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1.
J Manag Care Spec Pharm ; 28(10): 1190-1196, 2022 Oct.
Article in English | MEDLINE | ID: mdl-36125060

ABSTRACT

BACKGROUND: Recent attention to value frameworks has highlighted limitations of current conventional value and health technology assessment (V/HTA) methods (eg, cost-effectiveness). Multicriteria decision analysis (MCDA) has potential as a supplemental tool to incorporate additional value criteria into conventional value assessment. OBJECTIVE: To conduct a pilot study to illustrate the impact of an MCDA approach on the value perceptions of hypothetical treatment profiles from a multistakeholder panel. METHODS: Participants voted on value perceptions of 2 hypothetical treatments with similar cost-effectiveness evidence: Treatment A for aggressive B-cell non-Hodgkin lymphoma in adults and treatment B for episodic migraine in adults. Participants voted treatments A and B as low, intermediate, or high value before and after a weighting exercise on prespecified, additional value criteria. Weights from participants were used to calculate treatment-specific MCDA scores from 0 (least favorable) to 100 (most favorable) and were presented to participants for a second value-perception vote. Analyses compared changes in value perceptions within treatments A and B post-MCDA exercise. RESULTS: Before considering MCDA scores for treatment A, 0% of participants considered it to be low, 52% intermediate, and 48% high value. After considering MCDA scores for treatment A, 4% considered it low, 29% intermediate, and 67% high value. Both before and after considering MCDA scores for treatment B, 13%, considered it low, 57% intermediate, and 30% high value. Mean MCDA scores for treatments A and B were 67 and 63, respectively. Of all stakeholders, 41% altered their perception of value for treatment A (9% negatively and 32% positively) and, separately, 45% for treatment B (23% both negatively and positively) after considering MCDA scores. CONCLUSIONS: With nearly half of participants altering their perception of value after consideration of additional value criteria, findings support the need for a more inclusive and flexible value assessment process. DISCLOSURES: This study was funded by The National Pharmaceutical Council. Dr Perfetto was employed by the National Health Council (NHC) at the time this work was completed, and all honoraria and consulting and travel fees were paid to the NHC. The NHC is a not-for-profit, membership organization. It is supported through membership dues and sponsorship funds. The complete list of members and sponsors is located on the NHC's website at www.nationalhealthcouncil.org. She is also an advisor for the Brain Injury Association of America, Dan Lewis Foundation, and Canter for Medical Technology Policy.


Subject(s)
Decision Support Techniques , Technology Assessment, Biomedical , Adult , Female , Humans , Perception , Pharmaceutical Preparations , Pilot Projects , Technology Assessment, Biomedical/methods , United States
2.
Article in English | MEDLINE | ID: mdl-36141507

ABSTRACT

The Health Technology Assessment is based on the evaluation of the characteristics and effects of health technologies to properly spend resources in healthcare. For the needs of hospitals, a special HTA department, Hospital-Based Health Technology Assessment (HB-HTA), has been established. The objective of the article is to assess the possibility of implementing a functional model with the coordinating role of Health Departments of the Voivodeship Offices with the support of the National Health Fund and the HTA Agency in Poland. Ten semi-structured interviews were conducted with representatives from eight Voivodeship Offices. The interviews consisted of nine questions related to the possibility of introducing a functional model with the participation of the Voivodeship Office. The material was divided into seven codes relating to the questions included in the topic guide. From the perspective of Voivodeship Offices, HB-HTA could contribute to the improvement of the methodology used in the Evaluation Instrument of Investment Motions in Health. The lack of personnel in the Voivodeship Offices was identified as one of the greatest barriers to the implementation of HB-HTA. These public administration units should not be involved in the hospital health technology assessment process.


Subject(s)
Hospitals , Technology Assessment, Biomedical , Delivery of Health Care , Poland
3.
Article in English | MEDLINE | ID: mdl-36141691

ABSTRACT

Kazakhstan strives to obtain Universal Health Coverage (UHC) by using health technology assessment (HTA) for determining their health benefit package. This paper reports on employing evidence-informed deliberative processes (EDPs), a practical and stepwise approach to enhance legitimate health benefit package design in Kazakhstan. METHODS: The Ministry of Health of Kazakhstan approved the operationalization and application of EDPs during March 2019 and December 2020. We used a combination of desk research, conducting HTA, online surveys as well as a face-to-face workshop in Nur-Sultan, Kazakhstan, and two online workshops to prioritize 25 selected health technologies. During the latter, we tested two alternative approaches to prioritization: quantitative multicriteria decision analysis (MCDA) and the use of decision rules. RESULTS: For each of the HTA reports, evidence summaries were developed according to the decision criteria (safety, social priority disease, severity of disease, effectiveness, cost-effectiveness, level of evidence, financial risk protection and budget impact). When appraising the evidence, the advisory committee preferred using quantitative MCDA, and only when this would result in any controversy could decision rules be applied. CONCLUSIONS: Despite several challenges, including a partial disruption because of the COVID-19 pandemic, implementation of the process will likely play a key role in determining an evidence-informed and transparent health benefit package.


