Global and Regional Health Technology Assessment最新文献

{"title":"Costs of Tiotropium Bromide Delivered via the Respimat® Inhaler in COPD Patients in Italy","authors":"S. Iannazzo, Chiara Distante, A. Corsico","doi":"10.5301/GRHTA.5000220","DOIUrl":"https://doi.org/10.5301/GRHTA.5000220","url":null,"abstract":"Chronic Obstructive Pulmonary Disease (COPD) is a major cause of chronic morbidity and mortality worldwide. The clinical trial by Bateman and colleagues, that enrolled 3,991 moderate to very severe COPD patients in 31 Countries, demonstrated that tiotropium bromide delivered via the Respimat® inhaler can delay the time to first exacerbation and reduce overall exacerbation rates. The aim of our study was to estimate the costs associated with this device utilization to treat COPD in Italy. The analysis was conducted from the perspective of the Italian National Health Service (INHS) with a time horizon of one year. Tiotropium delivered with the Respimat® inhaler on top of the standard of care (SoC) was compared with SoC alone. Effectiveness was measured in terms of relative risk of exacerbations, derived from the Bateman trial. The average costs for routine COPD treatment and for the management of exacerbations were based on the economic literature. The total cost per patient/year was €3,469 (routine cost €670; exacerbation cost €2,799) with SoC and €3,369 (routine cost €840; exacerbation cost €2,529) with tiotropium in add-on to the SoC. The total saving per patient/year was about €100, corresponding to 2.9% of the total annual cost. Taking into account the total population with moderate to very severe COPD in Italy (1,880,500 patients, according to the available epidemiological data), this treatment strategy would result in a total saving of about €188 million per year. In conclusion, this study showed that adoption of tiotropium bromide delivered via the Respimat® inhaler has the potential to reduce the economic burden of COPD in Italy.","PeriodicalId":228031,"journal":{"name":"Global and Regional Health Technology Assessment","volume":"75 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2016-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"115928552","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":"Economic Evaluation of Nevirapine plus Raltegravir as Maintenance Antiretroviral Therapy in Virologically Suppressed HIV-1 Infected Patients","authors":"R. Ravasio, F. Rigo, E. Lattuada, E. Concia, M. Lanzafame","doi":"10.5301/GRHTA.5000217","DOIUrl":"https://doi.org/10.5301/GRHTA.5000217","url":null,"abstract":"Background A one-year cost analysis was conducted to estimate the impact on the Italian National Health Service (NHS) of nevirapine plus raltegravir administration as maintenance antiretroviral therapy in virologically suppressed HIV-1 infected patients. Methods Patient data were retrieved from the electronic medical record system in use (year 2014) in a reference HIV centre in Northern Italy. The analysis considered patients with long-term (more than one year) virological suppression (HIV-1 RNA <50 copies/ml) on Highly Active Antiretroviral Therapy (HAART) and no prior exposure to integrase inhibitors (INIs). To estimate the total HAART expenditure, we calculated the annual treatment cost for each enrolled patients. Subsequently, to estimate the dual therapy hypothetical expenditure, we assumed to treat the same patients with nevirapine (400 mg) and raltegravir (400 mg twice daily). We took into account only drug costs (ex-factory prices, included all discounts and VAT) from the perspective of the Italian NHS. Results In 2014, the total expenditure for the 103 enrolled HIV-1 patients treated with HAART was €814,543. The mean treatment cost per patient was €7,908. If all patients were treated with the dual therapy (nevirapine and raltegravir), the total expenditure would be €573,298 (-29.6%) with a mean treatment cost per patient of €5,566. Conclusions From the Italian NHS perspective, nevirapine/raltegravir represent a cost-saving option as maintenance antiretroviral therapy in virologically suppressed HIV-1 infected patients.","PeriodicalId":228031,"journal":{"name":"Global and Regional Health Technology Assessment","volume":"70 s289","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2016-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"113953754","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":"Economic Evaluation of Canagliflozin versus Glimepiride and Sitagliptin in Dual Therapy with Metformin for the Treatment of Type 2 Diabetes in Italy","authors":"R. Ravasio, P. Pisarra, R. Porzio, M. Comaschi","doi":"10.5301/GRHTA.5000229","DOIUrl":"https://doi.org/10.5301/GRHTA.5000229","url":null,"abstract":"Purpose To assess the treatment costs (direct medical costs) of canagliflozin versus glimepiride or sitagliptin 