V. Perrone, D. Sangiorgi, S. Buda, M. Andretta, S. Borrè, C. Cattaruzzi, G. Gasperini, F. Lena, A. Pisterna, L. Esposti
AIM: The aim of the study was to evaluate healthcare resource use and related costs for the management of people living with Human Immunodeficiency Virus (PLWHIV) with and without comorbidities, and to compare the burden of comorbidities in PLWHIV to the general population.METHODS: An observational retrospective analysis, based on administrative and laboratory databases from 6 Italian Local Health Units (LHUs) was performed. Individuals receiving either an HIV treatment [Antiretroviral therapy (ART) – ATC code: J05A)], or with an HIV positive laboratory test result between January 1st, 2014 and December 31st, 2014 were included. The date of first ART prescription or positive test of HIV was used as the Index Date (ID). Patients enrolled were followed-up for all time available from the ID (follow-up period) and their clinical characteristics were investigated from one year prior to the ID (characterization period). Comorbidities were measured by using the Charlson Comorbidity Index; findings were compared with those of a sample of the general population with the same age and sex distribution (OsMed 2015). Healthcare resource use and related cost was evaluated during the follow-up period.RESULTS: 1,214 patients were included, 837 were PLWHIV without any comorbidities and 377 were PLWHIV with at least one comorbidity. Mean prevalence of prescriptions for treatment of comorbidities was higher in the HIV-infected population than in the Italian general population. The annual healthcare cost of managing HIV patients with comorbidities, was significantly higher than that for patients without comorbidities (€ 10,615 vs. € 8,665, p < 0.001).CONCLUSIONS: Study results showed that 30% of PLWHIV had at least one comorbidity. The cost of managing PLWHIV who have comorbidities was significantly higher than that of managing PLWHIV without comorbidities. Our data confirm that care and treatment services should be adapted to address the specific needs of people living with both HIV and comorbidities.
{"title":"Healthcare Resources Use in Patients with Human Immunodeficiency Virus (HIV). Real-World Evidence From Six Italian Local Health Units","authors":"V. Perrone, D. Sangiorgi, S. Buda, M. Andretta, S. Borrè, C. Cattaruzzi, G. Gasperini, F. Lena, A. Pisterna, L. Esposti","doi":"10.7175/FE.V19I1.1353","DOIUrl":"https://doi.org/10.7175/FE.V19I1.1353","url":null,"abstract":"AIM: The aim of the study was to evaluate healthcare resource use and related costs for the management of people living with Human Immunodeficiency Virus (PLWHIV) with and without comorbidities, and to compare the burden of comorbidities in PLWHIV to the general population.METHODS: An observational retrospective analysis, based on administrative and laboratory databases from 6 Italian Local Health Units (LHUs) was performed. Individuals receiving either an HIV treatment [Antiretroviral therapy (ART) – ATC code: J05A)], or with an HIV positive laboratory test result between January 1st, 2014 and December 31st, 2014 were included. The date of first ART prescription or positive test of HIV was used as the Index Date (ID). Patients enrolled were followed-up for all time available from the ID (follow-up period) and their clinical characteristics were investigated from one year prior to the ID (characterization period). Comorbidities were measured by using the Charlson Comorbidity Index; findings were compared with those of a sample of the general population with the same age and sex distribution (OsMed 2015). Healthcare resource use and related cost was evaluated during the follow-up period.RESULTS: 1,214 patients were included, 837 were PLWHIV without any comorbidities and 377 were PLWHIV with at least one comorbidity. Mean prevalence of prescriptions for treatment of comorbidities was higher in the HIV-infected population than in the Italian general population. The annual healthcare cost of managing HIV patients with comorbidities, was significantly higher than that for patients without comorbidities (€ 10,615 vs. € 8,665, p < 0.001).CONCLUSIONS: Study results showed that 30% of PLWHIV had at least one comorbidity. The cost of managing PLWHIV who have comorbidities was significantly higher than that of managing PLWHIV without comorbidities. Our data confirm that care and treatment services should be adapted to address the specific needs of people living with both HIV and comorbidities.","PeriodicalId":41585,"journal":{"name":"Farmeconomia-Health Economics and Therapeutic Pathways","volume":"44 1","pages":""},"PeriodicalIF":0.5,"publicationDate":"2018-07-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"75621650","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. Gancitano, R. Ravasio, M. Dionisi, D. Cortinovis
BACKGROUND: Unlike the tissue one, liquid biopsy is a less invasive diagnostic method for the assessment of possible mutations of the tumor, based on the analysis of circulating free DNA (cfDNA) present in the plasma component of the blood. Because blood samples are easily obtainable, plasma biopsy is a non-invasive method, supplementing the more traditional biopsy techniques. AIM: A cost-consequence analysis was conducted to compare the adoption of three different diagnostic strategies in the first- and second-line treatment of locally advanced or metastatic NSCLC: i) tissue strategy (only tissue biopsy for first and second line), ii) combined strategy (first line: tissue biopsy. If unknown, liquid biopsy; second line: liquid biopsy. If negative, tissue biopsy) and iii) potential strategy (first line: tissue biopsy. If unknown or tissue ineligible, liquid biopsy; second line: liquid biopsy. If negative, tissue biopsy). METHODS: A decision-analytic model was developed considering the Italian NHS’s perspective. We only evaluated direct medical costs (tissue biopsy, management of complications associated with tissue and liquid biopsies) borne by the NHS. The CCA was conducted over a time horizon of 1 year, assuming that for each patient with mNSCLC the diagnostic pathway (first- and second-line treatment) ended within such period. Key variables were tested in the sensitivity analysis. RESULTS: Considering both the first and the second line of treatment, the potential strategy constitutes the cost-effective alternative, characterized by an average cost per correctly identified case (€ 685) lower than that estimated for the combined strategy (€ 732) or for the tissue strategy (€ 1,004). The potential strategy remains cost-effective, also considering the results referred to the first- or second-line treatment only. CONCLUSION: The choice of a correct diagnostic strategy is crucial in order to optimize cancer therapies in the first- and second-line treatment of locally advanced or metastasized NSCLC. The addition to the diagnostic pathway of the liquid biopsy would correctly identify a greater number of cases, supporting the prescription of the best oncological therapy.
