Melanoma is the most aggressive type of all skin cancers. In Italy the incidence is increasing both in men and in women with 13,800 new cases expected in 2016. The advanced melanoma therapy has changed in recent years with the use of immunotherapy and targeted therapies. In particular, treatment with BRAF inhibitors in patients with advanced BRAF V600 mutated melanoma has shown high rates of rapid response and survival. Due to development of acquired resistance with disease progression the rapid response observed with BRAF inhibitor therapy is not long lasting. Combining a BRAF inhibitor with a MEK inhibitor may help to delay the development of resistance and to enhance the antitumor activities with a further increase in the response and survival rate. Trametinib, an inhibitor of MEK kinases, and dabrafenib, an inhibitor of BRAF kinase, have authorizations as monotherapies and in combination with each other for treating adults with unresectable or metastatic melanoma with BRAF V600 mutation. Purpose of this report is to describe the combination in terms of clinical efficacy, safety, and economic impact. In particular, a cost-effectiveness analysis and a budget impact analysis were performed in order to evaluate the combination versus monotherapy and the financial sustainability of trametinib + dabrafenib on the Italian market. [In Italian]
{"title":"[Clinical and economic evaluation of the introduction of the combinazion trametinib + dabrafenib in the management of advanced melanoma in the Italian market]","authors":"L. Pradelli, P. Ascierto","doi":"10.7175/FE.V17I3S.1279","DOIUrl":"https://doi.org/10.7175/FE.V17I3S.1279","url":null,"abstract":"Melanoma is the most aggressive type of all skin cancers. In Italy the incidence is increasing both in men and in women with 13,800 new cases expected in 2016. The advanced melanoma therapy has changed in recent years with the use of immunotherapy and targeted therapies. In particular, treatment with BRAF inhibitors in patients with advanced BRAF V600 mutated melanoma has shown high rates of rapid response and survival. Due to development of acquired resistance with disease progression the rapid response observed with BRAF inhibitor therapy is not long lasting. Combining a BRAF inhibitor with a MEK inhibitor may help to delay the development of resistance and to enhance the antitumor activities with a further increase in the response and survival rate. Trametinib, an inhibitor of MEK kinases, and dabrafenib, an inhibitor of BRAF kinase, have authorizations as monotherapies and in combination with each other for treating adults with unresectable or metastatic melanoma with BRAF V600 mutation. Purpose of this report is to describe the combination in terms of clinical efficacy, safety, and economic impact. In particular, a cost-effectiveness analysis and a budget impact analysis were performed in order to evaluate the combination versus monotherapy and the financial sustainability of trametinib + dabrafenib on the Italian market. [In Italian]","PeriodicalId":41585,"journal":{"name":"Farmeconomia-Health Economics and Therapeutic Pathways","volume":"146 1","pages":"1-32"},"PeriodicalIF":0.5,"publicationDate":"2016-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88443014","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}
BACKGROUND: Venous thromboembolism (VTE), a collective term for deep vein thrombosis (DVT) and pulmonary embolism (PE), is a serious vascular condition associated to high economic and clinical burden. Apixaban, a Novel Oral Anticoagulant (NOAC) has shown non-inferiority efficacy versus the current standard of care (low molecular weight heparin [LMWH]/vitamin K antagonist [VKA]) in the acute treatment and prevention of VTE and a significant reduction in the risk of bleeding. AIM: Evaluate the economic impact of the use of apixaban for treatment and prevention of DVT and PE from the perspective of the Italian National Health System (NHS). METHODS: A budget impact model was adapted in order to compare clinical outcomes and economic consequences associated to apixaban vs. LMWH/VKA and others NOACs over a three-year time horizon in the Italian setting. In the analysis two scenario were compared: status quo scenario without apixaban and an alternative scenario with apixaban. Only direct healthcare costs have been considered. RESULTS: Assuming a population of patients receiving apixaban over the first 3 years equal to 20,957, the introduction of apixaban is associated to an incremental saving of € 821,748 in the first years, € 1,250,454 in the second year, and € 1,866,466 in the third year. The total net saving over the 3-year period is € 3,938,668, which is a 2.47% decrease from the total budget for the status quo scenario without apixaban. This saving is mainly due to reduced VTE events and bleeds by apixaban. Indeed apixaban is associated with less VTE events (both fatal and non-fatal), less major bleeding and less Clinical Relevant Non Major (CRNM) bleeding with a total of 52 fatal events avoided. CONCLUSIONS: The listing of apixaban for the treatment of VTE (both DVT and PE) and the prevention of recurrent VTE provides both significant clinical advantages, in terms of deaths and events avoided, and economical advantages, consisting in a reduction in the total expenditure on the Italian NHS.
