International Journal of Technology Assessment in Health Care最新文献

{"title":"PP128 A Transparent Methodology To Assess Innovativeness Of Health Technologies At Marketing Authorization Time","authors":"Ludmila Gargano, Isabela Freitas, Luila Henriques, Ariane André, Juliana Álvares-Teodoro, Francisco Acurcio, Augusto Guerra","doi":"10.1017/s0266462323002404","DOIUrl":"https://doi.org/10.1017/s0266462323002404","url":null,"abstract":"<span>Introduction</span><p>Defining drug innovation can be challenging and there is no consensus on what a truly “innovative” medicine is. The Italian Medicine Agency (AIFA) has established an approach to assess innovativeness based on therapeutic need, added therapeutic value, and quality of evidence. However, judgment can be subjective and may not be adequate for assessment at the time of marketing authorization, when only preliminary evidence – often from non-comparative or non-randomized trials – are available. We developed a transparent methodology for early assessment of innovativeness at the time of marketing authorization, based on AIFA guidelines.</p><span>Methods</span><p>Since the perspective was the marketing authorization date, only data available at agency’s Medical Review or pivotal trial publications were considered. AIFA criteria were revisited, using oncology medicines approved in the last 10 years as a base case. Impact of preliminary evidence and inadequate study design was considered.</p><span>Results</span><p>Each assessment should refer to the first approved specific indication and predefined clinically relevant outcomes. When more than one study was presented, best methodological quality, larger sample and/or longer follow-up was selected. Four domains were established: Therapeutical need: existence and clinical benefits of alternative therapies; Clinical benefit added when compared to those alternatives; Suitability of study design considering adequate comparator group, relevant outcome assessed and randomization; Risk of bias. For each domain, clear and specific criteria were defined in consensus by a group of experts in health technology assessment (HTA) and were applied to all cancer drugs evaluated.</p><span>Conclusions</span><p>Efficacy evidence available for marketing authorization are often based on preliminary data, arising from single randomized clinical trials or even non-comparative studies, which difficult early assessments of innovativeness. For this reason, transparent and reproducible methodologies can be useful not only to HTA bodies, but also for other key stakeholders in the pharmaceutical market, such as investors, researchers, doctors, and governments.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2023-12-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138631817","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"PP153 Efficacy And Safety of Onasemnogene Abeparvovec For The Treatment Of Patients With Spinal Muscular Atrophy Type 1: Meta-Analysis","authors":"Stefani Borges, Brígida Fernandes, Fernanda Rodrigues, Bárbara Krug, Hérica Núbia Cirilo, Ida Vanessa Schwartz, Livia Probst, Ivan Zimmermann","doi":"10.1017/s0266462323002556","DOIUrl":"https://doi.org/10.1017/s0266462323002556","url":null,"abstract":"<span>Introduction</span><p>Onasemnogene abeparvovec has been approved for the treatment of spinal muscular atrophy 5q (SMA) type 1 in several countries, which calls for an independent assessment of its evidence regarding efficacy and safety.</p><span>Methods</span><p>This study results from searches conducted on databases MEDLINE, Embase, LILACS and Cochrane Library up to November 2022, supported by additional searches on registry databases and by manual searches of references listed in eligible studies. Outcomes of interest were global survival and mechanical-ventilation-free survival, improvement in motor function and treatment-related adverse events. Risk of bias was assessed via ROBINS-I and certainty of evidence via GRADE. Proportional meta-analysis models were performed when applicable.</p><span>Results</span><p>Four reports of three open-label, non-comparative clinical trials (START, STR1VE-US and STR1VE-EU) covering 67 patients were included in review. Meta-analyses of data available in a 12-month follow-up estimate a global survival of 97.6% (95% confidence interval [CI]: 92.6, 99.9; I2 = 0%, n=67), an event-free survival of 96.5% (95%CI: 90.8, 99.5; I2 = 32%, n=66) and a CHOP-INTEND score of 40 points or less proportion of 87.3% (95%CI: 69.8, 97.8; I2 = 69%, n=67). Proportions of 61.1% (95%CI: 40, 80.2; I² = 62%, n=67) of serious adverse events and of 58.4% (95%CI: 46.5, 69.8; I2 = 78%, n=67) of treatment-related adverse events are estimated. Despite the significant effect magnitude, reviewed studies were assessed as high risk of bias and as having very low certainty of evidence due to imprecision and risk of bias.</p><span>Conclusions</span><p>Reduced sample size and follow-up time offer uncertainties as regards the long-term benefits of the gene therapy, which strongly calls for the monitoring and assessment of results in clinical practice.