{"title":"Cost-Consequence Analysis of Three Different Diagnostic Strategies in the First- and Second-Line Treatment of Locally Advanced or Metastatic Non-Small-Cell Lung Cancer","authors":"G. Gancitano, R. Ravasio, M. Dionisi, D. Cortinovis","doi":"10.7175/FE.V19I1.1354","DOIUrl":"https://doi.org/10.7175/FE.V19I1.1354","url":null,"abstract":"BACKGROUND: Unlike the tissue one, liquid biopsy is a less invasive diagnostic method for the assessment of possible mutations of the tumor, based on the analysis of circulating free DNA (cfDNA) present in the plasma component of the blood. Because blood samples are easily obtainable, plasma biopsy is a non-invasive method, supplementing the more traditional biopsy techniques. AIM: A cost-consequence analysis was conducted to compare the adoption of three different diagnostic strategies in the first- and second-line treatment of locally advanced or metastatic NSCLC: i) tissue strategy (only tissue biopsy for first and second line), ii) combined strategy (first line: tissue biopsy. If unknown, liquid biopsy; second line: liquid biopsy. If negative, tissue biopsy) and iii) potential strategy (first line: tissue biopsy. If unknown or tissue ineligible, liquid biopsy; second line: liquid biopsy. If negative, tissue biopsy). METHODS: A decision-analytic model was developed considering the Italian NHS’s perspective. We only evaluated direct medical costs (tissue biopsy, management of complications associated with tissue and liquid biopsies) borne by the NHS. The CCA was conducted over a time horizon of 1 year, assuming that for each patient with mNSCLC the diagnostic pathway (first- and second-line treatment) ended within such period. Key variables were tested in the sensitivity analysis. RESULTS: Considering both the first and the second line of treatment, the potential strategy constitutes the cost-effective alternative, characterized by an average cost per correctly identified case (€ 685) lower than that estimated for the combined strategy (€ 732) or for the tissue strategy (€ 1,004). The potential strategy remains cost-effective, also considering the results referred to the first- or second-line treatment only. CONCLUSION: The choice of a correct diagnostic strategy is crucial in order to optimize cancer therapies in the first- and second-line treatment of locally advanced or metastasized NSCLC. The addition to the diagnostic pathway of the liquid biopsy would correctly identify a greater number of cases, supporting the prescription of the best oncological therapy.","PeriodicalId":41585,"journal":{"name":"Farmeconomia-Health Economics and Therapeutic Pathways","volume":"2 1","pages":""},"PeriodicalIF":0.5,"publicationDate":"2018-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88581827","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}
R. Bernardini, G. Gancitano, A. Balice, R. D. Mauro, G. Cantarella, M. Dionisi
Great expectations are bound to the current evolution of medicine to personalized medicine. Thanks to rapid advances in genomics and molecular biology, new markers can be revealed for the presence of or susceptibility to a disease, or response to treatment. On such markers, diagnostic tests can be based; companion diagnostics (CDx, often called In Vitro devices) are diagnostic tests “coupled” with a therapeutic drug, aimed at assessing its applicability to a specific class of patients. As well as exemplifying some already implemented CDx applications, the purpose of this article is to highlight potentials and problems of personalized medicine today. In particular, the opportunity is analyzed for the co-development of a new drug and its CDx, through a parallel base research. This approach is promoted by the regulatory agencies but, due to scientific and economic factors implicit in the process, it is taking-off slowly. Personalized medicine deserves to grow and to expand, first of all because it simultaneously promises to substantially improve patient care and to make big costs savings for healthcare systems. From this point of view, all stakeholders (diagnostics manufacturers, clinical testing laboratories, pharmaceutical firms, the Department of health, and other bodies) should talk to each other in order to support the advancement of personalized medicine.
