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Cost-effectiveness thresholds (CETs) are widely used to inform health technology assessment and resource allocation, yet many countries continue to rely on the heuristic 1–3×GDP per capita (GDPpc) rule originally proposed by WHO. Using a synthesis of international empirical studies, we compare GDP-based thresholds with CETs derived from real-world estimates of the marginal productivity of health expenditure. Across 10 countries spanning different income levels, empirically estimated CETs consistently fall below the upper bound of the 1–3×GDPpc rule and, in most cases, below GDPpc itself – particularly in middle-income settings. Applying inflated thresholds is, therefore, likely to generate net population health losses, as resources are displaced from more productive uses. Our findings highlight a persistent misalignment between global heuristics and country-specific opportunity costs. We argue that empirically grounded CETs provide a more coherent and ethically defensible basis for decision-making and should be preferred over mechanical GDPpc-based rules in economic evaluations, research, and editorial standards.
Traditional health technology assessments (HTAs) primarily focus on safety, clinical effectiveness, and economic impact, typically through cost-effectiveness analyses conducted from the healthcare payer perspective using metrics such as cost per quality-adjusted life year. This approach overlooks the broader societal impacts of new health interventions and may lead to under- or overestimation of their overall value. Broadening the value framework to include the societal perspective would allow for the consideration of direct and indirect costs beyond health system costs, including lost productivity, caregiver impact, as well as the effect on other sectors such as education or welfare. Despite many HTA guidelines recommending its inclusion, few countries provide guidance on valuing non-health sector impacts or mandating the use of the societal perspective in the reference case. Although there are many challenges associated with the integration of the societal perspective into HTA evaluations, the lack of an internationally standardized context-specific framework remains the major barrier. Regional collaboration between HTA agencies to develop a societal perspective framework, build technical capacity, as well as share methodologies and data may address some challenges. Pilot studies should be encouraged to test the inclusion of societal elements, alongside the routine conduct of sensitivity analyses for evaluations undertaken from both healthcare sector and societal perspectives. This would enable policy makers to address uncertainty without compromising the core economic analysis. A broader, more flexible value framework may better align HTA with societal needs and values, and reward industry innovation while informing equitable funding decisions, capturing the full value of health technologies.
Health technology assessment (HTA) is a multidisciplinary approach that evaluates the clinical data and cost-effectiveness of health technologies within broader policy and societal contexts. This study aimed to identify barriers and facilitators to conducting HTA and implementing its findings in Jordan and to determine key technical and context-specific priorities to enhance HTA use.
Methods
A cross-sectional study was conducted using an online, self-administered questionnaire distributed between 1 June and 29 July 2024. Participants were purposively sampled and invited via email. The questionnaire’s face and content validity were assessed by two local experts. Responses from researchers and decision-makers were analyzed descriptively.
Results
A total of fifty-one participants were included. Both groups identified “lack of routinely collected local effectiveness data and national health statistics” and “absence of health state preference values for estimating quality-adjusted life-years (QALYs)” as major barriers to conducting HTA. The top-rated facilitator was “the development of a good-quality national real-world database.” Researchers additionally highlighted “financial incentives for particular interventions” as an important barrier, whereas decision-makers emphasized “the lack of formal willingness-to-pay thresholds” as the primary barrier to HTA implementation. Both groups identified “prioritization of economic evaluations targeting high-burden conditions” as the most important facilitator for implementation.
Conclusions
Significant systemic and methodological barriers hinder HTA conduct and implementation in Jordan – including limited local data, a lack of health state preference values, and the absence of explicit willingness-to-pay thresholds. Strengthening national data infrastructure, establishing clear policy frameworks, and prioritizing economic evaluations are critical for enhancing HTA integration and supporting evidence-informed decision-making.
Women with cancer who live in medically underserved areas could benefit from behavioral pain interventions, but access is limited. A randomized trial reported that a 4-session virtual program incorporating pain coping skills training (mPCST) was effective in improving pain outcomes compared to an attention-control condition. We performed a cost-effectiveness analysis of mPCST vs. control.
Methods
Data on medical resource use, therapist time, and participants’ attendance at intervention sessions and time associated with travel and using a mobile app were collected. The 5-level EuroQol 5-Dimension (EQ-5D-5L), a preference-weighted measure of health-related quality of life (HRQOL), was administered at baseline, after the intervention period, and 3 and 6 months later. Medicare payments were used to value medical resource use and therapist time to deliver mPCST. Patient time was valued using the average US wage.