{"title":"Budget impact analysis of apixaban to treat and prevent venous thromboembolism in Italy","authors":"M. Bellone, R. D. Virgilio, P. D. Rienzo","doi":"10.7175/FE.V17I3.1280","DOIUrl":"https://doi.org/10.7175/FE.V17I3.1280","url":null,"abstract":"BACKGROUND: Venous thromboembolism (VTE), a collective term for deep vein thrombosis (DVT) and pulmonary embolism (PE), is a serious vascular condition associated to high economic and clinical burden. Apixaban, a Novel Oral Anticoagulant (NOAC) has shown non-inferiority efficacy versus the current standard of care (low molecular weight heparin [LMWH]/vitamin K antagonist [VKA]) in the acute treatment and prevention of VTE and a significant reduction in the risk of bleeding. AIM: Evaluate the economic impact of the use of apixaban for treatment and prevention of DVT and PE from the perspective of the Italian National Health System (NHS). METHODS: A budget impact model was adapted in order to compare clinical outcomes and economic consequences associated to apixaban vs. LMWH/VKA and others NOACs over a three-year time horizon in the Italian setting. In the analysis two scenario were compared: status quo scenario without apixaban and an alternative scenario with apixaban. Only direct healthcare costs have been considered. RESULTS: Assuming a population of patients receiving apixaban over the first 3 years equal to 20,957, the introduction of apixaban is associated to an incremental saving of € 821,748 in the first years, € 1,250,454 in the second year, and € 1,866,466 in the third year. The total net saving over the 3-year period is € 3,938,668, which is a 2.47% decrease from the total budget for the status quo scenario without apixaban. This saving is mainly due to reduced VTE events and bleeds by apixaban. Indeed apixaban is associated with less VTE events (both fatal and non-fatal), less major bleeding and less Clinical Relevant Non Major (CRNM) bleeding with a total of 52 fatal events avoided. CONCLUSIONS: The listing of apixaban for the treatment of VTE (both DVT and PE) and the prevention of recurrent VTE provides both significant clinical advantages, in terms of deaths and events avoided, and economical advantages, consisting in a reduction in the total expenditure on the Italian NHS.","PeriodicalId":41585,"journal":{"name":"Farmeconomia-Health Economics and Therapeutic Pathways","volume":"19 1","pages":""},"PeriodicalIF":0.5,"publicationDate":"2016-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87881552","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. Cioffi, M. Oradei, R. Cerbo, Vittorio Di Pietro, G. Riccioni, G. Pardhanani, E. Capannini, M. Basile
BACKGROUND: Existing literature shows that the use of Botox®/onabotulinumtoxinA (BT) in chronic migraine (CM) is promising from a cost-effectiveness standpoint and the use of a clinical diagnostic therapeutic process (CDTP) dedicated to CM allows a reduction of pathology costs. The inclusion of BT in chronic migraine therapy at a Roman ASL involves the need to investigate the real treatment costs of a CDTP and to measure how a targeted organizational CDTP strategy for CM allows insuring treatment accessibility, sustainability, and appropriateness. OBJECTIVE: To conduct a cost-effectiveness analysis of providing administration of BT in patients with CM using real world data from an ASL in Rome. METHODS: The real world cost data for approximately 215 anonymous patients were summarized. The cost data were extrapolated from the database of the ASL and they populated a Markov decision model developed by Allergan. The analysis is based on a decision model populated with real drug and service cost data, for the years 2010-2012. The financial assessment was conducted from the viewpoint of the Italian National Health Service. RESULTS: Over a 2 year temporal horizon, incremental BT costs, compared to a placebo, are equal to € 261 against an incremental gain of 0.0655 QALY in favor of BT. The ratio between costs and incremental QALY generates an ICER of 3,983 €/QALY, favorable and below the acceptability threshold used by many countries for reimbursement decisions (25,000-40,000 € per QALY gained). CONCLUSIONS: The inclusion of BT in the CDTP dedicated to CM of an Italian ASL improves both clinical outcomes of the patients and the allocation of the SSN available resources. [Article in Italian]
