Health Technology Assessment Model Research Articles

HTA model for laboratory medicine technologies: overview of approaches adopted in some international agencies.

The Health Technology Assessment (HTA) Working Group of the Emerging Technology Division of International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) aims to develop a methodological approach for producing structured HTA information for laboratory medicine technologies. This approach seeks to support decision-making processes at the country, regional, and/or hospital levels regarding the introduction of specific technologies. The focus of this model will primarily be ondefining assessment elements within the domains of 'organizational aspects' and 'costs and economic evaluations', potentially differentiated by the type of diagnostic technology (e.g., genetic tests, molecular tests). To achieve this project's goal, a literature review and examination ofwebsites of international HTA agencies have been conducted. The research aims to identify multidisciplinary methodological approaches used to assess laboratory diagnostic technologies and to pinpoint the domains and assessment elements utilized. Wefound 7 methodological articles describing methodological approaches adopted toassess laboratory diagnostic technologies. Among the HTA organizations considered, 23 reports were found, of which 7 were produced by the European Network of HTA (EUnetHTA), 4 by the National Institute for Health and Care Excellence Diagnostic Assessment Program (NICE DAP), and 12 by other HTA agencies. The EUnetHTA reports wererapid collaborative assessments covering various domains, while the NICE DAP reports focused on diagnostic guidances, including descriptions of technologies, clinical need and practice, diagnostic tests, accuracy, effectiveness, and cost-effectiveness. Finally, a survey targeting laboratory professionals will be conducted to introduce assessment elements, differentiated by the type of diagnostic technology, primarily for organizational and economic domains.

OP57 Consumer Engagement In Health Technology Assessment: An Australian Journey To Date

IntroductionAustralian health technology assessment (HTA) committees and processes at the national level have needed to consider an increasing focus on patient involvement and interactions within their scope. As various approaches have been explored, the visibility and impacts of patient involvement and consumer representation has evolved markedly over the most recent five years.MethodsProgram activities were developed from review of contemporary HTA models of practice across various HTA sectors internationally alongside input from individual patients and patient groups. Practical application of program pilots was influenced by specific requirements of the Office of HTA, the coordination of HTA Committee procedures and timelines, and involvement of HTA Committee consumer members.ResultsThe development of capacity building programs for HTA consumer committee members, the growth of external activity and communications targeting patient groups and networks, and the establishment of an expert position to develop the HTA Consumer Evidence and Engagement Unit within the Department’s Office of HTA, are all examples of the work delivered in this period to better integrate patient evidence and inputs into HTA processes and decision-making. Activities over the next period will seek to establish formal frameworks for meaningful involvement that can demonstrate these contributions to evaluations and decision-making.ConclusionsVarious examples of patient involvement and participation in processes have evolved over time. The scope and impacts of these experiences have illustrated important participatory demands and resourcing needs, as well potential benefits for deliberations. The Australian Government and Departmental frameworks for HTA currently seek to enhance the development of patient evidence inputs and participation. These developments will be informed by the Australian context and comprehensive consultation with Australian patient groups and their networks. Strategies for improvements are anticipated to be relevant across all HTA processes and Committees within HTA areas.

Health technology assessment of genetic and genomic applications: is it possible to standardize?

Abstract Background The assessment of genetic and genomic applications (GGA) has long been used ad hoc frameworks, often based on the ACCE model, while less used are more traditional health technology assessment (HTA) approaches. While ACCE frameworks are mainly focused on technical aspects, HTA ones often include economic and organizational aspects in their assessment. The aim of this study was to develop a framework able to address a comprehensive assessment of GGAs. Methods We analysed the most important HTA model currently used in EU, the EUnetHTA HTA Core Model, to identify any possible shortcomings in the evaluation of GGAs. The Sapienza framework, based on a previous systematic review of GGAs assessment frameworks, was used as a reference. The HTA Core Model applications were than used as a basis for an assessment framework for GGAs, classified according to ‘GGA function/Use setting’ pairs. Results The Sapienza framework found full correspondence in the HTA Core Model. The “Screening Technology” application was suitable for diagnostic, pre-symptomatic, predictive and carrier GGAs when used in screening settings. The “Diagnostic Technologies” application was appropriate for the pairs ‘Diagnostic/Diagnosis', ‘Pre-symptomatic/Diagnosis', ‘Prognostic/Staging’ and ‘Pharmacogenetic/Staging', although it may require additional considerations, such as the need of screening in case of germline mutations, the use of appropriate accuracy measures for prognostic GGAs, or the evaluation of the clinical utility of pharmacogenetic/prognostic GGAs. Conclusions The proposed methodology aims to be a flexible tool that allows the GGA assessment according to a shared and validated methodology already in use for the HTA of medical devices, considering for their technical aspect, the clinical utility, the economic value, and the delivery models. Indeed, the HTA Core Model seems to fit the needs of GGAs assessment. However, some peculiarity of GGAs should be carefully considered during the HTA. Key messages • The EUnetHTA Core Model can provide a comprehensive framework for the evaluation of genetic and genomic applications, allowing a standardization with the procedures usually used for medical devices. • Some peculiar characteristics of genetic and genomic applications must be taken into consideration during their evaluation.

