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Costo per responder di risankizumab e secukinumab nel trattamento della psoriasi a placche da moderata a grave in Italia. 意大利中度至重度牛皮癣的治疗方案。
IF 0.5 Pub Date : 2021-01-01 DOI: 10.33393/grhta.2021.2258
Paolo Gisondi, Francesco Loconsole, Paola Raimondo, Roberto Ravasio
Cost per responder for risankizumab vs secukinumab in patients with moderate-to-severe plaque psoriasis in Italy Purpose: The objective of this analysis was to compare the cost per responder between risankizumab and secukinumab among patients with moderate-to-severe plaque psoriasis in Italy. Methods: The clinical efficacy was assessed based on IMMerge study of published efficacy data as measured by Psoriasis Area and Severity Index response (PASI 90 and PASI 100) for risankizumab and secukinumab. The treatment cost was based on the number of administrations dispensed in the first (induction plus maintenance period) and the second (maintenance period only) year of treatment and the ex-factory price of each treatment. The cost per responder was adopted as a cost-effectiveness indicator. Results: Independently of the PASI response (PASI 90 and PASI 100) used and the year of treatment considered, the cost per responder was consistently lower for risankizumab compared to secukinumab in all clinical measures. For example, considering the first-year costs and PASI 100, the cost per responder for risankizumab was € 24,506.83 compared to € 38,000.00 for secukinumab. The differences in the cost per responder between risankizumab and secukinumab increased when higher PASI response levels were considered. Conclusion: This economic evaluation suggested that the cost per responder is consistently lower for risankizumab compared to secukinumab from the perspective of the Italian National Health Service in the treatment of moderate-to-severe plaque psoriasis.
{"title":"Costo per responder di risankizumab e secukinumab nel trattamento della psoriasi a placche da moderata a grave in Italia.","authors":"Paolo Gisondi, Francesco Loconsole, Paola Raimondo, Roberto Ravasio","doi":"10.33393/grhta.2021.2258","DOIUrl":"https://doi.org/10.33393/grhta.2021.2258","url":null,"abstract":"Cost per responder for risankizumab vs secukinumab in patients with moderate-to-severe plaque psoriasis in Italy Purpose: The objective of this analysis was to compare the cost per responder between risankizumab and secukinumab among patients with moderate-to-severe plaque psoriasis in Italy. Methods: The clinical efficacy was assessed based on IMMerge study of published efficacy data as measured by Psoriasis Area and Severity Index response (PASI 90 and PASI 100) for risankizumab and secukinumab. The treatment cost was based on the number of administrations dispensed in the first (induction plus maintenance period) and the second (maintenance period only) year of treatment and the ex-factory price of each treatment. The cost per responder was adopted as a cost-effectiveness indicator. Results: Independently of the PASI response (PASI 90 and PASI 100) used and the year of treatment considered, the cost per responder was consistently lower for risankizumab compared to secukinumab in all clinical measures. For example, considering the first-year costs and PASI 100, the cost per responder for risankizumab was € 24,506.83 compared to € 38,000.00 for secukinumab. The differences in the cost per responder between risankizumab and secukinumab increased when higher PASI response levels were considered. Conclusion: This economic evaluation suggested that the cost per responder is consistently lower for risankizumab compared to secukinumab from the perspective of the Italian National Health Service in the treatment of moderate-to-severe plaque psoriasis.","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":null,"pages":null},"PeriodicalIF":0.5,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/b8/7b/grhta-8-120.PMC9616179.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9083773","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: 1
Analisi di costo-efficacia e budget impact per il vaccino antinfluenzale quadrivalente ad alto dosaggio nella popolazione anziana italiana. 高剂量四价流感疫苗在意大利老年人中的成本效益分析和预算影响。
IF 0.5 Pub Date : 2021-01-01 DOI: 10.33393/grhta.2021.2247
Filippo Rumi, Michele Basile, Americo Cicchetti
Cost-effectiveness and budget impact analysis for high dose quadrivalent influenza vaccine in the Italian elderly population Introduction: Influenza is a widespread acute respiratory disease and represents a serious Public Health problem, both from the NHS and society perspectives. The High Dose quadrivalent influenza vaccine (QIV HD) is a flu vaccine containing 4 times the antigens of a Standard Dose vaccine, resulting in demonstrated superior protection in the population aged 65 years and over. Methods: The analysis has been conducted from the perspective of the NHS. The CEA focuses on the comparison between QIV HD and the QIV SD vaccine. The BIM aims to estimate the potential economic impact for the National Health Service (NHS) resulting from the use of QIV HD in clinical practice in subjects aged 65 or over, when considering its introduction in combination with currently used vaccines, QIV SD and adjuvanted TIV. Results: In a scenario which considers hospitalizations possibly related to influenza, so including cardio-respiratory events, a dominant cost-effectiveness profile emerges in the comparison with QIV SD. In terms of budget impact, overall savings obtained by comparing the two scenarios regarding hospitalizations are equal to 92,766,429 € over the three years’ time horizon considered in the analysis. Conclusions: Nowadays, also considering the state of emergency due to the spread of the SARS-CoV-2 virus, it is crucial to implement innovative health technologies that improve the efficiency and sustainability of the health system. Also, it is essential to protect the elderly population, helping to avoid overload and healthcare systems disruption due to the many COVID-19 hospitalizations.