Results
Medical resource utilization was similar for both groups, but hospitalizations trended higher in the mPCST group. EQ-5D-5L preference weights were higher by an average of 0.066 (p = 0.04) with mPCST across the follow-up period, representing an incremental gain of 0.04 quality-adjusted life years (QALYs) (95% CI: 0.00–0.08). When including the base-case cost of mPCST of \$500 vs. \$0 for the control group, the incremental cost-effectiveness ratio (ICER) was \$12,725 per QALY (95% CI: 5,566–69,343). Including the value of patient time added \$303 to mPCST costs resulting in an ICER of \$20,438 per QALY (95% CI: 9,051–111,403).
Significance of results
mPCST is a cost-effective program that improves HRQOL for women with cancer living in medically underserved areas.
Task-sharing with non-specialist providers offers a promising solution to the mental health workforce shortage in low-resource settings. Supervision is essential to ensure treatment quality, but is often constrained by limited specialist availability.
Aims
This study evaluated the costs of developing PEERS, a smartphone app that can facilitate registering and scheduling supervision sessions, collecting patient outcomes, rating therapy quality and assessing supervision quality among community-based non-specialist providers delivering behavioural activation for depression.
Method
The PEERS digital application was developed between June 2021 and September 2022 for use in Madhya Pradesh and Goa, India. Development involved contributions from researchers, clinicians, technology experts and end users. Activity-based costing was used to systematically document the inputs and expenditures involved in developing the PEERS app and its accompanying training materials from a health systems perspective. Key cost components included human resources, leadership, IT support and infrastructure.
Results
Total development costs were US$130 027, with the costs of information technology accounting for the largest share (81%; US$105 110). Human resource contributions accounted for 17% (US$22 523), which included oversight and contributions from international research collaborators. Additional costs included overhead and infrastructure (US$2393).
Conclusions
Digital tools are increasingly being used to expand access to and support the delivery of mental health interventions in low-resource settings, yet few studies report on the development costs. By estimating the costs and resources required for developing a digital app for peer supervision, this study can inform efforts to facilitate broader implementation and adaptation of the app for use in other settings.
The objective of this study is to examine current practices regarding the integration of environmental and economic impact assessments in decision making for medical device procurement across French healthcare facilities. These findings will reveal the barriers to environmental criteria integration in Hospital-Based Health Technology Assessment (HB-HTA).
Methods
A cross-sectional survey, collected between 21 May and 12 July 2024, explored knowledge and implementation of environmental and economic assessments in hospital-based medical device procurement. Disseminated nationwide through the French Interregional Clinical Research and Innovation Groups (GIRCI), the French National Agency for Support to Healthcare Performance (ANAP) network, and via Territorial Hospital Groups, targeting public and private healthcare centers, the eight-section survey addressed governance, eco-responsible procurement, environmental data accessibility, and experience with joint assessments and certification practices.
Results
Twenty-nine healthcare centers were analyzed, mostly regional or university hospitals or community hospitals (88 percent), primarily in the public sector. A structured approach to ecological transition was reported by 76 percent of institutions. Eco-responsible purchasing measures were implemented in nineteen centers (83 percent); however, access to life-cycle assessment data, especially for upstream manufacturing phases, remained limited. Forty-five percent of institutions had conducted joint environmental-economic assessments. Although 70 percent of respondents were aware of responsible procurement certifications schemes, only 36 percent used them.
Conclusions
French healthcare institutes demonstrate growing awareness and engagement in sustainable procurement practices. However, limited access to standardized environmental data blocks systematic integration of environmental criteria into procurement practices and thus HB-HTA. Strengthening supplier transparency, harmonizing evaluation frameworks, and embedding environmental metrics into both processes could accelerate sustainable transition.
Out-of-hours primary care (OOH-PC) has been introduced in many health systems to reduce non-urgent emergency department (ED) use. While prior studies suggest potential efficiency gains, economic evaluations rarely stratify outcomes by patient risk, limiting policy relevance. This study assesses the cost-effectiveness of diverting low-risk patients from ED to OOH-PC.
Aim:
Compare direct medical costs, time spent at the facility, and hospitalization probability across risk and care setting subgroups from a societal perspective.
Methods:
We analysed data from a cluster-randomized trial conducted in Belgium that examined a nurse-led triage system. Under the study trial’s extended Manchester Triage System (eMTS) protocol, patients eligible for primary care were assigned to OOH-PC and are referred to in our study as low-risk, while those assigned to the ED are defined as high-risk. To complement previous work, we stratified costs and effects by risk group. Mixed-effects regression models estimated costs, time at the facility, and hospitalization, with bootstrap confidence intervals. We also calculated the incremental net monetary benefit (INMB).
