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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 Q4 HEALTH CARE SCIENCES & SERVICES Pub Date : 2023-01-01 DOI: 10.33393/grhta.2023.2562
Eugenio Di Brino, Claudio Jommi
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.
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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 Q4 HEALTH CARE SCIENCES & SERVICES Pub Date : 2023-01-01 DOI: 10.33393/grhta.2023.2492
Ludovica Borsoi, Patrizio Armeni, Maria Luisa Brandi

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.

及时诊断骨质疏松症是减轻其日益增长的临床和经济负担的关键。射频超声多光谱法(REMS)是一种使用超声方法的新型诊断技术,已被科学协会认可为患者护理途径的促进者。我们的目的是从意大利国家卫生服务(NHS)的角度,使用成本最小化分析(CMA)评估REMS与传统电离技术(双能x射线吸收仪,DXA)诊断骨质疏松症的成本。方法:我们进行了结构化定性访谈和结构化专家启发练习,以估计有目的的临床专家样本的医疗资源消耗。为了启发练习,开发了一个Excel工具,并要求专家为每个参数提供最低、最高和最可能的值。专家提供的估计值以同等权重取平均值。使用不同的公共资源检索单位成本。结果:考虑到基本情况(最可能的价值),专业人员的成本为REMS 31.9欧元,DXA 48.8欧元,仪器检查和实验室测试的成本为REMS 45.1欧元,DXA 68.2欧元。总体而言,就当前成本而言,REMS与每位患者为NHS平均节省40.0欧元(范围:27.6-71.5欧元)相关。结论:相对于DXA, REMS与较低的直接医疗成本相关。这些结果可能会告知政策制定者REMS技术在骨质疏松症早期诊断中的价值,并支持他们关于在意大利NHS中报销和推广该技术的决定。
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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 Q4 HEALTH CARE SCIENCES & SERVICES Pub Date : 2023-01-01 DOI: 10.33393/grhta.2023.2514
Francesco Malandrini, Cesare Borroni, Michela Meregaglia, Massimiliano Sarra, Oriana Ciani
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.
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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 Q4 HEALTH CARE SCIENCES & SERVICES 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
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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 Q4 HEALTH CARE SCIENCES & SERVICES Pub Date : 2022-11-10 eCollection Date: 2022-01-01 DOI: 10.33393/grhta.2022.2474
Giuseppe Pompilio, Davide Integlia
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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 Q4 HEALTH CARE SCIENCES & SERVICES 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
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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 Q4 HEALTH CARE SCIENCES & SERVICES Pub Date : 2022-10-05 eCollection Date: 2022-01-01 DOI: 10.33393/grhta.2022.2440
Francesca Patarnello, Emiliano Briante, Federico Villa
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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 Q4 HEALTH CARE SCIENCES & SERVICES 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

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.

导言:近年来,针对晚期非小细胞肺癌(NSCLC)特定分子改变的靶向疗法已被确定,并显示出优于非靶向疗法的疗效。无性淋巴瘤激酶(ALK)是治疗靶点之一;然而,在西班牙,并非所有非小细胞肺癌患者都能进行 ALK 诊断。本研究旨在估算晚期 NSCLC 患者 ALK 诊断给西班牙社会带来的经济效益:方法:从西班牙社会的角度出发,对晚期 NSCLC 患者进行 ALK 诊断与不诊断的成本效益进行了分析,时间跨度为 5 年。对成本、收益和成本收益比进行了测算。分析考虑了接受 ALK 酪氨酸激酶抑制剂(TKI)阿来替尼治疗的晚期 NSCLC 患者的总生存率。使用马尔可夫模型模拟了 NSCLC 的自然病史。成本和收益均采用 3% 的贴现率。结果通过确定性敏感性分析进行了检验:结果:在基础病例中,ALK诊断与非诊断的成本为1019万欧元,收益为1171万欧元。成本效益比为 1.15 欧元。在敏感性分析中,成本效益比可能从 0.89 欧元到 2.10 欧元不等:结果证明,在晚期 NSCLC 中普遍应用 ALK 诊断是合理的,它为西班牙社会带来的收益大于其成本,并能为这些患者提供最佳的靶向治疗。
{"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":"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","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
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 Q4 HEALTH CARE SCIENCES & SERVICES Pub Date : 2022-06-28 eCollection Date: 2022-01-01 DOI: 10.33393/grhta.2022.2445
Francesco Saverio Mennini
{"title":"The potential impact of PNNR on the management of patients with epilepsy.","authors":"Francesco Saverio Mennini","doi":"10.33393/grhta.2022.2445","DOIUrl":"10.33393/grhta.2022.2445","url":null,"abstract":"","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":"9 Suppl 2","pages":"1-3"},"PeriodicalIF":0.4,"publicationDate":"2022-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/26/f9/grhta-9-S2-1.PMC9796600.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10520978","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
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 Q4 HEALTH CARE SCIENCES & SERVICES Pub Date : 2022-05-24 eCollection Date: 2022-01-01 DOI: 10.33393/grhta.2022.2389
Fabrizio Ricci, Federico Archilletti, Raffaele De Caterina
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引用次数: 0
期刊
Global & Regional Health Technology Assessment
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