A SWOT analysis of the development of health technology assessment in Iran.

Health systems need to prioritize their services, ensuring efficiency and equitable health provision allocation and access. Alongside, health technology assessment (HTA) seeks to systematically evaluate various aspects of health technologies to be used by policy- and decision-makers. In the present study, we aim to identify strengths, weaknesses, opportunities, and threats in developing an HTA in Iran. This qualitative study was conducted using 45 semi-structured interviews from September 2020 to March 2021. Participants were selected from key individuals involved in health and other health-related sectors. Based on the objectives of the study, we used purposive sampling (snowball sampling) to select individuals. The range of length of the interviews was between 45 to 75 minutes. Four authors of the present study carefully reviewed the transcripts of interviews. Meanwhile, the data were coded on the four domains of strengths, weaknesses, opportunities, and threats (SWOT). Transcribed interviews were then entered into the software and analyzed. Data management was performed using MAXQDA software, and also analyzed using directed content analysis. Participants identified eleven strengths for HTA in Iran, namely the establishment of an administrative unit for HTA within the Ministry of Health and Medical Education (MOHME); university-level courses and degrees for HTA; adapted approach of HTA models to the Iranian context; HTA is mentioned as a priority on the agenda in upstream documents and government strategic plans. On the other hand, sixteen weaknesses in developing HTA in Iran were identified: unavailability of a well-defined organizational position for using HTA graduates; HTA advantages and its basic concept are unfamiliar to many managers and decision-makers; weak inter-sectoral collaboration in HTA-related research and key stakeholders; and, failure to use HTA in primary health care. Also, participants identified opportunities for HTA development in Iran: support from the political side for reducing national health expenditures; commitment and planning to achieve universal health coverage (on behalf of the government and parliament); improved communication among all stakeholders engaged in the health system; decentralization and regionalization of decisions; and capacity building to use HTA in organizations outside the MOHME. High inflation and bad economic situation; poor transparency in decisions; lack of support from insurance companies; lack of sufficient data to conduct HTA research; rapid change of managers in the health system; and economic sanctions against Iran are threats to the developmental path of HTA in Iran. HTA can be properly developed in Iran if we use its strengths and opportunities, and address its weaknesses and threats.

The added value of applying a disinvestment approach to the process of health technology assessment in Italy.

The objective of the present policy analysis was to understand how a disinvestment approach to the process of health technology assessment (HTA), applied to the field of medical devices, might help Italian policymakers to properly spend the resources in healthcare. Previous international and national experiences in disinvestment for medical devices were reviewed. Precious insights for the rational expenditure of the resources were derived by assessing the evidence available. The disinvestment of ineffective or inappropriate technologies or interventions with an inadequate value-for-money ratio has become a growing priority for National Health Systems. Different international disinvestment experiences of medical devices were identified and described through a rapid review. Although most of them have a strong theoretical framework, their practical application remains difficult. In Italy, there are no examples of large and complex HTA-based disinvestment practices, but their importance is becoming increasingly acknowledged, especially given the need to prioritize the funds provided by Recovery and Resilience Plan. Anchoring decisions on health technologies without reassessing the current technological landscape through a robust HTA model might expose to the risk of not ensuring the best employment of the resources available. Thus, it is necessary to develop a strong HTA ecosystem in Italy through adequate consultation with stakeholders to enable a data-driven and evidence-based prioritization of resources toward choices characterized by high value for both patients and society as a whole.

