 Subjects -> DISABILITY (Total: 103 journals)
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- Lifecycle evaluation of medical devices: supporting or jeopardizing
patient outcomes' A comparative analysis of evaluation models-
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Authors: Harkin; Kathleen R., Sorensen, Jan, Thomas, Steve
First page: 2
Abstract: ObjectivesLack of evidence regarding safety and effectiveness at market entry is driving the need to consider adopting a lifecycle approach to evaluating medical devices, but it is unclear what lifecycle evaluation means. This research sought to explore the tacit meanings of “lifecycle” and “lifecycle evaluation” as embodied within evaluation models/frameworks used for medical devices.MethodsDrawing on qualitative evidence synthesis methods and using an inductive approach, novel methods were developed to identify, appraise, analyze, and synthesize lifecycle evaluation models used for medical devices. Data was extracted (including purpose; audience; characterization; outputs; timing; and type of model) from key texts for coding, categorization, and comparison, exploring embodied meaning across four broad perspectives.ResultsFifty-two models were included in the synthesis. They demonstrated significant heterogeneity of meaning, form, scope, timing, and purpose. The “lifecycle” may represent a single stage, a series of stages, a cycle of innovation, or a system. “Lifecycle evaluation” focuses on the overarching goal of the stakeholder group, and may use a single or repeated evaluation to inform decision-making regarding the adoption of health technologies (Healthcare), resource allocation (Policymaking), investment in new product development or marketing (Trade and Industry), or market regulation (Regulation). The adoption of a lifecycle approach by regulators has resulted in the deferral of evidence generation to the post-market phase.ConclusionsUsing a “lifecycle evaluation” approach to inform reimbursement decision-making must not be allowed to further jeopardize evidence generation and patient safety by accepting inadequate evidence of safety and effectiveness for reimbursement decisions.
PubDate: 2024-01-05
DOI: 10.1017/S026646232300274X
- Using automated text classification to explore uncertainty in NICE
appraisals for drugs for rare diseases-
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Authors: Wiedmann; Lea, Blumenau, Jack, Carroll, Orlagh, Cairns, John
First page: 5
Abstract: ObjectiveThis study examined the application, feasibility, and validity of supervised learning models for text classification in appraisals for rare disease treatments (RDTs) in relation to uncertainty, and analyzed differences between appraisals based on the classification results.MethodsWe analyzed appraisals for RDTs (n = 94) published by the National Institute for Health and Care Excellence (NICE) between January 2011 and May 2023. We used Naïve Bayes, Lasso, and Support Vector Machine models in a binary text classification task (classifying paragraphs as either referencing uncertainty in the evidence base or not). To illustrate the results, we tested hypotheses in relation to the appraisal guidance, advanced therapy medicinal product (ATMP) status, disease area, and age group.ResultsThe best performing (Lasso) model achieved 83.6 percent classification accuracy (sensitivity = 74.4 percent, specificity = 92.6 percent). Paragraphs classified as referencing uncertainty were significantly more likely to arise in highly specialized technology (HST) appraisals compared to appraisals from the technology appraisal (TA) guidance (adjusted odds ratio = 1.44, 95 percent CI 1.09, 1.90, p = 0.004). There was no significant association between paragraphs classified as referencing uncertainty and appraisals for ATMPs, non-oncology RDTs, and RDTs indicated for children only or adults and children. These results were robust to the threshold value used for classifying paragraphs but were sensitive to the choice of classification model.ConclusionUsing supervised learning models for text classification in NICE appraisals for RDTs is feasible, but the results of downstream analyses may be sensitive to the choice of classification model.
PubDate: 2024-01-05
DOI: 10.1017/S0266462323002805
- Response to heterogeneity of tests and platforms in economic evaluations:
synthetic model adoption; derivatives of transferable practice-
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Authors: Jones; Benjamin
First page: 7
PubDate: 2024-01-15
DOI: 10.1017/S0266462323002787
- Quantifying stakeholders’ preference for implantable medical devices in
China: a discrete choice experiment-
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Authors: Wan; Bin, Shen, Jiaojie, Chen, Jiali, Weng, Linjia, Zhao, Peng, Deng, Yunfei, Zhang, Lingli, Zhang, Feiyi, Wang, Yingpeng, Li, Xin, Chang, Feng, Ding, Haixia, Lu, Yun
First page: 8
Abstract: ObjectivesThis study aims to gain insight into each attribute as presented in the value of implantable medical devices, quantify attributes’ strength and their relative importance, and identify the determinants of stakeholders’ preferences.MethodsA mixed-methods design was used to identify attributes and levels reflecting stakeholders’ preference toward the value of implantable medical devices. This design combined literature reviewing, expert’s consultation, one-on-one interactions with stakeholders, and a pilot testing. Based on the design, six attributes and their levels were settled. Among 144 hypothetical profiles, 30 optimal choice sets were developed, and healthcare professionals (decision-makers, health technology assessment experts, hospital administrators, medical doctors) and patients as stakeholders in China were surveyed. A total of 134 respondents participated in the survey. Results were analyzed by mixed logit model and conditional logit model.ResultsThe results of the mixed logit model showed that all the six attributes had a significant impact on respondents’ choices on implantable medical devices. Respondents were willing to pay the highest for medical devices that provided improvements in clinical safety, followed by increased clinical effectiveness, technology for treating severe diseases, improved implement capacity, and innovative technology (without substitutes).ConclusionsThe findings of DCE will improve the current evaluation on the value of implantable medical devices in China and provide decision-makers with the relative importance of the criteria in pricing and reimbursement decision-making of implantable medical devices.