Subject(s)
COVID-19 , Pandemics , COVID-19/epidemiology , Humans , Kazakhstan , Technology Assessment, Biomedical , Universal Health Insurance
4.
Ont Health Technol Assess Ser ; 22(4): 1-165, 2022.
Article in English | MEDLINE | ID: mdl-36160757

ABSTRACT

Background: Staphylococcus aureus (S. aureus) is the most common cause of surgical site infections, and the nose is the most common site for S. aureus colonization. Pre-surgical (in the days prior to surgery) nasal decolonization of S. aureus may reduce the bacterial load and prevent the organisms from being transferred to the surgical site, thus reducing the risk of surgical site infection. We conducted a health technology assessment of nasal decolonization of S. aureus (including methicillin-susceptible and methicillin-resistant strains) with or without topical antiseptic body wash to prevent surgical site infection in patients undergoing scheduled surgery, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding nasal decolonization of S. aureus, and patient preferences and values. Methods: We performed a systematic literature search of the clinical evidence to retrieve systematic reviews and selected and reported results from one review that was recent, of high quality, and relevant to our research question. We complemented the chosen systematic review with a literature search to identify randomized controlled trials published since the systematic review was published in 2019. We used the Risk of Bias in Systematic Reviews (ROBIS) tool to assess the risk of bias of each included systematic review and the Cochrane risk-of-bias tool for randomized controlled trials to assess the risk of bias of each included primary study. We assessed the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search and conducted both cost-effectiveness and cost-utility analyses using a decision-tree model with a 1-year time horizon from the perspective of Ontario's Ministry of Health. We also analyzed the budget impact of publicly funding nasal decolonization of S. aureus in pre-surgical patients in Ontario. To contextualize the potential value of nasal decolonization, we spoke with people who had recently undergone surgery, some of whom had received nasal decolonization, and one family member of a person who had recently had surgery. We also engaged participants through an online survey. Results: We included one systematic review and three randomized controlled trials in the clinical evidence review. In universal decolonization, compared with placebo or no intervention, nasal mupirocin alone may result in little to no difference in the incidence of overall and S. aureus-related surgical site infections in pre-surgical patients undergoing orthopaedic, cardiothoracic, general, oncologic, gynaecologic, neurologic, or abdominal digestive surgeries, regardless of S. aureus carrier status (GRADE: Moderate to Very low). Compared with placebo, nasal mupirocin alone may result in little to no difference in the incidence of overall and S. aureus-related surgical site infections in pre-surgical patients who are S. aureus carriers undergoing cardiothoracic, vascular, orthopaedic, gastrointestinal, general, oncologic, gynaecologic, or neurologic surgery (GRADE: Moderate to Very low). In targeted decolonization, compared with placebo, nasal mupirocin combined with chlorhexidine body wash lowers the incidence of S. aureus-related surgical site infection (risk ratio: 0.32 [95% confidence interval: 0.16-0.62]) in pre-surgical patients who are S. aureus carriers undergoing cardiothoracic, vascular, orthopaedic, gastrointestinal, or general surgery (GRADE: High). Compared with no intervention, nasal mupirocin combined with chlorhexidine body wash in pre-surgical patients who are not S. aureus carriers undergoing orthopaedic surgery may have little to no effect on overall surgical site infection, but the evidence is very uncertain (GRADE: Very low). Most included studies did not separate methicillin-susceptible and methicillin-resistant strains of S. aureus. No significant antimicrobial resistance was identified in the evidence reviewed; however, the existing literature was not adequately powered and did not have sufficient follow-up time to evaluate antimicrobial resistance.Our economic evaluation found that universal nasal decolonization using mupirocin combined with chlorhexidine body wash is less costly and more effective than both targeted and no nasal decolonization. Compared with no nasal decolonization treatment, universal and targeted nasal decolonization using mupirocin combined with chlorhexidine body wash would prevent 32 and 22 S. aureus-related surgical site infections, respectively, per 10,000 patients. Universal nasal decolonization would lead to cost savings, whereas targeted nasal decolonization would increase the overall cost for the health care system since patients must first be screened for S. aureus carrier status before receiving nasal decolonization with mupirocin. The annual budget impact of publicly funding universal nasal decolonization in Ontario over the next 5 years ranges from a savings of $2.98 million in year 1 to a savings of $15.09 million in year 5. The annual budget impact of publicly funding targeted nasal decolonization ranges from an additional cost of $0.08 million in year 1 to an additional cost of $0.39 million in year 5.Our interview and survey respondents felt strongly about the value of preventing surgical site infections, and most favoured a universal approach. Conclusions: Based on the best evidence available, decolonization of S. aureus using nasal mupirocin combined with chlorhexidine body wash prior to cardiothoracic, vascular, orthopaedic, gastrointestinal, or general surgery lowers the incidence of surgical site infection caused by S. aureus in patients who are S. aureus carriers (including methicillin-susceptible and methicillin-resistant strains) (i.e., targeted decolonization). However, nasal mupirocin alone may result in little to no difference in overall surgical site infections and S. aureus-related surgical site infections in pre-surgical patients prior to orthopaedic, cardiothoracic, general, oncologic, gynaecologic, neurologic, or abdominal digestive surgeries, regardless of their S. aureus carrier status (i.e., universal decolonization). No significant antimicrobial resistance was identified in the evidence reviewed.Compared with no nasal decolonization treatment, universal nasal decolonization with mupirocin combined with chlorhexidine body wash may reduce S. aureus-related surgical site infections and lead to cost savings. Targeted nasal decolonization with mupirocin combined with chlorhexidine body wash may also reduce S. aureus-related surgical site infections but increase the overall cost of treatment for the health care system. We estimate that publicly funding universal nasal decolonization using mupirocin combined with chlorhexidine body wash would result in a total cost savings of $45.08 million over the next 5 years, whereas publicly funding targeted nasal decolonization using mupirocin combined with chlorhexidine body wash would incur an additional cost of $1.17 million over the next 5 years.People undergoing surgery value treatments aimed at preventing surgical site infections.