{"title":"Analisi di costo-efficacia e budget impact per il vaccino antinfluenzale quadrivalente ad alto dosaggio nella popolazione anziana italiana.","authors":"Filippo Rumi, Michele Basile, Americo Cicchetti","doi":"10.33393/grhta.2021.2247","DOIUrl":"https://doi.org/10.33393/grhta.2021.2247","url":null,"abstract":"Cost-effectiveness and budget impact analysis for high dose quadrivalent influenza vaccine in the Italian elderly population Introduction: Influenza is a widespread acute respiratory disease and represents a serious Public Health problem, both from the NHS and society perspectives. The High Dose quadrivalent influenza vaccine (QIV HD) is a flu vaccine containing 4 times the antigens of a Standard Dose vaccine, resulting in demonstrated superior protection in the population aged 65 years and over. Methods: The analysis has been conducted from the perspective of the NHS. The CEA focuses on the comparison between QIV HD and the QIV SD vaccine. The BIM aims to estimate the potential economic impact for the National Health Service (NHS) resulting from the use of QIV HD in clinical practice in subjects aged 65 or over, when considering its introduction in combination with currently used vaccines, QIV SD and adjuvanted TIV. Results: In a scenario which considers hospitalizations possibly related to influenza, so including cardio-respiratory events, a dominant cost-effectiveness profile emerges in the comparison with QIV SD. In terms of budget impact, overall savings obtained by comparing the two scenarios regarding hospitalizations are equal to 92,766,429 € over the three years’ time horizon considered in the analysis. Conclusions: Nowadays, also considering the state of emergency due to the spread of the SARS-CoV-2 virus, it is crucial to implement innovative health technologies that improve the efficiency and sustainability of the health system. Also, it is essential to protect the elderly population, helping to avoid overload and healthcare systems disruption due to the many COVID-19 hospitalizations.","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":null,"pages":null},"PeriodicalIF":0.5,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/34/51/grhta-8-105.PMC9616183.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9083777","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: 1
Carcinoma a cellule renali metastatico: evidenze real-world da un ampio database amministrativo italiano. 转移性肾细胞癌:来自意大利大型行政数据库的现实世界证据。
IF 0.5 Pub Date : 2021-01-01 DOI: 10.33393/grhta.2021.2178
Giulia Ronconi, Letizia Dondi, Carlo Piccinni, Silvia Calabria, Anna Capponcelli, Antonella Pedrini, Maurizio Marangolo, Immacolata Esposito, Carmine Pinto, Nello Martini
Metastatic renal cancer: real-world evidence from a large Italian claims database Purpose: To assess the healthcare resources’ consumption and integrated costs of patients with renal cancer and new metastasis (mRCC), in the perspective of the Italian National Health System (NHS). Methods: From the ReS database, through the administrative data record linkage, adults with a primary/secondary hospital (ordinary/daily admissions) diagnosis (ICD9-CM code) of renal cancer and lymph node and/or distant metastases in the same hospital discharge (index date) were selected in 2015. Metastases were defined new if they were absent in the 2 previous years. Patients were described in terms of gender, age (mean ± SD) and comorbidities of interest. The 2-year survival and annual pharmacological treatments, hospitalization, outpatient specialist services and costs were analysed. Results: Out of >6 million adults in the 2015 ReS database, 133 (2.1 × 100,000) were hospitalized with a diagnosis of RCC and metastasis. Patients with new metastases were 63.2% (1.4 × 100,000; 73.8% males; mean age 68 ± 13). Hypertension was the most common comorbidity (70.2% of mRCC patients). The 2-year survival of mRCC patients was 26.2%. During 1-year follow-up, at least a drug was prescribed to 88.1% of mRCC patients (on average € 12,095/patient), 91.7% were hospitalized (€ 8,897/patient) and 82.1% entrusted the outpatient specialist care (€ 1,075/patient). The mean overall expenditure for the NHS was € 22,067 per capita. Conclusions: This study shows the mRCC burden on the Italian real clinical practice and its economic impact in the perspective of the NHS. Real-world analyses prove to be useful to concretely estimate the overall healthcare responsibility on patients affected by mRCC.