{"title":"Personalized medicine: biomarkers and companion diagnostics","authors":"R. Bernardini, G. Gancitano, A. Balice, R. D. Mauro, G. Cantarella, M. Dionisi","doi":"10.7175/FE.V19I1.1348","DOIUrl":"https://doi.org/10.7175/FE.V19I1.1348","url":null,"abstract":"Great expectations are bound to the current evolution of medicine to personalized medicine. Thanks to rapid advances in genomics and molecular biology, new markers can be revealed for the presence of or susceptibility to a disease, or response to treatment. On such markers, diagnostic tests can be based; companion diagnostics (CDx, often called In Vitro devices) are diagnostic tests “coupled” with a therapeutic drug, aimed at assessing its applicability to a specific class of patients. As well as exemplifying some already implemented CDx applications, the purpose of this article is to highlight potentials and problems of personalized medicine today. In particular, the opportunity is analyzed for the co-development of a new drug and its CDx, through a parallel base research. This approach is promoted by the regulatory agencies but, due to scientific and economic factors implicit in the process, it is taking-off slowly. Personalized medicine deserves to grow and to expand, first of all because it simultaneously promises to substantially improve patient care and to make big costs savings for healthcare systems. From this point of view, all stakeholders (diagnostics manufacturers, clinical testing laboratories, pharmaceutical firms, the Department of health, and other bodies) should talk to each other in order to support the advancement of personalized medicine.","PeriodicalId":41585,"journal":{"name":"Farmeconomia-Health Economics and Therapeutic Pathways","volume":"42 1","pages":""},"PeriodicalIF":0.5,"publicationDate":"2018-03-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81282547","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}
INTRODUCTION: The direct oral anticoagulants (DOACs) have demonstrated a more predictable effect and a more favorable risk-benefit ratio compared to the standard oral anticoagulant treatment for the prevention of stroke in patients with non-valvular atrial fibrillation (NVAF). AIM: To estimate the efficiency of DOACs (apixaban, dabigatran, edoxaban, and rivaroxaban vs. warfarin), in the prevention of clinical events in adult patients with NVAF. METHODS: A deterministic incremental cost-effectiveness analysis was performed to evaluate the avoidance of a clinical event and the incremental cost per avoided clinical event, in a hypothetical population of 100,000 adult patients with NVAF, over 1-year period. In the absence of head-to-head comparison trials between DOACs, relative risks were derived from a network meta-analysis. Clinical events considered include stroke/systemic embolism (SE) and major bleeding. Only direct health costs related to the management of clinical events and drug acquisition costs were considered. Clinical event management costs were derived from literature and from the Diagnosis Related Group (DRG) tariffs. Net annual treatment costs were calculated based on the daily dose reported in the Summary of Product Characteristics (SPCs) and the ex-factory price of each drug. RESULTS: Among DOACs, apixaban was associated with the highest net clinical benefit with 1,064 avoided events over 1 year, compared to warfarin (728 major bleeding events and 336 strokes/SE). Furthermore, apixaban is the most efficient DOAC, with a cost per avoided event equal to € 16,672 vs. warfarin (€ 24,120 for edoxaban 60 mg, € 36,777 for dabigatran 150 mg). CONCLUSION: Apixaban has the highest potential net clinical benefit among DOACs for patients with NVAF and the least incremental cost per avoided event for the Italian National Health Service.
{"title":"Estimating the cost-effectiveness of treatment for prevention of thromboembolic events in at-risk adults with non-valvular atrial fibrillation","authors":"M. Bellone, L. Pradelli, M. Bo","doi":"10.7175/FE.V19I1.1346","DOIUrl":"https://doi.org/10.7175/FE.V19I1.1346","url":null,"abstract":"INTRODUCTION: The direct oral anticoagulants (DOACs) have demonstrated a more predictable effect and a more favorable risk-benefit ratio compared to the standard oral anticoagulant treatment for the prevention of stroke in patients with non-valvular atrial fibrillation (NVAF). AIM: To estimate the efficiency of DOACs (apixaban, dabigatran, edoxaban, and rivaroxaban vs. warfarin), in the prevention of clinical events in adult patients with NVAF. METHODS: A deterministic incremental cost-effectiveness analysis was performed to evaluate the avoidance of a clinical event and the incremental cost per avoided clinical event, in a hypothetical population of 100,000 adult patients with NVAF, over 1-year period. In the absence of head-to-head comparison trials between DOACs, relative risks were derived from a network meta-analysis. Clinical events considered include stroke/systemic embolism (SE) and major bleeding. Only direct health costs related to the management of clinical events and drug acquisition costs were considered. Clinical event management costs were derived from literature and from the Diagnosis Related Group (DRG) tariffs. Net annual treatment costs were calculated based on the daily dose reported in the Summary of Product Characteristics (SPCs) and the ex-factory price of each drug. RESULTS: Among DOACs, apixaban was associated with the highest net clinical benefit with 1,064 avoided events over 1 year, compared to warfarin (728 major bleeding events and 336 strokes/SE). Furthermore, apixaban is the most efficient DOAC, with a cost per avoided event equal to € 16,672 vs. warfarin (€ 24,120 for edoxaban 60 mg, € 36,777 for dabigatran 150 mg). CONCLUSION: Apixaban has the highest potential net clinical benefit among DOACs for patients with NVAF and the least incremental cost per avoided event for the Italian National Health Service.","PeriodicalId":41585,"journal":{"name":"Farmeconomia-Health Economics and Therapeutic Pathways","volume":"83 1","pages":""},"PeriodicalIF":0.5,"publicationDate":"2018-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89676910","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: Enhanced pharmacokinetic profile of albutrepenonacog alfa allows to prolong the interdose period in prophylaxis, maintaining higher trough level, and to reduce dosage needed for bleeding. This improvement could lead to a better efficiency of the hemophilia B treatment. OBJECTIVES: To estimate the impact of this new drug on the Italian National Health System (NHS). METHODS: A model was developed from the NHS perspective to assess the budget impact of treating severe hemophilia B with reimbursed recombinant factor IX over 3 years in Italy. Target population was based on data from the National Registry of Congenital Coagulopathies, which collects data from 54 Hemophilia Treatment Centers. Treatment options were: albutrepenonacog alfa (Idelvion®), eftrenonacog alfa (Alprolix®) and nonacog alfa (BeneFIX®). Annual bleeding rate, dose and infusions needed to treat an episode based on clinical trials data were considered. RESULTS: Mean costs per patient were calculated for prophylaxis and bleeding treatment by age groups. Applying age-specific costs to the expected new pattern of drugs utilization, the impact on the NHS budget was € 6 million of savings cumulated in 3 years. The model results most sensitive to drug dosages. Lower drug consumption in prophylaxis and reduced bleeding rate than the alternatives reduce expenditures. Main limitations of this analysis were the assumptions that all severe patients receive prophylaxis and the lack of consideration of positive effects of hemorrhagic complications reduction (with consequent lower need of physiotherapy/prosthetic substitution). CONCLUSIONS: The introduction of Idelvion® as therapeutic option for hemophilia B is expected to decrease pharmaceutical costs and improve patient’s quality of life due to less frequent infusions.
