Cost-Utility Analysis of Prostatic Artery Embolization for Treatment of Lower Urinary Tract Symptoms.

PURPOSE: To perform a post hoc cost-utility analysis of a randomized controlled clinical trial comparing prostatic artery embolization (PAE) and transurethral resection of the prostate (TURP) in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia. MATERIALS AND METHODS: We conducted a cost-utility analysis over a 5-year period to compare PAE versus TURP from a Spanish National Health System perspective. Data were collected from a randomized clinical trial performed at a single institution. Effectiveness was measured as quality-adjusted life years (QALYs), and an incremental cost-effectiveness ratio (ICER) was derived from the cost and QALY values associated with these treatments. Further sensitivity analysis was performed to account for the impact of reintervention on the cost-effectiveness of both procedures. RESULTS: At the 1-year follow-up, PAE resulted in mean cost per patient of €2904.68 and outcome of 0.975 QALYs per treatment. In comparison, TURP had cost €3846.72 per patient and its outcome was 0.953 QALYs per treatment. At 5 years, the cost for PAE and TURP were €4117.13 and €4297.58, and the mean QALY outcome was 4.572 and 4.487, respectively. Analysis revealed an ICER of €2121.15 saved per QALY gained when comparing PAE to TURP at long-term follow-up. Reintervention rate for PAE and TURP was 12% and 0%, respectively. CONCLUSIONS: Compared to TURP, in short term, PAE could be considered a cost-effective strategy within the Spanish healthcare system for patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia. However, in long term, the superiority is less apparent due to higher reintervention rates.

Economic evaluation of a population strategy for the treatment of chronic hepatitis C with direct-acting antivirals.

The high initial cost of antivirals against hepatitis C prompted development of the "Strategic Plan for Tackling Chronic Hepatitis C in the Spanish National Health System". The objective of this study was the economic evaluation of the first two years of its application in Navarre, Spain. The change in the natural history of hepatitis C produced by the sustained virological response (SVR) was compared to an alternative without treatment and modeled with patient-level data. By means of a discrete events simulation model, the cost-effectiveness and the budget impact analysis of the treatment program were measured from the perspective of the Navarre Health Service. Of 656 patients treated, 98% had SVR. The average cost of the treatments was 18,743 euros per patient. The incremental cost-effectiveness ratio (ICER) with discount was 5,346 euros per quality-adjusted life years, which became more efficient as the stage of fibrosis increased until it reached levels of dominance in stage 4 fibrosis. The associated costs for chronic liver disease decreased as the benefit of the treatment was expressed. The implementation of the Strategic Plan is cost-effective, with an ICER well below the threshold, since the cost of treatment is largely compensated by savings in long-term health expenditure. The budgetary impact foresees a net saving from the third year on. The two key parameters were the decrease in the price of the treatment and the SVR in nearly 100% of the patients.

Cost-effectiveness analysis of therapeutic options for chronic hepatitis C genotype 3 infected patients.

BACKGROUND: This study provides a cost-effectiveness analysis of therapeutic strategies for chronic hepatitis C genotype 3 infected patients in Spain. METHODS: A Markov model was designed to simulate the progression in a cohort of patients aged 50 years over a lifetime horizon. RESULTS: Sofosbuvir (SOF) plus peginterferon and ribavirin for 12 weeks was a cost-effective option when compared to standard of care (SoC) in the treatment of both 'moderate fibrosis' and 'cirrhotic' patients. Incremental cost-effectiveness ratios were €35,276/QALY and €18,374/QALY respectively. ICERs for SOF plus daclatasvir (DCV) regimens versus SoC were over the threshold limit considered, at €56,178/QALY and €77,378/QALY for 'moderate fibrosis' and 'cirrhotic' patients respectively. CONCLUSION: Addition of SOF to IFN-based regimens for genotype 3 was cost-effective for both 'moderate fibrosis' and 'cirrhotic' patients. IFN-free options including SOF and DCV association required price reductions lower than the list prices to be considered cost-effective.

Cost-effectiveness analysis of simeprevir with daclatasvir for non-cirrhotic genotype-1b-naïve patients plus chronic hepatitis C.

