C Nappi

Budget impact analysis of the simplification to atazanavir + ritonavir + lamivudine dual therapy of HIV-positive patients receiving atazanavir-based triple therapies in Italy starting from data of the Atlas-M trial

Background This analysis aimed at evaluating the impact of a therapeutic strategy of treatment simplification of atazanavir (ATV)+ ritonavir (r) + lamivudine (3TC) in virologically suppressed patients receiving ATV+r+2 nucleoside reverse transcriptase inhibitors (NRTIs) on the budget of the Italian National Health Service (NHS). Methods A budget impact model with a 5-year time horizon was developed based on the clinical data of Atlas-M trial at 48 weeks (in terms of percentage of patients experiencing virologic failure and adverse events), from the Italian NHS perspective. A scenario in which the simplification strategy was not considered was compared with three scenarios in which, among a target population of 1,892 patients, different simplification strategies were taken into consideration in terms of percentage of patients simplified on a yearly basis among those eligible for simplification. The costs considered were direct medical costs related to antiretroviral drugs, adverse events management, and monitoring activities. Results The percentage of patients of the target population receiving ATV+r+3TC varies among the scenarios and is between 18.7% and 46.9% in year 1, increasing up to 56.3% and 84.4% in year 5. The antiretroviral treatment simplification strategy considered would lead to lower costs for the Italian NHS in a 5-year time horizon between −28.7 million € and −16.0 million €, with a reduction of costs between −22.1% (−3.6 million €) and −8.8% (−1.4 million €) in year 1 and up to −39.9% (−6.9 million €) and −26.6% (−4.6 million €) in year 5. Conclusion The therapy simplification for patients receiving ATV+r+2 NRTIs to ATV+r+3TC at a national level would lead to a reduction of direct medical costs over a 5-year period for the Italian NHS.

Cost-effectiveness analysis of the use of daclatasvir + sofosbuvir + ribavirin (16 weeks and 12 weeks) vs sofosbuvir + ribavirin (16 weeks and 24 weeks) for the treatment of cirrhotic patients affected with hepatitis C virus genotype 3 in Italy

The WHO estimates that more than 185 million people are infected with hepatitis C virus (HCV) worldwide. The aim of the study is to assess the incremental cost-effectiveness ratio (ICER) of the use of daclatasvir (DCV)xa0+xa0sofosbuvir (SOF)xa0+xa0ribavirin (RBV) for 12 and 16xa0weeks vs SOFxa0+xa0RBV for 16 and 24xa0weeks for the treatment of genotype 3 HCV infected cirrhotic patients from the Italian National Health Service (NHS) perspective. A published cohort-based Markov model was used to perform the analysis estimating the lifetime direct medical costs associated with the management of the pathology and the quality adjusted life years gained by patients. Deterministic and probabilistic sensitivity analyses were performed to test the robustness of the results. SOFxa0+xa0RBV for 16xa0weeks was excluded from the analysis due to the significant lower effectiveness, compared with SOFxa0+xa0RBV for 24xa0weeks (51% vs 79%). DCVxa0+xa0SOFxa0+xa0RBV would increase QALYs and costs in all the comparisons: the ICERs obtained comparing DCVxa0+xa0SOFxa0+xa0RBV for 12 and 16xa0weeks with SOFxa0+xa0RBV for 24xa0weeks (reference scenario) are 38,572xa0€/QALY and 16,436xa0€/QALY, respectively, both below the 40,000xa0€/QALY threshold identified by the Italian Health Economics Association. Sensitivity analyses confirmed the robustness of the results. The use of DCVxa0+xa0SOFxa0+xa0RBV is likely to be cost-effective compared with SOFxa0+xa0RBV (for 24xa0weeks) for the treatment of cirrhotic patients infected with genotype 3 HCV considering a threshold value of 40,000xa0€/QALY.

Epidemiology, patient profile, and health care resource use for hepatitis C in Italy

Objective The objectives of this study were to estimate the prevalence of Hepatitis C among six Italian Local Health Units (LHUs), to describe patient and antiviral drug characteristics, and to estimate the health care consumption rates and related costs for the management of patients affected by hepatitis C virus (HCV) infection by using data from routine clinical practice. Methods We conducted a retrospective study using administrative databases of six Italian LHUs. All patients who had a record related to HCV during the enrollment period (July 1, 2009, to December 31, 2014) and who had at least 6 months of data available prior to the first HCV record were included. The date of the first record related to HCV during the enrollment period was considered as a proxy of diagnosis and used as the index date. Patients were followed from the index date up to 1 year, death, or exiting the database. Using the overall cohort of HCV adult patients as the numerator, we estimated the prevalence of HCV among six LHUs. The denominators were obtained from the National Institute of Statistics (N=1,665,682). We also evaluated descriptive patient’s characteristics and treatment patterns, and estimated health care consumption rates and related costs for the management of the HCV patients. Results A total of 7,550 patients were analyzed, of whom 57% were male with a mean age of 57.6±16.4 years. The prevalence of HCV was estimated to be 0.45% (95% confidence interval 0.44–0.46). During the follow-up period, 78.6% of HCV patients had received no antiviral treatment. The annual health care cost associated with HCV infection was €6,022.7 (±7,922.6) while the cost specific to HCV care was €3,154.6 (±4,972.0) Conclusion Our findings showed that, in the Italian real-world setting, only a small proportion of HCV-infected patients received an antiviral treatment. Despite the current low prevalence of HCV, the economic impact of such disease remains high.