PubDate: 2024-01-15
DOI: 10.1017/S0266462323002799
- The National Health Service urgent cancer referral pathway for suspected
urological cancers: early economic evaluation of a risk prediction test-
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Authors: Cocco; Paola, Smith, Alison Florence, Neal, Richard D., Shinkins, Bethany
First page: 9
Abstract: ObjectivesIn the UK, the number of patients urgently referred for suspected cancer is increasing, and providers are struggling to cope with demand. We explore the potential cost-effectiveness of a new risk prediction test – the PinPoint test – to triage and prioritize patients urgently referred with suspected urological cancers.MethodsTwo simulation models were developed to reflect the diagnostic pathways for patients with (i) suspected prostate cancer, and (ii) bladder or kidney cancer, comparing the PinPoint test to current practice. An early economic analysis was conducted from a UK National Health Service (NHS) perspective. The primary outcomes were the percentage of individuals seen within 2 weeks and health care costs. An exploratory analysis was conducted to understand the potential impact of the Pinpoint test on quality-adjusted life years gained.ResultsAcross both models and applications, the PinPoint test led to more individuals with urological cancer being seen within 2 weeks. Using PinPoint only to prioritize patients led to increased costs overall, whereas using PinPoint to both triage and prioritize patients led to cost savings. The estimated impact on life years gained/lost was very small and highly uncertain.ConclusionsUsing the PinPoint test to prioritize urgent referrals meant that more individuals with urological cancer were seen within 2 weeks, but at additional cost to the NHS. If used as a triage and prioritization tool, the PinPoint test shortens wait times for referred individuals and is cost saving. More data on the impact of short-term delays to diagnosis on health-related quality of life is needed.
PubDate: 2024-01-12
DOI: 10.1017/S0266462324000023
- Acceptability of self-administered antigen test for COVID-19 in the
Philippines-
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Authors: Yang; Jayne Eunice U., Jackarain, Faisal H., de Vergara, Tisha Isabelle M., Santillan, Joshua F., Reyes, Patrick Wincy C., Arellano, Ma Cecilia Victoria B., Garcia, Jainor Timothy U., Samonte, Sheena Jasley G., Marfori, Anne Julienne G., Guerrero, Anna Melissa S.
First page: 10
Abstract: ObjectivesIn response to the Omicron surge in early 2022, the HTA Philippines evaluated the acceptability of Filipinos in using self-administered antigen tests (SAAgTs) as part of COVID-19 HTAs in the Philippines.MethodsScoping review from literature databases was initially conducted to identify preset codes in the use of SAAgT. Preset codes were used to establish the questions for focus group discussions (FGDs). Semi-structured questionnaires were created through Delphi technique. FGDs with four stakeholder groups (i.e., nine healthcare workers [HCWs], seven representatives of at-risk groups, six economic frontliners, and seven representatives of micro–small–medium-sized enterprises) were conducted.ResultsDiscomfort in being a target of stigma and being prescribed an “illness identity” when suspected or confirmed COVID-19-positive, along with lack of confidence to perform self-test, caused hesitancy in self-testing among participants. The need for subsidies for test kits from the government or employers was emphasized to increase its accessibility. Having a designated access point and reporting system for SAAgT was highlighted to avoid nepotism (padrino system attributed to debt of gratitude), inequitable distribution, and lapses in reporting. A participatory approach to education was perceived as crucial to reduce any misconceptions associated with the use of SAAgT.ConclusionsAll FGD groups expressed favorable reviews on the implementation of SAAgT because it can potentially reduce the burden of health facility-administered tests. These findings were considered by the HTA Council in the recommendation of SAAgT as part of the overarching national strategies for the diagnosis and screening of COVID-19.
PubDate: 2024-01-17
DOI: 10.1017/S0266462324000035
- A blueprint for health technology assessment capacity building: lessons
learned from Malta-
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Authors: Abraham; Katharina, Kvamme, Ingelin, Magrin Sammut, Sylvana, de Vries, Simone, Formosa, Tanya, Dupree, Rudy, Corro Ramos, Isaac, Goettsch, Wim, Franken, Margreet
First page: 11
Abstract: ObjectivesThe development and strengthening of health technology assessment (HTA) capacity on the individual and organizational level and the wider environment is relevant for cooperation on HTAs. Based on the Maltese case, we provide a blueprint for building HTA capacity.MethodsA set of activities were developed based on Pichler et al.’s framework and the starting HTA capacity in Malta. Individual level activities focused on strengthening epidemiological and health economic skills through online and in-person training. On the organizational level, a new HTA framework was developed which was subsequently utilized in a shadow assessment. Awareness campaign activities raised awareness and support in the wider environment where HTAs are conducted and utilized.ResultsThe time needed to build HTA capacity exceeded the planned two years accommodating the learning progress of the assessors. In addition to the planned trainings, webinars supplemented the online courses, allowing for more knowledge exchange. The advanced online course was extended over time to facilitate learning next to the assessors’ daily tasks. Training sessions were added to implement the new economic evaluation framework, which was utilized in a second shadow assessment. Awareness by decision-makers was achieved with reports, posters, and an article on the current and developing HTA capacity.ConclusionsIt takes time and much (hands-on) training to build skills for conducting complex assessment such as HTAs. Facilitating exchange with knowledgeable parties is crucial for succeeding as well as the buy-in of local managers motivating staff. Decision-makers need to be on-boarded for the continued success of HTA capacity building.