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2023-12-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138631828","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"PP71 Hospitalization Costs Associated With Advanced Non-Small Cell Lung Cancer In China: Real World Evidence From Jiangsu","authors":"Yu Xia, Yi Yang, Yingyao Chen","doi":"10.1017/s0266462323002076","DOIUrl":"https://doi.org/10.1017/s0266462323002076","url":null,"abstract":"<span>Introduction</span><p>Non-small cell lung cancer (NSCLC) constitutes 85 percent of lung cancer diagnoses and poses an economic threat to the sustainability of healthcare services. This study was conducted to estimate hospitalization costs associated with advanced NSCLC without sensitizing EGFR (epidermal growth factor receptor) and ALK (anaplastic lymphoma kinase) alterations in China and explore the potential predictors.</p><span>Methods</span><p>Data linked with patients with advanced NSCLC (stage IIIB–IV) without sensitizing EGFR and ALK alterations were obtained from the electronic medical record system of one general hospital and one cancer hospital in Jiangsu province, China, ranging from January 2017 to December 2020. We excluded patients with lung metastases from tumors elsewhere in the body. The socio-demographic characteristics, disease-related characteristics, and hospitalization cost of eligible patients were extracted. We used the generalized linear model (GLM) to assess the potential influencing factors of hospitalization cost.</p><span>Results</span><p>Patients with advanced NSCLC (n=7,260) were included in this study. The median hospitalization cost of advanced NSCLC was USD11,540.47. The median hospitalization examination and test costs were USD1,539.46, and the median hospitalization drug cost was USD6,351.47. GLM results showed that patients aged 60 or older (95% Confidence Interval [CI]: -1019.1,128.6), who had no gene driver (95%CI: -1,681.6,-233.6) were more likely to have relatively lower hospitalization costs for advanced NSCLC. Patients treated in cancer hospital (95%CI: 1,329.1,2,620.0) and with non-squamous carcinoma (95%CI: 171.3, 1,235.4) may have higher hospitalization costs. Compared with Urban Employee Basic Medical Insurance, patients with free medical services (95%CI: 1,248.4,6,298.7) were associated with higher hospitalization costs. Patients with higher hospitalization frequency and longer length of hospital stay (p &lt; 0.05) were linked to higher hospitalization costs.</p><span>Conclusions</span><p>The hospitalization costs linked to advanced NSCLC is considerable for patients, with drug costs accounting for the largest. More efforts still need to be made to alleviate the direct medical burden.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2023-12-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138631887","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"PP54 Machine Learning For Accelerating Screening In Literature Reviews","authors":"Mary Chappell, Mary Edwards, Deborah Watkins, Christopher Marshall, Lavinia Ferrante di Ruffano, Anita Fitzgerald, Sara Graziadio","doi":"10.1017/s0266462323001988","DOIUrl":"https://doi.org/10.1017/s0266462323001988","url":null,"abstract":"<span>Introduction</span><p>Systematic reviews are important for informing decision-making and primary research, but they can be time consuming and costly. With the advent of machine learning, there is an opportunity to accelerate the review process in study screening. We aimed to understand the literature to make decisions about the use of machine learning for screening in our review workflow.</p><span>Methods</span><p>A pragmatic literature review of PubMed to obtain studies evaluating the accuracy of publicly available machine learning screening tools. A single reviewer used ‘snowballing’ searches to identify studies reporting accuracy data and extracted the sensitivity (ability to correctly identify included studies for a review) and specificity, or workload saved (ability to correctly exclude irrelevant studies).</p><span>Results</span><p>Ten tools (AbstractR, ASReview Lab, Cochrane RCT classifier, Concept encoder, Dpedia, DistillerAI, Rayyan, Research Screener, Robot Analyst, SWIFT-active screener) were evaluated in a total of 16 studies. Fourteen studies were single arm where, although compared with a reference standard (predominantly single reviewer screening), there was no other comparator. Two studies were comparative, where tools were compared with other tools as well as a reference standard. All tools ranked records by probability of inclusion and either (i) applied a cut-point to exclude records or (ii) were used to rank and re-rank records during screening iterations, with screening continuing until most relevant records were obtained. The accuracy of tools varied widely between different studies and review projects. When used in method (ii), at 95 percent to 100 percent sensitivity, tools achieved workload savings of between 7 percent and 99 percent. It was unclear whether evaluations were conducted independent of tool developers.</p><span>Conclusions</span><p>Evaluations suggest the potential for tools to correctly classify studies in screening. However, conclusions are limited since (i) tool accuracy is generally not compared with dual reviewer screening and (ii) the literature lacks comparative studies and, because of between-study heterogeneity, it is not possible to robustly determine the accuracy of tools compared with each other. Independent evaluations are needed.