{"title":"[Organizational and financial aspects of the introduction of Botox® in the clinical diagnostic therapeutic process of chronic migraine at a Local Health Unit in Italy]","authors":"F. Cioffi, M. Oradei, R. Cerbo, Vittorio Di Pietro, G. Riccioni, G. Pardhanani, E. Capannini, M. Basile","doi":"10.7175/FE.V17I3.1262","DOIUrl":"https://doi.org/10.7175/FE.V17I3.1262","url":null,"abstract":"BACKGROUND: Existing literature shows that the use of Botox®/onabotulinumtoxinA (BT) in chronic migraine (CM) is promising from a cost-effectiveness standpoint and the use of a clinical diagnostic therapeutic process (CDTP) dedicated to CM allows a reduction of pathology costs. The inclusion of BT in chronic migraine therapy at a Roman ASL involves the need to investigate the real treatment costs of a CDTP and to measure how a targeted organizational CDTP strategy for CM allows insuring treatment accessibility, sustainability, and appropriateness. OBJECTIVE: To conduct a cost-effectiveness analysis of providing administration of BT in patients with CM using real world data from an ASL in Rome. METHODS: The real world cost data for approximately 215 anonymous patients were summarized. The cost data were extrapolated from the database of the ASL and they populated a Markov decision model developed by Allergan. The analysis is based on a decision model populated with real drug and service cost data, for the years 2010-2012. The financial assessment was conducted from the viewpoint of the Italian National Health Service. RESULTS: Over a 2 year temporal horizon, incremental BT costs, compared to a placebo, are equal to € 261 against an incremental gain of 0.0655 QALY in favor of BT. The ratio between costs and incremental QALY generates an ICER of 3,983 €/QALY, favorable and below the acceptability threshold used by many countries for reimbursement decisions (25,000-40,000 € per QALY gained). CONCLUSIONS: The inclusion of BT in the CDTP dedicated to CM of an Italian ASL improves both clinical outcomes of the patients and the allocation of the SSN available resources. [Article in Italian]","PeriodicalId":41585,"journal":{"name":"Farmeconomia-Health Economics and Therapeutic Pathways","volume":"1 1","pages":""},"PeriodicalIF":0.5,"publicationDate":"2016-10-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87769786","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}
BACKGROUND: Radioiodine ablation is an adjuvant procedure used to treat patients with differentiated thyroid cancer. For ablation to be successful, patients must have elevated levels of thyroid stimulating hormone (TSH). This can be achieved by withholding thyroid hormone therapy (endogenous stimulation), or by administration of recombinant human thyroid stimulating hormone (rhTSH; Thyrogen ® ; exogenous stimulation) to patients in the euthyroid state. AIM: To compare the estimated health benefits, cost and cost-effectiveness of TSH stimulation with and without Thyrogen ® in the Italian setting. METHODS: A cost-utility analysis was undertaken to assess the impact of exogenous vs. endogenous TSH stimulation before radioiodine remnant ablation of patients with newly diagnosed, well-differentiated papillary or follicular thyroid cancer who have undergone total or near-total thyroidectomy. A Markov model was developed to simulate treatment costs and health outcomes associated with exogenous and endogenous stimulation in four distinct health states: pre-ablation, ablation, post-ablation, and well/recovery. Treatment was stratified by patients who receive high- and low-activity (30-100 mCi, respectively) in the ablation state. The Italian National Health System perspective was adopted in the base case scenario while the impact of indirect costs was explored in a sensitivity analysis. Costs and quality-adjusted life years (QALY) specific to each health state were estimated, summarized and converted into a corresponding incremental cost-effectiveness ratio (ICER). RESULTS: We calculated a cost-effectiveness ratio of 18,357.18 €/QALY gained whereas the inclusion of indirect cost and accident cost produced reductions of the ICER to € 14,609.51 and € 15,515.26 per QALY, respectively. Finally, all results in the sensitivity analysis are below the lower bound of national and international cost- effective threshold. CONCLUSION: Thyrogen ® represents a cost-effective option for patients with differentiated thyroid cancer who underwent total or near-total thyroidectomy in Italy. Our findings are consistent with other cost-utility analyses.
