G. Furneri, L. Santoni, C. Marchesi, S. Iannazzo, P. Cortesi, A. Caputi, L. Mantovani
INTRODUCTION: Disease Modifying Therapies (DMTs) have significantly improved clinical conditions of Relapsing Remitting Multiple Sclerosis (RRMS) patients. However, several unmet needs are still relevant in RRMS. Recently, a new therapy, delayed-release dimethyl-fumarate (DMF; also known as gastro-resistant DMF), has been approved and reimbursed by the Italian Drug Agency (AIFA) for the treatment of RRMS. OBJECTIVE: To compare the cost-effectiveness of DMF vs. pharmacological alternatives indicated for the first-line treatment of RRMS in Italy. METHODS: The analysis was conducted from the perspective of the Italian National Healthcare Service (NHS) and outcomes and costs were evaluated over a 50-year time horizon (equivalent to a lifetime horizon). Both outcomes and costs were discounted at 3.5%. The Markov model estimates the clinical and economic consequences of treating RRMS patients with the following therapeutic options: DMF, interferon (IFN) beta-1a intramuscular (IM); IFN beta-1a subcutaneous (SC) at two different doses, 22 mcg and 44 mcg; IFN beta-1b SC; glatiramer acetate (GA) SC 20 mg; oral teriflunomide. Clinical efficacy data used in this analysis came from an elaboration of the mixed treatment comparison (MTC) already published. According to the Italian NHS perspective, only the following direct costs were considered: pharmacological treatment acquisition, treatment monitoring, relapse management, direct costs associated with disability, adverse event management. Administration costs were assumed equal to €0, because every treatment included in the economic analysis can be self-administered. One-way and probabilistic sensitivity analyses were developed and cost effectiveness acceptability curves generated. RESULTS: In the base-case analysis, DMF was more efficacious than alternatives, in terms of both survival (19.496 vs. 19.297-19.461 discounted LYs, respectively), and QALYs (6.548 vs. 5.172- 6.212 discounted QALYs, respectively). Per-patient lifetime costs with DMF amounted to € 276,500, similarly to the other options. DMF was the drug with the largest effect of disability cost reduction. DMF was dominant vs. IFN beta-1a 44 mcg and cost-effective vs. all other IFNs, GA and teriflunomide, with incremental cost-effectiveness ratio (ICERs) between € 11,272 and € 23,409. All ICER values were lower than the € 50,000 per QALY threshold. One-way sensitivity analysis showed that, for all tested scenarios, ICER of DMF vs. therapeutic alternatives remained favourable (≤ 50.000 €/QALY gained) and the results of probabilistic sensitivity analysis showed that the probability for DMF of being favourable (≤ 50.000 €/QALY gained) was between around 70% and 93%, thus ensuring robustness of the results. CONCLUSIONS: The results of this economic analysis show that, at the current price and the described assumptions, DMF represents a cost-effective option vs. other available first-line treatments indicated in RRMS in the perspective of the Italian NHS
{"title":"[Cost-effectiveness analysis of delayed-release dimethyl-fumarate in the treatment of relapsing-remitting multiple sclerosis in Italy]","authors":"G. Furneri, L. Santoni, C. Marchesi, S. Iannazzo, P. Cortesi, A. Caputi, L. Mantovani","doi":"10.7175/FE.V17I2.1251","DOIUrl":"https://doi.org/10.7175/FE.V17I2.1251","url":null,"abstract":"INTRODUCTION: Disease Modifying Therapies (DMTs) have significantly improved clinical conditions of Relapsing Remitting Multiple Sclerosis (RRMS) patients. However, several unmet needs are still relevant in RRMS. Recently, a new therapy, delayed-release dimethyl-fumarate (DMF; also known as gastro-resistant DMF), has been approved and reimbursed by the Italian Drug Agency (AIFA) for the treatment of RRMS. OBJECTIVE: To compare the cost-effectiveness of DMF vs. pharmacological alternatives indicated for the first-line treatment of RRMS in Italy. METHODS: The analysis was conducted from the perspective of the Italian National Healthcare Service (NHS) and outcomes and costs were evaluated over a 50-year time horizon (equivalent to a lifetime horizon). Both outcomes and costs were discounted