BACKGROUND: The cost of interferon-free combination therapies remains high to provide widespread access to treatment, regardless of fibrosis stage. AIM: To estimate the cost-effectiveness of simeprevir/daclatasvir (SMV/DCV) therapy in treatment-naïve chronic hepatitis C genotype-1b patients with moderate fibrosis. METHODS: A Markov model was developed to simulate the natural history of chronic hepatitis C progression. The model estimated lifetime healthcare costs and quality-adjusted life-years (QALY) for a cohort of patients from the Spanish National Healthcare System perspective. The cost-effectiveness threshold considered was €40,000/QALY. The treatment strategies analyzed were SMV/DCV, peginterferon/ribavirin/telaprevir, and peginterferon/ribavirin/boceprevir. A sensitivity analysis was carried out. RESULTS: The incremental cost-effectiveness ratios of the SMV/DCV strategy were €23,774/QALY and €28,524/QALY compared with that of telaprevir or boceprevir triple therapy, respectively, for genotype-1b patients with moderate fibrosis. CONCLUSIONS: SMV/DCV combination compared with the standard of care previous to the arrival of second-generation direct-acting antivirals fell below generally accepted willingness-to-pay threshold. Results obtained should be supported by ongoing clinical trials.

[Cost-effectiveness analysis of sofosbuvir-simeprevir regimens for chronic hepatitis C genotype 1 patients with advanced fibrosis]. / Análisis coste-efectividad del tratamiento de la hepatitis C crónica con sofosbuvir-simeprevir en pacientes con genotipo 1 y fibrosis avanzada.

BACKGROUND AND OBJECTIVE: The aim of this study was to measure the cost-effectiveness of the treatment with simeprevir and sofosbuvir in chronic hepatitis C genotype 1 patients with F3-F4 levels of fibrosis, according to the results of the COSMOS trial. MATERIAL AND METHODS: A Markov model was used to estimate the costs and clinical outcomes from the start of therapy. In the model, the progression was simulated alongside the different health states of the chronic liver disease associated with chronic hepatitis C using whole life as time-horizon. RESULTS: The 12-weeks treatment schemes was below the threshold of €40,000 per quality-adjusted life year. On the contrary, despite the 50% cost reduction, the 24-weeks regimen demonstrated a limited level of efficiency when compared with the willingness to pay used in the Spanish medical literature. CONCLUSIONS: This finding would support the introduction of a flat rate in the price of drugs without taking into account the duration of treatment to ensure that treatment with 24 weeks was efficient.

Cost-effectiveness analysis of sofosbuvir-based regimens for chronic hepatitis C.

BACKGROUND: A new scenario of therapy for chronic hepatitis C (CHC) is being established with the approval of sofosbuvir (SOF). OBJECTIVE: To estimate the cost-effectiveness of SOF-based regimens approved in the Summary of Product Characteristics (SmPC) versus the standard of care for different genotypes and patient populations (naive or pretreated). METHODS: A Markov model simulating CHC progression was used to estimate disease treatment costs and effects over patients' lifetimes, from the Spanish National Public Healthcare System perspective. Different therapeutic options were analysed for genotypes 1, 2 and 3 in naive population and for genotype 2 and 3 pretreated patients, according to data obtained from clinical trials. A one-way sensitivity analysis was performed to evaluate the uncertainty of certain parameters: treatment starting age, transition probabilities, drug costs and discount rate. A probabilistic sensitivity analysis was also carried out. RESULTS: For the naive population, the option SOF+pegylated-interferon-α (pIFN)+ribavirin (RBV) for 12 weeks recorded in SmPC for genotype 1 and 3 versus pIFN+RBV for 24 weeks estimated an incremental cost-effectiveness ratio (ICER) below the €40,000/quality-adjusted life-year (QALY) benchmark. For the pretreated population, SOF triple therapy reached an ICER on the threshold limit for genotype 3. Other options included in SmPC for different genotypes exceeded the accepted efficiency limit in our setting. CONCLUSIONS: The options that included SOF+RBV+pIFN in a 12-week course regimen fell below the efficiency threshold considered in our setting. IFN-free regimens administered for 24 weeks reached figures over the benchmark of €40,000/QALY.

Cost-effectiveness of protease inhibitor based regimens for chronic hepatitis C: a systematic review of published literature.

The treatment of chronic hepatitis C has experienced a substantial progress with the arrival of Boceprevir and Telaprevir due to the significant increase in sustained viral response. Given the high cost, their approval has been followed by great deal of pharmacoeconomic literature analysing their efficiency. A systematic review of this literature was carried out, evaluating both its results and the methodology employed. 54 references were revised including 11 studies, 6 on naive populations, 3 on pre-treated patients and 2 in both of them. As the clinical heterogeneity of patients influenced sustained viral response, therapy regimens were assessed conditioned to the interleukin 28B polymorphism, the early response to treatment and the level of fibrosis, among other variables. Most of the options evaluated on a naive population presented ICERs below the acceptability threshold. The same occurred in the pre-treated population, where the subgroups analysis is perceived as a methodological limitation.