A framework for developing and evaluating digital and public health tools

Abstract To paraphrase a classic, evaluating digital technologies in health is a bit like eating spinach - no one is against it in principle because it is good for you. However, no one would do it unless being asked to. In recent years, the sheer number of digital health technologies that potentially fulfil public health purposes has increased tremendously. The basis for evaluating such tools for public health purposes however has not met this pace, and in particular frameworks for the systematic development and evaluation of digital technologies in public health are rare. Existing frameworks for digital technologies focus on clinical aspects of digital health applications (e.g., NICE Evidence standards framework for digital health technologies), thus lacking both a population and prevention focus. Generic frameworks such as the Health Technology Assessment (HTA) methodology do not contain items specific to digital technologies and public health purposes. Here, we describe the process of developing a framework specific for the development and evaluation of digital public health technologies based on the core HTA model. We conduct a scoping review of frameworks for the development and the evaluation of technologies in public health and digital health, following PRISMA-SCR guidelines. The identified frameworks are then mapped onto the core HTA model to develop additional items specific for the development and the evaluation of digital technologies in public health. These additional items can be used to integrate the development and evaluation of digital technologies for public health purposes within the wider HTA context, making this process both transferable and scalable.

Standardization of the assessment process within telerehabilitation in chronic diseases: a scoping meta-review

BackgroundTelerehabilitation (TR) interventions are receiving increasing attention. They have been evaluated in various scientific areas through systematic reviews. However, there is a lack of data on how to standardize assessment and report on their domains to guide researchers across studies and bring together the best evidence to assess TR for chronic diseases.Aims and objectivesThe aim of this study was to identify domains of assessment in TR and to qualitatively and quantitatively analyze how and when they are examined to gain an overview of assessment in chronic disease.MethodsA scoping meta-review was carried out on 9 databases and gray literature from 2009 to 2019. The keyword search strategy was based on "telerehabilitation", “evaluation", “chronic disease" and their synonyms. All articles were subjected to qualitative analysis using the Health Technology Assessment (HTA) Core Model prior to further analysis and narrative synthesis.ResultsAmong the 7412 identified articles, 80 studies met the inclusion criteria and addressed at least one of the noncommunicable diseases (NCD) categories of cardiovascular disease (cardiovascular accidents), cancer, chronic respiratory disease, diabetes, and obesity. Regarding the domains of assessment, the most frequently occurring were “social aspect” (n = 63, 79%) (e.g., effects on behavioral changes) and “clinical efficacy” (n = 53, 66%), and the least frequently occurring was “safety aspects” (n = 2, 3%). We also identified the phases of TR in which the assessment was conducted and found that it most commonly occurred in the pilot study and randomized trial phases and least commonly occurred in the design, pretest, and post-implementation phases.ConclusionsThrough the HTA model, this scoping meta-review highlighted 10 assessment domains which have not been studied with the same degree of interest in the recent literature. We showed that each of these assessment domains could appear at different phases of TR development and proposed a new cross-disciplinary and comprehensive method for assessing TR interventions. Future studies will benefit from approaches that leverage the best evidence regarding the assessment of TR, and it will be interesting to extend this assessment framework to other chronic diseases.

A New Decision Model Approach for Health Technology Assessment and A Case Study for Dialysis Alternatives in Turkey.

Background: This paper presents a generic Multi-Criteria Decision Analysis (MCDA) model for Health Technology Assessment (HTA) decision-making, which can be applied to a wide range of HTA studies, regardless of the healthcare technology type under consideration. Methods: The HTA Core Model® of EUnetHTA was chosen as a basis for the development of the MCDA model because of its common acceptance among European Union countries. Validation of MCDA4HTA was carried out by an application with the HTA study group of the Turkish Ministry of Health. The commitment of the decision-making group is completed via an online application of 10 different questionnaires. The Analytic Hierarchy Process (AHP) is used to determine the weights. Scores of the criteria in MCDA4HTA are gathered directly from the HTA report. The performance matrix in this application is run with fuzzy Technique for Order Preference by Similarity to Ideal Solution (TOPSIS), fuzzy Vise Kriterijumska Optimizacija I Kompromisno Resenje (VIKOR), and goal programming MCDA techniques. Results: Results for fuzzy VIKOR, fuzzy TOPSIS, and goal programming are 0.018, 0.309, and 0.191 for peritoneal dialysis and 0.978, 0.677, and 0.327 for hemodialysis, respectively. Conclusions: Peritoneal dialysis is found to be the best choice under the given circumstances, despite its higher costs to society. As an integrated decision-making model for HTA, MCDA4HTA supports both evidence-based decision policy and the transparent commitment of multi-disciplinary stakeholders.