at 3.5%. The Markov model estimates the clinical and economic consequences of treating RRMS patients with the following therapeutic options: DMF, interferon (IFN) beta-1a intramuscular (IM); IFN beta-1a subcutaneous (SC) at two different doses, 22 mcg and 44 mcg; IFN beta-1b SC; glatiramer acetate (GA) SC 20 mg; oral teriflunomide. Clinical efficacy data used in this analysis came from an elaboration of the mixed treatment comparison (MTC) already published. According to the Italian NHS perspective, only the following direct costs were considered: pharmacological treatment acquisition, treatment monitoring, relapse management, direct costs associated with disability, adverse event management. Administration costs were assumed equal to €0, because every treatment included in the economic analysis can be self-administered. One-way and probabilistic sensitivity analyses were developed and cost effectiveness acceptability curves generated. RESULTS: In the base-case analysis, DMF was more efficacious than alternatives, in terms of both survival (19.496 vs. 19.297-19.461 discounted LYs, respectively), and QALYs (6.548 vs. 5.172- 6.212 discounted QALYs, respectively). Per-patient lifetime costs with DMF amounted to € 276,500, similarly to the other options. DMF was the drug with the largest effect of disability cost reduction. DMF was dominant vs. IFN beta-1a 44 mcg and cost-effective vs. all other IFNs, GA and teriflunomide, with incremental cost-effectiveness ratio (ICERs) between € 11,272 and € 23,409. All ICER values were lower than the € 50,000 per QALY threshold. One-way sensitivity analysis showed that, for all tested scenarios, ICER of DMF vs. therapeutic alternatives remained favourable (≤ 50.000 €/QALY gained) and the results of probabilistic sensitivity analysis showed that the probability for DMF of being favourable (≤ 50.000 €/QALY gained) was between around 70% and 93%, thus ensuring robustness of the results. CONCLUSIONS: The results of this economic analysis show that, at the current price and the described assumptions, DMF represents a cost-effective option vs. other available first-line treatments indicated in RRMS in the perspective of the Italian NHS","PeriodicalId":41585,"journal":{"name":"Farmeconomia-Health Economics and Therapeutic Pathways","volume":"49 1","pages":"67-80"},"PeriodicalIF":0.5,"publicationDate":"2016-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86917894","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: Replacement therapy with von Willebrand factor (VWF)/factor VIII (FVIII) concentrates represents an effective approach for patients with von Willebrand disease (VWD) who are unresponsive to desmopressin. However, various concentrates are available, with heterogeneous VWF content and VWF/FVIII ratio. AIM: To compare the costs associated to the replacement therapy with VWF/FVIII concentrates in Italy. METHODS: A cost-minimization analysis was performed to compare the pharmaceutical costs per patient of alternatives available for replacement therapy of VWD in the prospective of the Italian National Health Service. For each alternative the analysis calculated the number of vials, and relative costs, required to reach the target levels of VWF:RCo in patients who undergone to major surgery, minor surgery, spontaneous bleeding and prophylaxis. RESULTS: Haemate P® is associated with the lowest FVIII dosage, numbers of vials used and costs in all the clinical situations and at all the dosages considered. With Haemate P® the average costs in major surgery, minor surgery, spontaneous bleeding, and prophylaxis was € 710.94, € 592.45, € 473.96, and € 592.45, respectively. While the costs associated to Fanhdi®, Wilate®, and Wilfactin® was: € 1,309.28, € 1,071.23, € 952.20, and € 1,190.25; € 1,512.45, € 1,344.40, € 1,176.35, and € 1,344.40; € 3,814.09, € 3,269.22, € 3,269.22, and € 3,814.09. CONCLUSIONS: Treatment with Haemate P®, which presents a low FVIII content, allows to reach the target level of VWF:RCo with a lower number of vials and lower costs for the NHS. [Article in Italian]