Results:
Treating low-risk patients at the OOH-PC instead of at the ED reduced costs by €24 (€14–€39) per patient, shortened the time spent at the facility by 69 (52–94) minutes. From a societal perspective, the average INMB was €49.5 per low-risk patient. Aggregately, we estimated that the 37 intervention weekends in 2019 led to an average saving of €14,136 in direct medical costs and cumulative time savings of 28 days.
Conclusion:
Diverting low-risk patients from the ED to OOH-PC resulted in cost- and time-savings for low-risk patients at the study site. These findings highlight the potential to improve out-of-hours healthcare delivery to maximize benefits for patients and healthcare systems, although confirmation in other healthcare settings is required before wider implementation.
This systematic review explores which intersectoral costs and benefits (ICBs) are considered in the economic evaluation of pneumococcal conjugate vaccines (PCVs) across different age groups and the related impacts on the results of economic evaluations.
Methods
Seven databases were searched from 2009 to 2024 for full economic evaluations (Ees) of PCVs from a societal perspective. ICBs were presented narratively and in tabular form. Studies were appraised on quality, and PRISMA guidelines were followed.
Results
In all, 57 studies were included. ICBs were captured in the following sectors: patient and family, paid labor (productivity), nonpaid productivity, other sectors (education, leisure, consumption), unspecified sectors for ecological effects (herd immunity, serotype replacement, cross-protection), and equity. In cases where the comparator was no vaccination, 10 studies reported that PCVs were dominant when ICBs were included. After excluding dominant analyses, the median QALY-based incremental cost-effectiveness ratio (ICER) reduction ranged from −3.25 percent (for patient/family costs and productivity loss) to −46.02 percent (in children with ecological effects). Among DALY-based studies, the inclusion of ecological effects reduced the median ICER by −22.97 percent. In head-to-head comparisons, 16 studies reported that PCVs were dominant when ICBs were included.
Conclusion
Inclusion of ICBs, except for serotype replacement, showed favorable cost-effectiveness results. This study provides a framework for identifying the intersectoral costs and benefits for the health economic evaluation of PCVs in children and adults.
To identify economic evidence and evaluation for early-life interventions promoting healthy eating in the first 1000 days and to establish evidence gaps.
Design:
Five databases and five websites were searched using key words. Findings were synthesised narratively.
Setting:
Home, education and community settings.
Participants:
Pregnant women, infants and young children aged 0–2 years.
Results:
Twenty-four English-language, peer-reviewed economic evaluations reporting costs and consequences were selected. Overall, included studies demonstrated mixed quality. Using the Consolidated Health Economic Evaluation Reporting Standard (CHEERS) 2022, titles, comparators and outcomes were commonly reported, whereas health economic analysis plan (HEAP), heterogeneity and uncertainty were least reported. Four studies stated the analytical perspectives with clear decision contexts, making the results useful in decision-making. Several studies had a time horizon of one year or shorter with unclear decision context. Four studies presented relatively transparent methods, with the interpretation of results from cost–utility analyses being informative for decision-making.
Conclusions:
This review identified consistent methodological challenges in the economic evaluation of early-life nutrition interventions. Comparators were inconsistently defined, and most studies adopted short time horizons, limiting assessment of longer-term outcomes. Chosen outcomes were focused on immediate health outcomes, with limited consideration of broader impacts or population differences. More robust and transparent approaches to economic evaluations, supported by a HEAP could improve consistency and support evidence-based decision-making.
There is growing emphasis on the importance of active partner engagement in research and the design, planning, and implementation of new programs. Indeed, the science of engagement is gaining is receiving more attention from researchers, being formally included in research studies more often, and increasingly being required by funders. Financial costs and economic implications are well-known drivers of successful adoption, implementation, and sustainment of evidence-based programs; however, partner engagement costs are often excluded from economic evaluations even when elements of engagement may be relevant to sustainment and replication. Resource constraints in both research and practice highlight the need to better understand engagement costs to ensure that scarce resources are put towards the richest engagement activities. As part of the Rapid and Rigorous Patient-Centered Program (R2P2) in Colorado, we designed an approach to systematically document and analyze partner engagement costs across four prototype projects. We describe this approach, summarize needed adaptations, share an interactive data collection template, synthesize the relevant engagement costs during implementation, replication, and sustainment, and discuss lessons learned. Our experiences in R2P2 in costing initial engagement activities across four diverse projects offer direction for future research and practice that balances high-quality partner engagement with efficiency in addressing resource constraints facing researchers and practitioners.