PRO99 MULTI-CRITERIA DECISION ANALYSIS (MCDA) OF ELTROMBOPAG OLAMINE IN THE TREATMENT OF PATIENTS WITH REFRACTORY SEVERE APLASTIC ANEMIA UNDER THE PRIVATE HEALTHCARE SYSTEM IN BRAZIL: A HEALTH TECHNOLOGY ASSESSMENT (HTA) ALTERNATIVE MODEL

In Brazil, cost-effectiveness analysis is not the only indicator to orient the decision-making process, especially due to the absence of a willingness-to-pay threshold. Using an alternative health technology assessment (HTA) model, this study aimed to evaluate the incorporation of eltrombopag olamine for the treatment of refractory severe aplastic anemia (SAA) in the Brazilian supplementary healthcare system (SHS). An alternative HTA model, consisting of a Multi-Criteria Decision Analysis (MCDA) presented the following flow: problem context description, criteria selection, process structuring, criteria rationale construction, score attribution, mathematical model elaboration and software development. Criteria and score scales were based on literature review and validated by specialists in a second moment. The criteria were organized according to relevance level in a proposed HTA diagram, and they were classified as eliminators, decision-making and complementary. Eliminators criteria were the minimum requirements to enable the technology assessment on the next steps. Decision-making criteria represented the main aspects/indicators during the HTA processes, including clinical benefit and economic impact of eltrombopag. Complementary criteria were only evaluated in case the previous result demonstrated any uncertainty. Scores were indicated by a scale of 0 to 10. A sensitivity analysis was performed to verify the result robustness. Eltrombopag attended all requirements of eliminators criteria. Regarding the decision-making criteria, the new technology indicated to have an assertive clinical evidence (7.00), with very high drug effect (8.50) and very low budget impact (0.02) due to very small use expectation. Final score was 7.69, which indicated recommendation of eltrombopag incorporation. There was no need to evaluate the complementary criteria. Sensitivity analysis results demonstrated consistency to the base case. Considering the context of refractory SAA in Brazil, the incorporation of eltrombopag demonstrated to be favorable, being an option with high overall clinical benefit accompanied by a very low budget impact in the Brazilian SHS.

Health- Related Quality of Life for Multiple Myeloma Patients with Bone Metastases in Indonesia: A Cross-Sectional Study.

Objective:Multiple myeloma (MM) with bone metastases causes a skeletal-related event (SRE), and decreases health-related quality of life (HRQoL). HRQoL needs to be evaluated for health technology assessment (HTA). Furthermore, HRQoL is calculated as a health state utility and is used in the Markov Model for HTA. Therefore, this study aimed to describe the HRQoL of MM patients with bone metastases, using The EuroQol five-dimension five levels (EQ -5D-5L) in Indonesia. Methods:a cross-sectional, multicenter study for MM patients with bone metastases (aged over 18 years old) that consulted a physician between November 2018 - May 2019 was conducted. The calculated HRQoL illustrated the health state utility, which was assessed using the EQ-5D-5L questionnaire, with the Indonesian value set. In addition, Mann-Whitney analyses were performed to determine the difference in utility scores at different points within the Durie-Salmon staging system and skeletal condition. Results:in 93 patients who completed the questioner, pain was their major concern with prevalence of over 60% (all levels inclusive). Moreover, the mean utility of patients in stage II and III were 0.735 (SD = 0.205) and 0.383 (SD = 0.555), and those without SRE was 0.753 (SD = 0.213) while patients with SRE was 0.302 (SD = 0.562). Therefore, the lessened values were observed at stage III and SRE condition (p<0.05). Conclusion:MM patients with bone metastases have poor HRQoL, with pain as the most frequently reported challenge, which is associated with an advanced stage of MM and SRE event.