{"title":"[Cost-minimization analysis of replacement therapy in the treatment of von Willebrand disease]","authors":"G. Castaman","doi":"10.7175/FE.V17I2.1249","DOIUrl":"https://doi.org/10.7175/FE.V17I2.1249","url":null,"abstract":"BACKGROUND: Replacement therapy with von Willebrand factor (VWF)/factor VIII (FVIII) concentrates represents an effective approach for patients with von Willebrand disease (VWD) who are unresponsive to desmopressin. However, various concentrates are available, with heterogeneous VWF content and VWF/FVIII ratio. AIM: To compare the costs associated to the replacement therapy with VWF/FVIII concentrates in Italy. METHODS: A cost-minimization analysis was performed to compare the pharmaceutical costs per patient of alternatives available for replacement therapy of VWD in the prospective of the Italian National Health Service. For each alternative the analysis calculated the number of vials, and relative costs, required to reach the target levels of VWF:RCo in patients who undergone to major surgery, minor surgery, spontaneous bleeding and prophylaxis. RESULTS: Haemate P® is associated with the lowest FVIII dosage, numbers of vials used and costs in all the clinical situations and at all the dosages considered. With Haemate P® the average costs in major surgery, minor surgery, spontaneous bleeding, and prophylaxis was € 710.94, € 592.45, € 473.96, and € 592.45, respectively. While the costs associated to Fanhdi®, Wilate®, and Wilfactin® was: € 1,309.28, € 1,071.23, € 952.20, and € 1,190.25; € 1,512.45, € 1,344.40, € 1,176.35, and € 1,344.40; € 3,814.09, € 3,269.22, € 3,269.22, and € 3,814.09. CONCLUSIONS: Treatment with Haemate P®, which presents a low FVIII content, allows to reach the target level of VWF:RCo with a lower number of vials and lower costs for the NHS. [Article in Italian]","PeriodicalId":41585,"journal":{"name":"Farmeconomia-Health Economics and Therapeutic Pathways","volume":"29 1","pages":"59-65"},"PeriodicalIF":0.5,"publicationDate":"2016-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87439655","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}
vazioni della World Federation of Hemophilia riportando una prevalenza della malattia di 6,2/100.000 abitanti; nel 2013, dei 3.751 soggetti con emofilia A registrati, 1.752 risultavano affetti dalla forma grave. L’emofilia, per la quale ad oggi non esiste una cura, ha un impatto significativo sulla qualità della vita dei pazienti (scuola, lavoro, vita privata). Ad oggi, infatti, il trattamento per i pazienti affetti da emofilia A è costituito dalla somministrazione endovenosa del fattore carente o mancante (il FVIII), come riportato sia dalla linee guida internazionali (World Federation of Hemophilia) [2] che dalle linee guida italiane (Associazione Italiana Centri Emofilia) [3]. L’infusione di FVIII permette di trattare un’emorragia in atto attraverso una temporanea correzione della carenza del FVIII (terapia on demand) o, se effettuata con regolarità e a lungo termine (profilassi), consente una riduzione della tendenza al sanguinamento e delle conseguenze negative che le emorragie hanno sullo stato articolare, mantenendo dei livelli di fattore in circolo tali da evitare il sanguinamento spontaneo [2,3]. Tale somministrazione, che in tempi passati avveniva in regime ospedaliero, attualmente viene effettuata in regime domiciliare dopo adeguato training del paziente o dei caregiver, con conseguente impatto positivo sulla qualità di vita dei pazienti stessi e delle loro famiglie [4]. La profilassi è l’approccio attualmente riconosciuto come il trattamento più adatto per la prevenzione delle complicanze arL’emofiLia a L’emofilia, patologia rara a trasmissione genetica correlata al cromosoma X di tipo recessivo, fa parte delle malattie congenite della coagulazione del sangue caratterizzate dalla carenza di una delle proteine coinvolte nella cascata della coagulazione. In particolare si riscontra nei soggetti affetti da emofilia A un’alterazione del gene F8 codificante la proteina del Fattore VIII (FVIII), che risulta di conseguenza carente o con difetti funzionali. La presentazione clinica dell’emofilia A è caratterizzata da emorragie spontanee o traumatiche, con particolare interessamento dei muscoli e delle articolazioni (in particolare ginocchio, caviglia e gomito); in caso di mancato o inadeguato