Global & Regional Health Technology Assessment最新文献_第5页

Costo-efficacia di IMI/CIL/REL rispetto a CMS+IMI per il trattamento di infezioni batteriche Gram-negative non sensibili ai carbapenemi. IMI/CIL/REL与CMS+IMI相比，用于治疗对羧酸不敏感的革拉姆-阴性细菌感染的成本效益。

IF 0.5

Global & Regional Health Technology Assessment Pub Date : 2023-01-01 DOI: 10.33393/grhta.2023.2488

Martina Paoletti, Andrea Marcellusi, Joe Yang, Francesco Saverio Mennini

{"title":"Costo-efficacia di IMI/CIL/REL rispetto a CMS+IMI per il trattamento di infezioni batteriche Gram-negative non sensibili ai carbapenemi.","authors":"Martina Paoletti, Andrea Marcellusi, Joe Yang, Francesco Saverio Mennini","doi":"10.33393/grhta.2023.2488","DOIUrl":"https://doi.org/10.33393/grhta.2023.2488","url":null,"abstract":"Cost-effectiveness of IMI/CIL/REL for the treatment of carbapenem non-susceptible Gram-negative bacterial infections Objective: The objective of this analysis was to evaluate the cost-effectiveness of imipenem/cilastatin/relebactam compared to colistin-imipenem in the treatment of hospitalized patients with Gram-negative bacterial infections caused by imipenem-resistant pathogens. The perspective was both that of the National Health Service (NHS) and the social one. Methodology: A mixed model was developed to simulate a cohort of patients capable of highlighting the impacts of the disease on the quality of life and the absorption of economic resources of the patients in analysis. Modelled patients were those with hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP), complicated intra-abdominal infection (cIAI) or complicated urinal tract infection (cUTI) caused by carbapenem-resistant Gram-negative (GN) pathogens. The model begins with a short-term decision tree describing possible treatment routes and outcomes for patients during the hospitalization period. Patients who are healed in the decision tree enter the long-term Markov model, designed to capture the follow-up costs and health-related quality of life (HRQL) of patients healed over their lifetime. Results: The analysis, conducted on a hypothetical cohort of 1,000 patients, highlights how the use of imipenem/cilastatin/relebactam is advantageous both in terms of diagnosis and treatment in the short term and in terms of cost-effectiveness. In fact, it is dominant compared to colistin-imipenem both in the NHS and in the social perspective since, compared to an average saving of € 2,800.15 and € 3,174.63 respectively, it would generate an increase of 4.76 years of life and of 4.12 QALYs per patient.","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"10 ","pages":"18-28"},"PeriodicalIF":0.5,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/0e/55/grhta-10-18.PMC10105322.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9317188","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Prezzo e rimborso dei farmaci in caso di estensione delle indicazioni: i risultati di una survey sui soci di ISPOR Italy Rome Chapter. 信息扩展时的药品价格和报销:ISPOR Italy Chapter合作伙伴调查结果。

IF 0.5

Global & Regional Health Technology Assessment Pub Date : 2023-01-01 DOI: 10.33393/grhta.2023.2562

Eugenio Di Brino, Claudio Jommi

{"title":"Prezzo e rimborso dei farmaci in caso di estensione delle indicazioni: i risultati di una survey sui soci di ISPOR Italy Rome Chapter.","authors":"Eugenio Di Brino, Claudio Jommi","doi":"10.33393/grhta.2023.2562","DOIUrl":"https://doi.org/10.33393/grhta.2023.2562","url":null,"abstract":"Price and reimbursement of medicines when new indications are approved: the results of a survey on ISPOR Italy Rome Chapter members Multi-indication pricing models for medicines and some international impact evidence are available in the literature. Data on the Italian context are more limited. This paper illustrates the results of a study aimed at gathering the opinion on this topic of experts, members of the ISPOR Italy Rome Chapter. The opinion was collected through a structured questionnaire, validated by two potential responders, and administered online in the period October/July 2022. There were 45 responders (20% of the members); 67% of responders work in pharmaceutical companies and 13% in consultancy firms. The remainder belongs to regulators/payers and universities. The survey highlighted a preference for (i) non-automatic models, as automatic approaches are mainly based on price cuts/discount increases in relation to an increase in volumes, (ii) an “indication-based-pricing” model (where prices are differentiated by indication through discounts/risk sharing agreements), since it is more consistent with a value-based approach, even if more complex to manage, (iii) a mix of discounts/agreements according to existing evidence. The opinion collected is consistent with the opinions available in the literature, but not consistent with the Italian trend, where, compared to the past, a blended approach is prevailing. A blended pricing envisages a renegotiation of the single price for all indications, essentially based on a change in the discount. Our hope is that in the future the experts’ opinion will be taken into consideration and that a targeted indication-based-pricing will be adopted again.","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"10 ","pages":"40-45"},"PeriodicalIF":0.5,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/af/b5/grhta-10-40.PMC10158496.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9434963","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Analisi di impatto sul budget sanitario italiano di enzalutamide per il trattamento del carcinoma prostatico metastatico ormono-sensibile. 治疗转移性激素敏感前列腺癌的酶酰胺对意大利卫生预算的影响分析。