HERA-QUEST: HTA-Evaluation generischer Arzneimittel zur Verbesserung von Qualität, Oekonomie, Patientensicherheit und Transparenz bei Produktumstellungen in Kliniken

In view of the rising cost pressure and an increasing number of drug shortages, switches between generic drug preparations have become a daily routine in hospitals. To ensure consistently high treatment quality and best possible patient safety, the equivalence of the new and the previous drug preparation must be ensured before any change in the purchase of pharmaceutical products takes place. So far, no easily usable, transparent and standardized instrument for this kind of comparison between generic drug products has been available.A group of pharmaceutical experts has developed the drug HTA (health technology assessment) model “HERA” (HTA Evaluation of geneRic phArmaceutical products) through a multi-step process. The instrument is designed to perform both a qualitative and economic comparison of equivalent drug preparations (“aut idem” substitution) before switching products. The economic evaluation does not only consider unit prices and consumption quantity, but also the processing costs associated with a product change process. The qualitative comparison is based on the evaluation of 34 quality criteria belonging to six evaluation fields (e.g., approval status, practical handling, packaging design). The objective evaluation of the quality criteria is complemented by an assessment of special features of the individual hospital for complex drug switches, including the feedback of the physicians utilizing the drug preparation. Thus potentially problematic switches of pharmaceutical products can be avoided at the best possible rate, contributing to the improvement of patient safety.The novel drug HTA model HERA is a tool used in clinical practice that can add to an increase in quality, therapeutic safety and transparency of drug use while simultaneously contributing to the economic optimization of drug procurement in hospitals. Combining these two is essential for hospitals facing the tension between rising cost pressure and at the same time increasing demands on quality and transparency, triggered by, amongst others, current legislation (Hospital Structures Act, anti-corruption legislation).

A DECADE OF HEALTH TECHNOLOGY ASSESSMENT IN POLAND.

The objective of this study is to illustrate and provide a better understanding of the role of health technology assessment (HTA) processes in decision making for drug reimbursement in Poland and how this approach could be considered by other countries of limited resources. We analyzed the evolution of the HTA system and processes in Poland over the past decade and current developments based on publicly available information. The role of HTA in drug-reimbursement process in Poland has increased substantially over the recent decade, starting in 2005 with the formation the Agency for Health Technology Assessment and Tariff System (AOTMiT). The key success factors in this development were effective capacity building based on the use of international expertise, the implementation of transparent criteria into the drug reimbursement processes, and the selective approach to the adoption of innovative medicines based on the cost-effectiveness threshold among other criteria. While Poland is regarded as a leader in Central and Eastern Europe, there is room for improvement, especially with regard to the quality of HTA processes and the consistency of HTA guidelines with reimbursement law. In the "pragmatic" HTA model use by AOTMiT, the pharmaceutical company is responsible for the preparation of a reimbursement dossier of good quality in line with HTA guidelines while the assessment team in AOTMiT is responsible for critical review of that dossier. Adoption of this model may be considered by other countries with limited resources to balance differing priorities and ensure transparent and objective access to medicines for patients who need them.

The impact of HTA and procurement practices on the selection and prices of medical devices

Technological innovation in healthcare yields better health outcomes but also drives healthcare expenditure, and governments are struggling to maintain an appropriate balance between patient access to modern care and the economic sustainability of healthcare systems. Health Technology Assessment (HTA) and centralized procurement are increasingly used to govern the introduction and diffusion of new technologies in an effort to make access to innovation financially sustainable. However, little empirical evidence is available to determine how they affect the selection of new technologies and unit prices. This paper focuses on medical devices (MDs) and investigates the combined effect of various HTA governance models and procurement practices on the two steps of the MD purchasing process (i.e., selecting the product and setting the unit price). Our analyses are based on primary data collected through a national survey of Italian public hospitals. The Italian National Health Service is an ideal case study because it is highly decentralized and because regions have adopted different HTA governance models (i.e., regional, hospital-based, double-level or no HTA), often in combination with centralized regional procurement programs. Hence, the Italian case allows us to test the impact of different combinations of HTA models and procurement programs in the various regions. The results show that regional HTA increases the probability of purchasing the costliest devices, whereas hospital-based HTA functions more like a cost-containment unit. Centralized regional procurement does not significantly affect MD selection and is associated with a reduction in the MD unit price: on average, hospitals located in regions with centralized procurement pay 10.1% less for the same product. Hospitals located in regions with active regional HTA programs pay higher prices for the same device (+23.2% for inexpensive products), whereas hospitals that have developed internal HTA programs pay 8.3% on average more for the same product.