{"title":"Carcinoma a cellule renali metastatico: evidenze real-world da un ampio database amministrativo italiano.","authors":"Giulia Ronconi, Letizia Dondi, Carlo Piccinni, Silvia Calabria, Anna Capponcelli, Antonella Pedrini, Maurizio Marangolo, Immacolata Esposito, Carmine Pinto, Nello Martini","doi":"10.33393/grhta.2021.2178","DOIUrl":"https://doi.org/10.33393/grhta.2021.2178","url":null,"abstract":"Metastatic renal cancer: real-world evidence from a large Italian claims database Purpose: To assess the healthcare resources’ consumption and integrated costs of patients with renal cancer and new metastasis (mRCC), in the perspective of the Italian National Health System (NHS). Methods: From the ReS database, through the administrative data record linkage, adults with a primary/secondary hospital (ordinary/daily admissions) diagnosis (ICD9-CM code) of renal cancer and lymph node and/or distant metastases in the same hospital discharge (index date) were selected in 2015. Metastases were defined new if they were absent in the 2 previous years. Patients were described in terms of gender, age (mean ± SD) and comorbidities of interest. The 2-year survival and annual pharmacological treatments, hospitalization, outpatient specialist services and costs were analysed. Results: Out of >6 million adults in the 2015 ReS database, 133 (2.1 × 100,000) were hospitalized with a diagnosis of RCC and metastasis. Patients with new metastases were 63.2% (1.4 × 100,000; 73.8% males; mean age 68 ± 13). Hypertension was the most common comorbidity (70.2% of mRCC patients). The 2-year survival of mRCC patients was 26.2%. During 1-year follow-up, at least a drug was prescribed to 88.1% of mRCC patients (on average € 12,095/patient), 91.7% were hospitalized (€ 8,897/patient) and 82.1% entrusted the outpatient specialist care (€ 1,075/patient). The mean overall expenditure for the NHS was € 22,067 per capita. Conclusions: This study shows the mRCC burden on the Italian real clinical practice and its economic impact in the perspective of the NHS. Real-world analyses prove to be useful to concretely estimate the overall healthcare responsibility on patients affected by mRCC.","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":null,"pages":null},"PeriodicalIF":0.5,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/6d/26/grhta-8-1.PMC9616181.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10869812","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 costo-utilità di evolocumab in pazienti con ASCVD in Italia. 在意大利的ASCVD患者中进行cumab的成本效益分析。
IF 0.5 Pub Date : 2021-01-01 DOI: 10.33393/grhta.2021.2255
Andrea Marcellusi, Chiara Bini, Maria Assunta Rotundo, Emanuela Arcangeli, Laura Martinez, Francesc Sorio Vilela, Francesco Saverio Mennini
Cost-utility analysis of evolocumab in patients with ASCVD in Italy Objective: The aim of this work was to evaluate the cost-effectiveness of evolocumab in addition to standard statin therapy with or without ezetimibe in the treatment of patients with clinically evident atherosclerotic cardiovascular disease (ASCVD) with levels of LDL-C above 100 mg/dL. Method: A theoretical cohort of patients was forecast by a Markov model that includes 11 health states for a lifetime horizon. In the base-case, the standard therapy was characterized by statins with or without ezetimibe. Two sub-populations have been considered, Recent MI (Myocardial Infarction in the last year) and Multiple events (population with multiple MI). The results were also presented for a subset of the Multiple events populations consisting of patients who have experienced a myocardial infarction (MI) in the last year. Results: For the Recent MI and Multiple events populations, ICER values of € 39,547 and € 35,744 respectively were estimated. The value of ICER was lower for the Multiple events with MI < 1 year population (€ 29,949). Considering statins with ezetimibe as standard therapy, ICER values were found to be equal to € 39,781, € 35,986 and € 30,190 respectively for the populations Recent MI, Multiple events and Multiple events with MI < 1 year. Conclusions: The estimated ICER values for the Recent MI, Multiple events and Multiple events populations with MI < 1 year were below the cost-effectiveness threshold of € 40,000, suggesting therefore how the treatment with evolocumab in addition to the standard therapy can be a cost-effective treatment both compared to standard therapy with statins and standard therapy with statins + ezetimibe.
{"title":"Analisi di costo-utilità di evolocumab in pazienti con ASCVD in Italia.","authors":"Andrea Marcellusi,&nbsp;Chiara Bini,&nbsp;Maria Assunta Rotundo,&nbsp;Emanuela Arcangeli,&nbsp;Laura Martinez,&nbsp;Francesc Sorio Vilela,&nbsp;Francesco Saverio Mennini","doi":"10.33393/grhta.2021.2255","DOIUrl":"https://doi.org/10.33393/grhta.2021.2255","url":null,"abstract":"Cost-utility analysis of evolocumab in patients with ASCVD in Italy Objective: The aim of this work was to evaluate the cost-effectiveness of evolocumab in addition to standard statin therapy with or without ezetimibe in the treatment of patients with clinically evident atherosclerotic cardiovascular disease (ASCVD) with levels of LDL-C above 100 mg/dL. Method: A theoretical cohort of patients was forecast by a Markov model that includes 11 health states for a lifetime horizon. In the base-case, the standard therapy was characterized by statins with or without ezetimibe. Two sub-populations have been considered, Recent MI (Myocardial Infarction in the last year) and Multiple events (population with multiple MI). The results were also presented for a subset of the Multiple events populations consisting of patients who have experienced a myocardial infarction (MI) in the last year. Results: For the Recent MI and Multiple events populations, ICER values of € 39,547 and € 35,744 respectively were estimated. The value of ICER was lower for the Multiple events with MI < 1 year population (€ 29,949). Considering statins with ezetimibe as standard therapy, ICER values were found to be equal to € 39,781, € 35,986 and € 30,190 respectively for the populations Recent MI, Multiple events and Multiple events with MI < 1 year. Conclusions: The estimated ICER values for the Recent MI, Multiple events and Multiple events populations with MI < 1 year were below the cost-effectiveness threshold of € 40,000, suggesting therefore how the treatment with evolocumab in addition to the standard therapy can be a cost-effective treatment both compared to standard therapy with statins and standard therapy with statins + ezetimibe.","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":null,"pages":null},"PeriodicalIF":0.5,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/f9/68/grhta-8-155.PMC9616188.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10310443","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
Preparation of intravenous chemotherapy bags: evaluation of a dose banding approach in an Italian oncology hospital. 静脉化疗袋的制备:意大利肿瘤医院剂量带法的评价。
IF 0.5 Pub Date : 2021-01-01 DOI: 10.33393/grhta.2021.2202
Marco Chiumente, Alberto Russi, Federica Todino, Daniele Mengato, Marina Coppola, Melania Rivano, Angelo C Palozzo, Claudio Jommi

Introduction: Dose banding is an original approach that manages intravenous (IV) chemotherapy preparation by generating on a weekly basis a series of bags containing scaled dosages of the active agent. These predetermined, fixed dosage bags are intended to replace the traditional bags prepared daily that contain fully individualized dosages.