{"title":"Albutrepenonacog alfa (Idelvion®) for the treatment of Italian patients with hemophilia B: a budget impact model","authors":"L. Pradelli, S. Villa, G. Castaman","doi":"10.7175/FE.V19I1.1328","DOIUrl":"https://doi.org/10.7175/FE.V19I1.1328","url":null,"abstract":"BACKGROUND: Enhanced pharmacokinetic profile of albutrepenonacog alfa allows to prolong the interdose period in prophylaxis, maintaining higher trough level, and to reduce dosage needed for bleeding. This improvement could lead to a better efficiency of the hemophilia B treatment. OBJECTIVES: To estimate the impact of this new drug on the Italian National Health System (NHS). METHODS: A model was developed from the NHS perspective to assess the budget impact of treating severe hemophilia B with reimbursed recombinant factor IX over 3 years in Italy. Target population was based on data from the National Registry of Congenital Coagulopathies, which collects data from 54 Hemophilia Treatment Centers. Treatment options were: albutrepenonacog alfa (Idelvion®), eftrenonacog alfa (Alprolix®) and nonacog alfa (BeneFIX®). Annual bleeding rate, dose and infusions needed to treat an episode based on clinical trials data were considered. RESULTS: Mean costs per patient were calculated for prophylaxis and bleeding treatment by age groups. Applying age-specific costs to the expected new pattern of drugs utilization, the impact on the NHS budget was € 6 million of savings cumulated in 3 years. The model results most sensitive to drug dosages. Lower drug consumption in prophylaxis and reduced bleeding rate than the alternatives reduce expenditures. Main limitations of this analysis were the assumptions that all severe patients receive prophylaxis and the lack of consideration of positive effects of hemorrhagic complications reduction (with consequent lower need of physiotherapy/prosthetic substitution). CONCLUSIONS: The introduction of Idelvion® as therapeutic option for hemophilia B is expected to decrease pharmaceutical costs and improve patient’s quality of life due to less frequent infusions.","PeriodicalId":41585,"journal":{"name":"Farmeconomia-Health Economics and Therapeutic Pathways","volume":" 16","pages":""},"PeriodicalIF":0.5,"publicationDate":"2018-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72536190","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}
L. Pradelli, G. Perri, G. Rizzardini, E. Martelli, S. Giardina, M. Povero
BACKGROUND: Highly Active Antiretroviral Therapy (HAART) has transformed HIV into a lifelong condition. Following the chronicity of the disease, and significant increase in lifespan – the prevalence of comorbidities increased in HIV+ subjects that are exposed both to a higher risk of developing cardiovascular disease, renal disease, osteopenia/osteoporosis and diabetes, and to the risk of developing them early. Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Fumarate (E/C/F/TAF), a complete, Single-Tablet antiretroviral Regimen (STR) that combines the effectiveness and tolerability of integrase inhibitors with an innovative backbone was recently introduced in Italy. Compared to Tenofovir Disoproxil Fumarate (TDF), TAF reaches the sites of action more efficiently, reducing tenofovir plasma concentration to more than 90% and the risk of off-target effects. OBJECTIVE: A patient-level micro-simulation model was adapted to the Italian context to evaluate E/C/F/TAF cost-effectiveness vs three boosted regimens for HIV+ patients treatment. METHODS: A Markov micro-simulation model was adapted to the Italian context for the evaluation of the cost-effectiveness in patients with HIV. The total cost per patient accounts for drug therapies and the management of adverse events and comorbidities. The quality-adjusted life expectancy (in QALYs) is calculated by weighing the years of life lived by the utility weights. A 70-year time horizon was adopted to simulate a lifetime analysis; shorter time horizons were considered in the sensitivity analyses. 3.5% discount rate was applied both for costs and future benefits. The rate of virologic suppression at 48 weeks with E/C/F/TAF is 92.3%; for the other treatments such proportion is calculated by applying to the reference rate the relative risks, as calculated in a recent network meta-analysis (NMA). Alternative treatments considered in this analysis are three boosted regimens commonly used in Italy: tenofovir disoproxil fumarate/emtricitabine/elvitegravir/cobicistat in STR; tenofovir disoproxil fumarate/emtricitabine + darunavir/ritonavir; tenofovir disoproxil fumarate/emtricitabine + atazanavir/ritonavir. RESULTS: E/C/F/TAF improves survival and quality of life (20.17 LY and 14.89 QALY), with the lowest total cost (€ 280,528), thus resulting dominant over three comparators considered as starting therapy. The sensitivity analysis confirms the results of the base case: at a willingness-to-pay threshold of € 30,000 per QALY, the E/C/F/TAF strategy is the most cost-effective, with a 90% probability and it is the most cost-effective even with a threshold of € 10,000 per QALY, with a 50% probability. CONCLUSION: E/C/F/TAF can be a sustainable alternative to currently available treatments, combining the advantage of the STR to lower risks of kidney and bone damage than observed in regimens based on TDF.