PubDate: 2024-02-29
DOI: 10.1017/S0266462324000072
- Conducting a health technology assessment in the West Bank, occupied
Palestinian territory: lessons from a feasibility project-
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Authors: Isbeih; Mervett, Heupink, Lieke-Fleur, Qaddomi, Sharif, Salman, Rand, Chola, Lumbwe
First page: 12
Abstract: ObjectivesTo achieve universal health coverage (UHC), countries must make difficult choices to optimize the use of scarce resources. There is a growing interest in using evidence-based priority setting processes, such as Health Technology Assessment (HTA), to inform these decisions. In 2020, the Palestinian Institute of Public Health (PNIPH) and the Norwegian Institute of Public Health (NIPH) initiated a pilot to test the feasibility of coproducing an HTA on breast cancer screening in the West Bank, occupied Palestinian Territory. Additionally, a secondary aim was to test whether using an adaptive HTA (aHTA) approach that searched and transferred published evidence syntheses could increase the speed of HTA production.MethodsThe applied stepwise approach to the HTA is described in detail and can be summarized as defining a core team, topic selection, and prioritization; undertaking the HTA including adaptation using tools from the European Network for HTA (EUnetHTA) and stakeholder engagement; and concluding with dissemination.ResultsThe aHTA approach was faster but not as quick as anticipated, which is attributed to (i) the lack of availability of local evidence for contextualizing findings and (ii) the necessity to build trust between the team and stakeholders. Some delays followed from the COVID-19 pandemic, which showed the importance of good risk anticipation and mitigation. Lastly, other important lessons included the ability of virtual collaborations, the value of capacity strengthening initiatives within low- and middle-income countries (LMICs), and the need for early stakeholder engagement. Overall, the pilot was successfully completed.ConclusionThis was the first HTA of its kind produced in Palestine, and despite the challenges, it shows that HTA analysis is feasible in this setting.
PubDate: 2024-02-15
DOI: 10.1017/S0266462324000084
- Early technology review: towards an expedited pathway
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Authors: Levin; Leslie, Sheldon, Murray, McDonough, Robert S., Aronson, Naomi, Rovers, Maroeska, Gibson, C. Michael, Tunis, Sean Robert, Kuntz, Richard E.
First page: 13
Abstract: ObjectivesEvidence development for medical devices is often focused on satisfying regulatory requirements with the result that health professional and payer expectations may not be met, despite considerable investment in clinical trials. Early engagement with payers and health professionals could allow companies to understand these expectations and reflect them in clinical study design, increasing chances of positive coverage determination and adoption into clinical practice.MethodsAn example of early engagement through the EXCITE International model using an early technology review (ETR) is described which includes engagement with payers and health professionals to better inform companies to develop data that meet their expectations. ETR is based on an early evidence review, a framework of expectations that guides the process and identified gaps in evidence. The first fourteen ETRs were reviewed for examples of advice to companies that provided additional information from payers and health professionals that was thought likely to impact on downstream outcomes or strategic direction. Given that limitations were imposed by confidentiality, examples were genericized.ResultsAdvice through early engagement can inform evidence development that coincides with expectations of payers and health professionals through a structured, objective, evidence-based approach. This could reduce the risk of business-related adverse outcomes such as failure to secure a positive coverage determination and/or acceptance by expert health professionals.ConclusionsEarly engagement with key stakeholders exemplified by the ETR approach offers an alternative to the current approach of focusing on regulatory expectations. This could reduce the time to reimbursement and clinical adoption and benefit patient outcomes and/or health system efficiencies.
PubDate: 2024-01-29
DOI: 10.1017/S0266462324000047
- The cost-effectiveness of germline BRCA testing-guided olaparib treatment
in metastatic castration resistant prostate cancer-
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Authors: Teppala; Srinivas, Scuffham, Paul A., Tuffaha, Haitham
First page: 14
Abstract: BackgroundOlaparib targets the DNA repair pathways and has revolutionized the management of metastatic castration resistant prostate cancer (mCRPC). Treatment with the drug should be guided by genetic testing; however, published economic evaluations did not consider olaparib and genetic testing as codependent technologies. This study aims to assess the cost-effectiveness of BRCA germline testing to inform olaparib treatment in mCRPC.MethodsWe conducted a cost-utility analysis of germline BRCA testing-guided olaparib treatment compared to standard care without testing from an Australian health payer perspective. The analysis applied a decision tree to indicate the germline testing or no testing strategy. A Markov multi-state transition approach was used for patients within each strategy. The model had a time horizon of 5 years. Costs and outcomes were discounted at an annual rate of 5 percent. Decision uncertainty was characterized using probabilistic and scenario analyses.ResultsCompared to standard care, BRCA testing-guided olaparib treatment was associated with an incremental cost of AU$7,841 and a gain of 0.06 quality-adjusted life-years (QALYs). The incremental cost-effectiveness ratio (ICER) was AU$143,613 per QALY. The probability of BRCA testing-guided treatment being cost effective at a willingness-to-pay threshold of AU$100,000 per QALY was around 2 percent; however, the likelihood for cost-effectiveness increased to 66 percent if the price of olaparib was reduced by 30 percent.ConclusionThis is the first study to evaluate germline genetic testing and olaparib treatment as codependent technologies in mCRPC. Genetic testing-guided olaparib treatment may be cost-effective with significant discounts on olaparib pricing.
PubDate: 2024-03-05
DOI: 10.1017/S0266462324000011
- A health technology assessment of personalized nutrition interventions
using the EUnetHTA HTA Core Model-
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Authors: Galekop; Milanne Maria Johanna, del Bas, Josep Maria, Calder, Philip C., Uyl-De Groot, Carin A., Redekop, William Ken
First page: 15
Abstract: ObjectivesPoor nutrition links to chronic diseases, emphasizing the need for optimized diets. The EU-funded project PREVENTOMICS, introduced personalized nutrition to address this. This study aims to perform a health technology assessment (HTA) comparing personalized nutrition interventions developed through this project, with non-personalized nutrition interventions (control) for people with normal weight, overweight, or obesity. The goal is to support decisions about further development and implementation of personalized nutrition.MethodsThe PREVENTOMICS interventions were evaluated using the European Network for HTA Core Model, which includes a methodological framework that encompasses different domains for value assessment. Information was gathered via [1] different statistical analyses and modeling studies, [2] questions asked of project partners and, [3] other (un)published materials.ResultsClinical trials of PREVENTOMICS interventions demonstrated different body mass index changes compared to control; differences ranged from −0.80 to 0.20 kg/m2. Long-term outcome predictions showed generally improved health outcomes for the interventions; some appeared cost-effective (e.g., interventions in UK). Ethical concerns around health inequality and the lack of specific legal regulations for personalized nutrition interventions were identified. Choice modeling studies indicated openness to personalized nutrition interventions; decisions were primarily affected by intervention’s price.ConclusionsPREVENTOMICS clinical trials have shown promising effectiveness with no major safety concerns, although uncertainties about effectiveness exist due to small samples (n=60–264) and short follow-ups (10–16 weeks). Larger, longer trials are needed for robust evidence before implementation could be considered. Among other considerations, developers should explore financing options and collaborate with policymakers to prevent exclusion of specific groups due to information shortages.