Subject(s)
Anti-Infective Agents, Local , Staphylococcal Infections , Anti-Infective Agents, Local/therapeutic use , Chlorhexidine/therapeutic use , Humans , Methicillin , Mupirocin/therapeutic use , Staphylococcal Infections/drug therapy , Staphylococcal Infections/epidemiology , Staphylococcal Infections/prevention & control , Staphylococcus aureus , Surgical Wound Infection/drug therapy , Surgical Wound Infection/prevention & control , Systematic Reviews as Topic , Technology Assessment, Biomedical/methods
5.
Syst Rev ; 11(1): 206, 2022 Sep 27.
Article in English | MEDLINE | ID: mdl-36167611

ABSTRACT

BACKGROUND: A systematic review (SR) helps us make sense of a body of research while minimizing bias and is routinely conducted to evaluate intervention effects in a health technology assessment (HTA). In addition to the traditional de novo SR, which combines the results of multiple primary studies, there are alternative review types that use systematic methods and leverage existing SRs, namely updates of SRs and overviews of SRs. This paper shares guidance that can be used to select the most appropriate review type to conduct when evaluating intervention effects in an HTA, with a goal to leverage existing SRs and reduce research waste where possible. PROCESS: We identified key factors and considerations that can inform the process of deciding to conduct one review type over the others to answer a research question and organized them into guidance comprising a summary and a corresponding flowchart. This work consisted of three steps. First, a guidance document was drafted by methodologists from two Canadian HTA agencies based on their experience. Next, the draft guidance was supplemented with a literature review. Lastly, broader feedback from HTA researchers across Canada was sought and incorporated into the final guidance. INSIGHTS: Nine key factors and six considerations were identified to help reviewers select the most appropriate review type to conduct. These fell into one of two categories: the evidentiary needs of the planned review (i.e., to understand the scope, objective, and analytic approach required for the review) and the state of the existing literature (i.e., to know the available literature in terms of its relevance, quality, comprehensiveness, currency, and findings). The accompanying flowchart, which can be used as a decision tool, demonstrates the interdependency between many of the key factors and considerations and aims to balance the potential benefits and challenges of leveraging existing SRs instead of primary study reports. CONCLUSIONS: Selecting the most appropriate review type to conduct when evaluating intervention effects in an HTA requires a myriad of factors to be considered. We hope this guidance adds clarity to the many competing considerations when deciding which review type to conduct and facilitates that decision-making process.


Subject(s)
Evidence-Based Medicine , Technology Assessment, Biomedical , Biomedical Technology , Canada , Humans , Systematic Reviews as Topic
6.
Health Econ ; 31 Suppl 1: 1-9, 2022 Sep.
Article in English | MEDLINE | ID: mdl-36068719

ABSTRACT

The field of medical devices has attracted considerable interest from scholarly research in health economics in recent years. Medical devices are indispensable tools for quality health care delivery, but their assessment and appropriate use pose significant challenges to healthcare systems. More research is needed to overcome existing gaps associated with evaluation of digital technologies, address challenges in the use of real-world data in generating evidence for decision-making and to uncover drivers of variation in access to medical devices across countries. Furthermore, the translation of the results and recommendations stemming from research projects into health technology assessment practices needs to be strengthened. The European Union (EU) project COMED aimed to address these gaps by improving existing research and developing new research streams on the methods for evaluation and diffusion of medical devices. The project also intended to provide directly applicable policy advice and tools to inform decision-making, with the aim of impacting public health in the EU. This Health Economics Supplement, together with references of other published outputs of the project, is intended to be the main source for researchers and policy makers seeking information on the COMED project.


Subject(s)
Delivery of Health Care , Technology Assessment, Biomedical , Economics, Medical , Europe , European Union , Humans , Technology Assessment, Biomedical/methods
7.
Annu Int Conf IEEE Eng Med Biol Soc ; 2022: 3281-3284, 2022 Jul.
Article in English | MEDLINE | ID: mdl-36086143

ABSTRACT

The Undergraduate Program in Biomedical Engineering ITB, Indonesia, introduce the Health Technology Assessment and Management as an elective course in 2021. This course is implemented to support the World Health Assembly that urges the member states to establish national strategies in health technology assessment and management, particularly medical devices. Furthermore, it is designed to give biomedical engineering students a broader insight into their career opportunities. Therefore, this course is delivered by the practitioner and guided by the main lecturer. The course syllabus is developed from the WHO Medical Devices Technical Series and European Network for Health Technology Assessment. It tries to implement HTA Core Model for Rapid Relative Effectiveness Assessments. A questionnaire is used to measure the students' perception of the course implementation. Moreover, it is used to obtain the students' comments and feedback. The course that is delivered by the practitioner not only gives the course content but also the context. After attending the course, students have a broader insight into the career opportunities as biomedical engineers in Indonesia.


