{"title":"A new payment-by-results method for determining the fair price of new oncological drugs","authors":"E. Ballatori, L. Ferrante, B. Ruggeri, F. Roila","doi":"10.5301/GRHTA.5000198","DOIUrl":"https://doi.org/10.5301/GRHTA.5000198","url":null,"abstract":"The high prices of new cancer drugs are likely to undermine national health services sustainability. As a solu tion to this problem, the “payment-by-results” method was proposed and nowadays this approach is commonly implemented by national drug agencies: the drug manufacturer is set to refund to the National Health Service the price of the drug if the benefits expected for the patient are not achieved. Based on the payment-by-results approach, we developed a new and easy to implement model, that can set a fair price, so that neither industry, nor National Health Service can obtain an undue gain. Obviously, this price can be modified by adjusting refund amounts to new healthcare and market conditions.","PeriodicalId":228031,"journal":{"name":"Global and Regional Health Technology Assessment","volume":"37 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2015-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115524998","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Budget impact analysis of infliximab biosimilar: the Italian scenery","authors":"C. Lucioni, S. Mazzi, R. Caporali","doi":"10.5301/GRHTA.5000194","DOIUrl":"https://doi.org/10.5301/GRHTA.5000194","url":null,"abstract":"Chronic inflammatory diseases, while seriously impairing patients' quality of life, are a heavy financial cost to the National Health Service (NHS) and to society. The availability of biological drugs – among which infliximab (Remicade®) – greatly improved treatment efficacy. On the other hand, these drugs are an expensive resource. Infliximab patent protection is going to expire, and a biosimilar has been recently approved.A budget impact (BI) analysis was conducted to evaluate the favourable consequences – for the Italian NHS – of the biosimilar availability in terms of cost containment (savings), thanks to its lower price compared to the originator's. The analysis model expects that some patients in treatment with the originator will switch (according to a prudent assumption of the market uptake rate) to the biosimilar and that many naive patients will directly start treatment with the biosimilar (according to a bolder uptake rate assumed). Separately considering all the different diseases for which in...","PeriodicalId":228031,"journal":{"name":"Global and Regional Health Technology Assessment","volume":"163 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2015-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127331129","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Social cost of chronic pain in Italy","authors":"M. Allegri, C. Lucioni, S. Mazzi, G. Serra","doi":"10.5301/GRHTA.5000187","DOIUrl":"https://doi.org/10.5301/GRHTA.5000187","url":null,"abstract":"Chronic pain negatively impacts on sick people's daily life and their working ability, and it is a heavy financial burden on the health systems. This article is aimed at evaluating the social costs of chronic pain in Italy.The analysis is based on national tariffs and prices and on epidemiologic, health resource consumption, and absence from work published data; when no information specifically related to Italy was available, results from studies carried out in other European Countries were used as appropriate.The average annual cost per patient amounts to €4,556, 31% of which (€1,400) is charged on the National Health Service. Of this share, 51% is due to hospitalisation and 6% to analgesic drug (mostly NSAIDs) costs. Indirect costs (€3,157) are caused by sickness leaves (31%) and retirements.Based on an estimated prevalence of 8 million people with pain in Italy, the impact of chronic pain direct costs on public health expenditure results 9.6%, whereas the impact of total costs on gross domestic product...","PeriodicalId":228031,"journal":{"name":"Global and Regional Health Technology Assessment","volume":"227 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2015-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"124513002","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Bevacizumab nel trattamento del carcinoma metastatico del colon-retto: l'RFOM nell'esperienza dell'A.O. Universitaria Senese","authors":"Davide Paoletti, Silvano Giorgi","doi":"10.5301/GRHTA.5000188","DOIUrl":"https://doi.org/10.5301/GRHTA.5000188","url":null,"abstract":"","PeriodicalId":228031,"journal":{"name":"Global and Regional Health Technology Assessment","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2015-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"130928923","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Addendum all'articolo “Health Technology Assessment e vaccinazioni in Italia”","authors":"R. Gasparini","doi":"10.33393/grhta.2015.327","DOIUrl":"https://doi.org/10.33393/grhta.2015.327","url":null,"abstract":"","PeriodicalId":228031,"journal":{"name":"Global and Regional Health Technology Assessment","volume":"4 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2015-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121189644","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The Pharmaceutical Sector is at Default Risk. A Proposal to Re-Establish the Economic Balance and Define a New Governance","authors":"N. Martini","doi":"10.5301/GRHTA.5000192","DOIUrl":"https://doi.org/10.5301/GRHTA.5000192","url":null,"abstract":"The pharmaceutical governance in Italy is provided by a cap applied as a percentage of the National Health Fund to the territorial (11.35%) and hospital expenditure (3.5%). The amount of overspending is charged to the pharmaceutical companies with a payback procedure. For the years 2014-2016 the overspending is estimated at about 3.8 billion euros, which is likely to result in a system default. In this article a new pharmaceutical governance is proposed and discussed; its aim is to avoid financial imbalance and to identify appropriate measures to bridge the gap between the very high prices of new/innovative drugs and the system sustainability.","PeriodicalId":228031,"journal":{"name":"Global and Regional Health Technology Assessment","volume":"19 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2015-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128218304","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