{"title":"A cost-effectiveness analysis of E/C/F/TAF vs three boosted regimens in the Italian context","authors":"L. Pradelli, G. Perri, G. Rizzardini, E. Martelli, S. Giardina, M. Povero","doi":"10.7175/FE.V18I1.1312","DOIUrl":"https://doi.org/10.7175/FE.V18I1.1312","url":null,"abstract":"BACKGROUND: Highly Active Antiretroviral Therapy (HAART) has transformed HIV into a lifelong condition. Following the chronicity of the disease, and significant increase in lifespan – the prevalence of comorbidities increased in HIV+ subjects that are exposed both to a higher risk of developing cardiovascular disease, renal disease, osteopenia/osteoporosis and diabetes, and to the risk of developing them early. Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Fumarate (E/C/F/TAF), a complete, Single-Tablet antiretroviral Regimen (STR) that combines the effectiveness and tolerability of integrase inhibitors with an innovative backbone was recently introduced in Italy. Compared to Tenofovir Disoproxil Fumarate (TDF), TAF reaches the sites of action more efficiently, reducing tenofovir plasma concentration to more than 90% and the risk of off-target effects. OBJECTIVE: A patient-level micro-simulation model was adapted to the Italian context to evaluate E/C/F/TAF cost-effectiveness vs three boosted regimens for HIV+ patients treatment. METHODS: A Markov micro-simulation model was adapted to the Italian context for the evaluation of the cost-effectiveness in patients with HIV. The total cost per patient accounts for drug therapies and the management of adverse events and comorbidities. The quality-adjusted life expectancy (in QALYs) is calculated by weighing the years of life lived by the utility weights. A 70-year time horizon was adopted to simulate a lifetime analysis; shorter time horizons were considered in the sensitivity analyses. 3.5% discount rate was applied both for costs and future benefits. The rate of virologic suppression at 48 weeks with E/C/F/TAF is 92.3%; for the other treatments such proportion is calculated by applying to the reference rate the relative risks, as calculated in a recent network meta-analysis (NMA). Alternative treatments considered in this analysis are three boosted regimens commonly used in Italy: tenofovir disoproxil fumarate/emtricitabine/elvitegravir/cobicistat in STR; tenofovir disoproxil fumarate/emtricitabine + darunavir/ritonavir; tenofovir disoproxil fumarate/emtricitabine + atazanavir/ritonavir. RESULTS: E/C/F/TAF improves survival and quality of life (20.17 LY and 14.89 QALY), with the lowest total cost (€ 280,528), thus resulting dominant over three comparators considered as starting therapy. The sensitivity analysis confirms the results of the base case: at a willingness-to-pay threshold of € 30,000 per QALY, the E/C/F/TAF strategy is the most cost-effective, with a 90% probability and it is the most cost-effective even with a threshold of € 10,000 per QALY, with a 50% probability. CONCLUSION: E/C/F/TAF can be a sustainable alternative to currently available treatments, combining the advantage of the STR to lower risks of kidney and bone damage than observed in regimens based on TDF.","PeriodicalId":41585,"journal":{"name":"Farmeconomia-Health Economics and Therapeutic Pathways","volume":"185 1","pages":""},"PeriodicalIF":0.5,"publicationDate":"2017-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86817434","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}
L. Mantovani, G. Furneri, P. Cortesi, M. Amato, A. Caputi, P. Piacentini, A. Solari, C. Pozzilli, G. Comi
The present health technology assessment (HTA) evaluates the clinical and economic profile of delayed-release dimethylfumarate (DMF, also known as gastro-resistant DMF) in the treatment of relapsing-remitting multiple sclerosis (RRMS) in Italy. Chapter 1 briefly introduces the condition (multiple sclerosis and, more specifically, the relapsing-remitting form) and provides an overall description of the main therapeutic options for physicians, in terms of clinical evidence, regulatory status in Europe and approval status and reimbursement (refunding) criteria in Italy. In the next sections (Chapters 2-5), key-topics regarding RRMS are analysed: epidemiology, clinical burden, quality of life/social impact and the economic implications for healthcare services, patients and society. In Chapter 6, the clinical evidence supporting the use of DMF in RRMS is summarized. Data from phase III randomized clinical trials (DEFINE, CONFIRM), plus the pooled post-hoc analysis of the two studies, were evaluated to assess the level of clinical benefit provided by DMF. Finally, in Chapter 7, a review of the health economic evidence assessing DMF is performed, with a specific focus on Italy. Overall, the methodological quality of registration studies, together with the robustness and consistency of the study results, support the conclusion that DMF is an effective and safe treatment for RRMS. The economic assessment of DMF in Italy, based on cost-effectiveness and budget impact analyses (adopting clinical input data from a mixed treatment comparison and economic input data relative to the Italian healthcare setting), confirm that DMF is a cost-effective and economically sustainable treatment for the Italian National Healthcare Service. These findings are in line with the results of most international publications and the assessments from well-recognized HTA agencies (e.g. NICE/SMC). In summary, both the clinical and economic evidence analyzed in this HTA substantiate DMF as an important therapeutic option for the treatment of RRMS.