100 mg in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin from the perspective of the Italian National Health Service. Methods A cost-minimization analysis (CMA) was conducted to compare the mean annual costs for a patient with T2DM treated with canagliflozin 100 or 300 mg, glimepiride (mean dose of 5.6 mg), or sitagliptin 100 mg. Two models were constructed to compare canagliflozin versus glimepiride and canagliflozin versus sitagliptin. Both models estimated annual patient costs using data from two clinical trials. In both models, only direct medical costs (antidiabetic drugs, concomitant drugs, hospitalizations, hypoglycemic events, glycemic control, genital mycotic infections, and weight) were considered. Italian costs were drawn from the literature and local sources. Uncertainty was assessed by deterministic sensitivity analyses and threshold analyses. Results Canagliflozin 100 and 300 mg were associated with lower expected costs (€2,785.46 and €2,979.52, respectively) versus glimepiride (€3,167.90). In the second comparison, canagliflozin 100 or 300 mg were also associated with lower expected costs (€2,820.05 and €3,013.96, respectively) versus sitagliptin 100 mg (€3,030.38). Sensitivity analyses generally supported the base case findings. Conclusions This CMA showed that treatment with canagliflozin 100 or 300 mg is a cost-saving strategy compared with glimepiride or sitagliptin 100 mg in patients with T2DM inadequately controlled with metformin from the perspective of the Italian National Health Service.","PeriodicalId":228031,"journal":{"name":"Global and Regional Health Technology Assessment","volume":"28 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2016-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"126122760","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 Strategies and Health Costs of Patients Admitted for a Cardiovascular Event in Italy","authors":"C. Lucioni, S. Mazzi, E. Rossi, R. Rielli, S. Calabria, A. Maggioni","doi":"10.5301/GRHTA.5000221","DOIUrl":"https://doi.org/10.5301/GRHTA.5000221","url":null,"abstract":"Objectives To assess in a community setting the clinical characteristics, the outcomes and the related costs of patients admitted for an acute coronary syndrome (ACS), or a cerebrovascular disease (CVD), or a peripheral artery disease (PAD). In particular, to assess how patients discharged alive are treated with statins (rate of prescription, dosages, patients’ adherence). Methods A record linkage analysis was carried out of discharge records and prescription data, based on the ARNO Observatory, including 2,989,512 subjects of seven Local Health Units throughout Italy. The accrual period lasted from January 1 to December 31, 2011. The follow-up period was 12 months after the index hospitalization. Results Of the 2,989,512 subjects, 6,226 (2.1%) were hospitalized for ACS, 9,939 (3.3%) for CVD and 1,048 (0.4%) for PAD. The mean age of hospitalized patients was 73 years and males accounted for 56%; diabetes was reported in 28% of patients and in-hospital all-cause death occurred in 5,7%. Of patients discharged alive, 44% were on a statin treatment, of whom 55,2% treated with high dosage statins. In the follow-up period, adherence to treatment was observed in 64.5% of the treated patients. More than half (55.7%) of the discharged patients required readmission. The average annual cost per ACS patient was €14,871 (drugs: €1,315; hospitalizations: €12,836; diagnostics and outpatient visits: €720); the corresponding cost was €9,537 per CVD patient (drugs: €795; hospitalizations: €8,338); and €12,004 per PAD patient (drugs: €1,206; hospitalizations: €9,911). Conclusions Statin prescription rate after a CV event seems to be subottimal. NHS costs are higher for patients with ACS or PAD, with re-hospitalizations during the follow-up period being the main cost-driver.","PeriodicalId":228031,"journal":{"name":"Global and Regional Health Technology Assessment","volume":"52 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2016-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125619940","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":"An Approach to Evaluate Payment-by-Results Agreements","authors":"Clement Tournier, Valerie Deroo, S. Villa, G. Giuliani, C. Lucioni, S. Mazzi, R. Ravasio","doi":"10.5301/GRHTA.5000234","DOIUrl":"https://doi.org/10.5301/GRHTA.5000234","url":null,"abstract":"Payment-by-Results (PbR) agreements are negotiated by the Italian Medicine Agency (AIFA) with the purpose of minimizing the risk of paying for unsuccessful treatments in the early phases of access when real world utilization evidence is limited. According to such agreements, the manufacturer shall pay back the full drug cost of the therapy in case of early drop-outs due to progression or unsustainable