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2023-12-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138631888","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"PP156 Choice Of Different Implant Combinations of Total Hip Arthroplasty For Patients With Degenerative Joint Disease","authors":"YuHan Huang, Ta-Wei Tai, Jung-Der Wang, Li Jung Elizabeth Ku","doi":"10.1017/s026646232300257x","DOIUrl":"https://doi.org/10.1017/s026646232300257x","url":null,"abstract":"<span>Introduction</span><p>In Taiwan, people with hip osteoarthritis (OA) receive a total hip arthroplasty (THA). They can apply for National Health Insurance (NHI) coverage for metal-on-polyethylene (MoP) implant or USD1,313.2 co-pay for new bearing surface materials. This study aimed to report the number of first primary THAs, and calculate the costs of THA by different choices of prothesis implant.</p><span>Methods</span><p>A retrospective cohort study of patients aged 50 years or older who had OA (as an indication for THA) from 1 January 2010 through to 31 December 2018 was established from Taiwan’s NHI Claims Data. The cohort was followed-up until 31 December 2019. THA Implant combinations were defined by bearing surface materials e.g., “ceramic-metal” into alumina or composites made from alumina and zirconia, including metal-on-polyethylene (MOP), ceramic-metal composite ceramic-on-polyethylene (c-COP), alumina ceramic-on-ceramic (a-COC), ceramic-metal composite ceramic-on-ceramic (c-COC). Since only MOP was covered by the NHI, patients who chose the COP or COC implant had to pay for additional costs. We used hospital costs comparison data to calculate the average out-of-pocket (OOP) costs for different implant combinations.</p><span>Results</span><p>This study comprised 23,560 patients with first primary THA over 9 years. The number of patients of first primary THA increased from 1,802 in 2010 to 3,251 in 2018. The mean age of patients at baseline was 68 years, and the majority were women (70.6%). The share of users for each THA implant type were: MOP implant (49.2%), c-COC implant, (20.8%), a-COC implant, (6.5%), and c-COP implant, 5.9%. The average OOP costs of each implant were: USD3,578.60 for c-COC (SD=381.80), USD2,073.00 for a-COC (SD=279.80), and USD2,082.1 for c-COP (SD=334.1).</p><span>Conclusions</span><p>Although only MOP was fully covered by NHI, only about 50% of the OA patients chose this type of implant, and 26.7 percent chose alumina and zirconia ceramic composite despite this being a much higher OOP cost. Whether choosing more expensive implants would be cost-effective for THA in Taiwan’s healthcare system requires further analysis.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2023-12-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138631955","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"PP84 Evaluation Of The Evidence Level Of Scrambler Therapy For Musculoskeletal Pain Relief: A Systematic Literature Review","authors":"Hye Eun Eom, Seung Jin Han, Kyoung-Hoon Kim","doi":"10.1017/s0266462323002143","DOIUrl":"https://doi.org/10.1017/s0266462323002143","url":null,"abstract":"<span>Introduction</span><p>Non-invasive Scrambler Therapy (ST) reduces pain by attaching electrodes to neural pathways of major nerves, transmitting information along with microcurrent to the nerves to induce a painless sensation. The ST has been widely used to reduce pain for patients with musculoskeletal pain. However, little is known about the musculoskeletal pain relief effect of the ST. Therefore, this study aims to evaluate the treatment effectiveness of the ST.</p><span>Methods</span><p>A systematic literature review was conducted based on the following search strategy and databases, and all studies published before August 2021 were included in Pubmed, Embase, and Cochrane library, Ovid Medline, Koreamed, kmbase, and Science On. The subjects were patients with intractable and musculoskeletal pain, excluding cancer pain, and intervention methods included non-invasive ST alone or in combination with physical therapy. In addition, the comparative method was not limited. The outcome variables were the degree of pain relief, total analgesic use, health-related quality of life, pressure pain threshold, pain intensity and functional interference scales, and pain sensitivity. Safety-related outcome variables were all side effects. Cochrane Risk of Bias 1.0 was used to assess the risk of bias in the literature.</p><span>Results</span><p>Two hundred forty-one articles were retrieved using a pre-determined search strategy. Of these, 15 duplicate articles, 215 articles after reviewing the abstract and title, and nine articles after checking the full text were excluded. Two studies with randomized controlled trials (RCTs) were finally selected. When comparing ST and placebo groups for musculoskeletal pain, the pain reduction effect of ST lasted for three weeks. Moreover, patients with neuropathic pain treated with ST had a lower pain intensity for one to three months compared to the drug treatment group.</p><span>Conclusions</span><p>Based on this systematic review, the effectiveness of ST is yet sufficient owing to small sample size and possibility of selective report bias. More studies with well-designed RCTs are required to further assess the effectiveness of the ST.