Methods: Three different scenarios were examined: (1) the current method of daily preparation of individualized bags at the hospital pharmacy; (2) the weekly preparation at the hospital pharmacy of non-individualized bags containing discrete, predefined doses covering an adequate range of doses (dose banding); (3) the use of commercial ready-to-use bags based on the same approach of dose banding. The objective of this study was to compare these three different approaches in terms of cost per patient. We considered five cancer drugs (gemcitabine, oxaliplatin, paclitaxel, trastuzumab and 5-fluorouracil) that were suitable for the dose ranging approach. Appropriate dose bands for these five agents were identified. Costs were estimated for each of the three approaches.

Results: A total of 13,490 fully individualized bags were studied, which corresponded to the real bags prepared at our institution for these five agents in 2018. Dose banding was predicted to determine savings ranging from €10,998 (-0.84%) for trastuzumab to €169,429.60 (-8.39%) for paclitaxel.

Conclusion: The introduction of dose banding can determine economic savings along with other advantages, such as improved work conditions, management reorganization and containment of waste. The pharmaceutical industry can hopefully support these experiences by producing ready-to-use bags in predetermined dosages.

剂量带是一种管理静脉(IV)化疗制剂的原始方法,通过每周产生一系列含有按比例剂量的活性剂的袋子。这些预定的、固定的剂量袋旨在取代每天制备的、含有完全个体化剂量的传统剂量袋。方法:考察三种不同的情况:(1)目前医院药房每日个体化药袋的制备方法;(2)每周在医院药房配制非个体化的药袋,药袋中装有离散的、预先确定的剂量,覆盖足够的剂量范围(剂量带);(3)使用基于相同剂量带的商业即用袋。本研究的目的是比较这三种不同的方法在每个病人的成本方面。我们考虑了五种适合剂量范围方法的抗癌药物(吉西他滨、奥沙利铂、紫杉醇、曲妥珠单抗和5-氟尿嘧啶)。确定了这五种药物的适当剂量范围。对这三种方法的成本进行了估计。结果:共研究了13490个完全个性化的袋子,与我所2018年为这5个代理人准备的真实袋子相对应。剂量分级预计将决定从曲妥珠单抗的10,998欧元(-0.84%)到紫杉醇的169,429.60欧元(-8.39%)的节省。结论:采用带剂量可以节约经济成本,并具有改善工作条件、整顿管理、遏制废物等优点。制药行业有望通过生产预先确定剂量的即用袋来支持这些经验。
{"title":"Preparation of intravenous chemotherapy bags: evaluation of a dose banding approach in an Italian oncology hospital.","authors":"Marco Chiumente,&nbsp;Alberto Russi,&nbsp;Federica Todino,&nbsp;Daniele Mengato,&nbsp;Marina Coppola,&nbsp;Melania Rivano,&nbsp;Angelo C Palozzo,&nbsp;Claudio Jommi","doi":"10.33393/grhta.2021.2202","DOIUrl":"https://doi.org/10.33393/grhta.2021.2202","url":null,"abstract":"<p><strong>Introduction: </strong>Dose banding is an original approach that manages intravenous (IV) chemotherapy preparation by generating on a weekly basis a series of bags containing scaled dosages of the active agent. These predetermined, fixed dosage bags are intended to replace the traditional bags prepared daily that contain fully individualized dosages.</p><p><strong>Methods: </strong>Three different scenarios were examined: (1) the current method of daily preparation of individualized bags at the hospital pharmacy; (2) the weekly preparation at the hospital pharmacy of non-individualized bags containing discrete, predefined doses covering an adequate range of doses (dose banding); (3) the use of commercial ready-to-use bags based on the same approach of dose banding. The objective of this study was to compare these three different approaches in terms of cost per patient. We considered five cancer drugs (gemcitabine, oxaliplatin, paclitaxel, trastuzumab and 5-fluorouracil) that were suitable for the dose ranging approach. Appropriate dose bands for these five agents were identified. Costs were estimated for each of the three approaches.</p><p><strong>Results: </strong>A total of 13,490 fully individualized bags were studied, which corresponded to the real bags prepared at our institution for these five agents in 2018. Dose banding was predicted to determine savings ranging from €10,998 (-0.84%) for trastuzumab to €169,429.60 (-8.39%) for paclitaxel.</p><p><strong>Conclusion: </strong>The introduction of dose banding can determine economic savings along with other advantages, such as improved work conditions, management reorganization and containment of waste. The pharmaceutical industry can hopefully support these experiences by producing ready-to-use bags in predetermined dosages.</p>","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":null,"pages":null},"PeriodicalIF":0.5,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/35/d4/grhta-8-29.PMC9616189.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10869819","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: 3
Clinical and economic benefits of a new paradigm of HCV diagnosis and treatment. HCV诊断和治疗新模式的临床和经济效益。
IF 0.5 Pub Date : 2021-01-01 DOI: 10.33393/grhta.2021.2183
Stefano Fagiuoli, Matteo Ruggeri, Filipa Aragao, Rob Blissett

Introduction: The current paradigm (CP) of hepatitis C virus (HCV) diagnosis and treatment in Italy's National Health Service system has numerous steps. The European Association for the Study of the Liver recommends initiation of a pan-genotypic direct-acting antiviral regimen after a simple diagnostic process. The present study estimated the efficiency gains resulting from two simplified pathways from diagnosis to treatment of chronic hepatitis C patients in Italy over the next 5 years from a societal perspective.