Subject(s)
Biomedical Engineering , Technology Assessment, Biomedical , Bioengineering , Biomedical Engineering/education , Curriculum , Humans , Students
8.
Value Health ; 25(9): 1463-1468, 2022 Sep.
Article in English | MEDLINE | ID: mdl-36049796

ABSTRACT

This article discusses a recent methodological change to assess the additional benefit of drug intervention by the German Federal Joint Committee (Gemeinsamer Bundesausschuss), a key stakeholder in EUnetHTA21 (European Network for Health Technology Assessment joint consortium for future EU HTA regulation), methodological workstream. The German Federal Joint Committee (Gemeinsamer Bundesausschuss) set a universal individual response threshold at ≥ 15% of the scale range of the measurement instrument, for all patient-reported outcomes, to achieve an additional benefit rating for a given pharmaceutical intervention. This approach is originally based on a corresponding recommendation from the Institute for Quality and Efficiency in Health Care. The merits of this approach are reviewed from various perspectives, including the evidence basis, statistical and psychometric considerations, and regulatory perspectives by the ISPOR Clinical Outcomes Assessment Special Interest Group's multistakeholder group of authors (academia, contract research organizations, and industry). Particular focus is placed on the patient perspective within the Institute for Quality and Efficiency in Health Care approach. The article development incorporated feedback from ISPOR members during well-attended ISPOR US and European conference presentations and 2 formal rounds of written review. The authors concluded that the ≥ 15% response threshold is incongruent with previously defined and scientifically established thresholds and is not well-suited for universal implementation. Further scientific evidence and discussion among all stakeholders are needed, especially should this universal rule be considered in the context of future joint clinical assessments of health technologies in the European Union scheduled from 2025 onward.


Subject(s)
Public Opinion , Technology Assessment, Biomedical , Humans , Patient Reported Outcome Measures
9.
Ont Health Technol Assess Ser ; 22(3): 1-155, 2022.
Article in English | MEDLINE | ID: mdl-36158868

ABSTRACT

Background: Familial hypercholesterolemia (FH) is an inherited disorder characterized by abnormally elevated low-density lipoprotein (LDL) cholesterol serum levels from birth, which increases the risk of premature atherosclerotic cardiovascular disease. Genetic testing is a type of a medical test that looks for changes in genes or chromosome structure to discover genetic differences, anomalies, or mutations that may prove pathological. It is regarded as the gold standard for screening and diagnosing FH. We conducted a health technology assessment on genetic testing for people with FH and their relatives (i.e., cascade screening). The assessment included an evaluation of clinical utility (the ability of a test to improve health outcomes), the diagnostic yield (ability of a test to identify people with FH), cost-effectiveness, the budget impact of publicly funding genetic testing for FH, and patient preferences and values. Methods: We performed a systematic literature search of the clinical evidence. For evaluation of clinical utility, we assessed the risk of bias of each included study using the ROBINS-I tool and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria.We performed a systematic economic literature search and conducted a cost-effectiveness and cost-utility analysis with a lifetime horizon from a public payer perspective. We assessed the cost-effectiveness of using genetic testing both for confirming a FH clinical diagnosis and for cascade screening in relatives of genetically confirmed cases. We evaluated the cost effectiveness of cascade screening strategies with genetic testing, sequential testing, and lipid testing approaches. We also analyzed the budget impact of publicly funding genetic testing in Ontario. Results: We included 11 studies in the clinical evidence review. Overall, our review found that genetic testing to diagnose FH improves several health outcomes (GRADE: Moderate) compared with clinical evaluation without a genetic test. We also found that genetic cascade screening leads to a high diagnostic yield of FH.According to our primary economic evaluation, genetic testing is a dominant strategy (more effective and less costly) compared with no genetic testing for individuals with a FH clinical diagnosis. It reduced the number of FH diagnoses, led to fewer cardiovascular events, and improved QALYs. For first-degree relatives of genetically confirmed cases, all cascade screening strategies (genetic testing, sequential testing, and lipid testing) were cost-effective when compared with no cascade screening in a pairwise fashion. The ICERs of cascade screening with genetic, sequential, and lipid testing compared with no cascade screening were $58,390, $50,220, and $45,754 per QALY gained, respectively. When comparing all screening strategies together, cascade screening with lipid testing was the most cost-effective strategy. At commonly used willingness-to-pay values of $50,000 and $100,000 per QALY gained, the probability of lipid cascade screening being cost-effective was 53.5% and 71.5%, respectively.The annual budget impact of publicly funding genetic testing for individuals with a clinical FH diagnosis in Ontario ranged from a cost saving of $2 million in year 1 to $64 million in year 5, for a total of $141 million saved over the next 5 years, assuming the cost of genetic testing remains at $490 per person. If only testing-related costs were considered, the budget impact was estimated to be an additional cost of $7 million in year 1, increasing to $20 million in year 5, for a total cost of $64 million over the next 5 years. For relatives of genetically confirmed cases, publicly funding genetic cascade screening would lead to an additional cost of $5 million in year 1, increasing to $27 million in year 5, for a total cost of $73 million over the next 5 years. If only testing-related costs were considered, the budget impact was estimated to be an additional of $66 million. Conclusions: Genetic testing for FH has a higher clinical utility than clinical evaluation without a genetic test. It also results in a high diagnostic yield of FH through cascade screening. For individuals with a clinical diagnosis of FH, genetic testing would be a cost-saving and more effective diagnostic strategy. For relatives of index cases confirmed through genetic testing, genetic and lipid cascade screening are both cost-effective compared with no screening, but genetic cascade screening is less cost-effective than lipid cascade screening. We estimated that publicly funding genetic testing for individuals with a clinical diagnosis of FH in Ontario would save $141 million, and publicly funding genetic testing in a cascade screening program for relatives would cost an additional $73 million over the next five years.Most people with a positive genetic test perceived the screening, diagnosis, and treatment for FH more positively. The discovery of the condition can lead people to adhere to relevant treatments in an effort to control their cholesterol levels. People we spoke with felt that greater awareness and education would allow for more efficient uptake of cascade screening.


