrable to patients (i.e., pregnant women) and committee members, was developed and administered to both groups to measure their preferences about the addition of fetal chromosomal anomalies to a prenatal screening program. A conceptual framework consisting of three dimensions (relative advantage, compatibility, and complexity) was used for data collection and analyses.

Committee members considered the DCE instrument, when used with both patients and committee members, to be particularly valuable in raising awareness of potential biases. These biases, generated by committee members’ interests and disciplinary perspectives, can reduce the importance of the patient perspective in decision making by advisory committees.

This qualitative study provides insight into the perceptions of nonlayperson advisory committee members regarding the added value of a DCE instrument administered to patients and committee members regarding an intervention. Additional studies are required to explore the perceptions of other stakeholders (e.g., managers, patients, and public representatives) regarding the application of DCE and to assess its impact on HTA recommendations regarding the value of new health interventions.

This assessment aimed to identify the degree and parameters of demand for support from HTAsiaLink, the Asia regional health technology assessment (HTA) hub, for HTA ecosystem development.

A sequential, exploratory, mixed-method design was implemented, starting with a literature review to define the Asia region’s HTA landscape. Then an online survey was sent to 125 Asia-focused HTA practitioners and support organizations to obtain their thoughts on HTA development needs and how a regional hub could serve them. Finally, fifty purposively selected key informants representing government HTA agencies in Asia, funding partner organizations, philanthropic foundations, global HTA support, and regional HTA hub organizations were invited to participate in semi-structured interviews. Nineteen Asian countries and territories were represented in documents reviewed. Twenty-five recipients from ten Asian countries and territories responded to the survey, and twenty-eight individuals from eight Asian countries and territories plus eight international organizations participated in interviews.

Identified needs include support to fill HTA human resources gaps, strengthen the capacity of the existing HTA workforce, produce HTA public goods, improve harmonization within and across country systems, and strengthen political will. Other important considerations include the need to adapt the hub’s purpose to an expanding role and adopt sustainable financing approaches accordingly.

Demand for an HTA hub in Asia is high, including to support HTA technical, deliberative processes, and institutional capacity strengthening. Findings underscore the importance of both conducting HTAs and fostering demand for HTA output. HTAsiaLink is recognized as well-positioned to play an expanded support role to address these needs.

This study aimed to evaluate the required test characteristics that a psoriatic arthritis (PsA) biomarker test would need to achieve to be considered cost-effective.

We adapted an existing Markov model to compare a hypothetical biomarker with current practice. The model followed a patient cohort aged 45 years with moderate psoriasis (PsO) in which PsA was prevalent but unrecognized over a 40-year time horizon. Patients were assumed to be routinely seen at a dermatology clinic. In the current practice arm, patients with PsA were clinically detected. In the biomarker arm, a hypothetical test was assumed to be administered at baseline. Patients who screened positive would accept a combination of conventional disease-modifying antirheumatic drugs and targeted treatment to slow disease progression. Progression was modeled as linear changes in Health Assessment Questionnaire (HAQ) scores. We varied the sensitivity, specificity, and biomarker price based on current development progress. Scenario analyses considered alternative patient cohorts with mild and severe PsO separately.

The base case showed that a biomarker test with 70 percent sensitivity, 80 percent specificity, and a price of US$500 would be cost-effective (incremental cost-effectiveness ratio US$47,566 per quality-adjusted life-year [QALY]). Three-way analyses showed that a test with 80 percent specificity could be cost-effective at a US$50,000 per QALY threshold with a sensitivity as low as 66 percent at US$500. Only a near-perfect test would be cost-effective at a US$1,000 price point. Results were sensitive to HAQ progression under treatment, therapy costs, and the patient population.

This study supports the continued product development of candidate PsA biomarkers.

This study explored patient involvement in healthcare decision-making in the Asia Pacific region (APAC) by identifying roles and factors influencing differences between healthcare systems. Proposed recommendations to enhance patient engagement were made.

This systematic literature review was conducted using studies from Australia, China, Japan, Malaysia, New Zealand, the Philippines, South Korea, Singapore, Taiwan, and Thailand. Studies were included if they provided data on patient involvement in health technology assessment (HTA) and/or funding decisions for medicines. Extracted data were scored according to eleven parameters adapted from the National Health Council (NHC) rubric, which assessed the level of patient involvement in healthcare system decision-making.

We identified 159 records between 2018 and 2022, including methodology guidelines from Government websites. Most mentioned parameters were patient partnership, patient-reported outcome, and mechanism to incorporate patient input. Limited information was available on diversity and patient-centered data sources. Tools for collecting patient experience included quality-of-life questionnaires, focus groups, interviews, and surveys, with feedback options like structured templates, videos, and public sessions.

Beyond input in assessment process, involvement of patients in decision-making phase has evolved within HTA bodies over time with considerable variation. Few APAC healthcare systems involve patients in the appraisal process as members of the recommendation or decision-making committee.

The findings indicate that while patient involvement in pharmaceutical reimbursement decisions exists, improvements are needed. Effective integration of patient input requires transparency, education, and resource planning. This study establishes a baseline to track progress and assess the long-term impact of patient involvement.

Health technology assessment (HTA) is a form of policy analysis that informs decisions about funding and scaling up health technologies to improve health outcomes. An equity-focused HTA recommendation explicitly addresses the impact of health technologies on individuals disadvantaged in society because of specific health needs or social conditions. However, more evidence is needed on the relationships between patient engagement processes and the development of equity-focused HTA recommendations.

The objective of this study is to assess relationships between patient engagement processes and the development of equity-focused HTA recommendations.

We analyzed sixty HTA reports published between 2013 and 2021 from two Canadian organizations: Canada’s Drug Agency and Ontario Health.

Quantitative analysis of the HTA reports showed that direct patient engagement (odds ratio (OR): 3.85; 95 percent confidence interval (CI): 2.40–6.20) and consensus in decision-making (OR: 2.27; 95 percent CI: 1.35–3.84) were more likely to be associated with the development of equity-focused HTA recommendations than indirect patient engagement (OR: .26; 95 percent CI: .16–.41) and voting (OR: .44; 95 percent CI: .26–.73).

The results can inform the development of patient engagement strategies in HTA. These findings have implications for practice, research, and policy. They provide valuable insights into HTA.

To provide an overview of learning strategies that health technology assessment (HTA) agencies use worldwide to educate laypeople about HTA.

A scoping review focused on learning strategies to educate laypeople about HTA using the Joanna Briggs Institute frameworks was conducted across databases and gray literature. The study reviewed qualitative, quantitative, and mixed-methods studies from four databases, including practice documents from the HTA and health organization websites.

Fifteen studies were included in this review. The United Kingdom, Spain, and Canada mainly contributed to knowledge about educating laypeople in HTA. The main strategies employed were conference-like events, educational materials, training, and plain language. International HTA and health agencies developed courses, online training, and guidance materials to increase laypeople’s participation in the HTA process.

Efforts to improve public involvement in HTA focus on structured consultations, digital platforms, and capacity-building to enhance accessibility. Strategies like workshops and plain language aim to encourage lay participation, but challenges such as technical complexity and limited resources persist. Despite these challenges, incorporating patient perspectives has increased research relevance and public trust. Future studies should examine standardized frameworks for involvement, the impact of lay participation on policy, and solutions to barriers to a more equitable HTA process.