{"title":"Cost-effectiveness profile, organizational implications and patient preferences on the use of exogenous TSH therapy (Thyrogen®) vs. THW in thyroid residue ablation in Italy","authors":"G. Danieli, F. Monari, R. Lazzarini, F. Cipriani","doi":"10.7175/FE.V17I3.1264","DOIUrl":"https://doi.org/10.7175/FE.V17I3.1264","url":null,"abstract":"BACKGROUND: Radioiodine ablation is an adjuvant procedure used to treat patients with differentiated thyroid cancer. For ablation to be successful, patients must have elevated levels of thyroid stimulating hormone (TSH). This can be achieved by withholding thyroid hormone therapy (endogenous stimulation), or by administration of recombinant human thyroid stimulating hormone (rhTSH; Thyrogen ® ; exogenous stimulation) to patients in the euthyroid state. AIM: To compare the estimated health benefits, cost and cost-effectiveness of TSH stimulation with and without Thyrogen ® in the Italian setting. METHODS: A cost-utility analysis was undertaken to assess the impact of exogenous vs. endogenous TSH stimulation before radioiodine remnant ablation of patients with newly diagnosed, well-differentiated papillary or follicular thyroid cancer who have undergone total or near-total thyroidectomy. A Markov model was developed to simulate treatment costs and health outcomes associated with exogenous and endogenous stimulation in four distinct health states: pre-ablation, ablation, post-ablation, and well/recovery. Treatment was stratified by patients who receive high- and low-activity (30-100 mCi, respectively) in the ablation state. The Italian National Health System perspective was adopted in the base case scenario while the impact of indirect costs was explored in a sensitivity analysis. Costs and quality-adjusted life years (QALY) specific to each health state were estimated, summarized and converted into a corresponding incremental cost-effectiveness ratio (ICER). RESULTS: We calculated a cost-effectiveness ratio of 18,357.18 €/QALY gained whereas the inclusion of indirect cost and accident cost produced reductions of the ICER to € 14,609.51 and € 15,515.26 per QALY, respectively. Finally, all results in the sensitivity analysis are below the lower bound of national and international cost- effective threshold. CONCLUSION: Thyrogen ® represents a cost-effective option for patients with differentiated thyroid cancer who underwent total or near-total thyroidectomy in Italy. Our findings are consistent with other cost-utility analyses.","PeriodicalId":41585,"journal":{"name":"Farmeconomia-Health Economics and Therapeutic Pathways","volume":"12 1","pages":""},"PeriodicalIF":0.5,"publicationDate":"2016-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87754410","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}
D. Centonze, E. Puma, C. Saleri, G. Vestri, S. Iannazzo, L. Santoni, L. Giuliani, P. Canonico
Pegylation is a procedure used for drug development since the 1970s and consists of the conjugation of a polyethylene glycol molecule (PEG) to a drug. PEG has shown to be safe and effective in improving the pharmacokinetic and pharmacodynamic profile of drugs. Recently, a 20 kDa linear chain of PEG was conjugated to interferon beta-1a with the aim to offer a new treatment option to relapsing-remitting multiple sclerosis (RRMS) patients. Due to a prolonged bioavailability, this new drug can be administered less frequently (every two weeks) than the other interferons beta available, thus allowing to hypothesize a better adherence to the treatment, which, in turn, should result in better clinical and economic outcomes. A phase III clinical trial has proven its effectiveness compared to placebo in RRMS patients, as well as a safety profile comparable to that found in other interferon beta preparations. The immunogenicity of this new molecule is < 1%, thus minimizing the suppression or reduction of interferon beta biological activity that could come from the development of Neutralizing Antibodies (NAbs). [Article in Italian]