</p>","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2023-12-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138631972","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"OP168 Costs And Effectiveness Of Whole Exome Sequencing (WES) In Patients With Unsolved Rare Disease Through The Diagnostic Pathway","authors":"Deborah A Marshall, Koen Degeling, Toni Tagimacruz, Trevor A. Seeger, Kym M Boycott, Francois Bernier, Roberto Mendoza-Londona, Karen V. MacDonald, Taila Hartley, Robin Z. Hayeems","doi":"10.1017/s0266462323001617","DOIUrl":"https://doi.org/10.1017/s0266462323001617","url":null,"abstract":"IntroductionPatients suspected of having a rare genetic disease often experience lengthy and costly diagnostic odysseys. The timing of whole exome sequencing (WES) in the testing sequence, its diagnostic yield and test costs in the sequence all factor into estimates of cost-effectiveness analysis for health technology assessment.MethodsWe modeled the diagnostic pathway using a discrete event simulation model, starting with the first test result. We defined and populated the simulation based on data from the electronic medical records of n=307 from the Care-for-Rare SOLVE multi-center Canadian observational cohort. Five alternative diagnostic pathways were modeled based on the observed data: no WES, and WES as the first, second, third or fourth test in the sequence. WES as the second test in the sequence is considered standard of care in medical genetic centers in Canada. We assessed effectiveness of WES in terms of diagnostic yield, time to diagnosis, and costs as patient-level overall test costs (2020 CAD/USD) across the diagnostic pathway.ResultsCompared to molecular and specialized diagnostic tests only (i.e., no WES), WES increased diagnostic yield from 5 percent to 40 percent. The shortest time to diagnosis for those with a diagnosis was 1.82 years in the diagnostic pathway with WES as the second test. Test costs for each pathway were CAD2,800 (USD2,087, no WES), CAD2,700 (USD2,013, WES as first test), CAD3,500 (USD2,609, WES as second test), CAD4,500 (USD3,354, WES as third test), and CAD5,300 (USD3,951, WES as fourth test).ConclusionsPlacing WES earlier in the diagnostic pathway for patients suspected of having a rare disease is associated with an increased diagnostic yield, reduced time to diagnosis and lower overall test costs with the benefits being greater the earlier in the pathway that WES is implemented.","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2023-12-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138689182","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"PP18 Unlocking The Potential Of Medical Device Reimbursement In India For Better Health Outcomes","authors":"Ashwin Goel, Stephen Sunderland, Shruti Srinivasan, Arif Fahim, Monika Pusha, Kirti Kataria","doi":"10.1017/s0266462323001757","DOIUrl":"https://doi.org/10.1017/s0266462323001757","url":null,"abstract":"IntroductionThe Indian healthcare landscape has witnessed several promising changes including the introduction of a comprehensive medical technology inclusion process, Diagnosis-related group (DRG)-pilot and value-based incentives for hospital services under the national public health insurance scheme. Realizing the need for a more patient-centric stance towards improving healthcare outcomes as the way forward, we propose incremental changes including greater participation of public and private care-providers in topic prioritization and the appraisal committee. We also propose a unique evidence-driven approach using reimbursement as a lever for rewarding quality and innovation in medical technologies.MethodsWe developed two discussion guides to capture the ideas around deeper involvement of care-providers and patient societies, and introduction of value-based reimbursement for incentivizing high-quality implantable medical devices in India. The guides were prepared using secondary research and key informant interviews. Over 25 key stakeholders representing payers, regulatory agencies, government authorities, clinical experts, and industry players selected through quota sampling participated in a roundtable meeting. Based on the meeting outcomes, key recommendations for leveraging medical device reimbursement for better health outcomes were developed.ResultsThis qualitative research was carried out with participation of key stakeholders across the medical device reimbursement process. The group proposed recommendations for bringing care-providers closer to the process through a structured and inclusive nomination approach involving therapy users and patient groups at various stages of evaluation. Complementing the existing value-based incentives framework for hospital services, we proposed a similar two-step pathway for incentivizing quality of implantable medical devices. The proposal includes the introduction of certification-based and outcome-based incentives built on a scientific and holistic evaluation criterion.ConclusionsThrough this process, we created a pragmatic and concrete call for a stronger voice from care-providers and patient groups in the evaluation process. Consecutively, the proposed innovative framework introducing value-based incentives for implantable medical devices will be instrumental in enabling access to quality health care to poor patients. These strategies follow the principles of value-based care and will go a long way in achieving better health outcomes for the population. The scientific initiative has been made possible with the support of St. Jude Medical India Pvt Ltd. (now Abbott).","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2023-12-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138689281","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"OP66 Adoption Of The World Health Organization Algorithm For Essential Medicines In The