Subject(s)
Hyperlipoproteinemia Type II , Technology Assessment, Biomedical , Cholesterol , Cost-Benefit Analysis , Genetic Testing , Humans , Hyperlipoproteinemia Type II/diagnosis , Hyperlipoproteinemia Type II/genetics , Lipids , Lipoproteins, LDL , Technology Assessment, Biomedical/methods
10.
Zhongguo Zhong Yao Za Zhi ; 47(17): 4778-4788, 2022 Sep.
Article in Chinese | MEDLINE | ID: mdl-36164885

ABSTRACT

This study evaluated and compared the efficacy, safety and economy of four Chinese patent medicines(CPMs) in the treatment of functional dyspepsia(FD) using the method of rapid health technology assessment. It aims to provide decision-makers with rapid decision-making information. The eight Chinese and English databases were comprehensively and systematically searched for the relevant clinical research. Studies were screened and evaluated. A total of 110 studies were identified, including 95 randomized controlled trials(RCTs), 7 controlled clinical trials(CCTs), 7 systematic review/Meta-analysis and 1 economic evaluation, among which 28 were Dalitong Granules, 49 were Zhizhu Kuanzhong Capsules, 3 were Biling Weitong Granules and 30 were Qizhi Weitong Granules(Tablets/Capsules). The quality of the included literature was generally low. The efficacy of four CPMs alone or combined with western medicine in the treatment of FD is different. Dalitong Granules was used to treat motility disorder in FD. Zhizhu Kuanzhong Capsules and Qizhi Weitong Granules(Tablets/Capsules) can treat FD patients with anxiety and depression. Qizhi Weitong Granules(Tablets/Capsules) were mainly used in FD for perimenopausal patients. There were no serious adverse reactions in the clinical study of four CPMs in the treatment of FD. Dalitong Granules has better effects than mosapride in the treatment of FD, but the cost is slightly higher. The cost-effectiveness ratio of Zhizhu Kuanzhong Capsules in the treatment of FD patients with anxiety and depression was lower than that of Domperidone. In terms of average daily price, Qizhi Weitong Tablets has the highest price(27.00 yuan per day), Qizhi Weitong Granules has the lowest price(5.04 yuan per day), Biling Weitong Granules has a relatively high price(15.53 yuan per day), followed by Dalitong Granules(13.03 yuan per day). The evidence of Dalitong Granules covered the efficacy, safety and economy, which is relatively complete compared with the other three drugs. It has effective potential in the treatment of motility disorder in FD. Further research in this field in the future is needed.


Subject(s)
Drugs, Chinese Herbal , Dyspepsia , Capsules , China , Chlorobenzenes , Domperidone/therapeutic use , Drugs, Chinese Herbal/therapeutic use , Dyspepsia/drug therapy , Humans , Nonprescription Drugs/therapeutic use , Stomach , Sulfides , Tablets , Technology Assessment, Biomedical
11.
Front Public Health ; 10: 921226, 2022.
Article in English | MEDLINE | ID: mdl-35910914

ABSTRACT

The aim of this paper is to identify the barriers that are specifically relevant to the use of Artificial Intelligence (AI)-based evidence in Central and Eastern European (CEE) Health Technology Assessment (HTA) systems. The study relied on two main parallel sources to identify barriers to use AI methodologies in HTA in CEE, including a scoping literature review and iterative focus group meetings with HTx team members. Most of the other selected articles discussed AI from a clinical perspective (n = 25), and the rest are from regulatory perspective (n = 13), and transfer of knowledge point of view (n = 3). Clinical areas studied are quite diverse-from pediatric, diabetes, diagnostic radiology, gynecology, oncology, surgery, psychiatry, cardiology, infection diseases, and oncology. Out of all 38 articles, 25 (66%) describe the AI method and the rest are more focused on the utilization barriers of different health care services and programs. The potential barriers could be classified as data related, methodological, technological, regulatory and policy related, and human factor related. Some of the barriers are quite similar, especially concerning the technologies. Studies focusing on the AI usage for HTA decision making are scarce. AI and augmented decision making tools are a novel science, and we are in the process of adapting it to existing needs. HTA as a process requires multiple steps, multiple evaluations which rely on heterogenous data. Therefore, the observed range of barriers come as a no surprise, and experts in the field need to give their opinion on the most important barriers in order to develop recommendations to overcome them and to disseminate the practical application of these tools.