{"title":"Pegylation and interferons in multiple sclerosis","authors":"D. Centonze, E. Puma, C. Saleri, G. Vestri, S. Iannazzo, L. Santoni, L. Giuliani, P. Canonico","doi":"10.7175/FE.V17I2S.1229","DOIUrl":"https://doi.org/10.7175/FE.V17I2S.1229","url":null,"abstract":"Pegylation is a procedure used for drug development since the 1970s and consists of the conjugation of a polyethylene glycol molecule (PEG) to a drug. PEG has shown to be safe and effective in improving the pharmacokinetic and pharmacodynamic profile of drugs. Recently, a 20 kDa linear chain of PEG was conjugated to interferon beta-1a with the aim to offer a new treatment option to relapsing-remitting multiple sclerosis (RRMS) patients. Due to a prolonged bioavailability, this new drug can be administered less frequently (every two weeks) than the other interferons beta available, thus allowing to hypothesize a better adherence to the treatment, which, in turn, should result in better clinical and economic outcomes. A phase III clinical trial has proven its effectiveness compared to placebo in RRMS patients, as well as a safety profile comparable to that found in other interferon beta preparations. The immunogenicity of this new molecule is < 1%, thus minimizing the suppression or reduction of interferon beta biological activity that could come from the development of Neutralizing Antibodies (NAbs). [Article in Italian]","PeriodicalId":41585,"journal":{"name":"Farmeconomia-Health Economics and Therapeutic Pathways","volume":"42 1","pages":"5-11"},"PeriodicalIF":0.5,"publicationDate":"2016-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73214986","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":"[Pegylated interferon beta-1a on the Italian market]","authors":"M. Eandi","doi":"10.7175/FE.V17I2S.1228","DOIUrl":"https://doi.org/10.7175/FE.V17I2S.1228","url":null,"abstract":"","PeriodicalId":41585,"journal":{"name":"Farmeconomia-Health Economics and Therapeutic Pathways","volume":"1 1","pages":"3-4"},"PeriodicalIF":0.5,"publicationDate":"2016-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86567688","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}
S. Iannazzo, L. Santoni, C. Saleri, E. Puma, G. Vestri, L. Giuliani, D. Centonze, P. Canonico
BACKGROUND: 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 objective of this analysis was to estimate the economic impact due to the introduction of peginterferon beta-1a in Italy. METHODS: This analysis was conducted with a three-year time horizon with the support of a simple decision-analytic model adopting the perspective of the Italian National Healthcare Service (NHS). Healthcare costs sustained by the Italian NHS to manage the RRMS population (drug treatment, monitoring, relapse management, adverse events management) were calculated over 3 years and compared in two scenarios: the base scenario where interferons-beta and glatiramer acetate (GA) are used to treat RRMS patients, and an alternative scenario where peginterferon beta-1a can also be used to treat RRMS patients. The target population was approximately 35,500, 37,500 and 39,500 patients at year 1, 2 and 3 respectively, based on the published literature and market data. The efficacy of treatments was simulated as a reduction of relapse rates and was derived from a Network Meta-analysis. Unit costs were based on current prices and tariffs, and the published literature. A one-way sensitivity analysis was developed. RESULTS: According to current price and described assumptions, it was estimated that the introduction of peginterferon beta-1a would result in a decrease of total costs when compared with the base scenario. The cost in the base scenario was estimated to be € 321.5, € 339.7 and € 357.8 million in years 1, 2, and 3, respectively. In the alternative scenario, the same costs resulted in about € 321.1, € 338.6 and € 356.2 million, respectively. The cumulative budget impact over three years period was approximately a cost saving of € 3.1 million (about 0.3% saving). CONCLUSION: The adoption of peginterferon beta-1a for the treatment of RRMS would be viewed as economically sustainable by the Italian NHS. [Article in Italian]