IF 0.5

Global & Regional Health Technology Assessment Pub Date : 2023-01-01 DOI: 10.33393/grhta.2023.2507

Francesca Fiorentino, Paolo Di Rienzo

{"title":"Analisi di impatto sul budget sanitario italiano di enzalutamide per il trattamento del carcinoma prostatico metastatico ormono-sensibile.","authors":"Francesca Fiorentino, Paolo Di Rienzo","doi":"10.33393/grhta.2023.2507","DOIUrl":"https://doi.org/10.33393/grhta.2023.2507","url":null,"abstract":"ABSTRACT Budget impact analysis of enzalutamide for the treatment of hormone-sensitive metastatic prostate cancer in Italy Backgroud: After demonstrating additional benefit versus standard of care in ARCHES and ENZAMET studies, enzalutamide was reimbursed in Italy in May 2022 by the National Health Service (NHS) for the treatment of hormone-sensitive metastatic prostate cancer (mHSPC). Objective: This study estimates the financial impact associated to the introduction of enzalutamide for patients with mHSPC. Methods: A budget impact model was developed with a dynamic cost calculator approach, in which the impact on subsequent lines of therapy was considered. The analysis considered the NHS perspective and a 3-year time horizon. Included costs were related to drug acquisition and administration, monitoring, patient follow-up and adverse events. Eligible population was estimated based on published literature, real-world data and experts’ opinion while market shares were assessed considering real-world data and assumptions. National tariffs and published literature were considered for unit costs. Results: Eligible population was estimated at 6,200, 6,206 and 6,212 in years 1, 2 and 3 respectively. The introduction of enzalutamide, considering a progressive increase of market shares of 10%, 18% and 25%, is expected to overall increase NHS healthcare expenditure by € 688 thousands and € 2.6 and € 5.6 million in years 1, 2 and 3 respectively, corresponding on average to 1.55% of the overall prostate cancer expenditure. Results are robust across one-way sensitivity analyses, while confidential discount agreements of on-patent drugs might significantly impact the estimates. Conclusion: The introduction of enzalutamide for the treatment of adult patients with mHSPC is expected to increase patients’ health with a moderate impact on costs for the Italian NHS.","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"10 ","pages":"29-39"},"PeriodicalIF":0.5,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/d7/c2/grhta-10-29.PMC10105321.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9317186","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Cost-minimization analysis to support the HTA of Radiofrequency Echographic Multi Spectrometry (REMS) in the diagnosis of osteoporosis. 成本最小化分析支持HTA的射频超声多光谱(REMS)在骨质疏松症的诊断。

IF 0.5

Global & Regional Health Technology Assessment Pub Date : 2023-01-01 DOI: 10.33393/grhta.2023.2492