toxicity. This short paper is aimed at showing that a PbR agreement on a new drug is equivalent to an improved evaluation of the drug efficacy, under a payer's perspective. When the National Health Service (NHS) pays the treatment cost only for those patients who are still responding well at a pre-determined timeline, this means that it takes into consideration a sub-population which has a better clinical outcome as compared with the whole eligible population. In other words, the NHS would actually pay for a drug with a higher efficacy than the one which the price negotiation was based on. This argument is supported by a couple of graphical examples, built with data from two clinical studies: GOG-0240 (Avastin®, bevacizumab) and EMILIA (Kadcyla®, trastuzumab emtansine) respectively. The response to therapy is defined in terms of progression-free survival. In a context of economic pressure, PbR is a tool allowing payers to rationalize their spending reducing the risk of paying for unsuccessful treatments, while still funding innovation and therefore increasing the value-for-money.","PeriodicalId":228031,"journal":{"name":"Global and Regional Health Technology Assessment","volume":"81 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2016-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"121976101","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":"Abstracts Del 15° Convegno Nazionale Economia e Politica Del Farmaco e Delle Tecnologie Sanitarie Novara, 23 Giugno 2016","authors":"Sergio Lannazzo, L. Santoni, Cecilia Saleri, Elisa Puma, Giulia Vestri, Luigi Giuliani, Pier Luigi Canonico, D. Centonze","doi":"10.5301/grhta-itj.2016.15917","DOIUrl":"https://doi.org/10.5301/grhta-itj.2016.15917","url":null,"abstract":"","PeriodicalId":228031,"journal":{"name":"Global and Regional Health Technology Assessment","volume":"9 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2016-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132049676","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":"Some Considerations about the Value Based Pricing in Oncology: An Analysis on Metastatic First Line Medicinal Products","authors":"F. Spandonaro, D. Giannarelli, B. Polistena","doi":"10.5301/GRHTA.5000218","DOIUrl":"https://doi.org/10.5301/GRHTA.5000218","url":null,"abstract":"Some considerations about the value based pricing in oncology: an analysis on metastatic first line medicinal products. Introduction: In recent years public health systems have faced the challenge of ensuring sustainable costs for inno-vative medicinal products. The aim of this study is to analyse pricing behaviour applied in the Italian oncology sector. Methods: The study examined all new oncologic compounds that are reimbursed in Italy, for utilization in the first-line metastatic setting. A regression model was developed to analyse the relation between drug price, clini-cal benefit, market potential and the year in which reimbursement was granted in Italy. The clinical benefit was measured by increment in Overall Survival respect to standard of care; two different metrics were considered, namely median and mean. \u0000Results: The analysis revealed a strong correlation between price and clinical benefit and a weak negative correla-tion between prices and volumes; no time trends were observed in reimbursement price reduction. As regards pricing, the Italian Medicines Agency seems to have maintained basically consistent reference levels over the 10 years. Nevertheless, the analysis highlighted significant differences: some compounds showed lower prices than expected; conversely, vemurafenib, sunitinib and, to a much lesser degree, pazopanib prices were higher than expected. The only drug for which price evaluation is inverted depending on whether median or mean val-ues are used is ipilimumab, the only immunotherapeutic compound considered. \u0000Discussion: The study highlights the extent to which the value of oncological drugs depends on the endpoints considered in the analysis, as well as on the metric adopted, , confirming that the decision must be multidimen-sional, as required by an Health Technology Assessment rationale.","PeriodicalId":228031,"journal":{"name":"Global and Regional Health Technology Assessment","volume":"5 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2016-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129494862","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 Minimization Analysis of Bont-As in the Treatment of Upper Limb Spasticity and Cervical Dystonia","authors":"L. Bartolomei, A. Bentivoglio, M. Bizzarini, P. M. Caglioni, Luana Cerbarano, M. Frontoni, G. Lus, G. Majorana, S. Nassetti, M. Osio, R. Ravasio, R. Ravenni, A. Santoro, N. Smania, Flavia Torlizzi, S. Valvo","doi":"10.5301/GRHTA.5000207","DOIUrl":"https://doi.org/10.5301/GRHTA.5000207","url":null,"abstract":"of