{"title":"[Tecfidera® (delayed-release dimethylfumarate) in the treatment of relapsing-remitting multiple sclerosis]","authors":"L. Mantovani, G. Furneri, P. Cortesi, M. Amato, A. Caputi, P. Piacentini, A. Solari, C. Pozzilli, G. Comi","doi":"10.7175/FE.V18I2S.1320","DOIUrl":"https://doi.org/10.7175/FE.V18I2S.1320","url":null,"abstract":"The present health technology assessment (HTA) evaluates the clinical and economic profile of delayed-release dimethylfumarate (DMF, also known as gastro-resistant DMF) in the treatment of relapsing-remitting multiple sclerosis (RRMS) in Italy. Chapter 1 briefly introduces the condition (multiple sclerosis and, more specifically, the relapsing-remitting form) and provides an overall description of the main therapeutic options for physicians, in terms of clinical evidence, regulatory status in Europe and approval status and reimbursement (refunding) criteria in Italy. In the next sections (Chapters 2-5), key-topics regarding RRMS are analysed: epidemiology, clinical burden, quality of life/social impact and the economic implications for healthcare services, patients and society. In Chapter 6, the clinical evidence supporting the use of DMF in RRMS is summarized. Data from phase III randomized clinical trials (DEFINE, CONFIRM), plus the pooled post-hoc analysis of the two studies, were evaluated to assess the level of clinical benefit provided by DMF. Finally, in Chapter 7, a review of the health economic evidence assessing DMF is performed, with a specific focus on Italy. Overall, the methodological quality of registration studies, together with the robustness and consistency of the study results, support the conclusion that DMF is an effective and safe treatment for RRMS. The economic assessment of DMF in Italy, based on cost-effectiveness and budget impact analyses (adopting clinical input data from a mixed treatment comparison and economic input data relative to the Italian healthcare setting), confirm that DMF is a cost-effective and economically sustainable treatment for the Italian National Healthcare Service. These findings are in line with the results of most international publications and the assessments from well-recognized HTA agencies (e.g. NICE/SMC). In summary, both the clinical and economic evidence analyzed in this HTA substantiate DMF as an important therapeutic option for the treatment of RRMS.","PeriodicalId":41585,"journal":{"name":"Farmeconomia-Health Economics and Therapeutic Pathways","volume":"96 1","pages":""},"PeriodicalIF":0.5,"publicationDate":"2017-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76023006","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}
M. Celeste, F. Marco, C. Fresco, G. Musumeci, R. Ravasio
BACKGROUND: Dabigatran 150 mg BID (D150) and rivaroxaban 20 mg (R20) are indicated for the prevention of thromboembolic events in patients with Non-Valvular Atrial Fibrillation (NVAF). Outcomes from observational study demonstrated that D150 and R20 reduced the rate of thromboembolic events. OBJECTIVE: This analysis estimated the budget impact of the use of D150 and R20 for the treatment of NAFV patients in Italy. METHODS: A budget-impact model (BIM) was developed to estimate the direct costs up to 12 months from an Italian NHS perspective. The resource utilization (drugs and intracranial hemorrhage or major extracranial bleeding event) was derived from an observational study. Only direct medical costs were considered. Ex-factory prices and National Tariffs were considered to estimate the costs of drugs and medical resource used, respectively. The BIM showed the difference of expenditure and clinical events (intracranial hemorrhage or major extracranial bleeding) generated by the base case calculated for current prescription volumes (D150 30%, R20 100%), and for different prescription volume scenarios (D150 at 70% and 100%). Key variables were tested in the sensitivity analysis. RESULTS: D150 was associated with a medical cost offset driven by fewer intracranial hemorrhage and major extracranial bleeding event, these offset the incremental drug cost and results in an annual saving per patient treated (D150: € 1,052.78; R20: € 1,161.23). The present scenario determines an annual cost of € 262,543,583. The impact of total annual costs for the Italian NHS would be lower if D150 prescription volumes would be higher. The total cost is predicted to decrease by 3.8% if the D150 prescription increase to 70% and it is predicted to decrease by 6.7% if the D150 prescription increase to 100%. CONCLUSION: The use of D150, as an alternative to R20 to prevent events in patients with NVAF, could represent a cost-saving option for the Italian NHS.