Ludovica Borsoi, Patrizio Armeni, Maria Luisa Brandi

{"title":"Cost-minimization analysis to support the HTA of Radiofrequency Echographic Multi Spectrometry (REMS) in the diagnosis of osteoporosis.","authors":"Ludovica Borsoi, Patrizio Armeni, Maria Luisa Brandi","doi":"10.33393/grhta.2023.2492","DOIUrl":"https://doi.org/10.33393/grhta.2023.2492","url":null,"abstract":"Introduction: A timely diagnosis of osteoporosis is key to reducing its growing clinical and economic burden. Radiofrequency Echographic Multi Spectrometry (REMS), a new diagnostic technology using an ultrasound approach, has been recognized by scientific associations as a facilitator of patients' care pathway. We aimed at evaluating the costs of REMS vs. the conventional ionizing technology (dual-energy X-ray absorptiometry, DXA) for the diagnosis of osteoporosis from the perspective of the Italian National Health Service (NHS) using a cost-minimization analysis (CMA).Methods: We carried out structured qualitative interviews and a structured expert elicitation exercise to estimate healthcare resource consumption with a purposeful sample of clinical experts. For the elicitation exercise, an Excel tool was developed and, for each parameter, experts were asked to provide the lowest, highest and most likely value. Estimates provided by experts were averaged with equal weights. Unit costs were retrieved using different public sources.Results: Considering the base-case scenario (most likely value), the cost of professionals amounts to €31.9 for REMS and €48.8 for DXA, the cost of instrumental examinations and laboratory tests to €45.1 for REMS and €68.2 for DXA. Overall, in terms of current costs, REMS is associated with a mean saving for the NHS of €40.0 (range: €27.6-71.5) for each patient.Conclusions: REMS is associated with lower direct healthcare costs with respect to DXA. These results may inform policy-makers on the value of the REMS technology in the earlier diagnosis for osteoporosis, and support their decision regarding the reimbursement and diffusion of the technology in the Italian NHS.","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"10 ","pages":"1-11"},"PeriodicalIF":0.5,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/11/a2/grhta-10-1.PMC9923405.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10744081","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Il ruolo degli esiti riferiti dal paziente nelle decisioni di rimborso e innovatività dei farmaci in Italia. 患者报告的结果在意大利报销和药物创新决策中的作用。

IF 0.5

Global & Regional Health Technology Assessment Pub Date : 2023-01-01 DOI: 10.33393/grhta.2023.2514

Francesco Malandrini, Cesare Borroni, Michela Meregaglia, Massimiliano Sarra, Oriana Ciani

{"title":"Il ruolo degli esiti riferiti dal paziente nelle decisioni di rimborso e innovatività dei farmaci in Italia.","authors":"Francesco Malandrini, Cesare Borroni, Michela Meregaglia, Massimiliano Sarra, Oriana Ciani","doi":"10.33393/grhta.2023.2514","DOIUrl":"https://doi.org/10.33393/grhta.2023.2514","url":null,"abstract":"The role of patient-reported outcomes in reimbursement decisions and drug innovation in Italy The attention paid by regulatory authorities to patient-reported outcomes (PROs) and their related measures (PROMs) has progressively increased to allow for a more complete description of the patient’s health status. This work aimed at investigating the use of PROs/PROMs in relation to reimbursement agreement and innovativeness recognition by the Italian Medicines Agency (AIFA). The list of European Public Assessment Reports (EPARs), downloaded from the European Medicine Agency (EMA) website, was analyzed to identify drugs authorized between 2017 and 2021. The associations between the use of PROs/PROMs in the EPARs and the reimbursement and innovativeness status in Italy were explored through Chi2 test and logistic regression. In addition, each innovativeness report was analyzed to identify any further evidence about the consideration of PROs/PROM in the decision-making process. Of the 403 EPARs analyzed, 197 (48.9%) reported the use of PROs/PROMs. A subsample of 229 drugs with a reimbursement class (A, H, or C) officially assigned by AIFA was further investigated. Of them, 49.3% reported the use of PROs/PROMs. The Chi2 test revealed a statistically significant association between the use of PROs/PROMs and innovativeness (p = 0.001) and orphan status (p = 0.012). In the logistic regression, orphan status and availability of PROs/PROMs are significant predictors of the innovativeness status. However, of the 46 innovative drugs, only 9 (19.6%) explicitly reported a consideration of a PRO/PROM in their innovativeness reports. Robust instrument’s validation, reliable data collection and growing potential’s awareness are keys to increase the consideration of PROs at every step of the drug development process.","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"10 ","pages":"12-17"},"PeriodicalIF":0.5,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/37/79/grhta-10-12.PMC9923404.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10744083","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

La territorializzazione del farmaco in epoca di PNRR: prospettive, opportunità e spunti di riflessione da un panel di esperti. PNRR 时代的毒品属地化：专家小组的观点、机遇和见解。

IF 0.4

Global & Regional Health Technology Assessment Pub Date : 2022-12-05 eCollection Date: 2022-01-01 DOI: 10.33393/grhta.2022.2495

Anna Maria Marata, Walter Marrocco, Emanuela Arcangeli, Mattia Battistini, Giuliano Buzzetti, Riccardo Candido, Gianluigi Casadei, Francesco Cattel, Arturo Cavaliere, Agostino Consoli, Giovanni Corrao, Guido Didoni, Mauro Di Gesù, Alberto Giovanzana, Matteo Lenzi, Massimo Medaglia, Marta Meloncelli, Stefano Palcic, Marcello Pani, Francesca Patarnello, Emanuele Pria, Dario Scaduto, Valeria Tozzi, Marco Zibellini, Elisa Crovato