Methods: The CP, a New Paradigm 1 (NP1), and a New Paradigm 2 (NP2) were evaluated in a Markov model. The NP1 model simplifies monitoring and laboratory test requirements in the diagnosis and treatment phases. The NP2 model also eliminates the primary care referral requirement.

Results: Treatment process time for non-cirrhotic patients was 48, 43, and 25 weeks in the CP, NP1, and NP2, respectively, and in cirrhotic patients was 49, 46, and 37 weeks. Under the CP, 19% of patients/year would be lost to follow-up, which decreases by 11% in NP1 and 100% in NP2. Compared with the CP, implementation of NP1 at 5 years would reduce compensated cirrhosis, decompensated cirrhosis, hepatocellular carcinoma, and liver-related deaths by 12.6%, 12.4%, 8.1%, and 8.8%, respectively; these cases would be reduced by 94.0%, 93.8%, 61.0%, and 58.4% in NP2. Total 5-year costs with the CP, NP1, and NP2 are estimated at 135.6€ million, 110.5€ million, and 80.5€ million, respectively.

Conclusions: Simplification of HCV diagnosis and monitoring requirements would allow Italy to move closer to international guidelines with significant health benefits and economic gains.

意大利国家卫生服务系统目前丙型肝炎病毒(HCV)诊断和治疗的范例(CP)有许多步骤。欧洲肝脏研究协会建议在简单的诊断过程后启动泛基因型直接作用抗病毒方案。本研究从社会角度估计了未来5年意大利慢性丙型肝炎患者从诊断到治疗的两种简化途径所带来的效率收益。方法:采用马尔可夫模型对CP、新范式1 (NP1)和新范式2 (NP2)进行评价。NP1模型简化了诊断和治疗阶段的监测和实验室测试要求。NP2模式还消除了初级保健转诊的要求。结果:CP、NP1和NP2组非肝硬化患者的治疗时间分别为48、43和25周,肝硬化患者的治疗时间分别为49、46和37周。在CP下,19%的患者/年将失去随访,NP1患者减少11%,NP2患者减少100%。与CP相比,在5年时实施NP1将使代偿性肝硬化、失代偿性肝硬化、肝细胞癌和肝脏相关死亡分别减少12.6%、12.4%、8.1%和8.8%;这些病例在NP2区分别减少94.0%、93.8%、61.0%和58.4%。CP、NP1和NP2的5年总成本预计分别为1.356亿欧元、1.105亿欧元和8050万欧元。结论:简化HCV诊断和监测要求将使意大利更接近国际指南,具有显著的健康效益和经济收益。
{"title":"Clinical and economic benefits of a new paradigm of HCV diagnosis and treatment.","authors":"Stefano Fagiuoli,&nbsp;Matteo Ruggeri,&nbsp;Filipa Aragao,&nbsp;Rob Blissett","doi":"10.33393/grhta.2021.2183","DOIUrl":"https://doi.org/10.33393/grhta.2021.2183","url":null,"abstract":"<p><strong>Introduction: </strong>The current paradigm (CP) of hepatitis C virus (HCV) diagnosis and treatment in Italy's National Health Service system has numerous steps. The European Association for the Study of the Liver recommends initiation of a pan-genotypic direct-acting antiviral regimen after a simple diagnostic process. The present study estimated the efficiency gains resulting from two simplified pathways from diagnosis to treatment of chronic hepatitis C patients in Italy over the next 5 years from a societal perspective.</p><p><strong>Methods: </strong>The CP, a New Paradigm 1 (NP1), and a New Paradigm 2 (NP2) were evaluated in a Markov model. The NP1 model simplifies monitoring and laboratory test requirements in the diagnosis and treatment phases. The NP2 model also eliminates the primary care referral requirement.</p><p><strong>Results: </strong>Treatment process time for non-cirrhotic patients was 48, 43, and 25 weeks in the CP, NP1, and NP2, respectively, and in cirrhotic patients was 49, 46, and 37 weeks. Under the CP, 19% of patients/year would be lost to follow-up, which decreases by 11% in NP1 and 100% in NP2. Compared with the CP, implementation of NP1 at 5 years would reduce compensated cirrhosis, decompensated cirrhosis, hepatocellular carcinoma, and liver-related deaths by 12.6%, 12.4%, 8.1%, and 8.8%, respectively; these cases would be reduced by 94.0%, 93.8%, 61.0%, and 58.4% in NP2. Total 5-year costs with the CP, NP1, and NP2 are estimated at 135.6€ million, 110.5€ million, and 80.5€ million, respectively.</p><p><strong>Conclusions: </strong>Simplification of HCV diagnosis and monitoring requirements would allow Italy to move closer to international guidelines with significant health benefits and economic gains.</p>","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":null,"pages":null},"PeriodicalIF":0.5,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/6b/e9/grhta-8-58.PMC9616196.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9083779","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 Budget Impact di ponatinib per il management di pazienti affetti da leucemia mieloide cronica. 预算分析ponatinib对慢性骨髓白血病患者管理的影响。
IF 0.5 Pub Date : 2021-01-01 DOI: 10.33393/grhta.2021.2238
Michele Basile, Filippo Rumi, Americo Cicchetti
Budget Impact analysis of ponatinib for the management of patients with chronic myeloid leukemia Background: The current clinical practice for patients affected by chronic myeloid leukemia (CML) is based on the evaluation of second generation alternatives following therapeutic failure that leads to a lengthening of patients’ management times and a consequent negative impact in terms of quality of life. Objective: To determine the economic absorption of resources associated to the management of patients with CML in a scenario in which an early recourse to ponatinib is considered as compared with a scenario based on the current Italian clinical practice characterized by a cyclical recourse to the available therapies. Methods: A Budget Impact model was