trattamento, emartri ricorrenti a carico della stessa articolazione possono provocare un processo degenerativo dei tessuti articolari (artropatia emofilica) che, nel tempo, risulta in deformità e impotenza funzionale dell’articolazione. Inoltre, nel caso le emorragie si verifichino a livello intracranico oppure interessino gli organi interni, possono mettere a rischio la vita del soggetto emofilico. La patologia viene classificata in forme lievi, moderate e gravi, in funzione della percentuale di attività del FVIII residuo in circolo. Nell’emofilia A grave i livelli di FVIII sono praticamente indosabili (<1%). Dal punto di vista epidemiologico in Italia il Registro Nazionale delle Coagulopatie Congenite [1] conferma sostanzialmente le rileLetter to the e
{"title":"[Kovaltry® for the replacement therapy in patients with Hemophilia A]","authors":"D. Roggeri, A. Colombo, A. Roggeri","doi":"10.7175/FE.V17I2.1250","DOIUrl":"https://doi.org/10.7175/FE.V17I2.1250","url":null,"abstract":"vazioni della World Federation of Hemophilia riportando una prevalenza della malattia di 6,2/100.000 abitanti; nel 2013, dei 3.751 soggetti con emofilia A registrati, 1.752 risultavano affetti dalla forma grave. L’emofilia, per la quale ad oggi non esiste una cura, ha un impatto significativo sulla qualità della vita dei pazienti (scuola, lavoro, vita privata). Ad oggi, infatti, il trattamento per i pazienti affetti da emofilia A è costituito dalla somministrazione endovenosa del fattore carente o mancante (il FVIII), come riportato sia dalla linee guida internazionali (World Federation of Hemophilia) [2] che dalle linee guida italiane (Associazione Italiana Centri Emofilia) [3]. L’infusione di FVIII permette di trattare un’emorragia in atto attraverso una temporanea correzione della carenza del FVIII (terapia on demand) o, se effettuata con regolarità e a lungo termine (profilassi), consente una riduzione della tendenza al sanguinamento e delle conseguenze negative che le emorragie hanno sullo stato articolare, mantenendo dei livelli di fattore in circolo tali da evitare il sanguinamento spontaneo [2,3]. Tale somministrazione, che in tempi passati avveniva in regime ospedaliero, attualmente viene effettuata in regime domiciliare dopo adeguato training del paziente o dei caregiver, con conseguente impatto positivo sulla qualità di vita dei pazienti stessi e delle loro famiglie [4]. La profilassi è l’approccio attualmente riconosciuto come il trattamento più adatto per la prevenzione delle complicanze arL’emofiLia a L’emofilia, patologia rara a trasmissione genetica correlata al cromosoma X di tipo recessivo, fa parte delle malattie congenite della coagulazione del sangue caratterizzate dalla carenza di una delle proteine coinvolte nella cascata della coagulazione. In particolare si riscontra nei soggetti affetti da emofilia A un’alterazione del gene F8 codificante la proteina del Fattore VIII (FVIII), che risulta di conseguenza carente o con difetti funzionali. La presentazione clinica dell’emofilia A è caratterizzata da emorragie spontanee o traumatiche, con particolare interessamento dei muscoli e delle articolazioni (in particolare ginocchio, caviglia e gomito); in caso di mancato o inadeguato trattamento, emartri ricorrenti a carico della stessa articolazione possono provocare un processo degenerativo dei tessuti articolari (artropatia emofilica) che, nel tempo, risulta in deformità e impotenza funzionale dell’articolazione. Inoltre, nel caso le emorragie si verifichino a livello intracranico oppure interessino gli organi interni, possono mettere a rischio la vita del soggetto emofilico. La patologia viene classificata in forme lievi, moderate e gravi, in funzione della percentuale di attività del FVIII residuo in circolo. Nell’emofilia A grave i livelli di FVIII sono praticamente indosabili (<1%). Dal punto di vista epidemiologico in Italia il Registro Nazionale delle Coagulopatie Congenite [1] conferma sostanzialmente le rileLetter to the e","PeriodicalId":41585,"journal":{"name":"Farmeconomia-Health Economics and Therapeutic Pathways","volume":"13 1","pages":"97-100"},"PeriodicalIF":0.5,"publicationDate":"2016-06-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90386013","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":"Moving