The Development of the Romanian Scorecard HTA System

ObjectivesTo present the characteristics of the scorecard health technology assessment (HTA) implemented since 2014 and to show the results of this HTA process by the end of 2015. MethodsThe health care context and the Romanian HTA legislation were studied while considering the reasons behind HTA introduction, the key stakeholders, and the HTA process as a whole. A critical appraisal was done covering public HTA reports and the decisions made by the Ministry of Health. ResultsThe scorecard HTA model is in place from 2014 and is based on six criteria: France HTA decision, UK HTA decision, Germany HTA decision, the number of European Union countries with reimbursement, the development of a local real-world data study, and a budget impact assessment. By December 2015, more than 200 HTA dossiers were evaluated and the scorecard HTA results were reflected in three processes of the drug reimbursement list update. Consequently, 25 new drugs, 11 fixed-dose combinations, 2 new indications, and 4 orphan drugs received unconditional inclusion, and 5 drugs received conditional inclusion via commercial arrangements. Moreover, the scorecard system was used for delisting drugs: 16 were delisted and another 21 were moved to a lower level of reimbursement (20%). ConclusionsThe implementation of the scorecard HTA started in 2014 using combined information from Romania and other countries. Although the scorecard HTA system makes no direct evaluation of the value of drugs, authorities consider it to be effective, being designed only to favor cost-saving drugs and to promote high discounts.

Processo de Incorporação dos Inibidores de Protease para Hepatite C Crônica em Sistemas Públicos de Saúde: estudo de caso comparativo entre Brasil, Austrália, Canadá e Inglaterra.

Os estudos de Avaliação em Tecnologias em Saúde (ATS) subsidiam decisões quanto ao uso racional das tecnologias em saúde. Encontrar um equilíbrio entre a sustentabilidade dos sistemas de saúde, e o adequado acesso e utilização das tecnologias, representa um desafio e pressupõe o uso de ferramentas consistentes. Foram analisadas neste trabalho as características gerais das agências ou instituições responsáveis pela ATS, bem como o processo de avaliação e a incorporação dos inibidores de protease, telaprevir e boceprevir, para o tratamento da hepatite C crônica por meio de um estudo de caso comparativo de Brasil, Austrália, Canadá e Inglaterra. Trata-se de estudo de caso. Foi realizada pesquisa nos relatórios publicados sobre telaprevir e boceprevir, em 2013, nos endereços eletrônicos dos órgãos avaliadores dos países escolhidos. Observou-se, comparativamente a outras agências, que a Comissão brasileira (CONITEC), diferentemente das demais, aceitou a submissão e publicou no mesmo relatório a avaliação de medicamentos diferentes; sua composição tem perfil diverso das demais agências, cujos membros são indicados por sua expertise em ATS; o modelo de ATS é homogêneo entre os países; Houve divergências nos critérios de elegibilidade da população-alvo, mesmo com aprovação do medicamento; o preço praticado no Brasil foi o menor; a Comissão Brasileira definiu no relatório de avaliação da incorporação do telaprevir e boceprevir também as regras de organização da rede assistencial, a elaboração de protocolos clínicos e diretrizes terapêuticas.

When pneumonia does not respond to antibiotics: a challenging neonatal diagnosis

Baby girl C was born at 41+2 weeks, weighing 2.8 kg, by vaginal delivery after induction of labour. This was the 24-year-old mother's first pregnancy, which was uncomplicated, with normal...

Adopting European Network for Health Technology Assessments (EunetHTA) core model for diagnostic technologies for improving the accuracy and appropriateness of blood gas analyzers' assessment.

Point-of-care testing (POCT) is a successful methodology for meeting clinical expectations of rapid and accurate results. Scientific literature has moreover highlighted and confirmed the necessity of individuating the best technological solution, in accordance with clinical requirements and contextualized to the whole health organization, where it will be implemented. Health Technology Assessment (HTA) can assist in reaching an appropriate and contextualized decision on a health technology. The aim of this study is to adapt a HTA core model for improving the evaluation of a POCT technology: blood gas analyzers. The European Network for Health Technology Assessment (EUnetHTA) core model for diagnostic technologies was applied for evaluating globally marketed blood gas analyzers. Evaluation elements were defined according to available literature and validated using the Delphi method. A HTA model of 71 issues, subdivided into 26 topics and 10 domains, was obtained by interviewing 11 healthcare experts over two rounds of Delphi questionnaires. Ten context parameters were identified in order to define the initial scenario from which the technology assessment was to begin. The model presented offers a systematic and objective structure for the evaluation of blood gas analyzers, which may play a guidance role for healthcare operators approaching the evaluation of such technologies thus improving, in a contextualized fashion, the appropriateness of purchasing.