developed to compare the resources absorbed in the scenarios under assessment considering a 3-year time horizon and the perspective of the Italian National Health Service. Results are expressed in terms of differential resources absorbed in the alternative scenarios. Results: The increase in the recourse to ponatinib allowed a saving of resources for the Italian NHS over the 3-year time horizon of –€ 1,979,322 (€ 825,104,350 vs € 823,125,028). The parameter affecting the most of the results achieved in the base-case is the monthly cost of bosutinib used as a third-line treatment. Conclusions: The increase in the recourse to ponatinib in patients affected by CML that failed to respond to a previous pharmacological therapy resulted to be associated to a lower level of resources’ absorption in the Italian NHS allowing to re-allocate health founds to other fields of the care sector ensuring greater sustainability of the system.
{"title":"Analisi di Budget Impact di ponatinib per il management di pazienti affetti da leucemia mieloide cronica.","authors":"Michele Basile,&nbsp;Filippo Rumi,&nbsp;Americo Cicchetti","doi":"10.33393/grhta.2021.2238","DOIUrl":"https://doi.org/10.33393/grhta.2021.2238","url":null,"abstract":"Budget Impact analysis of ponatinib for the management of patients with chronic myeloid leukemia Background: The current clinical practice for patients affected by chronic myeloid leukemia (CML) is based on the evaluation of second generation alternatives following therapeutic failure that leads to a lengthening of patients’ management times and a consequent negative impact in terms of quality of life. Objective: To determine the economic absorption of resources associated to the management of patients with CML in a scenario in which an early recourse to ponatinib is considered as compared with a scenario based on the current Italian clinical practice characterized by a cyclical recourse to the available therapies. Methods: A Budget Impact model was developed to compare the resources absorbed in the scenarios under assessment considering a 3-year time horizon and the perspective of the Italian National Health Service. Results are expressed in terms of differential resources absorbed in the alternative scenarios. Results: The increase in the recourse to ponatinib allowed a saving of resources for the Italian NHS over the 3-year time horizon of –€ 1,979,322 (€ 825,104,350 vs € 823,125,028). The parameter affecting the most of the results achieved in the base-case is the monthly cost of bosutinib used as a third-line treatment. Conclusions: The increase in the recourse to ponatinib in patients affected by CML that failed to respond to a previous pharmacological therapy resulted to be associated to a lower level of resources’ absorption in the Italian NHS allowing to re-allocate health founds to other fields of the care sector ensuring greater sustainability of the system.","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":null,"pages":null},"PeriodicalIF":0.5,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/a3/3d/grhta-8-87.PMC9616198.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10869813","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
Valutazione delle conseguenze epidemiologiche ed economiche generate dal ritardo di trattamento dei pazienti HIV-positivi causato dalla pandemia COVID-19. 评估大流行covi -19对hiv阳性患者治疗延误所造成的流行病学和经济后果。
IF 0.5 Pub Date : 2021-01-01 DOI: 10.33393/grhta.2021.2279
Andrea Marcellusi, Chiara Bini, Massimo Andreoni, Andrea Antinori, Francesco Saverio Mennini
Objective: To assess, from an epidemiological and economic point of view, the consequences of the reduction in the supply of antiretroviral drugs due to the COVID-19 pandemic.Method: The analysis was conducted by adapting a Markov model previously published in literature. The simulations were conducted considering the possibility of continuous treatment for patients already diagnosed (no therapeutic interruptions are expected) and an immediate start of patients with new diagnosis during 2021. This analysis was compared with a scenario involving a therapeutic interruption or diagnostic delay caused by COVID-19.Results: The analysis showed that the scenario characterized by a treatment delay, compared to the scenario of early resumption of therapy, could generate an increase in the number of patients with CD4 < 200 equal to 1,719 subjects (+16%) and a reduction in the number of patients with CD4 500 equal to 6,751 (−9%). A timely resumption of treatment for HIV+ patients could prevent 296, 454 and 687 deaths in the third, fifth and tenth years of analysis respectively with a potential cost reduction equal to 78,9 million at a 10 year time horizon.Conclusions: These findings show that it is essential, especially in a pandemic situation such as the present one, to introduce technological, digital and organizational solutions, aimed at promoting timely diagnosis and at accelerating the therapeutic switch for patients who are no longer targeted.