引用次数: 0

Costo per responder del metotrexato rispetto ad altre terapie in pazienti con psoriasi a placche da moderata a grave in Italia. 意大利中重度斑块状银屑病患者使用甲氨蝶呤与其他疗法相比，每个应答者的成本。

IF 0.4

Global & Regional Health Technology Assessment Pub Date : 2022-11-10 eCollection Date: 2022-01-01 DOI: 10.33393/grhta.2022.2474

Giuseppe Pompilio, Davide Integlia

引用次数: 0

La gestione del trattamento del paziente con diagnosi di Lupus Eritematoso Sistemico: un’analisi di consenso Delphi. 系统性红斑狼疮患者的治疗管理：德尔菲共识分析。

IF 0.4

Global & Regional Health Technology Assessment Pub Date : 2022-10-10 eCollection Date: 2022-01-01 DOI: 10.33393/grhta.2022.2470

Gian Domenico Sebastiani, Marta Mosca, Roberto Ravasio, Pietro Brambilla, Paola Raimondo, Andrea Doria

引用次数: 0

Il valore generato dall’effetto moltiplicatore degli investimenti dell’industria del farmaco in Italia: proposte di riforma per favorire competitività e attrattività. 意大利制药业投资乘数效应产生的价值：促进竞争力和吸引力的改革建议。

IF 0.4

Global & Regional Health Technology Assessment Pub Date : 2022-10-05 eCollection Date: 2022-01-01 DOI: 10.33393/grhta.2022.2440

Francesca Patarnello, Emiliano Briante, Federico Villa

引用次数: 0

Cost-benefit analysis of ALK diagnosis vs. non-diagnosis in patients with advanced non-small cell lung cancer in Spain. 西班牙晚期非小细胞肺癌患者 ALK 诊断与非诊断的成本效益分析。

IF 0.4

Global & Regional Health Technology Assessment Pub Date : 2022-09-12 eCollection Date: 2022-01-01 DOI: 10.33393/grhta.2022.2449

Margarita Majem, Rosa Álvarez, Ana Laura Ortega, Lucía Ruiz de Alda, Rocío Gordo, J Francisco García, Yoana Ivanova-Markova, Almudena González-Domínguez, Raquel Sánchez San Cristóbal, Federico Rojo

{"title":"Cost-benefit analysis of ALK diagnosis vs. non-diagnosis in patients with advanced non-small cell lung cancer in Spain.","authors":"Margarita Majem, Rosa Álvarez, Ana Laura Ortega, Lucía Ruiz de Alda, Rocío Gordo, J Francisco García, Yoana Ivanova-Markova, Almudena González-Domínguez, Raquel Sánchez San Cristóbal, Federico Rojo","doi":"10.33393/grhta.2022.2449","DOIUrl":"10.33393/grhta.2022.2449","url":null,"abstract":"Introduction: In recent years, target therapies to specific molecular alterations in advanced non-small cell lung cancer (NSCLC) have been identified and have shown superior efficacy compared to non-targeted treatments. Anaplastic lymphoma kinase (ALK) is one of the therapeutic targets; nevertheless, ALK diagnosis is not performed in all NSCLC patients in Spain. The objective of this study is to estimate in monetary terms the benefit for the Spanish society of ALK diagnosis in advanced NSCLC patients.Methods: A cost-benefit analysis of ALK diagnosis vs. non-diagnosis in advanced NSCLC patients was carried out from the Spanish social perspective, with a time horizon of 5 years. Costs, benefits and the cost-benefit ratio were measured. The analysis has considered the overall survival in advanced NSCLC patients treated with the ALK-tyrosine kinase inhibitor (TKI) alectinib. The natural history of NSCLC was simulated using a Markov model. A 3% discount rate was applied to both costs and benefits. The result was tested using a deterministic sensitivity analysis.Results: The cost of ALK diagnosis vs. non-diagnosis in the base case would be €10.19 million, generating benefits of €11.71 million. The cost-benefit ratio would be €1.15. In the sensitivity analysis, the cost-benefit ratio could range from €0.89 to €2.10.Conclusions: The results justify the universal application of ALK diagnosis in advanced NSCLC, which generates a benefit for Spanish society that outweighs its costs and allows optimal treatment with targeted therapies for these patients.","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"9 ","pages":"82-90"},"PeriodicalIF":0.4,"publicationDate":"2022-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/1f/ba/grhta-9-82.PMC9793412.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10511648","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0