Self-harm and suicide are major public health concerns and leading causes of mortality worldwide, highlighting a pressing need for policymakers to identify and implement cost-effective interventions. This systematic review (PROSPERO registration #CRD42023460339) followed the PRISMA guidelines and aimed to synthesize the available cost-effectiveness evidence for the prevention of self-harm and suicide. Systematic searches were performed in MEDLINE, Embase, PsycINFO, CINAHL, Econlit, and ProQuest to identify full economic evaluations and return-on-investment studies on preventive interventions for self-harm and suicide published up to January 15, 2026. Methodological quality was assessed using Drummond’s 10-item checklist, and findings were synthesized narratively. A total of 69 eligible studies evaluated 22 types of interventions: three universal, five selective, five indicated, and nine multi-level. Most studies were rated as high-quality (n = 61/69) and conducted in high-income countries (HICs) (n = 63/69), primarily assessing the cost-effectiveness of universal interventions like means restriction (n = 6), selective and indicated interventions like psychotherapy (n = 30), support services (n = 15), and medication (n = 5). Evidence consistently found that interventions for self-harm and suicide prevention were generally cost-effective or cost-saving. Strong evidence supported the cost-effectiveness of several universal (e.g. awareness training), selective (e.g. psychotherapy, support services), indicated (e.g. suicide risk screening, support services, psychotherapy for adults in HICs like Australia, US, Canada), and multi-level interventions. However, more economic evaluations are needed for interventions targeting older adults and children in all countries, especially in low- and middle-income countries, where evidence is lacking.
International evidence suggests that Early Intervention for Psychosis (EIP) services are both effective and cost-effective. Such evidence, however, comes almost exclusively from high-income countries.
Aims
Our aim was to estimate the cost-effectiveness of EIP services in a Latin American setting.
Method
We compared EIP services against community mental health teams (CMHT) from the Chilean health system perspective. We developed a six-state Markov model to estimate the costs, benefits (measured as quality-adjusted life-years (QALYs)) and incremental cost-effectiveness ratio (ICER) for a 10-year time horizon. The model was populated with data from a Chilean EIP cohort, published literature and expert opinion. We characterised uncertainty through probabilistic sensitivity analysis and calculated the value of information to reduce such uncertainty.
Results
In the base case analysis, EIP was cost-effective compared with CMHT, with an ICER of 5 550 044 Chilean pesos per QALY (USD 13 742 adjusted for purchasing power parity). Uncertainty analysis revealed an 80% probability of EIP services being the most cost-effective option at a willingness-to-pay threshold of one gross domestic product per capita (USD 15 923). Sensitivity analysis showed that the results were sensitive to parameters such as intervention effectiveness and cost, suggesting that a new trial might be worthwhile to reduce uncertainty.
Conclusions
This model suggests that implementing EIP services in Chile may cost more, but it is likely to be cost-effective. Nonetheless, more evidence about affordability, equity and broader perspectives is needed to improve the economic case of implementing EIP services in less-resourced settings, such as in Latin America.
Meta-analysis of economic evaluations (MAEEs), using the incremental net benefit approach, enables quantitative synthesis of cost-effectiveness evidence and may support policy decisions. However, little is known about users’ perceptions or utility of MAEEs. This study examined end users’ perceptions and applicability of MAEE findings in real-world decision-making.
Methods
A cross-sectional online survey was conducted among individuals attending an ISPOR Real-World Evidence Summit 2025 breakout session on MAEEs. The survey collected data on respondent characteristics, prior awareness of and experience with MAEEs, perceived usefulness, potential applications, and the likelihood of future use. Responses were summarized using descriptive statistics, and associations between participant characteristics and perceptions were analyzed using chi-square tests and odds ratios (95 percent confidence interval).
Results
Seventy-six participants completed the survey. Most respondents were from the WHO South-East Asia Region (72 percent) and represented Industry/Pharma/MedTech (36 percent) or Academia/Research (34 percent). Perceptions were positive: 78 percent considered MAEEs “definitely” or “possibly” beneficial, and 55 percent indicated they would likely or very likely use MAEEs in policymaking. MAEEs were perceived as useful for highlighting variation across studies, reducing single-study bias, and improving precision when multiple EEs exist on the same topic within a country. Potential users included national health authorities, policy makers, hospitals/insurers, and countries with limited EE capacity. No significant associations were observed between respondent characteristics and perceived benefits or likelihood of use (p > 0.05).