Trial-based cost-effectiveness of abatacept for rheumatoid arthritis patients in Italy

Introduction: Rheumatoid arthritis (RA) is a chronic, inflammatory disorder leading to disability and reduced quality of life. Effective treatment is a significant economic burden on the Italian healthcare system. Economic models in RA are commonly based on indirect treatment comparisons. Methods: This study assessed the cost–effectiveness of abatacept relative to adalimumab for RA in Italy based on a head-to-head trial by means of a cost–consequence analysis. Results: Health benefits based on the most stringent efficacy criteria were in favor of abatacept compared to adalimumab. Rates for more costly adverse events were higher for adalimumab compared to abatacept, which was reflected in the lower costs for abatacept (-€237,246 or -€237per patient). Conclusion: The health economic value of abatacept compared with adalimumab from the perspective of the Italian NHS depends on the choice of health outcome. Health gains with abatacept were generally based on more stringent criteria and lower total costs.

Cost-effectiveness analysis of Daclatasvir/Sofosbuvir for the treatment of the HCV patients failed after the first line with second generation of DAAs in Italy

ABSTRACT Background: Daclatasvir (DCV) combinated with Sofosbuvir (SOF) has shown good efficacy and safety profile for HCV patients. The aim was to evaluate the cost-effectiveness of DCV/SOF regimen versus HCV alternative treatments for patients who failed to achieve the SVR12 after a first DAA treatment from Italian perspective (PITER cohort). Methods: A Markov model of HCV chronically infected patients was used to develop two scenarios: 1) DCV+ SOF versus Ledipasvir (LDV)+ SOF in Genotype (Gt)1 and Gt4; 2) DCV+ SOF versus no retreatment option in Gt1, Gt3, and Gt4. The percentage of patients who failed the first line with SOF/Simeprevir/Ribavirin (RBV) or SOF/RBV and were retreated or not according to evidences from PITER cohort, were used to populate the model. HCV resources consumption and SVR rates were quantified using PITER data. Transition probabilities and utility rates were derived from the literature. The outcomes were expressed in terms of Quality adjusted life years (QALYs). Probabilistic sensitivity analysis (PSA) was performed considering a cost-effectiveness threshold of € 30,000/QALY. Results: In the base-case analysis, DCV+ SOF represents a cost-effectiveness therapy with ICERs lower than the threshold. The PSA showed robust results, ICERs remain below the threshold in 94% and 99% simulations in Scenario 1 and 2, respectively.

Cost per response for abatacept versus adalimumab in rheumatoid arthritis by ACPA subgroups in Germany, Italy, Spain, US and Canada

Rheumatoid arthritis (RA) is a chronic inflammatory disorder leading to disability and reduced quality of life. Effective treatment with biologic DMARDs poses a significant economic burden. The Abatacept versus Adalimumab Comparison in Biologic-Naïve RA Subjects with Background Methotrexate (AMPLE) trial was a head-to-head, randomized study comparing abatacept in serum anti-citrullinated protein antibody (ACPA)-positive patients, with increasing efficacy across ACPA quartile levels. The aim of this study was to evaluate the cost per response accrued using abatacept versus adalimumab in ACPA-positive and ACPA-negative patients with RA from the health care perspective in Germany, Italy, Spain, the US and Canada. A cost-consequence analysis (CCA) was designed to compare the monthly costs per responding patient/patient in remission. Efficacy, safety and resource use inputs were based on the AMPLE trial. A one-way deterministic sensitivity analysis (OWSA) was also performed to assess the impact of model inputs on the results for total incremental costs. Cost per response in ACPA-positive patients favoured abatacept compared with adalimumab (ACR20, ACR90 and HAQ-DI). Subgroup analysis favoured abatacept with increasing stringency of response criteria and serum ACPA levels. Cost per remission (DAS28-CRP) favoured abatacept in ACPA-negative patients, while cost per CDAI and SDAI favoured abatacept in ACPA-positive patients. Abatacept was consistently favoured in ACPA-Q4 patients across all outcomes and countries. Cost savings were greater with abatacept when more stringent response criteria were applied and also with increasing ACPA levels, which could lead to a lower overall health care budget impact with abatacept compared with adalimumab.

Cost-Effectiveness of Abatacept Compared to Adalimumab In Italy Based on A Head-To-Head Outcomes Study In Rheumatoid Arthritis

events were considered, reflecting the year 2015. All outcomes were discounted at 3.5% annually. Results: Regarding the AS subpopulation, the total treatment cost for IFX, ADA, CZP, ETA, GOL and CC was: € 67,736, € 38,914, € 38,721, € 38,290, € 35,338 and € 4,110; and the quality-adjusted life years (QALYs) were: 10.031, 9.882, 9.949, 9.933, 9.903 and 9.360, respectively. CZP dominated ADA and it was costeffective compared to ETA generating an incremental cost-effectiveness ratio (ICER) of € 26,848/QALY gained (willingness-to-pay threshold: € 34,000). CZP was less effective (-0.082 QALYs) but less costly (-€ 29,015) than IFX, whereas it was more effective (+0.046 QALYs) and more costly (+€ 3,383) than GOL. CZP and GOL provided the lowest ICERs versus CC amongst comparators. Regarding nr-axSpA, the total treatment cost with CC, ADA and CZP was: € 4,754, € 33,748 and € 34,625; and QALYs were: 10.412, 10.681 and 10.948. The ICER of CZP versus CC and ADA was € 55,726 and € 3,289, respectively; CZP dominated ADA. ConClusions: CZP may be considered a cost-effective option with respect to the alternative axSpA therapies in Greece.