total costs. In the base scenario (no peginterferon beta-1a) the total cost to treat Italian RRMS patients was estimated to be approximately € 321.5, € 339.7 and € 357.8 million in years 1, 2, and 3, respectively. In the alterna- tive scenario (adoption of peginterferon beta-1a), the same costs resulted in about € 321.1, € 338.6 and € 356.2 million, respectively. The cumulative budget impact over the three year period resulted in an approximate cost saving of € 3.1 million (about 0.3%). The sensitivity analysis confirmed the robustness and reliability of the base-case results. Conclusions: Peginterferon beta-1a showed a favourable pharmaco-eco- nomic profile versus the first line injectable therapies for the treatment of RRMS, being both cost-effective and financially sustainable, and thus repre- sents an efficient treatment option for RRMS patients in Italy. Italy). Introduction: Multiple sclerosis (MS) is a condition with a significant eco- nomic and social burden that affects young adults in their active working phase. The most recent evaluations show an annual average social cost of €38,000–39,000 per patient. Peginterferon beta-1a, injected every two weeks, is the first approved pegylated interferon beta-1a for the treatment of relapsing remitting multiple sclerosis (RRMS), the most common form of MS. The efficacy and safety of peginterferon beta-1a was demonstrated in the placebo-controlled ADVANCE trial. Objective: The objective of this study was the cost-effectiveness and the budget impact analysis of peginterferon beta-1a as compared to injectable first-line treatments for RRMS in Italy. Methods : The cost-effectiveness analysis was developed through a Markov model with lifetime simulation in the perspective of the Italian National Healthcare Service (NHS). An additional scenario analysis was developed to take into account the Italian societal perspective. Outcomes were measured in terms of life years (LYs), quality adjusted life years (QALYs), lifetime costs and incremental cost-effectiveness One-way probabilis- sensitivity cost-effectiveness acceptability budget impact three- support of a simple decision-analytic model years of of a reduction of relapse one-way sensitivity tiveness and meta-analysis matology to 15% in adult rheumatology). Similarly, the economic analysis showed that also average monthly costs vary from €1,054 in dermatology (highest monthly cost) to € 729 in adult rheumatology (lowest monthly cost). Finally the economic analysis showed that in general the highest costs were observed achieved in the maintenance group. Conclusions: The analysis shows high variability across different areas and indications. This is mainly due to patients’ characteristics, type of disease, available treatments and their mix. The huge heterogeneity in monthly costs is due to the fact that costs are collected from a real world administrative database, therefore the annual costs depend on real patients’ exposure time to treatments. In fact","PeriodicalId":228031,"journal":{"name":"Global and Regional Health Technology Assessment","volume":"14 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2016-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128907228","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-of-Illness Study of Diabetes Mellitus: Focus on Patients with Type 2 Diabetes","authors":"R. Pirolo, A. Bettiol, Jenny Bolcato, G. Franchin, P. Deambrosis, A. Paccagnella, P. Giusti, A. Chinellato","doi":"10.5301/GRHTA.5000209","DOIUrl":"https://doi.org/10.5301/GRHTA.5000209","url":null,"abstract":"ObjectiveThe aim of the study was to assess the cost of management of diabetic patients; moreover, for type 2 not insulin-dependent patients, also the durability of treatments was evaluated, in ord...","PeriodicalId":228031,"journal":{"name":"Global and Regional Health Technology Assessment","volume":"41 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2016-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133638247","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":"Immuno-Therapy in the Treatment of Cancer: Implications for Efficacy and Economic Evaluations","authors":"C. Jommi, F. Mennini, P. Canonico, P. Bruzzi","doi":"10.5301/GRHTA.5000219","DOIUrl":"https://doi.org/10.5301/GRHTA.5000219","url":null,"abstract":"In the last few years, immuno-oncology has partially modified the paradigm of cancer treatment, due to the observation of long-term survivors among patients with advanced tumors and with a predicte...","PeriodicalId":228031,"journal":{"name":"Global and Regional Health Technology Assessment","volume":"5 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2016-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129337804","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}