Subject(s)
Artificial Intelligence , Technology Assessment, Biomedical , Child , Humans , Technology Assessment, Biomedical/methods
12.
Front Public Health ; 10: 932093, 2022.
Article in English | MEDLINE | ID: mdl-36033790

ABSTRACT

In recent years, the rapid proliferation of genomic tests for use in clinical practice has prompted healthcare systems to use a health technology assessment (HTA) approach to distinguish valuable from unwarranted applications. In this study, we narratively review the Italian HTA mechanisms for medical devices (MDs), both at the national and regional levels, and discuss the opportunity and benefits of extending them to genomic technologies, for which a dedicated assessment path was advocated by the National Plan for Public Health Genomics in 2017. We found that the National Health Technology Assessment Program for MDs, completed in 2019, had developed a structured pathway for the HTA of MDs; it established a hub-and-spoke structure, run by a governmental institution, and put in place transparent methodological procedures to cover all four HTA phases (i.e., proposal and prioritization, assessment, appraisal, and dissemination). However, several factors have hindered its adoption, and the regions are at different stages of its implementation. For these reasons, efforts should be made to ensure its effective deployment, both at national and regional levels. In addition, we argue that to harmonize the institutional roles and methodological procedures adopted, the time has come to concentrate resources on a single pathway for the assessment of all technologies that include both MDs and genomic applications.


Subject(s)
State Medicine , Technology Assessment, Biomedical , Delivery of Health Care , Genomics , Italy
13.
BMC Med Res Methodol ; 22(1): 217, 2022 08 08.
Article in English | MEDLINE | ID: mdl-35941551

ABSTRACT

BACKGROUND: Anchored covariate-adjusted indirect comparisons inform reimbursement decisions where there are no head-to-head trials between the treatments of interest, there is a common comparator arm shared by the studies, and there are patient-level data limitations. Matching-adjusted indirect comparison (MAIC), based on propensity score weighting, is the most widely used covariate-adjusted indirect comparison method in health technology assessment. MAIC has poor precision and is inefficient when the effective sample size after weighting is small. METHODS: A modular extension to MAIC, termed two-stage matching-adjusted indirect comparison (2SMAIC), is proposed. This uses two parametric models. One estimates the treatment assignment mechanism in the study with individual patient data (IPD), the other estimates the trial assignment mechanism. The first model produces inverse probability weights that are combined with the odds weights produced by the second model. The resulting weights seek to balance covariates between treatment arms and across studies. A simulation study provides proof-of-principle in an indirect comparison performed across two randomized trials. Nevertheless, 2SMAIC can be applied in situations where the IPD trial is observational, by including potential confounders in the treatment assignment model. The simulation study also explores the use of weight truncation in combination with MAIC for the first time. RESULTS: Despite enforcing randomization and knowing the true treatment assignment mechanism in the IPD trial, 2SMAIC yields improved precision and efficiency with respect to MAIC in all scenarios, while maintaining similarly low levels of bias. The two-stage approach is effective when sample sizes in the IPD trial are low, as it controls for chance imbalances in prognostic baseline covariates between study arms. It is not as effective when overlap between the trials' target populations is poor and the extremity of the weights is high. In these scenarios, truncation leads to substantial precision and efficiency gains but induces considerable bias. The combination of a two-stage approach with truncation produces the highest precision and efficiency improvements. CONCLUSIONS: Two-stage approaches to MAIC can increase precision and efficiency with respect to the standard approach by adjusting for empirical imbalances in prognostic covariates in the IPD trial. Further modules could be incorporated for additional variance reduction or to account for missingness and non-compliance in the IPD trial.


Subject(s)
Models, Statistical , Technology Assessment, Biomedical , Bias , Computer Simulation , Humans , Models, Theoretical
14.
Front Public Health ; 10: 922708, 2022.
Article in English | MEDLINE | ID: mdl-35968493

ABSTRACT

Patients' perspectives are important to identify preferences, estimate values and appreciate unmet medical needs in the process of research and development and subsequent assessment of new health technologies. Patient and public involvement in health technology assessment (HTA) is essential in understanding and assessing wider implications of coverage and reimbursement decisions for patients, their relatives, caregivers, and the general population. There are two approaches to incorporating the patients' voice in HTA, preferably used in a mix. In the first one, patients, caregivers and/or their representatives directly participate at discussions in different stages of the HTA process, often at the same table with other stakeholders. Secondly, patient involvement activities can be supported by evidence on patient value and experience collected directly from patients, caregivers and/or their representatives often by patient groups Patient involvement practices, however, are limited in Central and Eastern European (CEE) countries without clear methodology or regulatory mechanisms to guide patient involvement in the HTA process. This poses the question of transferability of practices used in other countries, and might call for the development of new CEE-specific guidelines and methods. In this study we aim to map potential barriers of patient involvement in HTA in countries of the CEE region.