{"title":"Valutazione delle conseguenze epidemiologiche ed economiche generate dal ritardo di trattamento dei pazienti HIV-positivi causato dalla pandemia COVID-19.","authors":"Andrea Marcellusi,&nbsp;Chiara Bini,&nbsp;Massimo Andreoni,&nbsp;Andrea Antinori,&nbsp;Francesco Saverio Mennini","doi":"10.33393/grhta.2021.2279","DOIUrl":"https://doi.org/10.33393/grhta.2021.2279","url":null,"abstract":"Objective: To assess, from an epidemiological and economic point of view, the consequences of the reduction in the supply of antiretroviral drugs due to the COVID-19 pandemic.\u0000Method: The analysis was conducted by adapting a Markov model previously published in literature. The simulations were conducted considering the possibility of continuous treatment for patients already diagnosed (no therapeutic interruptions are expected) and an immediate start of patients with new diagnosis during 2021. This analysis was compared with a scenario involving a therapeutic interruption or diagnostic delay caused by COVID-19.\u0000Results: The analysis showed that the scenario characterized by a treatment delay, compared to the scenario of early resumption of therapy, could generate an increase in the number of patients with CD4 < 200 equal to 1,719 subjects (+16%) and a reduction in the number of patients with CD4 500 equal to 6,751 (−9%). A timely resumption of treatment for HIV+ patients could prevent 296, 454 and 687 deaths in the third, fifth and tenth years of analysis respectively with a potential cost reduction equal to 78,9 million at a 10 year time horizon.\u0000Conclusions: These findings show that it is essential, especially in a pandemic situation such as the present one, to introduce technological, digital and organizational solutions, aimed at promoting timely diagnosis and at accelerating the therapeutic switch for patients who are no longer targeted.","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":null,"pages":null},"PeriodicalIF":0.5,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/fd/af/grhta-8-147.PMC9616186.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10869821","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
Nuovi criteri di definizione del prezzo di un farmaco in Italia: riflessioni e proposte per supportare valore ed innovazione. 意大利药品定价的新标准:支持价值和创新的想法和建议。
IF 0.5 Pub Date : 2021-01-01 DOI: 10.33393/grhta.2021.2207
Francesca Patarnello, Federico Villa
The definition of criteria and processes for the submission of price and reimbursement requests (P&R) of a drug in Italy cannot be separated from the definition of an overall “Pharmaceutical Policy” that includes, in an organic vision: (i) the governance related to the research, marketing and monitoring of drugs in the Italian market; (ii) the availability of drugs on the national territory as an element included in the essential levels of care (LEA) and the related conditions in terms of timing and equity of access between different regions, as well as towards other European countries; (iii) the assessment criteria used. The decree published in the Italian Official Journal in the summer of 2020, which defines the new criteria for the regulation of P&R of medicines in Italy, focuses on the final part of the process, i.e. the price negotiation. It would be necessary to frame this last step within a broader and more organic structure of drug policies aimed at: 1. optimising healthcare funding by encouraging competition between healthcare technologies; 2. reducing assessment time by simplifying processes; 3. improving early access to drugs for unmet need; 4. increasing the quality of P&R dossiers by improving interaction with the companies; 5. encouraging innovative agreements and complementary elements to the price; 6. encouraging the reproducibility of assessment methodologies in a value-based pricing system; 7. considering cost-benefit analyses as tools for the definition of price and conditions of reimbursability; 8. creating a place for discussion on drug policies.