Center Stage: patients claim their role in healthcare","authors":"A. Holtorf, N. Bertelsen","doi":"10.7175/FE.V17I1.1240","DOIUrl":"https://doi.org/10.7175/FE.V17I1.1240","url":null,"abstract":"","PeriodicalId":41585,"journal":{"name":"Farmeconomia-Health Economics and Therapeutic Pathways","volume":"206 1","pages":"3-6"},"PeriodicalIF":0.5,"publicationDate":"2016-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"80428890","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: Empagliflozin is the most recent molecule in the SGLT-2i class, new antidiabetic drugs that reduce renal glucose absorption by determining the excretion in the urine. The high prevalence of T2D, the chronicity of the condition and the severe economic and social burden caused by the disease, impose the need for a careful health economic assessment on each therapeutic innovation in this area. AIM: The aim of this study was to assess the budget impact of adopting empagliflozin in the diabetic population currently treated with sulfonylureas and potentially eligible for treatment with SGLT-2i. METHODS: The budget impact analysis was conducted from the perspective of the Italian National Health Service over a period of three years, through an analytic model developed in MS Excel. The target population was estimated in about 170,000 patients currently treated with sulfonylureas, based on the growth forecasts of the Italian population, epidemiological estimates and drug-use information available in the literature on diabetes in Italy. In the base case was assumed a replacement rate of sulfonylureas equal to 10%, 20% and 30% respectively at the first, second and third year of analysis. A scenario analysis was considered assuming a constant uptake of 100% since the first year. The following direct healthcare costs were considered: 1) acquisition of antidiabetic drugs as the main therapy and as rescue therapy; 2) self-monitoring of blood glucose; 3) management of severe hypoglycemic events and 4) management of major cardiovascular events. Clinical effectiveness data was based on the published literature and unit costs were derived from current prices and tariffs. Oneway sensitivity analysis was developed to assess the impact of input’s uncertainty on the overall result. RESULTS: The base case analysis presented a substantially neutral impact on the budget. The 3-year cumulative impact was -454.337 €, corresponding to a 0.1% saving. This means that the replacement of sulphonylureas with empagliflozin determines an increase in acquisition costs of drugs, which is entirely offset by the reduction in costs of self-monitoring of blood glucose, management of hypoglycemic events and cardiovascular events. The scenario analysis, based on the assumption of a full substitution of sulphonylureas with empagliflozin at the first year, yielded a more enhanced savings. The cumulative impact was -2.269.517 €, corresponding to a 0.6% saving. CONCLUSIONS: The present study shows that the replacement of sulfonylureas (a class of generic products) with empagliflozin, motivated by the advantageous efficacy and safety profile, can take place optimizing healthcare expenditure for the management of DT2. [In Italian]
{"title":"Budget impact analysis of empagliflozin for the treatment of type 2 diabetes in Italy","authors":"S. Iannazzo, E. Mannucci, L. Mantovani","doi":"10.7175/FE.V17I1.1238","DOIUrl":"https://doi.org/10.7175/FE.V17I1.1238","url":null,"abstract":"BACKGROUND: Empagliflozin is the most recent molecule in the SGLT-2i class, new antidiabetic drugs that reduce renal glucose absorption by determining the excretion in the urine. The high prevalence of T2D, the chronicity of the condition and the severe economic and social burden caused by the disease, impose the need for a careful health economic assessment on each therapeutic innovation in this area. AIM: The aim of this study was to assess the budget impact of adopting empagliflozin in the diabetic population currently treated with sulfonylureas and potentially eligible for treatment with SGLT-2i. METHODS: The budget impact analysis was conducted from the perspective of the Italian National