{"title":"[Budget impact analysis for peginterferon beta-1a in relapsing remitting multiple sclerosis in Italy]","authors":"S. Iannazzo, L. Santoni, C. Saleri, E. Puma, G. Vestri, L. Giuliani, D. Centonze, P. Canonico","doi":"10.7175/FE.V17I2S.1231","DOIUrl":"https://doi.org/10.7175/FE.V17I2S.1231","url":null,"abstract":"BACKGROUND: 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 objective of this analysis was to estimate the economic impact due to the introduction of peginterferon beta-1a in Italy. METHODS: This analysis was conducted with a three-year time horizon with the support of a simple decision-analytic model adopting the perspective of the Italian National Healthcare Service (NHS). Healthcare costs sustained by the Italian NHS to manage the RRMS population (drug treatment, monitoring, relapse management, adverse events management) were calculated over 3 years and compared in two scenarios: the base scenario where interferons-beta and glatiramer acetate (GA) are used to treat RRMS patients, and an alternative scenario where peginterferon beta-1a can also be used to treat RRMS patients. The target population was approximately 35,500, 37,500 and 39,500 patients at year 1, 2 and 3 respectively, based on the published literature and market data. The efficacy of treatments was simulated as a reduction of relapse rates and was derived from a Network Meta-analysis. Unit costs were based on current prices and tariffs, and the published literature. A one-way sensitivity analysis was developed. RESULTS: According to current price and described assumptions, it was estimated that the introduction of peginterferon beta-1a would result in a decrease of total costs when compared with the base scenario. The cost in the base scenario was estimated to be € 321.5, € 339.7 and € 357.8 million in years 1, 2, and 3, respectively. In the alternative scenario, the same costs resulted in about € 321.1, € 338.6 and € 356.2 million, respectively. The cumulative budget impact over three years period was approximately a cost saving of € 3.1 million (about 0.3% saving). CONCLUSION: The adoption of peginterferon beta-1a for the treatment of RRMS would be viewed as economically sustainable by the Italian NHS. [Article in Italian]","PeriodicalId":41585,"journal":{"name":"Farmeconomia-Health Economics and Therapeutic Pathways","volume":"23 1","pages":"37-48"},"PeriodicalIF":0.5,"publicationDate":"2016-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88342978","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}
A. Belisari, S. Iannazzo, G. Pasquale, C. Fresco, L. Mantovani, M. P. Ruggeri, D. Toni, R. Landolfi
BACKGROUND: Each drug therapy with an anticoagulant effect may require, in emergency conditions, a rapid and specific strategy for a prompt restoration of coagulation. Dabigatran is the first-in-class of the so-called new oral anticoagulants (NAO), that have been made available in recent years in addition to traditionally-used vitamin K antagonists (VKA). Idarucizumab is a monoclonal antibody that binds to dabigatran, neutralizing its anticoagulant effect. OBJECTIVE: To assess the economic effect of idarucizumab in patients treated with dabigatran when the rapid reversal of its anticoagulant effect is required. METHODS: The analysis was carried over through the development of a budget impact model specifically adapted to the context of Italian care. The analysis was conducted along a time horizon of five years. The target population was defined by those patients on dabigatran treatment presenting uncontrolled and life-threatening bleedings (gastro-intestinal, intracranial or other) or requiring emergency surgery or urgent procedures. The estimation of healthcare resources (i.e. diagnostic procedures, medications, and other in-hospital services) needed for the management of uncontrolled bleeding and emergency surgery in patients treated with dabigatran was obtained from a panel of five Italian Clinical Experts. Unit costs were derived from current prices and tariffs. RESULTS: The total cost of management with the current therapeutic