Conclusions
MAEEs are well-received by participants. Larger surveys and qualitative studies are needed to explore context-specific applicability, refine methodology, and enhance their utility across diverse settings.
To model the potential value for money of implementing proposed unhealthy food advertising restrictions on Western Australian (WA) transport-owned assets to prevent obesity-related diseases.
Design:
A cost–benefit analysis using a societal perspective was undertaken to model the policy intervention over a 30-year time horizon. The effectiveness of the intervention was based on a similar policy implemented in the United Kingdom by Transport for London, adapted to the WA context. The ACE-Obesity Policy model, a validated multi-state lifetable Markov model, was used to assess the expected health (quantified as health-adjusted life years (HALY)) and economic outcomes of the intervention’s impact on unhealthy food consumption. The potential costs of policy development and monitoring and revenue impacts on government and industry (outdoor advertising companies) were included in the modelled analysis.
Setting:
Western Australia.
Participants:
Greater Perth population.
Results:
The cost of implementing the policy was estimated at A$28 million (95 % uncertainty intervals (UI): $23, $35), 71 % borne by the government and the remaining by outdoor advertisers. A mean population weight reduction of 0·58 kg (95 % UI: 0·28, 0·90) was estimated, which translated to 5906 health-adjusted life years gained (95 % UI: 2750, 9084) with a monetary value of A$1374 million (95 % UI: $642, $2112). Eight percent of the monetised benefits were attributed to healthcare cost savings, while 92 % were associated with monetised health gains. The intervention was estimated to generate a net-present value of $1346 million (95 % UI: $614, $2082) and benefit–cost ratio of 50 (95 % UI: 23, 81).
Conclusion:
Policy to restrict advertising of unhealthy foods on WA transport-owned assets is likely to represent excellent value for money.
While rapid health technology assessments (HTA) are important for decision makers, there is no universally accepted definition or standardized methods. The objective of this study was to analyze the content and conduct of published rapid and mini-HTA reports.
Methods
We conducted a cross-sectional analysis of rapid and mini-HTA reports identified from the International HTA Database (2014–April 2024) and supplementary searches of HTA agency websites. We extracted descriptive data on rapid HTA products; specifically, which traditional HTA domains were included or omitted, evidence synthesis methods, and approaches to interest-holder (formerly known as stakeholder) engagement. Data analysis was conducted in Stata.
Results
We included 203 rapid HTA reports. Most frequently included HTA domains were clinical effectiveness (99 percent) and safety (82.3 percent). Legal aspects (12.3 percent) and budget impact analyses (10.8 percent) were less frequently reported. Across reports reviewing clinical effectiveness (n = 201), generic literature searches were the most predominantly self-reported evidence synthesis method (37.8 percent), with updates (1.5 percent) and overviews (2 percent) of systematic reviews less common. Cost-utility analyses were the most commonly self-reported form of economic evaluation (36.2 percent). Additionally, public consultations (68 percent) were the most commonly reported ways to engage with interest holders.
Conclusion
Our analysis highlights variations across rapid HTA reports and will contribute to wider research aiming to establish a clearer definition and framework of rapid HTAs and inform when and how rapid HTAs are performed. Clearer reporting and justification of simplifications in rapid HTA reports are needed.
Economic evaluation supports public funding decisions about the use of health technologies within the Portuguese National Health System (NHS). The methods guide for economic evaluation in Portugal serves both companies preparing economic evaluation submissions and the independent commission appraising the evidence submitted.
Methods
This article presents the revised methods guide for economic evaluation in Portugal. The revisions reflect advances in economic evaluation, updates to regulatory policies, and responses to the evolving economic context. The paper highlights the most significant changes to the guidance, comparing the new Portuguese guidelines to those from the United Kingdom and Canada. The discussion is framed around key comments received during public consultation.
Results
The updated guidelines recommend cost-effectiveness analyses based on quality-adjusted life years and advocate for long-term modelling, a 4 percent discount rate, and a focus on NHS costs. New features include guidance on the identification and management of uncertainty within a dynamic appraisal process with regular contract negotiations (which can trigger reappraisals). The guide also covers how cost-effectiveness models, typically centrally developed, should be adapted to the Portuguese context. It highlights the key role of structured expert elicitation to address uncertainties in evidence, including those related to model adaptation.