{"title":"Budget impact analysis of dabigatran compared with rivaroxaban in the prevention of the thromboembolic risk in patients with non-valvular atrial fibrillation","authors":"M. Celeste, F. Marco, C. Fresco, G. Musumeci, R. Ravasio","doi":"10.7175/FE.V18I1.1327","DOIUrl":"https://doi.org/10.7175/FE.V18I1.1327","url":null,"abstract":"BACKGROUND: Dabigatran 150 mg BID (D150) and rivaroxaban 20 mg (R20) are indicated for the prevention of thromboembolic events in patients with Non-Valvular Atrial Fibrillation (NVAF). Outcomes from observational study demonstrated that D150 and R20 reduced the rate of thromboembolic events. OBJECTIVE: This analysis estimated the budget impact of the use of D150 and R20 for the treatment of NAFV patients in Italy. METHODS: A budget-impact model (BIM) was developed to estimate the direct costs up to 12 months from an Italian NHS perspective. The resource utilization (drugs and intracranial hemorrhage or major extracranial bleeding event) was derived from an observational study. Only direct medical costs were considered. Ex-factory prices and National Tariffs were considered to estimate the costs of drugs and medical resource used, respectively. The BIM showed the difference of expenditure and clinical events (intracranial hemorrhage or major extracranial bleeding) generated by the base case calculated for current prescription volumes (D150 30%, R20 100%), and for different prescription volume scenarios (D150 at 70% and 100%). Key variables were tested in the sensitivity analysis. RESULTS: D150 was associated with a medical cost offset driven by fewer intracranial hemorrhage and major extracranial bleeding event, these offset the incremental drug cost and results in an annual saving per patient treated (D150: € 1,052.78; R20: € 1,161.23). The present scenario determines an annual cost of € 262,543,583. The impact of total annual costs for the Italian NHS would be lower if D150 prescription volumes would be higher. The total cost is predicted to decrease by 3.8% if the D150 prescription increase to 70% and it is predicted to decrease by 6.7% if the D150 prescription increase to 100%. CONCLUSION: The use of D150, as an alternative to R20 to prevent events in patients with NVAF, could represent a cost-saving option for the Italian NHS.","PeriodicalId":41585,"journal":{"name":"Farmeconomia-Health Economics and Therapeutic Pathways","volume":"13 1","pages":""},"PeriodicalIF":0.5,"publicationDate":"2017-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78498842","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. Variola, A. Massella, A. Geccherle, P. Bocus, R. Tessari, T. Zuppini, R. Ravasio
BACKGROUND: Inflammatory bowel disease (IBD) represents a group of chronic conditions characterized by elevated costs. Over the last years, also a considerable healthcare burden associated with IBD has emerged, due to an increasing use of biological drugs and hospitalization costs. Despite the creation of local or regional databases, data regarding healthcare expenditure are lacking in Italy. AIM: To evaluate the treatment cost (biological drugs and hospitalizations) for patients with ulcerative colitis (UC) or Crohn’s disease (CD) treated with biological drugs. METHODS: Disease severity was evaluated by clinical scores (partial Mayo score and Harvey Bradshaw Index). We analyzed retrospectively patients treated with biologics referred to our IBD Unit between May 2015-April 2016 who underwent at least six months of follow-up (last visit October 2016). We calculated a mean cost per month of treatment for each patient. We also investigated the presence of any correlation between the monthly cost of treatment and demographic or clinical variables. RESULTS: We enrolled 142 patients (52 UC, mean age 44.3 years, male 40.4%; 90 CD, mean age 38.8 years, male 56.7%). About half of CD patients (48.9%) underwent previous intestinal surgery. The disease severity was higher in UC group vs CD group. In UC group infliximab was the most prescribed biologic (51.9%), followed by golimumab (26.9%) and adalimumab (21.2%). While CD patients were treated with adalimumab in 54.4% and infliximab in 45.6%. The mean monthly cost of treatment was € 1,235.41 ± 358.38 for UC and € 1,148.92 ± 337.36 for CD (p = 0.16). In both groups expenditure due to biologics amounts for more than 80%. We found a correlation between costs and disease activity (UC: p < 0.01; CD: p < 0.01). CONCLUSION: The main cost is due to biological drugs, but patients enrolled were the most severe in comparison to the whole IBD population under conventional therapy. As no cost differences were found between biologic drugs and the way of administration (intravenous or subcutaneous), the therapeutic choice should be driven by clinical reasons and not only economic ones.
背景:炎症性肠病(IBD)是一组以成本升高为特征的慢性疾病。在过去几年中，由于生物药物的使用和住院费用的增加，也出现了与IBD相关的相当大的医疗负担。尽管建立了地方或区域数据库，但意大利缺乏关于医疗保健支出的数据。目的:评价生物药物治疗溃疡性结肠炎(UC)或克罗恩病(CD)患者的治疗成本(生物药物和住院费用)。方法:采用临床评分(部分Mayo评分和Harvey Bradshaw指数)评估疾病严重程度。我们回顾性分析了2015年5月至2016年4月期间在IBD部门接受生物制剂治疗的患者，这些患者接受了至少6个月的随访(最后一次随访是2016年10月)。我们计算了每位患者每月的平均治疗费用。我们还调查了每月治疗费用与人口统计学或临床变量之间是否存在相关性。结果:我们纳入142例患者(52例UC)，平均年龄44.3岁，男性40.4%;90例，平均年龄38.8岁，男性56.7%)。大约一半的乳糜泻患者(48.9%)曾接受过肠道手术。UC组疾病严重程度高于CD组。在UC组中，英夫利昔单抗是处方最多的生物制剂(51.9%)，其次是戈利单抗(26.9%)和阿达木单抗(21.2%)。而接受阿达木单抗和英夫利昔单抗治疗的CD患者分别占54.4%和45.6%。UC的平均每月治疗费用为1,235.41±358.38欧元，CD的平均每月治疗费用为1,148.92±337.36欧元(p = 0.16)。在这两组中，由于生物制剂的支出占80%以上。我们发现成本与疾病活动性之间存在相关性(UC: p < 0.01;CD: p < 0.01)。结论:主要成本是生物药物，但与常规治疗的IBD人群相比，入组的患者是最严重的。由于生物药物和给药方式(静脉注射或皮下注射)之间没有成本差异，因此治疗选择应由临床原因驱动，而不仅仅是经济原因。