modalities ranged from € 16.5 million in year 1 to € 20.1 million in year 5. In the scenario with idarucizumab the total cost ranged from € 15.4 million in year 1 to € 18.7 million in year 5. The adoption of idarucizumab resulted in a cumulative 5-year savings of 6.5 million euro corresponding to 7.1% of the total expense. CONCLUSION: Idarucizumab for the management of patients treated with dabigatran in emergency / urgent situations has the potential for substantial savings, compared to treatments currently available. This preliminary assessment will require further confirmatory evidence when the product will become available in Italian healthcare setting. [Article in Italian]
{"title":"[Budget impact analysis of idarucizumab for the management of patients treated with dabigatran in emergency / urgent situations in Italy]","authors":"A. Belisari, S. Iannazzo, G. Pasquale, C. Fresco, L. Mantovani, M. P. Ruggeri, D. Toni, R. Landolfi","doi":"10.7175/FE.V17I2.1243","DOIUrl":"https://doi.org/10.7175/FE.V17I2.1243","url":null,"abstract":"BACKGROUND: Each drug therapy with an anticoagulant effect may require, in emergency conditions, a rapid and specific strategy for a prompt restoration of coagulation. Dabigatran is the first-in-class of the so-called new oral anticoagulants (NAO), that have been made available in recent years in addition to traditionally-used vitamin K antagonists (VKA). Idarucizumab is a monoclonal antibody that binds to dabigatran, neutralizing its anticoagulant effect. OBJECTIVE: To assess the economic effect of idarucizumab in patients treated with dabigatran when the rapid reversal of its anticoagulant effect is required. METHODS: The analysis was carried over through the development of a budget impact model specifically adapted to the context of Italian care. The analysis was conducted along a time horizon of five years. The target population was defined by those patients on dabigatran treatment presenting uncontrolled and life-threatening bleedings (gastro-intestinal, intracranial or other) or requiring emergency surgery or urgent procedures. The estimation of healthcare resources (i.e. diagnostic procedures, medications, and other in-hospital services) needed for the management of uncontrolled bleeding and emergency surgery in patients treated with dabigatran was obtained from a panel of five Italian Clinical Experts. Unit costs were derived from current prices and tariffs. RESULTS: The total cost of management with the current therapeutic modalities ranged from € 16.5 million in year 1 to € 20.1 million in year 5. In the scenario with idarucizumab the total cost ranged from € 15.4 million in year 1 to € 18.7 million in year 5. The adoption of idarucizumab resulted in a cumulative 5-year savings of 6.5 million euro corresponding to 7.1% of the total expense. CONCLUSION: Idarucizumab for the management of patients treated with dabigatran in emergency / urgent situations has the potential for substantial savings, compared to treatments currently available. This preliminary assessment will require further confirmatory evidence when the product will become available in Italian healthcare setting. [Article in Italian]","PeriodicalId":41585,"journal":{"name":"Farmeconomia-Health Economics and Therapeutic Pathways","volume":"33 1","pages":"47-58"},"PeriodicalIF":0.5,"publicationDate":"2016-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76944958","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}
Christine M. Fray-Aiken, R. Wilks, A. Abdulkadri, A. McCaw-Binns