PubDate: 2024-03-06
DOI: 10.1017/S0266462324000060
- Evaluating clinical decision support software (CDSS): challenges for
robust evidence generation-
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Authors: Laka; Mah, Carter, Drew, Merlin, Tracy
First page: 16
Abstract: ObjectivesComputerized clinical decision support software (CDSS) are digital health technologies that have been traditionally categorized as medical devices. However, the evaluation frameworks for traditional medical devices are not well adapted to assess the value and safety of CDSS. In this study, we identified a range of challenges associated with CDSS evaluation as a medical device and investigated whether and how CDSS are evaluated in Australia.MethodsUsing a qualitative approach, we interviewed 11 professionals involved in the implementation and evaluation of digital health technologies at national and regional levels. Data were thematically analyzed using both data-driven (inductive) and theory-based (deductive) approaches.ResultsOur results suggest that current CDSS evaluations have an overly narrow perspective on the risks and benefits of CDSS due to an inability to capture the impact of the technology on the sociotechnical environment. By adopting a static view of the CDSS, these evaluation frameworks are unable to discern how rapidly evolving technologies and a dynamic clinical environment can impact CDSS performance. After software upgrades, CDSS can transition from providing information to specifying diagnoses and treatments. Therefore, it is not clear how CDSS can be monitored continuously when changes in the software can directly affect patient safety.ConclusionOur findings emphasize the importance of taking a living health technology assessment approach to the evaluation of digital health technologies that evolve rapidly. There is a role for observational (real-world) evidence to understand the impact of changes to the technology and the sociotechnical environment on CDSS performance.
PubDate: 2024-02-08
DOI: 10.1017/S0266462324000059
- HTA community perspectives on the use of patient preference information:
lessons learned from a survey with members of HTA bodies-
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Authors: Hiligsmann; Mickael, Liden, Barry, Beaudart, Charlotte, Germeni, Evi, Hanna, Alissa, Joshi, Maya, Koola, Catherine P., Stein, Barry, Tonkinson, Mandy, Marshall, Deborah, Fifer, Simon
First page: 17
Abstract: This research sought to assess whether and how patient preference (PP) data are currently used within health technology assessment (HTA) bodies and affiliated organizations involved in technology/drug appraisals and assessments. An exploratory survey was developed by the PP Project Subcommittee of the HTA International Patient and Citizen Involvement Interest Group to gain insight into the use, impact, and role of PP data in HTA, as well as the perceived barriers to its incorporation. Forty members of HTA bodies and affiliated organizations from twelve countries completed the online survey. PP data were reported to be formally considered as part of the HTA evidence review process by 82.5 percent of the respondents, while 39.4 percent reported that most of the appraisals and assessments within their organization in the past year had submitted PP data. The leading reason for why PP data were not submitted in most assessments was time/resource constraints followed by lack of clarity on PP data impact. Participants reported that PP data had a moderate level of influence on the deliberative process and outcome of the decision, but a higher level of influence on the decision’s quality. Most (81.8 percent) felt patient advocacy groups should be primarily responsible for generating and submitting this type of evidence. Insights from the survey confirm the use of PP data in HTA but reveal barriers to its broader and more meaningful integration. Encouragingly, participants believe obstacles can be overcome, paving the way for a second phase of research involving in-depth collaborative workshops with HTA representatives.
PubDate: 2024-03-05
DOI: 10.1017/S0266462324000138
- Preparing future doctors for evidence-based practice: a study on health
technology assessment awareness and its predictors in Malaysia-
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Authors: Mohamad; Nur Farhana, Mansor, Zawiah, Mahmud, Aidalina, Mohamed Ghazali, Izzuna Mudla, Sarimin, Roza
First page: 18
Abstract: ObjectivesTo determine the level of awareness of health technology assessment (HTA) and its predictors among clinical year medical students in public universities in Klang Valley, Malaysia.MethodsA cross-sectional study using the stratified random sampling method was conducted among clinical year medical students in four public universities in Klang Valley, Malaysia. Data on the level of awareness of HTA and its associated factors were collected using a self-administered online questionnaire. Descriptive, bivariate, and multivariate analyses were performed using IBM SPSS version 27 to determine the level of awareness of HTA and its predictors.ResultsMajority (69 percent) of participants had a low level of awareness of HTA. The predictors of high-level awareness of HTA were attitude toward HTA (adjusted odds ratio (AOR) = 7.417, 95 percent confidence interval (CI): 3.491, 15.758), peer interaction on HTA (AOR = 0.320, 95 percent CI: 0.115, 0.888), and previous training on HTA (AOR = 4.849, 95 percent CI: 1.096, 21.444).ConclusionsMost future doctors in public universities exhibit a low awareness of HTA. This study highlights the interplay between attitudes toward HTA, peer interaction, and previous training as influential predictors of HTA awareness. An integrated and comprehensive educational approach is recommended to cultivate a positive attitude and harness the positive aspects of peer interaction while mitigating the potential negative impact of misconceptions. Emphasizing early exposure to HTA concepts through structured programs is crucial for empowering the upcoming generation of healthcare professionals, enabling them to navigate HTA complexities and contribute to evidence-based healthcare practices in Malaysia and beyond.