C. Lucioni, S. Iannazzo, S. Mazzi, G. Saporiti, S. Chiroli
{"title":"Cost-effectiveness of ponatinib in chronic myeloid leukemia in Italy","authors":"C. Lucioni, S. Iannazzo, S. Mazzi, G. Saporiti, S. Chiroli","doi":"10.5301/GRHTA.5000189","DOIUrl":"https://doi.org/10.5301/GRHTA.5000189","url":null,"abstract":"An area-under-the-curve Markov model was designed to evaluate the cost-effectiveness of ponatinib as a third line treatment of Chronic Myeloid Leukemia-Chronic Phase (CML-CP) with reference to Italy. As for current guidelines, comparators were dasatinib, nilotinib, bosutinib, allogeneic stem cell transplantation (SCT), hydroxyurea. The economic perspective was the Italian National Health Service's (NHS), where costs for treatment drugs, monitoring and follow-up, adverse events, SCT procedure were considered on a lifetime span. Costs (mainly based on current tariffs in Italy) and benefits (QALYs) were discounted at a 3.5% annual rate. Ponatinib resulted dominant versus SCT. The lowest ICER was €13,090 (ponatinib vs hydroxyurea); the highest was €22,529 (ponatinib vs dasatinib). Sensitivity analysis – both deterministic (one way) and probabilistic – was focused on the comparison between ponatinib and dasatinib. The deterministic analysis showed that the most critical parameter in the model was ponatinib pri...","PeriodicalId":228031,"journal":{"name":"Global and Regional Health Technology Assessment","volume":"188 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2015-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"123352648","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
F. Mennini, A. Marcellusi, P. Giannantoni, S. Valente, A. Rinaldi, E. Franco
{"title":"Budget impact of pneumococcal vaccination in adults and elderly in Italy","authors":"F. Mennini, A. Marcellusi, P. Giannantoni, S. Valente, A. Rinaldi, E. Franco","doi":"10.5301/GRHTA.5000193","DOIUrl":"https://doi.org/10.5301/GRHTA.5000193","url":null,"abstract":"BackgroundStreptococcus pneumoniae or pneumococcus, is responsible for severe invasive infections (IPD) in high risk groups and in the elderly. Moreover the pneumococcus is the most common cause of...","PeriodicalId":228031,"journal":{"name":"Global and Regional Health Technology Assessment","volume":"3 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2015-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129237165","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"‘Therapeutic Alternatives’: Procurement Rules for Drugs with Same Indication but without Equivalence Certification Released According to the Balduzzi Law","authors":"A. Messori, V. Fadda, S. Trippoli","doi":"10.5301/GRHTA.5000202","DOIUrl":"https://doi.org/10.5301/GRHTA.5000202","url":null,"abstract":"","PeriodicalId":228031,"journal":{"name":"Global and Regional Health Technology Assessment","volume":"73 14","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2015-03-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131898468","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Cost-effectiveness analysis of paliperidone palmitate versus long-acting risperidone as maintenance treatment in schizophrenia patients in Italy","authors":"R. Ravasio, G. Nicolò, M. Vaggi","doi":"10.5301/GRHTA.5000186","DOIUrl":"https://doi.org/10.5301/GRHTA.5000186","url":null,"abstract":"Objective\u0000To evaluate the cost-effectiveness of paliperidone palmitate (paliperidone long-acting injectable; PP) compared with long-acting injectable risperidone (RRP) in multi-episode patients (two or more relapses) with schizophrenia in Italy.\u0000Methods\u0000A pre-existing Markov model was utilized to simulate the history of a cohort of multi-episode patients transitioning through different health states on a monthly basis over a 12 or 24 month horizon from the perspective of the Italian National Health Service. Therapeutic strategies consisted of treatment with long-acting injectable risperidone (mean dose 37.5 mg every 2 weeks) or paliperidone palmitate (mean dose 75 mg equivalent [eq.] every month). Probability of relapse, level of adherence, side effects (extrapyramidal symptoms, tardive dyskinesia, weight gain and diabetes) and treatment discontinuation (switch) were derived from long-term observational data when feasible. The cost-effectiveness analysis considered quality adjusted life-years (QALYs) and direct medical costs. QALYs and costs (expressed in 2014 euro) were discounted at 3% annually. A one-way sensitivity analysis and a probabilistic sensitivity analysis were conducted.\u0000Results\u0000Paliperidone palmitate is the dominant long-acting injectable therapeutic option: a more effective (additional QALYs, less relapses) and less costly treatment option compared with long-acting injectable risperidone over a 12 or 24 month horizon. Results were robust when tested in sensitivity and probabilistic analyses.\u0000Conclusions\u0000Paliperidone palmitate was cost-saving from the Italian National Health Service perspective compared with long-acting injectable risperidone in the long-term treatment of multi-episode (two or more relapses) schizophrenia patients.","PeriodicalId":228031,"journal":{"name":"Global and Regional Health Technology Assessment","volume":"39 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2014-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"131758119","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}