Conclusions
The revision was developed through stakeholder consultations and aligns with international best practices, offering more explicit and transparent methods to support health resource allocation decisions.
Our objective was to identify key patterns and discuss the lessons learned from the use of real-world data (RWD) in the cost-effectiveness analyses (CEAs) of innovative health products (IHPs) as assessed by the French National Authority for Health from January 2016 to May 2023.
Methods
A retrospective analysis was conducted on the use of RWD in the CEAs of IHPs. Our material included HAS assessments of CEAs and manufacturers’ technical reports. The RWD studies were classified into eight categories, and a specific template was constructed to report and discuss their use in terms of predefined methodological aspects.
Results
In all, 88 percent (129/147) of the CEAs integrated RWD studies. Retrospective cohorts were the most frequently used kind of study in the CEAs, while prospective cohorts were mainly used to identify the analyzed population and to externally validate models. We identified opposing temporal trends in the use of cohort studies versus registries. Approximately 8 percent (10/129) of the CEAs could be adjudged as invalidated due to major limitations regarding RWD use (e.g., lack of relative effectiveness).
Conclusions
We learned several lessons from the use of RWD in the HAS assessments of the CEAs of IHPs. Retrospective cohort studies were the most commonly used RWD source to populate CEA parameters of the CEAs regardless of the type of IHP, and their use has increased over time. The implementation of good practices for the use of RWD studies should improve the role of RWD in economic modeling and address uncertainties surrounding CEAs.
Mental health issues are prevalent among children and young people (CYP) with chronic conditions like epilepsy, yet few access evidence-based psychological therapies. Evidence from the Mental Health Intervention for Children with Epilepsy (MICE) trial supports the effectiveness of a personalised modular psychological intervention, but cost-effectiveness is unknown.
Aims
To assess the cost-effectiveness of the MICE intervention compared with assessment-enhanced usual care at 12-months follow-up, taking a health and social care perspective.
Method
We conducted a within-trial economic evaluation. Outcomes were the Strengths and Difficulties Questionnaire (SDQ; primary) and quality-adjusted life years (QALYs; secondary) for CYP, caregivers, and CYP and caregivers combined. Sensitivity analyses examined missing data and intervention-costing assumptions.
Results
Cost-effectiveness results for the SDQ indicated that MICE had a higher probability of being cost-effective compared with control at a willingness to pay ≥£368 per unit improvement. For QALYs, MICE had a lower probability of being cost-effective for CYP compared with control (35 to 42%) across the £20 000–£30 000 per QALY threshold range. However, at the upper threshold this finding was reversed in sensitivity analyses with missing data imputed (45 to 58%) and with MICE costed at 75%, assuming the intervention partly substituted standard services (46 to 55%). Furthermore, MICE had a higher probability of being cost-effective for caregiver QALYs (52 to 63%) and combined CYP and caregiver QALYs (62 to 75%).
Conclusions
MICE appears to be cost-effective compared with assessment-enhanced usual care when considering QALYs for CYP and caregivers combined, though uncertainty exists across willingness-to-pay thresholds.
The National Institute for Health and Care Excellence (NICE) in England introduced early value assessments (EVAs) as an evidence-based method of accelerating access to promising health technologies that could address unmet needs and contribute to the National Health Service’s Long Term Plan. However, there are currently no published works considering differences and commonalities in methods used between Assessment Reports for EVAs.
Methods
This rapid scoping review included all completed EVAs published on the NICE website up to 23 July 2024. One reviewer screened potentially relevant records for eligibility, checked by a second reviewer. Pairs of independent reviewers extracted information on the methods used in included EVAs using a prepiloted form; these were checked for accuracy. Data were described in graphical or tabular format with an accompanying narrative summary.
Results
In total, seventeen EVA Reports of sixteen EVAs were included in this scoping review. Five Reports did not specify how many reviewers undertook screening, whereas five did not report data extraction methods. Five EVAs planned to conduct meta-analyses, nine planned narrative syntheses, and seven planned narrative summaries. Eleven conceptual decision models were presented, with available evidence used to construct cost-utility analyses (N = 5); cost-effectiveness analyses (CEAs; N = 4); a mix of CEAs and cost-consequence analyses (CCA; N = 2); one CCA; and one cost-comparison.
Conclusion
Future EVA Reports should enhance the transparency of the methods used. Furthermore, EVAs could provide opportunities for the adoption of innovative methodological approaches and more flexible communication between EVA authors and key stakeholders, including patients and clinicians, companies, and NICE.
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.
Methods
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.
Results
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.
Conclusions
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.