PubDate: 2024-02-28
DOI: 10.1017/S0266462324000102
- Application of natural language processing to predict final recommendation
of Brazilian health technology assessment reports-
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Authors: Cardoso; Marilia Mastrocolla de Almeida, Machado-Rugolo, Juliana, Thabane, Lehana, da Rocha, Naila Camila, Barbosa, Abner Mácula Pacheco, Komoda, Denis Satoshi, de Almeida, Juliana Tereza Coneglian, Curado, Daniel da Silva Pereira, Weber, Silke Anna Theresa, de Andrade, Luis Gustavo Modelli
First page: 19
Abstract: IntroductionHealth technology assessment (HTA) plays a vital role in healthcare decision-making globally, necessitating the identification of key factors impacting evaluation outcomes due to the significant workload faced by HTA agencies.ObjectivesThe aim of this study was to predict the approval status of evaluations conducted by the Brazilian Committee for Health Technology Incorporation (CONITEC) using natural language processing (NLP).MethodsData encompassing CONITEC’s official report summaries from 2012 to 2022. Textual data was tokenized for NLP analysis. Least Absolute Shrinkage and Selection Operator, logistic regression, support vector machine, random forest, neural network, and extreme gradient boosting (XGBoost), were evaluated for accuracy, area under the receiver operating characteristic curve (ROC AUC) score, precision, and recall. Cluster analysis using the k-modes algorithm categorized entries into two clusters (approved, rejected).ResultsThe neural network model exhibited the highest accuracy metrics (precision at 0.815, accuracy at 0.769, ROC AUC at 0.871, and recall at 0.746), followed by XGBoost model. The lexical analysis uncovered linguistic markers, like references to international HTA agencies’ experiences and government as demandant, potentially influencing CONITEC’s decisions. Cluster and XGBoost analyses emphasized that approved evaluations mainly concerned drug assessments, often government-initiated, while non-approved ones frequently evaluated drugs, with the industry as the requester.ConclusionsNLP model can predict health technology incorporation outcomes, opening avenues for future research using HTA reports from other agencies. This model has the potential to enhance HTA system efficiency by offering initial insights and decision-making criteria, thereby benefiting healthcare experts.
PubDate: 2024-04-12
DOI: 10.1017/S0266462324000163
- Introduction of hospital-based health technology assessment in China:
experiences from seven pilot hospitals-
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Authors: Lyu; Lanting, Shi, Wenkai, Kidholm, Kristian, Bai, Fei, Lin, Xia, Fu, Jinlan, Li, Tianqing, Li, Guoxun, Luo, Li, Wang, Ting, Yang, Hai
First page: 20
Abstract: ObjectivesThis study aimed to introduce a pilot program for hospital-based health technology assessment (HB-HTA) in China and present the participants’ experiences based on seven case studies from seven tertiary hospitals.MethodsOne-year pilot projects were initiated at the beginning of 2018. Seven pilot hospitals were closely followed from the beginning until the completion of their pilot HTA project. Regular interviews were conducted with the hospital managers leading the HB-HTA projects and key members of the special HTA teams. Observations were made based on field trips and written HTA reports.ResultsThree pilot projects evaluated the use of medical consumables, three evaluated the use of surgical or medical interventions, and one evaluated an innovative management model for ventilators. Real-world data were collected from all the pilot projects to assist with the assessments. Most HB-HTA pilot projects achieved remarkable results such as improvements in economic efficiency; however, there were also obvious deficiencies such as the lack of a necessary cost-effectiveness analysis.ConclusionsThe results varied among the seven HB-HTA pilot projects. The HB-HTA pilot program was implemented to promote the use of HB-HTA in hospital decision making in China. At the same time, HB-HTA in China faces challenges. We have made some policy recommendations based on the findings of the pilot projects.
PubDate: 2024-01-29
DOI: 10.1017/S0266462323002738
- Design of a multiple criteria decision analysis framework for prioritizing
high-impact health technologies in a regional health service-
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Authors: Sánchez-Martínez; Fernando-Ignacio, Abellán-Perpiñán, José-María, Martínez-Pérez, Jorge-Eduardo, Gómez-Torres, Jorge-Luis
First page: 21
Abstract: ObjectivesThis study aims to develop a framework for establishing priorities in the regional health service of Murcia, Spain, to facilitate the creation of a comprehensive multiple criteria decision analysis (MCDA) framework. This framework will aid in decision-making processes related to the assessment, reimbursement, and utilization of high-impact health technologies.MethodBased on the results of a review of existing frameworks for MCDA of health technologies, a set of criteria was proposed to be used in the context of evaluating high-impact health technologies. Key stakeholders within regional healthcare services, including clinical leaders and management personnel, participated in a focus group (n = 11) to discuss the proposed criteria and select the final fifteen. To elicit the weights of the criteria, two surveys were administered, one to a small sample of healthcare professionals (n = 35) and another to a larger representative sample of the general population (n = 494).ResultsThe responses obtained from health professionals in the weighting procedure exhibited greater consistency compared to those provided by the general public. The criteria more highly weighted were “Need for intervention” and “Intervention outcomes.” The weights finally assigned to each item in the multicriteria framework were derived as the equal-weighted sum of the mean weights from the two samples.ConclusionsA multi-attribute function capable of generating a composite measure (multicriteria) to assess the value of high-impact health interventions has been developed. Furthermore, it is recommended to pilot this procedure in a specific decision context to evaluate the efficacy, feasibility, usefulness, and reliability of the proposed tool.