Health Service over a period of three years, through an analytic model developed in MS Excel. The target population was estimated in about 170,000 patients currently treated with sulfonylureas, based on the growth forecasts of the Italian population, epidemiological estimates and drug-use information available in the literature on diabetes in Italy. In the base case was assumed a replacement rate of sulfonylureas equal to 10%, 20% and 30% respectively at the first, second and third year of analysis. A scenario analysis was considered assuming a constant uptake of 100% since the first year. The following direct healthcare costs were considered: 1) acquisition of antidiabetic drugs as the main therapy and as rescue therapy; 2) self-monitoring of blood glucose; 3) management of severe hypoglycemic events and 4) management of major cardiovascular events. Clinical effectiveness data was based on the published literature and unit costs were derived from current prices and tariffs. Oneway sensitivity analysis was developed to assess the impact of input’s uncertainty on the overall result. RESULTS: The base case analysis presented a substantially neutral impact on the budget. The 3-year cumulative impact was -454.337 €, corresponding to a 0.1% saving. This means that the replacement of sulphonylureas with empagliflozin determines an increase in acquisition costs of drugs, which is entirely offset by the reduction in costs of self-monitoring of blood glucose, management of hypoglycemic events and cardiovascular events. The scenario analysis, based on the assumption of a full substitution of sulphonylureas with empagliflozin at the first year, yielded a more enhanced savings. The cumulative impact was -2.269.517 €, corresponding to a 0.6% saving. CONCLUSIONS: The present study shows that the replacement of sulfonylureas (a class of generic products) with empagliflozin, motivated by the advantageous efficacy and safety profile, can take place optimizing healthcare expenditure for the management of DT2. [In Italian]","PeriodicalId":41585,"journal":{"name":"Farmeconomia-Health Economics and Therapeutic Pathways","volume":"72 1","pages":"19-27"},"PeriodicalIF":0.5,"publicationDate":"2016-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90755370","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}
U. Restelli, A. Alberti, A. Lazzarin, M. Bonfanti, C. Nappi, D. Croce
BACKGROUND: Hepatitis C Virus (HCV) infection represents a global health problem, leading to chronic cirrhosis, hepatocellular carcinoma (HCC), hepatic decompensation and liver transplant. The aim of the study was the evaluation of the impact on the budget of the Italian National Health Service (INHS) of the use of Daclatasvir (DCV) for the treatment of HCV genotype 3 in patients with advanced fibrosis. METHODS: An analytical decision model with a five year time horizon was implemented. Two scenarios were considered: a. 100% of market share for Interferon (INF-α)+Ribavirin (RBV)+Sofosbuvir (SOF) for 12 weeks; b. SOF+DCV+RBV for 24 weeks with annual market shares of 50% in 2015 and 2016, 55% in 2017 and 2018, 60% in 2019, and INF-α+RBV+SOF for 12 weeks with the remaining market shares. Every annual cycle a percentage of patients equal to the effectiveness of the antiviral treatment reach a sustained virologic response and during the first year of treatment patients may experience treatment related adverse events. The costs considered (2015) are those of the antiviral therapy, and direct medical costs for health state and adverse events management. Univariate and multivariate sensitivity analyses were performed. RESULTS: DCV would lead to an increase of the costs for the INHS (year 1 +21.31 millions, year 2 +21.35 millions, year 3 + 23.37 millions, year 4 + 23.26 millions and year 5 +16.37 millions). The sensitivity analysis confirmed the robustness of the results. CONCLUSIONS: The use of DCV is likely to have a short term impact on the INHS budget increasing resources use compared to the sole use of INF-α+RBV+SOF. However, a trend of reduction of the costs increase is observed due to the management of health states and adverse events which may lead to the possibility to reduce costs in the long term.