Philippine National Formulary Listing Process","authors":"Sheena Jasley Samonte, Princess Allyza Mondala, Lara Alyssa Liban, Patrick Wincy Reyes, Anne Julienne Marfori, Anna Melissa Guerrero, Bu Castro, Isidro Sia, Maria Minerva Calimag, Cecilia Maramba-Lazarte, Imelda Peña","doi":"10.1017/s0266462323000934","DOIUrl":"https://doi.org/10.1017/s0266462323000934","url":null,"abstract":"IntroductionThe Philippine National Formulary (PNF) System preceded the health technology assessment (HTA) process in the Philippines, which was institutionalized in 2019. The transition led to previously prioritized topics of expert bodies overseeing the PNF System being endorsed to the HTA Council. However, the advent of COVID-19 forced the HTA Philippines to focus on emergency assessment needs and financing recommendations for the national government, resulting in limited capacity to assess non-public health emergency topics. To address this and improve patient access to medicines, we adopted the World Health Organization (WHO) process for evaluating and selecting medicines in the National Essential Medicines List (NEML).MethodsIn assessing the pre-pandemic topics, we matched the population, intervention, comparator, and outcomes of the WHO clinical evidence reviews with those scoped with relevant stakeholders and performed local costing analyses to ensure applicability of findings to the Philippine setting. When needed, we subjected the topics to price negotiation or conducted qualitative assessments.ResultsWe found the method efficient in expediting the decision-making process of the HTA Council. However, given the limited internal capacity of the HTA Philippines to conduct assessments for all ongoing HTA tracks, some of the topics responsive to Universal Health Care will be outsourced to the HTA Research Network, which is yet to be established. There is also a need to improve alignment among the topics being assessed, since the priorities of the proponents, national health program, and national payer have already evolved.ConclusionsIt is important to identify the priority areas for stakeholders as part of the topic nomination process, account for analytic capacity when setting the number of topics for HTA, establish mechanisms to allow proponents to conduct HTAs based on the HTA Council’s methodological standards, and proactively work with the national regulatory agency on horizon scanning and early HTA. We also recommend efficient monitoring, evaluation, and updating of the Philippine HTA guidelines so that they are more responsive to the needs of the healthcare system and the Filipino people.","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2023-12-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138689505","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"OP141 Expert Knowledge Elicitation in Health Technology Assessment: Our Experience Using the Sheffield Elicitation Framework","authors":"Danielle Stringer, Ning Ma, David Tivey","doi":"10.1017/s0266462323001423","DOIUrl":"https://doi.org/10.1017/s0266462323001423","url":null,"abstract":"IntroductionExpert judgement has an important role in health technology assessment (HTA), including as a source of evidence to inform economic modeling when published data are lacking. Quantitative information may be elicited from experts to inform model inputs and associated uncertainty using one of many expert elicitation methodologies. Here, the feasibility and potential benefits of one expert elicitation method, the Sheffield Elicitation Framework (SHELF), to the HTA process is examined.MethodsThe SHELF method seeks to express the knowledge of multiple experts in the form of a subjective probability distribution. Eliciting a subjective probability distribution allows the uncertainty of experts to be included in probabilistic sensitivity analysis, which is becoming an increasingly prominent feature of HTAs. The individual knowledge of participating experts is combined through behavioral aggregation, where experts participate in a discussion before being asked to provide judgments from the perspective of a rational impartial observer. The whole process is led by a facilitator who ensures all participants contribute and confirm that the final distribution is a product of consensus, not compromise.ResultsWe recently conducted two SHELF elicitations as part of an ongoing project aiming to streamline the assessment of positron emission tomography (PET) in Australia. These elicitations provided insight into the usefulness of SHELF within the HTA setting. Given the constraints imposed by the COVID-19 pandemic, the elicitation sessions were conducted online rather than in the ideal face-to-face manner. In collaboration with one of the developers, we successfully adapted the method by making use of video conferencing technology to provide an online environment that mimicked the face-to-face setup as much as possible.ConclusionsSHELF provides a rigorous and scientific method by which to elicit the knowledge of multiple experts in the form of a probability distribution. However, the method is resource intensive and may be best reserved for when data on key drivers are lacking.","PeriodicalId":14467,"journal":{"name":"International Journal of Technology Assessment in Health Care","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2023-12-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138689506","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}