PubDate: 2024-04-05
DOI: 10.1017/S0266462324000205
- Value-based payment for high-cost treatments in Singapore: a qualitative
study of stakeholders’ perspectives-
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Authors: Bayani; Diana Beatriz, Wee, Hwee Lin
First page: 22
Abstract: ObjectivesThe rising costs of drugs have necessitated the exploration of innovative payment methods in healthcare systems. Risk-sharing agreements (RSAs) have been implemented in many countries as a value-based payment mechanism to manage the uncertainty associated with expensive technologies. This study aimed to investigate stakeholder perspectives on value-based payment in the Singaporean context, providing insights for future directions in health technology assessment and financing.MethodsThis descriptive qualitative inquiry involved participant interviews conducted between October 2021 and April 2022. Thematic analysis was conducted in two phases to analyze the interview transcripts.ResultsSeventeen respondents participated in the study, and five key themes emerged from the analysis. Stakeholders viewed RSAs as moderately positive, despite limited experience with them. They emphasized the importance of clearly defining objectives and establishing transparent criteria for implementing these schemes. The current data infrastructure was identified as both a barrier and facilitator, as RSAs impose administrative burdens. To successfully implement these payment mechanisms, capacity building, and effective stakeholder engagement that fosters mutual trust and cocreation are crucial.ConclusionThis study confirms previously identified barriers and facilitators to successful RSA implementation while contextualizing them within the Singaporean setting. The findings suggest that value-based payment has the potential to address uncertainty and improve access to healthcare technologies, but these barriers must be addressed for the schemes to be effective.
PubDate: 2024-04-17
DOI: 10.1017/S0266462324000217
- A systematic review on the appropriate discounting rates for the economic
evaluation of gene therapies: whether a specific approach is justified to
tackle the challenges'-
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Authors: Qiu; Tingting, Aballéa, Samuel, Pochopień, Michal, Toumi, Mondher, Dussart, Claude, Yan, Dan
First page: 23
Abstract: ObjectivesDiscounting the cost and effect for health intervention is a controversial topic over the last two decades. In particular, the cost-effectiveness of gene therapies is especially sensitive to the discount rate because of the substantial delay between the upfront cost incurred and long-lasing clinical benefits received. This study aims to investigate the influence of employing alternative discount rates on the incremental cost-effectiveness ratio (ICER) of gene therapies.MethodsA systematic review was conducted to include health economic evaluations of gene therapies that were published until April 2023.ResultsSensitivity or scenario analysis indicated that discount rate represented one of the most influential factors for the ICERs of gene therapies. Discount rate for cost and benefit was positively correlated with the cost-effectiveness of gene therapies, that is, a lower discount rate significantly improves the ICERs. The alternative discount rate employed in some cases could be powerful to alter the conclusion on whether gene therapies are cost-effective and acceptable for reimbursement.ConclusionsAlthough discount rate will have substantial influence on the ICERs of gene therapies, there lacks solid evidence to justify a different discounting rule for gene therapies. However, it is proposed that the discount rate in the reference case should be updated to reflect the real-time preference, which in turn will affect the ICERs and reimbursement of gene therapies more profoundly than conventional therapies.
PubDate: 2024-05-10
DOI: 10.1017/S0266462324000096
- Health technology assessment in traditional and complementary medicine: a
scoping review of international activity and examples of acupuncture-
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Authors: Ai; Dan-Dan, Sui, Bin-Yan, Duan, Cheng-A-Xin, Xu, Qian, Zhao, Kun
First page: 24
Abstract: BackgroundTraditional therapies are crucial in maintaining and improving human well-being. China’s healthcare policymakers are attempting to use health technology assessment (HTA) as a decision-making supportive tool. The value assessment framework for Chinese patent medicine (CPM) has been developed and is being adopted and validated widely by research institutions. Subsequently, the healthcare decision-makers particularly hanker for the value framework of traditional non-pharmacological therapies.MethodsTo construct a practical value framework for traditional non-pharmacological therapies, a scoping review methodology was adopted to identify the evaluation domains and obstacles. A search, screening, and analysis process was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR). Evidence was retrieved from scientific databases and HTA agencies’ websites.ResultsThe search strategy identified 5 guidelines records and 17 acupuncture HTA reports. By synthesizing the valuable reports of CPM and acupuncture evaluation in representative countries, this study found that Mainland China was promoting the comprehensive value assessment of CPM, whereas the United Kingdom, Singapore, Canada, the United States, and Malaysia had carried out the HTA evaluation of acupuncture for various conditions among which chronic pain was the most common. UK and Singapore applied the HTA results to support acupuncture reimbursement decisions. Three domains, including safety, effectiveness, and economy, were commonly adopted. The identified biggest challenge of evaluating traditional non-pharmacological therapies is the scarce high-quality clinical evidence.ConclusionsThis study identified value domains and issues of traditional therapies, and pointed out future research implications, to promote the development value framework of traditional therapies.
PubDate: 2024-04-05
DOI: 10.1017/S0266462324000151
- Health technology assessment and healthcare environmental sustainability:
Prioritizing effort and maximizing impact-
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Authors: Hensher; Martin
First page: 25
Abstract: The growing global focus on and sense of urgency toward improving healthcare environmental sustainability and moving to low-carbon and resilient healthcare systems is increasingly mirrored in discussions of the role of health technology assessment (HTA). This Perspective considers how HTA can most effectively contribute to these goals and where other policy tools may be more effective in driving sustainability, especially given the highly limited pool of resources available to conduct environmental assessments within HTA. It suggests that HTA might most productively focus on assessing those technologies that have intrinsic characteristics which may cause specific environmental harms or vulnerabilities, while the generic environmental impacts of most other products may be better addressed through other policy and regulatory mechanisms.
