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

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":null,"pages":null},"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":null,"pages":null},"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

The potential impact of PNNR on the management of patients with epilepsy. PNNR 对癫痫患者管理的潜在影响。

IF 0.4

Global & Regional Health Technology Assessment Pub Date : 2022-06-28 eCollection Date: 2022-01-01 DOI: 10.33393/grhta.2022.2445

Francesco Saverio Mennini

引用次数: 0

Approccio diagnostico e terapeutico al paziente con sindrome coronarica acuta. 急性冠状动脉综合征患者的诊断和治疗方法。

IF 0.4

Global & Regional Health Technology Assessment Pub Date : 2022-05-24 eCollection Date: 2022-01-01 DOI: 10.33393/grhta.2022.2389

Fabrizio Ricci, Federico Archilletti, Raffaele De Caterina

引用次数: 0

Erratum in: Cost per responder for upadacitinib vs abatacept in patients with moderate-to-severe Rheumatoid Arthritis in Italy. 勘误：意大利中重度类风湿性关节炎患者中，达帕替尼与阿帕他赛的每次应答成本。

IF 0.4

Global & Regional Health Technology Assessment Pub Date : 2022-02-17 eCollection Date: 2022-01-01 DOI: 10.33393/grhta.2022.2383

Roberto Caporali, Roberto Ravasio, Paola Raimondo, Fausto Salaffi

引用次数: 0

Cost analysis of extended half-life recombinant factor IX products in the treatment of haemophilia B in Italy: an update. 意大利治疗血友病 B 的延长半衰期重组因子 IX 产品的成本分析：最新情况。

IF 0.4

Global & Regional Health Technology Assessment Pub Date : 2022-01-19 eCollection Date: 2022-01-01 DOI: 10.33393/grhta.2022.2331

Andrea Aiello, Maria E Mancuso, Serena Leone, Letizia Rossi, Lorenzo Cioni, Cristina Teruzzi

{"title":"Cost analysis of extended half-life recombinant factor IX products in the treatment of haemophilia B in Italy: an update.","authors":"Andrea Aiello, Maria E Mancuso, Serena Leone, Letizia Rossi, Lorenzo Cioni, Cristina Teruzzi","doi":"10.33393/grhta.2022.2331","DOIUrl":"10.33393/grhta.2022.2331","url":null,"abstract":"Haemophilia B (HB) is a rare disease which may lead to chronic disabling arthropathy, resulting in a significant clinical, social and economic impact. In recent years, new extended half-life (EHL) factor IX concentrates produced by recombinant technology (rFIX) have been developed. They have shown significantly prolonged half-life as compared to other rFIX products and improved bleeding control when used as prophylaxis. To date, EHL rFIX products reimbursed in Italy are a recombinant coagulation factor IX produced with Fc technology (rFIXFc) and a recombinant fusion protein containing rFIX fused with recombinant albumin (rIX-FP). The results of extension studies with injection intervals with a median of almost every 14 days for the complete individualized interval prophylaxis (IP) group on rFIXFc and 21 days for a selected subgroup of patients on rIX-FP have recently been published. The aim of this analysis was to estimate the cost of prophylactic treatment with rFIXFc and rIX-FP in adult patients, in the light of new clinical evidence and current average prices in Italy. The cost of therapy was estimated on the basis of the results of extension studies, the average prices reported in regional drug tenders and assuming an average patient weight of 70 kg. The analysis estimated a cost per patient/year between €224,407 and €230,355 for rFIXFc and between €242,259 and €368,587 for rIX-FP. The sensitivity analysis confirmed the robustness of the results. The use of rFIXFc over rIX-FP proves to be the least expensive choice for the treatment of HB in Italy.","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":null,"pages":null},"PeriodicalIF":0.4,"publicationDate":"2022-01-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/cb/ce/grhta-9-9.PMC9768593.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10521006","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