{"title":"Economic implications in inflammatory bowel disease: results from a retrospective analysis in an Italian Centre","authors":"A. Variola, A. Massella, A. Geccherle, P. Bocus, R. Tessari, T. Zuppini, R. Ravasio","doi":"10.7175/FE.V18I1.1324","DOIUrl":"https://doi.org/10.7175/FE.V18I1.1324","url":null,"abstract":"BACKGROUND: Inflammatory bowel disease (IBD) represents a group of chronic conditions characterized by elevated costs. Over the last years, also a considerable healthcare burden associated with IBD has emerged, due to an increasing use of biological drugs and hospitalization costs. Despite the creation of local or regional databases, data regarding healthcare expenditure are lacking in Italy. AIM: To evaluate the treatment cost (biological drugs and hospitalizations) for patients with ulcerative colitis (UC) or Crohn’s disease (CD) treated with biological drugs. METHODS: Disease severity was evaluated by clinical scores (partial Mayo score and Harvey Bradshaw Index). We analyzed retrospectively patients treated with biologics referred to our IBD Unit between May 2015-April 2016 who underwent at least six months of follow-up (last visit October 2016). We calculated a mean cost per month of treatment for each patient. We also investigated the presence of any correlation between the monthly cost of treatment and demographic or clinical variables. RESULTS: We enrolled 142 patients (52 UC, mean age 44.3 years, male 40.4%; 90 CD, mean age 38.8 years, male 56.7%). About half of CD patients (48.9%) underwent previous intestinal surgery. The disease severity was higher in UC group vs CD group. In UC group infliximab was the most prescribed biologic (51.9%), followed by golimumab (26.9%) and adalimumab (21.2%). While CD patients were treated with adalimumab in 54.4% and infliximab in 45.6%. The mean monthly cost of treatment was € 1,235.41 ± 358.38 for UC and € 1,148.92 ± 337.36 for CD (p = 0.16). In both groups expenditure due to biologics amounts for more than 80%. We found a correlation between costs and disease activity (UC: p < 0.01; CD: p < 0.01). CONCLUSION: The main cost is due to biological drugs, but patients enrolled were the most severe in comparison to the whole IBD population under conventional therapy. As no cost differences were found between biologic drugs and the way of administration (intravenous or subcutaneous), the therapeutic choice should be driven by clinical reasons and not only economic ones.","PeriodicalId":41585,"journal":{"name":"Farmeconomia-Health Economics and Therapeutic Pathways","volume":"48 1","pages":""},"PeriodicalIF":0.5,"publicationDate":"2017-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78832210","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}
R. Ravasio, F. Rigo, E. Lattuada, E. Concia, M. Lanzafame
BACKGROUND: In order to reduce/prevent combination Anti-Retroviral Therapy (cART)-related toxicity, while maintaining its therapeutic effectiveness over time, the optimization of the antiretroviral therapy could be performed. AIM: To estimate the economic impact on the Italian National Health Service (NHS) of a cART optimization pathway as maintenance therapy in HIV-1 infected patients over one-year period. METHODS: Patient data were retrieved from the electronic medical record system in use (year 2015) in a reference HIV Center in Northern Italy. The analysis considered naive patients and non-naive patients. To estimate the actual ART expenditure charged to the Center we calculated the cost of cART received during 12 months for each patient. Subsequently, referring to the same patients, a "potential" cART expenditure was estimated. This potential expenditure was estimated taking in consideration the adoption of a specific optimization pathway aimed at maintaining over the time the cART efficacy. Lastly, to assess the sustainability of the optimization pathway, we compared the actual cART expenditure with the potential one. We considered only drug costs (ex-factory prices, included all discounts and VAT) from the perspective of the Italian NHS. RESULTS: In the 2015, the total expenditure for 564 enrolled HIV-1 patients treated with cART was € 4,042,983. The mean treatment cost per patient was € 7,168. If the Center adopted a specific optimization pathway, the total expenditure would be € 3,914,855 (€ -128,128). CONCLUSIONS: From the Italian NHS’s perspective, the adoption of a specific cART optimization pathway represents a cost-saving option as maintenance antiretroviral therapy in HIV-1 infected patients.
{"title":"The cost of a combination Anti-Retroviral Therapy (cART) optimization pathway as maintenance therapy in HIV-1 infected patients","authors":"R. Ravasio, F. Rigo, E. Lattuada, E. Concia, M. Lanzafame","doi":"10.7175/FE.V18I1.1325","DOIUrl":"https://doi.org/10.7175/FE.V18I1.1325","url":null,"abstract":"BACKGROUND: In order to reduce/prevent combination Anti-Retroviral Therapy (cART)-related toxicity, while maintaining its therapeutic effectiveness over time, the optimization of the antiretroviral therapy could be performed. AIM: To estimate the economic impact on the Italian National Health Service (NHS) of a cART optimization pathway as maintenance therapy in HIV-1 infected patients over one-year period. METHODS: Patient data were retrieved from the electronic medical record system in use (year 2015) in a reference HIV Center in Northern Italy. The analysis considered naive patients and non-naive patients. To estimate the actual ART expenditure charged to the Center we calculated the cost of cART received during 12 months for each patient. Subsequently, referring to the same patients, a \"potential\" cART expenditure was estimated. This potential expenditure was estimated taking in consideration the adoption of a specific optimization pathway aimed at maintaining over the time the cART efficacy. Lastly, to assess the sustainability of the optimization pathway, we compared the actual cART expenditure with the potential one. We considered only drug costs (ex-factory prices, included all discounts and VAT) from the perspective of the Italian NHS. RESULTS: In the 2015, the total expenditure for 564 enrolled HIV-1 patients treated with cART was € 4,042,983. The mean treatment cost per patient was € 7,168. If the Center adopted a specific optimization pathway, the total expenditure would be € 3,914,855 (€ -128,128). CONCLUSIONS: From the Italian NHS’s perspective, the adoption of a specific cART optimization pathway represents a cost-saving option as maintenance antiretroviral therapy in HIV-1 infected patients.","PeriodicalId":41585,"journal":{"name":"Farmeconomia-Health Economics and Therapeutic Pathways","volume":"7 1","pages":""},"PeriodicalIF":0.5,"publicationDate":"2017-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90781443","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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