PubDate: 2024-05-10
DOI: 10.1017/S0266462324000230
- Experiences of patient organizations’ involvement in medicine appraisal
and reimbursement processes in Finland – a qualitative study-
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Authors: Tran Minh; Mirjami, Airaksinen, Marja, Lahti, Tuuli
First page: 26
Abstract: BackgroundThis study investigated how patient representatives have experienced their involvement in medicines appraisal and reimbursement processes with the Council for Choices in Health Care in Finland (COHERE) and the Pharmaceuticals Pricing Board (PPB) and how authorities perceive the role of patient organizations’ input.MethodsSemi-structured thematic individual and pair interviews were conducted in 2021 with representatives (n = 14) of patient organizations and government officials (n = 7) of the Ministry of Social Affairs and Health. The interview data were analyzed using qualitative content analysis.ResultsPatient representatives expressed their appreciation for the PPB and the COHERE in creating consultation processes and systematic models that support involvement. However, there were many challenges: patient representatives were uncertain about how their submissions were utilized in official processes and whether their opinions had any significance in decision-making. Patients or patient organizations lack representation in appraisal and decision-making bodies, and patient representatives felt that decision-making lacked transparency. The importance of patient involvement was highlighted by the authorities, but they also emphasized that the patient organizations’ contributions were complementary to the other materials. Submissions regarding the medications used to treat rare diseases and those with limited research evidence were considered particularly valuable. However, the submissions may not necessarily have a direct impact on decisions.ConclusionsThe interviews provided relevant input for the development of involvement processes at the PPB and COHERE. The interviews confirmed the need for increased transparency in the medicines assessment, appraisal, and decision-making procedures in Finland.
PubDate: 2024-07-02
DOI: 10.1017/S0266462324000229
- A situational and stakeholder analysis of health technology assessment in
Zimbabwe-
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Authors: Dzingirai; Blessing, Dambiko, Prudence, Matyanga, Celia, Manyau, Pinky, Tagwireyi, Dexter, Postma, Maarten J., Mafirakureva, Nyashadzaishe, van Hulst, Marinus
First page: 27
Abstract: ObjectivesSystematic priority setting is necessary for achieving high-quality healthcare using limited resources in low- and middle-income countries. Health technology assessment (HTA) is a tool that can be used for systematic priority setting. The objective of this study was to conduct a stakeholder and situational analysis of HTA in Zimbabwe.MethodsWe identified and analyzed stakeholders using the International Decision Support Initiative checklist. The identified stakeholders were invited to an HTA workshop convened at the University of Zimbabwe. We used an existing HTA situational analysis questionnaire to ask for participants’ views on the need, demand, and supply of HTA. A follow-up survey was done among representatives of stakeholder organizations that failed to attend the workshop. We reviewed two health policy documents relevant to the HTA. Qualitative data from the survey and document review were analyzed using thematic analysis.ResultsForty-eight organizations were identified as stakeholders for HTA in Zimbabwe. A total of 41 respondents from these stakeholder organizations participated in the survey. Respondents highlighted that the HTA was needed for transparent decision making. The demand for HTA-related evidence was high except for the health economic and ethics dimensions, perhaps reflecting a lack of awareness. Ministry of Health was listed as a major supplier of HTA data.ConclusionsThere is no formal HTA agency in the Zimbabwe healthcare system. Various institutions make decisions on prioritization, procurement, and coverage of health services. The activities undertaken by these organizations provide context for the institutionalization of HTA in Zimbabwe.
PubDate: 2024-04-29
DOI: 10.1017/S0266462324000266
- Deliberative process of health technology reassessment by health
technology assessment agency in Korea-
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Authors: Shin; Sangjin, Kim, Yunjung, Choi, Jieun, Park, Jung Yul
First page: 28
Abstract: In 2019, the National Evidence-based Healthcare Collaborating Agency (NECA) in Korea established a health technology reassessment (HTR) system to manage the life cycle of health technologies and develop operational measures promoting the efficient use of healthcare resources. The purpose of this study is to introduce the detailed implementation process and practical functional methods of the HTR implemented by NECA.The HTR is a structured multidisciplinary method for analyzing health technologies currently used in the healthcare system based on the latest information on parameters, such as clinical safety, effectiveness, and cost-effectiveness of optimizing the use of healthcare resources as well as social and ethical issues. All decision-making stages of the HTR are carefully reviewed and transparently managed. The HTR committee makes significant decisions, and the subcommittee decides the details related to the assessment process.Since the pilot began in 2018, 262 cases have been reassessed, of which, 126 cases (48.1 percent) were health services not covered by the National Health Insurance (NHI). Over the past 5 years, approximately 130 recommendations for the in-use technologies were determined by the HTR committee. In the near future, it will be necessary to officially develop and establish a Korean HTR system and a legal foundation to optimize the NHI system.
PubDate: 2024-05-13
DOI: 10.1017/S026646232400014X
- Assessing medical devices: a qualitative study from the validate
perspective-
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Authors: Bloemen; Bart, Oortwijn, Wija
First page: 29
Abstract: ObjectivesOur objective was to explore procedures and methods used at health technology assessment (HTA) agencies for assessing medical devices and the underlying views of HTA practitioners about appropriate methodology to identify challenges in adopting new methodologies for assessing devices. We focused on the role of normative commitments of HTA practitioners in the adoption of new methods.MethodsAn online survey, including questions on procedures, scoping, and assessments of medical devices, was sent to members of the International Network of Agencies for Health Technology Assessment. Interviews were conducted with survey respondents and HTA practitioners involved in assessments of transcatheter aortic valve implantation to gain an in-depth understanding of choices made and views about assessing medical devices. Survey and interview questions were inspired by the “values in doing assessments of health technologies” approach towards HTA, which states that HTA addresses value-laden questions and information.ResultsThe current practice of assessing medical devices at HTA agencies is predominantly based on procedures, methods, and epistemological principles developed for assessments of drugs. Both practical factors (available time, demands of decision-makers, existing legal frameworks, and HTA guidelines), as well as commitments of HTA practitioners to principles of evidence-based medicine, make the adoption of a new methodology difficult.ConclusionsThere is a broad recognition that assessments of medical devices may need changes in HTA methodology. In order to realize this, the HTA community may require both a discussion on the role, responsibility, and goals of HTA, and resulting changes in institutional context to adopt new methodologies.