{"title":"Budget impact analysis of the use of daclatasvir in Italy for the treatment of Hepatitis C Virus (HCV) genotype 3 patients","authors":"U. Restelli, A. Alberti, A. Lazzarin, M. Bonfanti, C. Nappi, D. Croce","doi":"10.7175/FE.V17I1.1225","DOIUrl":"https://doi.org/10.7175/FE.V17I1.1225","url":null,"abstract":"BACKGROUND: Hepatitis C Virus (HCV) infection represents a global health problem, leading to chronic cirrhosis, hepatocellular carcinoma (HCC), hepatic decompensation and liver transplant. The aim of the study was the evaluation of the impact on the budget of the Italian National Health Service (INHS) of the use of Daclatasvir (DCV) for the treatment of HCV genotype 3 in patients with advanced fibrosis. METHODS: An analytical decision model with a five year time horizon was implemented. Two scenarios were considered: a. 100% of market share for Interferon (INF-α)+Ribavirin (RBV)+Sofosbuvir (SOF) for 12 weeks; b. SOF+DCV+RBV for 24 weeks with annual market shares of 50% in 2015 and 2016, 55% in 2017 and 2018, 60% in 2019, and INF-α+RBV+SOF for 12 weeks with the remaining market shares. Every annual cycle a percentage of patients equal to the effectiveness of the antiviral treatment reach a sustained virologic response and during the first year of treatment patients may experience treatment related adverse events. The costs considered (2015) are those of the antiviral therapy, and direct medical costs for health state and adverse events management. Univariate and multivariate sensitivity analyses were performed. RESULTS: DCV would lead to an increase of the costs for the INHS (year 1 +21.31 millions, year 2 +21.35 millions, year 3 + 23.37 millions, year 4 + 23.26 millions and year 5 +16.37 millions). The sensitivity analysis confirmed the robustness of the results. CONCLUSIONS: The use of DCV is likely to have a short term impact on the INHS budget increasing resources use compared to the sole use of INF-α+RBV+SOF. However, a trend of reduction of the costs increase is observed due to the management of health states and adverse events which may lead to the possibility to reduce costs in the long term.","PeriodicalId":41585,"journal":{"name":"Farmeconomia-Health Economics and Therapeutic Pathways","volume":"4 1","pages":"7-12"},"PeriodicalIF":0.5,"publicationDate":"2016-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75139383","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}
G. Koçkaya, T. Zengin, F. Yenilmez, C. Dalgic, S. Malhan, P. Çerçi, E. Oksuz, S. Unal
OBJECTIVE: Infection with the human immunodeficiency virus (HIV), the causative agent of acquired immune deficiency syndrome (AIDS), is a major global health problem. Patients with HIV can live normal lives with today’s new treatment options. As the treatment is generally successful, the life expectancy of patients infected with HIV is rising. As a result, the economic burden of HIV treatment on health systems is set to increase. According to the Ministry of Health, there were more than 6000 HIV-positive patients in Turkey in 2013. The aim of this study was to determine the direct costs of HIV treatment in Turkey. METHOD: A retrospective data analysis was performed from the reimbursement agency perspective. Data for 252 patients at a university hospital in Ankara from 2001 to 2012 were used for the analysis. The average costs of treatment per HIV patient and the average costs per HIV patient, depending on the state of the patient’s health, were calculated. The latter was determined according to the number of CD4 cells/ml, as defined by the CDC’s classification system for HIV infection. The cost of treatment was calculated based on published reimbursement prices in 2013, per patient per year. RESULTS: The CD4 values of 25.3%, 29%, and 45.7% of the 252 patients were 300 cells/mm3, respectively. The treatment costs per patient per year for 2013 for those with CD4 values of 300+ cells/mm3 were $ 5,637.04, $ 2,211.54, and $ 2,182.35, respectively. The weighted average of the treatment cost per patient was $ 3,344.64 for 2013. CONCLUSION: This analysis is unique to Turkey and calculates the cost only of HIV treatment in Turkey. Lower CD4 values are associated with higher treatment costs. Appropriate HIV treatment is crucial for controlling CD4 values and lowering the treatment costs of HIV patients. These findings need to be considered by policy makers who may need to focus on HIV.