Subject(s)
Patient Participation , Technology Assessment, Biomedical , Europe , Humans , Technology Assessment, Biomedical/methods
15.
Int J Technol Assess Health Care ; 38(1): e71, 2022 Aug 26.
Article in English | MEDLINE | ID: mdl-36016516

ABSTRACT

OBJECTIVE: The aim of this scoping review is to map the available evidence about the use of health technology assessment (HTA) in the assessment of whole genome sequencing (WGS). METHODS: A scoping review methodology was adopted. The population, concept, and context framework was used to build up the research question and to establish the eligibility criteria. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews was adopted to implement a comprehensive search strategy. Evidence was retrieved from scientific databases and HTA organizations Web sites. Reports were classified as full HTA, mini-HTA, rapid reviews or other. RESULTS: The search strategy identified seven reports. Five HTA organizations from five countries elaborated the reports: one full HTA, four rapid reviews, and two classified as others. The reports were mainly focused on the evaluation of the clinical utility and cost-effectiveness of genome-wide sequencing as well as informing policy questions by providing analyses of organizational and ethical considerations. CONCLUSIONS: Few HTA organizations are drafting reports for WGS. It is essential to stimulate a critical reflection during the elaboration of HTA reports for WGS to steer choices of decision makers in the establishment of priorities for research and policy and reimbursement rates.


Subject(s)
Technology Assessment, Biomedical , Cost-Benefit Analysis , Whole Genome Sequencing
16.
Curr Oncol ; 29(8): 5774-5791, 2022 08 16.
Article in English | MEDLINE | ID: mdl-36005193

ABSTRACT

BACKGROUND: Advances in cancer medicines have resulted in tangible health impacts, but the magnitude of benefits of approved cancer medicines could vary greatly. Health Technology Assessment (HTA) is a multidisciplinary process used to inform resource allocation through a systematic value assessment of health technology. This paper reviews the challenges in conducting HTA for cancer medicines arising from oncology trial designs and uncertainties of safety-efficacy data. METHODS: Multiple databases (PubMed, Scopus and Google Scholar) and grey literature (public health agencies and governmental reports) were searched to inform this policy narrative review. RESULTS: A lack of robust efficacy-safety data from clinical trials and other relevant sources of evidence has made HTA for cancer medicines challenging. The approval of cancer medicines through expedited pathways has increased in recent years, in which surrogate endpoints or biomarkers for patient selection have been widely used. Using these surrogate endpoints has created uncertainties in translating surrogate measures into patient-centric clinically (survival and quality of life) and economically (cost-effectiveness and budget impact) meaningful outcomes, with potential effects on diverting scarce health resources to low-value or detrimental interventions. Potential solutions include policy harmonization between regulatory and HTA authorities, commitment to generating robust post-marketing efficacy-safety data, managing uncertainties through risk-sharing agreements, and using value frameworks. CONCLUSION: A lack of robust efficacy-safety data is a central problem for conducting HTA of cancer medicines, potentially resulting in misinformed resource allocation.


Subject(s)
Neoplasms , Technology Assessment, Biomedical , Biomarkers , Cost-Benefit Analysis , Humans , Neoplasms/drug therapy , Quality of Life , Technology Assessment, Biomedical/methods
17.
Am J Manag Care ; 28(6 Suppl): S104-S111, 2022 Aug.
Article in English | MEDLINE | ID: mdl-35997774

ABSTRACT

BACKGROUND: The FINE-CKD model was developed to estimate the cost-effectiveness of finerenone in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D). OBJECTIVE: To perform internal and external validation by comparing the model estimates with trial results and outcomes from other models. METHODS: Incidence rates from trials were compared with the model predictions. Statistical tests were then performed to assess whether modeled event rates aligned with trial observations. A cross-validation was also performed using the online version of the SHARP CKD-Cardiovascular Disease (SHARP CKD-CVD) model, with population characteristics from the finerenone trials analyzed. Where no finerenone data were available, the default SHARP CKD-CVD values were used. Comparison of the results considered the ranges from both models. RESULTS: The outcomes of the FINE-CKD model reflect the event rates observed in the trials. Based on the results of the statistical tests, the hypothesis of no difference between observed and modeled events cannot be rejected for any of the outcomes. The results of the FINE-CKD model are within the ranges from the SHARP CKD-CVD model. Disease progressions align across the models; however, incident kidney failure events in the SHARP CKD-CVD model were higher. This can be explained by simulation of more severely affected patients in the SHARP CKD-CVD model. CONCLUSIONS: This study demonstrates that the FINE-CKD model adequately reflects the clinical data and provides reliable extrapolation relative to the existing predictive tools while also being conservative in its approach.