Tracing a roadmap for vitamin B12 testing using the health technology assessment approach

In our hospital, we are currently working to manage the appropriateness of vitamin B₁₂ (B12) testing. Unfortunately, the classic evidence-based approach is unhelpful in this process and meta-analyzing data on the accuracy of this marker for cobalamin deficiency detection is misleading due to the lack of reference diagnostic methods. The approach currently proposed by the Health Technology Assessment (HTA) enables us to tackle the issue of B₁₂ requests as a "healthcare" problem by considering the position of stakeholders involved in ordering, performing, interpreting the test, and receiving its results. Clinical expectations, methodological issues, and ethical aspects concerning the performance of the test can aid us in providing more guidance on the use of this marker. By building such structured information, hemodialysis patients and pregnant women have emerged as those groups preferentially requiring B₁₂ testing, as it may potentially improve the clinical outcome. To avoid misinterpretation of B₁₂ results more care should be taken in considering its biochemical and biological features, as well as the analytical issues. Spurious values obtained by current automated immunoassays may reflect suboptimal pre-analytical steps as well as known interfering conditions. Furthermore, the harmonization of results by available methods is still a far-reaching goal and the approach to interpret an individual's results should be improved. Tracing a roadmap for B₁₂ testing by exploiting the HTA model to balance the stakeholders' claims and maximizing the patient's outcome may help to manage the marker demand.

Twenty-five-gauge vitrectomy versus 23-gauge vitrectomy in the management of macular diseases: a comparative analysis through a Health Technology Assessment model

Small-gauge vitreoretinal techniques have been shown to be safe and effective in the management of a wide spectrum of vitreoretinal diseases. However, the costs of the new technologies may represent a critical issue for national health systems. The aim of the study is to plan a Health Technology Assessment (HTA) by performing a comparative analysis between the 23- and 25-gauge techniques in the management of macular diseases (epiretinal membranes, macular holes, vitreo-macular traction syndrome). In this prospective study, 45-80-year-old patients undergoing vitrectomy surgery for macular disease were enrolled at the Torino Eye Hospital. In the HTA model we assessed the safety, clinical effectiveness, and cost and financial evaluation of 23-gauge compared with 25-gauge vitrectomies. Fifty patients entered the study; 14 patients underwent 23-gauge vitrectomy and 36 underwent 25-gauge vitrectomy. There was no statistically significant difference in post-operative visual acuity at 1 year between the two groups. No cases of retinal detachment or endophtalmitis were registered at 1-year follow-up. The 23-gauge technique was slightly more expensive than the 25-gauge: the total surgical costs were EUR1217.70 versus EUR1164.84 (p = 0.351). We provide a financial comparison between new vitreoretinal procedures recently introduced in the market and reimbursed by the Italian National Health System and we also stimulate a critical debate about the expensive technocratic model of medicine.

Value-Based Approaches to Healthcare Systems and Pharmacoeconomics Requirements in Asia

Asian healthcare systems are very diverse, representing cultures, political systems and economies from more than 30 countries with varying histories. Despite the diversity in the region, there has been enormous growth in health economics and outcomes research since the beginning of the 21st century. Whilst Japan has seen very limited use of health technology assessment (HTA), South Korea, Taiwan and Thailand have had remarkable success in establishing government agencies for HTA, employing HTA concepts from the UK National Institute for Health and Clinical Excellence (NICE). These three countries are driven by the following common factors: (i) a desire to establish universal healthcare insurance coverage in their respective nations; (ii) the need for rational allocation of scarce resources; (iii) a desire for government to provide leadership in HTA; and (iv) availability of HTA professionals and faculties through international networks. The HTA models introduced by these three countries are both similar to and different from those of HTA agencies in Europe, but might work well as examples for other countries in the region.