{"title":"Analysis of the treatment cost of HIV/AIDS in Turkey","authors":"G. Koçkaya, T. Zengin, F. Yenilmez, C. Dalgic, S. Malhan, P. Çerçi, E. Oksuz, S. Unal","doi":"10.7175/FE.V17I1.1219","DOIUrl":"https://doi.org/10.7175/FE.V17I1.1219","url":null,"abstract":"OBJECTIVE: Infection with the human immunodeficiency virus (HIV), the causative agent of acquired immune deficiency syndrome (AIDS), is a major global health problem. Patients with HIV can live normal lives with today’s new treatment options. As the treatment is generally successful, the life expectancy of patients infected with HIV is rising. As a result, the economic burden of HIV treatment on health systems is set to increase. According to the Ministry of Health, there were more than 6000 HIV-positive patients in Turkey in 2013. The aim of this study was to determine the direct costs of HIV treatment in Turkey. METHOD: A retrospective data analysis was performed from the reimbursement agency perspective. Data for 252 patients at a university hospital in Ankara from 2001 to 2012 were used for the analysis. The average costs of treatment per HIV patient and the average costs per HIV patient, depending on the state of the patient’s health, were calculated. The latter was determined according to the number of CD4 cells/ml, as defined by the CDC’s classification system for HIV infection. The cost of treatment was calculated based on published reimbursement prices in 2013, per patient per year. RESULTS: The CD4 values of 25.3%, 29%, and 45.7% of the 252 patients were 300 cells/mm3, respectively. The treatment costs per patient per year for 2013 for those with CD4 values of 300+ cells/mm3 were $ 5,637.04, $ 2,211.54, and $ 2,182.35, respectively. The weighted average of the treatment cost per patient was $ 3,344.64 for 2013. CONCLUSION: This analysis is unique to Turkey and calculates the cost only of HIV treatment in Turkey. Lower CD4 values are associated with higher treatment costs. Appropriate HIV treatment is crucial for controlling CD4 values and lowering the treatment costs of HIV patients. These findings need to be considered by policy makers who may need to focus on HIV.","PeriodicalId":41585,"journal":{"name":"Farmeconomia-Health Economics and Therapeutic Pathways","volume":"59 1","pages":"13-17"},"PeriodicalIF":0.5,"publicationDate":"2016-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78167117","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. Adami, P. Maggi, V. Montinaro, M. Povero, L. Pradelli, R. Bellagamba, P. Bonfanti, A. Biagio, S. Rusconi, F. D. Campli, G. Forastieri, M. Mancini
The “chronicization” of HIV infection brings about a growing necessity to attentively evaluate current and potential complications when prescribing the individual therapeutic regimen. Starting from this need, we developed two HIV-comorbidity simulators that, basing on the evidence available in medical literature and starting from the current clinical and demographic features of the individual patient, project and compare the risks of developing and worsening of nephropathy and osteopathy associated with possible ARV regimens. These simulators are embedded in a desktop, user-friendly software thought to be used by the treating physician during prescription discussion with his/her patients, in order to highlight expected clinical outcomes and healthcare resource consumption that may differ according to the therapeutic strategy selected. In this article we present the sources and methods used in developing the mathematical models, alongside a set of examples and the results of cohort-level validation runs.
{"title":"Simulating the development and progression of Chronic Kidney Disease and osteoporosis in people living with HIV","authors":"S. Adami, P. Maggi, V. Montinaro, M. Povero, L. Pradelli, R. Bellagamba, P. Bonfanti, A. Biagio, S. Rusconi, F. D. Campli, G. Forastieri, M. Mancini","doi":"10.7175/FE.V17I1S.1236","DOIUrl":"https://doi.org/10.7175/FE.V17I1S.1236","url":null,"abstract":"The “chronicization” of HIV infection brings about a growing necessity to attentively evaluate current and potential complications when prescribing the individual therapeutic regimen. Starting from this need, we developed two HIV-comorbidity simulators that, basing on the evidence available in medical literature and starting from the current clinical and demographic features of the individual patient, project and compare the risks of developing and worsening of nephropathy and osteopathy associated with possible ARV regimens. These simulators are embedded in a desktop, user-friendly software thought to be used by the treating physician during prescription discussion with his/her patients, in order to highlight expected clinical outcomes and healthcare resource consumption that may differ according to the therapeutic strategy selected. In this article we present the sources and methods used in developing the mathematical models, alongside a set of examples and the results of cohort-level validation runs.","PeriodicalId":41585,"journal":{"name":"Farmeconomia-Health Economics and Therapeutic Pathways","volume":"455 1","pages":"3-23"},"PeriodicalIF":0.5,"publicationDate":"2016-02-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78801061","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 aging of Europe. The unexplored potential","authors":"M. Jakovljevic","doi":"10.7175/FE.V16I4.1220","DOIUrl":"https://doi.org/10.7175/FE.V16I4.1220","url":null,"abstract":"","PeriodicalId":41585,"journal":{"name":"Farmeconomia-Health Economics and Therapeutic Pathways","volume":"33 1","pages":"89-92"},"PeriodicalIF":0.5,"publicationDate":"2015-12-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73497925","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}
京公网安备 11010802042870号
京ICP备2023020795号-1
扫码关注我们
求助内容：
应助结果提醒方式：