Subject(s)
Cardiovascular Diseases , Diabetes Mellitus, Type 2 , Renal Insufficiency, Chronic , Cardiovascular Diseases/epidemiology , Cardiovascular Diseases/etiology , Diabetes Mellitus, Type 2/complications , Diabetes Mellitus, Type 2/drug therapy , Disease Progression , Humans , Renal Insufficiency, Chronic/complications , Renal Insufficiency, Chronic/drug therapy , Renal Insufficiency, Chronic/epidemiology , Technology Assessment, Biomedical
18.
J Manag Care Spec Pharm ; 28(9): 1053-1058, 2022 Sep.
Article in English | MEDLINE | ID: mdl-36001106

ABSTRACT

BACKGROUND: Health plans guide enrollees' access to specialty drugs through coverage policies. Practice guidelines recommend that the evidence supporting drug coverage policies should be comprehensive and routinely updated to reflect evidence-based medicine. OBJECTIVE: To examine the frequency with which health plans update their coverage criteria and supporting evidence and to determine the pattern with which plans cited relevant literature in their coverage policies. METHODS: Coverage policies from 17 large US commercial health plans were retrieved from the Tufts Medical Center Specialty Drug Evidence and Coverage database for August 2017 and August 2019. We identified drug-indication pairs (eg, infliximab for rheumatoid arthritis) for which plans had issued coverage policies in August 2017 and August 2019. We examined the frequency with which plans reissued these policies (ie, issued a new coverage document) between these 2 time points and the frequency with which plans altered coverage criteria or updated the cited evidence. A random sample of 20 drug-indication pairs was chosen to determine the comprehensiveness of cited evidence from the Specialty Drug Evidence and Coverage database. For each pair, a systematic literature search was conducted to identify relevant clinical and economic studies. A comparison of the systematic literature search with the evidence cited in each drug-indication pair's coverage policy was conducted to determine the comprehensive nature of each coverage policy's evidence. RESULTS: We identified 4,597 instances of plans issuing a coverage policy for the same drug-indication pair in both August 2017 and August 2019. Of those 4,597 instances, plans reissued an updated coverage document in 4,468 (97%). Fifteen percent of reissued policies revised both their coverage criteria and the evidence cited, 2% only their coverage criteria, 69% only the cited evidence, and 14% made no change. A total of 2,760 literature documents were identified relevant to at least one of the 20 drug-indication pairs, of which at least one plan cited 146 of these documents at least once (5.3%). Plans cited health technology assessments, randomized controlled trials (RCTs), systematic reviews/meta-analyses, and clinical guidelines most comprehensively. CONCLUSIONS: Health plans reissued most of their specialty drug coverage policies over a 2-year period. When plans revised their drug coverage criteria, they also tended to revise the evidence cited in their coverage polices. Of all the evidence found in our systematic review, plans more comprehensively cite health technology assessments, RCTs, and systematic reviews/meta-analyses. DISCLOSURES: This study was funded by the National Pharmaceutical Council.


Subject(s)
Arthritis, Rheumatoid , Pharmacy , Evidence-Based Medicine , Humans , Insurance Coverage , Technology Assessment, Biomedical
19.
Article in English | MEDLINE | ID: mdl-36011499

ABSTRACT

Frail chronic patients consume the largest share of resources in advanced healthcare systems, with more hospitals waiting to receive them in the acute phase (awaiting paradigm) than there are effective public health interventions to keep them out of hospitals as much as possible. Effective chronic care management (CCM) requires organizational research as much as biomedical research (and, in some cases, perhaps more). Otherwise, excellent clinical care is wasted by poor coordination among professionals and institutions, with frail patients and their families paying the most expensive price. Comprehensive health technology assessment (HTA) procedures include organizational, social, and ethical dimensions to precisely capture the environmental factors that make medical interventions effective, accessible, and sustainable. Clinical outcomes and financial data are used extensively to evaluate care pathways from the providers' perspective, but much remains to be done to capture equally important indicators from the perspective of patients and society. The authors hypothesize that the ordinary use of patient-reported experience measurement (PREMs) in HTA can help reduce gaps and inequalities by identifying frail patients on time, curbing the risks of isolation and the burden on care givers, preventing complications and inappropriate emergency care use, improving adherence, health communication and behavior, supporting risk assessment, and relieving the frequency of the healthcare environment.


Subject(s)
Public Health , Technology Assessment, Biomedical , Critical Pathways , Delivery of Health Care , Humans , Long-Term Care
20.
Value Health ; 25(8): 1257-1267, 2022 08.
Article in English | MEDLINE | ID: mdl-35931428

ABSTRACT

Health technology assessment (HTA) has been growing in use over the past 40 years, especially in its impact on decisions regarding the reimbursement, adoption, and use of new drugs, devices, and procedures. In countries or jurisdictions with "pluralistic" healthcare systems, there are multiple payers or sectors, each of which could potentially benefit from HTA. Nevertheless, a single HTA, conducted centrally, may not meet the needs of these different actors, who may have different budgets, current standards of care, populations to serve, or decision-making processes. This article reports on the research conducted by an ISPOR Health Technology Assessment Council Working Group established to examine the specific challenges of conducting and using HTA in countries with pluralistic healthcare systems. The Group used its own knowledge and expertise, supplemented by a narrative literature review and survey of US payers, to identify existing challenges and any initiatives taken to address them. We recommend that countries with pluralistic healthcare systems establish a national focus for HTA, develop a uniform set of HTA methods guidelines, ensure that HTAs are produced in a timely fashion, facilitate the use of HTA in the local setting, and develop a framework to encourage transparency in HTA. These efforts can be enhanced by the development of good practice guidance from ISPOR or similar groups and increased training to facilitate local use of HTA.


Subject(s)
Budgets , Technology Assessment, Biomedical , Delivery of Health Care , Humans , Technology Assessment, Biomedical/methods
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