OBJECTIVE: To estimate the economic cost of Chronic Non-Communicable Diseases (CNCDs) and the portion attributable to obesity among patients in Jamaica. METHODS: The cost-of-illness approach was used to estimate the cost of care in a hospital setting in Jamaica for type 2 diabetes mellitus, hypertension, coronary heart disease, stroke, gallbladder disease, breast cancer, colon cancer, osteoarthritis, and high cholesterol. Cost and service utilization data were collected from the hospital records of all patients with these diseases who visited the University Hospital of the West Indies (UHWI) during 2006. Patients were included in the study if they were between15 and 74 years of age and if female, were not pregnant during that year. Costs were categorized as direct or indirect. Direct costs included costs for prescription drugs, consultation visits (emergency and clinic visits), hospitalizations, allied health services, diagnostic and treatment procedures. Indirect costs included costs attributed to premature mortality, disability (permanent and temporary), and absenteeism. Indirect costs were discounted at 3% rate. RESULTS: The sample consisted of 554 patients (40%) males (60%) females. The economic burden of the nine diseases was estimated at US$ 5,672,618 (males 37%; females 63%) and the portion attributable to obesity amounted to US$ 1,157,173 (males 23%; females 77%). Total direct cost was estimated at US$ 3,740,377 with female patients accounting for 69.9% of this cost. Total indirect cost was estimated at US$ 1,932,241 with female patients accounting for 50.6% of this cost. The greater cost among women was not found to be statistically significant. Overall, on a per capita basis, males and females accrued similar costs-of-illness (US$ 9,451.75 vs. US$ 10,758.18). CONCLUSIONS: In a country with per capita GDP of less than US$ 5,300, a per capita annual cost of illness of US$ 10,239 for CNCDs is excessive and has detrimental implications for the health and development of Jamaica.
{"title":"Cost of care of chronic non-communicable diseases in Jamaican patients: the role of obesity","authors":"Christine M. Fray-Aiken, R. Wilks, A. Abdulkadri, A. McCaw-Binns","doi":"10.7175/FE.V17I2.1232","DOIUrl":"https://doi.org/10.7175/FE.V17I2.1232","url":null,"abstract":"OBJECTIVE: To estimate the economic cost of Chronic Non-Communicable Diseases (CNCDs) and the portion attributable to obesity among patients in Jamaica. METHODS: The cost-of-illness approach was used to estimate the cost of care in a hospital setting in Jamaica for type 2 diabetes mellitus, hypertension, coronary heart disease, stroke, gallbladder disease, breast cancer, colon cancer, osteoarthritis, and high cholesterol. Cost and service utilization data were collected from the hospital records of all patients with these diseases who visited the University Hospital of the West Indies (UHWI) during 2006. Patients were included in the study if they were between15 and 74 years of age and if female, were not pregnant during that year. Costs were categorized as direct or indirect. Direct costs included costs for prescription drugs, consultation visits (emergency and clinic visits), hospitalizations, allied health services, diagnostic and treatment procedures. Indirect costs included costs attributed to premature mortality, disability (permanent and temporary), and absenteeism. Indirect costs were discounted at 3% rate. RESULTS: The sample consisted of 554 patients (40%) males (60%) females. The economic burden of the nine diseases was estimated at US$ 5,672,618 (males 37%; females 63%) and the portion attributable to obesity amounted to US$ 1,157,173 (males 23%; females 77%). Total direct cost was estimated at US$ 3,740,377 with female patients accounting for 69.9% of this cost. Total indirect cost was estimated at US$ 1,932,241 with female patients accounting for 50.6% of this cost. The greater cost among women was not found to be statistically significant. Overall, on a per capita basis, males and females accrued similar costs-of-illness (US$ 9,451.75 vs. US$ 10,758.18). CONCLUSIONS: In a country with per capita GDP of less than US$ 5,300, a per capita annual cost of illness of US$ 10,239 for CNCDs is excessive and has detrimental implications for the health and development of Jamaica.","PeriodicalId":41585,"journal":{"name":"Farmeconomia-Health Economics and Therapeutic Pathways","volume":"17 1","pages":"81-95"},"PeriodicalIF":0.5,"publicationDate":"2016-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74874354","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}
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