PubDate: 2024-04-24
DOI: 10.1017/S0266462324000254
- Development of a disease-specific health utility score for chronic
obstructive pulmonary disease from a discrete choice experiment patient
preference study-
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Authors: Jones; Byron, Ryan, Mandy, Cook, Nigel S., Gutzwiller, Florian S.
First page: 30
Abstract: ObjectivesWhile patient input to health technology assessment (HTA) has traditionally been of a qualitative nature, there is increasing interest to integrate quantitative evidence from patient preference studies into HTA decision making. Preference data can be used to generate disease-specific health utility data. We generated a health utility score for patients with chronic obstructive pulmonary disease (COPD) and consider its use within HTAs.MethodsBased on qualitative research, six symptoms were identified as important to COPD patients: shortness of breath, exacerbations, chronic cough, mucus secretion, sleep disturbance, and urinary incontinence. We employed a discrete choice experiment (DCE) and the random parameter logistic regression technique to estimate utility scores for all COPD health states. The relationship between patients’ COPD health utility scores, self-perceived COPD severity, and EQ-5D-3L utility scores was analyzed, with data stratified according to disease severity and comorbidity subgroups.ResultsThe COPD health utility score had face validity, with utility scores negatively correlated with patients’ self-perceived COPD severity. The correlation between the COPD health utility scores and EQ-5D-3L values was only moderate. While patient EQ-5D-3L scores were impacted by comorbidities, the COPD health utility score was less impacted by comorbid conditions.ConclusionsOur COPD utility measure, derived from a DCE, provides a patient-centered health utility score and is more sensitive to the COPD health of the individual and less sensitive to other comorbidities. This disease-specific instrument should be considered alongside generic health-related quality of life instruments when valuing new COPD therapies in submissions to licensing and reimbursement agencies.
PubDate: 2024-05-02
DOI: 10.1017/S0266462324000242
- Remembering Ken Stein
-
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Authors: Husereau; Don, Claxton, Karl
First page: 31
PubDate: 2024-05-10
DOI: 10.1017/S0266462324000278
- A systematic review of the cost and cost-effectiveness of immunoglobulin
treatment in patients with hematological malignancies-
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Authors: Carrillo de Albornoz; Sara, Chai, Khai Li, Higgins, Alisa M., Petrie, Dennis, Wood, Erica M., McQuilten, Zoe K.
First page: 32
Abstract: ObjectivesPatients with hematological malignancies are likely to develop hypogammaglobulinemia. Immunoglobulin (Ig) is commonly given to prevent infections, but its overall costs and cost-effectiveness are unknown.MethodsA systematic review was conducted following the PRISMA guidelines to assess the evidence on the costs and cost-effectiveness of Ig, administered intravenously (IVIg) or subcutaneously (SCIg), in adults with hematological malignancies.ResultsSix studies met the inclusion criteria, and only two economic evaluations were identified; one cost-utility analysis (CUA) of IVIg versus no Ig, and another comparing IVIg with SCIg. The quality of the evidence was low. Compared to no treatment, Ig reduced hospitalization rates. One study reported no significant change in hospitalizations following a program to reduce IVIg use, and an observational study comparing IVIg with SCIg suggested that there were more hospitalizations with SCIg but lower overall costs per patient. The CUA comparing IVIg versus no Ig suggested that IVIg treatment was not cost-effective, and the other CUA comparing IVIg to SCIg found that home-based SCIg was more cost-effective than IVIg, but both studies had serious limitations.ConclusionsOur review highlighted key gaps in the literature: the cost-effectiveness of Ig in patients with hematological malignancies is very uncertain. Despite increasing Ig use worldwide, there are limited data regarding the total direct and indirect costs of treatment, and the optimal use of Ig and downstream implications for healthcare resource use and costs remain unclear. Given the paucity of evidence on the costs and cost-effectiveness of Ig treatment in this population, further health economic research is warranted.
PubDate: 2024-05-16
DOI: 10.1017/S026646232400028X
- Can requests for real-world evidence by the French HTA body be planned' An
exhaustive retrospective case–control study of medicinal products
appraisals from 2016 to 2021-
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Authors: Fernandez; Judith, Babin, Céleste, Thomassin, Camille, Pelon, Floriane, Kelley, Sophie, Cochat, Pierre, Galbraith, Margaret, Berdaï, Driss, Pariente, Antoine, Salvo, Francesco, Vanier, Antoine
First page: 33
Abstract: ObjectivesIn France, decisions for pricing and reimbursement for medicinal products are based on appraisals performed by the National authority for health (Haute Autorité de Santé (HAS)). During the appraisal process, additional real-world evidence can be requested as “Post-Registration Studies” (PRS) when there are uncertainties in evidence that could be resolved by additional data collection. To facilitate PRS planning, a retrospective exploratory analysis was conducted to identify the characteristics of medicinal products associated with a PRS request.MethodsThis analysis encompassed all appraisals finalized between January 1, 2016 and December 31, 2021 and compared products for which the appraisal led to a PRS request with those that did not.ResultsSix hundred positive opinions for reimbursement were identified, with a PRS request present in 17 percent (n = 103) of cases. The independent characteristics associated with a PRS request were a mild or moderate clinical benefit score, a major to moderate or minor clinical added value score, previous availability under an early access program, and certain therapeutic areas (neurology, pulmonology, and endocrinology). These findings suggest two different profiles of PRS requests: (i) products for which there is uncertainty in the size of the clinical benefit and (ii) innovative products for which a substantial benefit is expected but uncertainties persist.ConclusionsThese results will assist health technology developers to better anticipate data generation to promptly address uncertainties identified by HAS. It may also help HAS and other assessment agencies to work together to improve postlaunch evidence generation according to the characteristics of the medicinal products.
PubDate: 2024-05-17
DOI: 10.1017/S0266462324000291
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