{"title":"Nuovi criteri di definizione del prezzo di un farmaco in Italia: riflessioni e proposte per supportare valore ed innovazione.","authors":"Francesca Patarnello,&nbsp;Federico Villa","doi":"10.33393/grhta.2021.2207","DOIUrl":"https://doi.org/10.33393/grhta.2021.2207","url":null,"abstract":"The definition of criteria and processes for the submission of price and reimbursement requests (P&R) of a drug in Italy cannot be separated from the definition of an overall “Pharmaceutical Policy” that includes, in an organic vision: (i) the governance related to the research, marketing and monitoring of drugs in the Italian market; (ii) the availability of drugs on the national territory as an element included in the essential levels of care (LEA) and the related conditions in terms of timing and equity of access between different regions, as well as towards other European countries; (iii) the assessment criteria used. The decree published in the Italian Official Journal in the summer of 2020, which defines the new criteria for the regulation of P&R of medicines in Italy, focuses on the final part of the process, i.e. the price negotiation. It would be necessary to frame this last step within a broader and more organic structure of drug policies aimed at: 1. optimising healthcare funding by encouraging competition between healthcare technologies; 2. reducing assessment time by simplifying processes; 3. improving early access to drugs for unmet need; 4. increasing the quality of P&R dossiers by improving interaction with the companies; 5. encouraging innovative agreements and complementary elements to the price; 6. encouraging the reproducibility of assessment methodologies in a value-based pricing system; 7. considering cost-benefit analyses as tools for the definition of price and conditions of reimbursability; 8. creating a place for discussion on drug policies.","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":null,"pages":null},"PeriodicalIF":0.5,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/64/25/grhta-8-131.PMC9616182.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10513338","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: 1
Analisi costo-efficacia di caplacizumab nel nuovo standard of care della porpora trombotica trombocitopenica immune in Italia. 意大利免疫血小板减少紫癜新护理标准中的caplacizumab的成本效益分析。
IF 0.5 Pub Date : 2021-01-01 DOI: 10.33393/grhta.2021.2191
Giovanni Di Minno, Roberto Ravasio
Cost-effectiveness analysis of caplacizumab in the new standard of care for immune Thrombotic Thrombocytopenic Purpura in Italy Objectives: To evaluate the cost-effectiveness analysis (CEA) of caplacizumab in combination with plasmapheresis (PEX) and immunosuppression compared to PEX and immunosuppression in the treatment of acute episodes of iTTP. Methods: A Markov model was used to conduct the CEA from the perspective of the hospital, over a lifetime horizon. Clinical data derived from HERCULES trial and a systematic literature review. Economic input included direct costs only. Utility and disutility values were obtained from literature. Data on healthcare resources and costs were retrieved from HERCULES trial, literature, TTP guidelines and Italian tariffs. A sensitivity analysis was conducted. The cost-effectiveness probability was tested for several options of discount levels considering a suggested willingness to pay (WTP) threshold of € 60,000 in Italy. Results: The use of caplacizumab in combination with PEX and immunosuppression is associated with a positive difference in survival of 3.27 life years (24.53 vs 21.26) and in quality of life of 3.06 QALY (22.01 vs 18.96) when compared to PEX and immunosuppression. Caplacizumab leads to an ICER per life years of € 41,653 and an ICER per QALY of € 44,572. For the suggested WTP threshold, the probability of caplacizumab being cost-effective is 82.4% (no discount), 92.8% (15% discount), 95.3% (20% discount), 96.9% (25% discount) and 98.2% (30% discount). Conclusions: Caplacizumab in addition to PEX and immunosuppression is cost-effective, allowing the hospital to achieve greater efficiency in managing the burden of a life-threatening disease such as iTTP.
{"title":"Analisi costo-efficacia di caplacizumab nel nuovo standard of care della porpora trombotica trombocitopenica immune in Italia.","authors":"Giovanni Di Minno,&nbsp;Roberto Ravasio","doi":"10.33393/grhta.2021.2191","DOIUrl":"https://doi.org/10.33393/grhta.2021.2191","url":null,"abstract":"Cost-effectiveness analysis of caplacizumab in the new standard of care for immune Thrombotic Thrombocytopenic Purpura in Italy Objectives: To evaluate the cost-effectiveness analysis (CEA) of caplacizumab in combination with plasmapheresis (PEX) and immunosuppression compared to PEX and immunosuppression in the treatment of acute episodes of iTTP. Methods: A Markov model was used to conduct the CEA from the perspective of the hospital, over a lifetime horizon. Clinical data derived from HERCULES trial and a systematic literature review. Economic input included direct costs only. Utility and disutility values were obtained from literature. Data on healthcare resources and costs were retrieved from HERCULES trial, literature, TTP guidelines and Italian tariffs. A sensitivity analysis was conducted. The cost-effectiveness probability was tested for several options of discount levels considering a suggested willingness to pay (WTP) threshold of € 60,000 in Italy. Results: The use of caplacizumab in combination with PEX and immunosuppression is associated with a positive difference in survival of 3.27 life years (24.53 vs 21.26) and in quality of life of 3.06 QALY (22.01 vs 18.96) when compared to PEX and immunosuppression. Caplacizumab leads to an ICER per life years of € 41,653 and an ICER per QALY of € 44,572. For the suggested WTP threshold, the probability of caplacizumab being cost-effective is 82.4% (no discount), 92.8% (15% discount), 95.3% (20% discount), 96.9% (25% discount) and 98.2% (30% discount). Conclusions: Caplacizumab in addition to PEX and immunosuppression is cost-effective, allowing the hospital to achieve greater efficiency in managing the burden of a life-threatening disease such as iTTP.","PeriodicalId":12627,"journal":{"name":"Global & Regional Health Technology Assessment","volume":null,"pages":null},"PeriodicalIF":0.5,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/34/43/grhta-8-43.PMC9616191.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10869820","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: 3
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Global & Regional Health Technology Assessment
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