Cost-effectiveness analysis of triple therapy with protease inhibitors in treatment-naive hepatitis C patients.

BACKGROUND: Chronic hepatitis C is the leading cause of chronic liver disease, representing a significant burden in terms of morbidity, mortality and costs. A new scenario of therapy for hepatitis C virus (HCV) genotype 1 infection is being established with the approval of two effective HCV protease inhibitors (PIs) in combination with the standard of care (SOC), peginterferon and ribavirin. OBJECTIVE: Our objective was to estimate the cost effectiveness of combination therapy with new PIs (boceprevir and telaprevir) plus peginterferon and ribavirin versus SOC in treatment-naive patients with HCV genotype 1 according to data obtained from clinical trials (CTs). METHODS: A Markov model simulating chronic HCV progression was used to estimate disease treatment costs and effects over patients' lifetimes, in the Spanish national public healthcare system. The target population was treatment-naive patients with chronic HCV genotype 1, demographic characteristics for whom were obtained from the published pivotal CTs SPRINT and ADVANCE. Three options were analysed for each PI based on results from the two CTs: universal triple therapy, interleukin (IL)-28B-guided therapy and dual therapy with peginterferon and ribavirin. A univariate sensitivity analysis was performed to evaluate the uncertainty of certain parameters: age at start of treatment, transition probabilities, drug costs, CT efficacy results and a higher hazard ratio for all-cause mortality for patients with chronic HCV. Probabilistic sensitivity analyses were also carried out. RESULTS: Incremental cost-effectiveness ratios (ICERs) of €2012 per quality-adjusted life-year (QALY) gained were used as outcome measures. According to the base-case analysis, using dual therapy as the comparator, the alternative IL28B-guided therapy presents a more favorable ICER (€18,079/QALY for boceprevir and €25,914/QALY for telaprevir) than the universal triple therapy option (€27,594/QALY for boceprevir and €33,751/QALY for telaprevir), with an ICER clearly below the efficiency threshold for medical interventions in the Spanish setting. Sensitivity analysis showed that age at the beginning of treatment was an important factor that influenced the ICER. A potential reduction in PI costs would also clearly improve the ICER, and transition probabilities influenced the results, but to a lesser extent. Probabilistic sensitivity analyses showed that 95 % of the simulations presented an ICER below €40,000/QALY. Post hoc estimations of sustained virological responses of the IL28B-guided therapeutic option represented a limitation of the study. CONCLUSION: The therapeutic options analysed for the base-case cohort can be considered cost-effective interventions for the Spanish healthcare framework. Sensitivity analysis estimated an acceptability threshold of the IL28B-guided strategy of patients younger than 60 years.

Potential for simplification of HIV treatment with boosted protease inhibitor monotherapy.

BACKGROUND: Previous studies have evaluated the simplification of HIV treatment with ritonavir-boosted protease inhibitor monotherapy, demonstrating acceptable efficacy and advantages such as avoidance of the adverse effects of reverse transcriptase inhibitors. To achieve the best results, patients should be appropriately selected for this therapy. OBJECTIVE: The purpose of this study was to estimate the proportion of HIV patients suitable for boosted protease inhibitor monotherapy according to clinical trial criteria. Setting The study was conducted in the outpatient hospital pharmacy service of the Complejo Hospitalario de Navarra in northern Spain. METHOD: A retrospective analysis was performed on data from 635 adults on antiretroviral therapy. The eligibility criteria were: (1) >18 years of age; (2) prior triple-drug antiretroviral regimen; (3) durability of current treatment >18 months; (4) viral load <400 copies/mL over the 18 months before evaluation and <50 copies/mL over the last 6 months; (5) CD4 count ≥250 cells/µL; (6) CD4 count nadir >100 cells/µL; (7) no previous virological failure under prior protease inhibitor-based regimen; (8) absence of co-infection with hepatitis B virus; (9) absence of HIV-related neurological disease; and (10) adherence >95 %. The average cost of the current treatment was calculated for patients who met all criteria, as well as the potential economic impact of simplification to monotherapy. MAIN OUTCOME MEASURE: Number of patients meeting all criteria for simplification to monotherapy according to clinical trial standards. RESULTS: One hundred and three patients (16.5 %) met the clinical trial criteria for protease inhibitor monotherapy. One hundred and fifty patients (24 %) failed to fulfil only one of the conditions. Fifty-four percent of the patients who met all of the criteria had been treated for more than 10 years. The average saving per patient per year was 2,850-3,400. CONCLUSION: This treatment strategy represents a realistic, albeit minority, option. Fulfilment of the above conditions should be the basis for simplification to protease inhibitor monotherapy, though the final decision depends on clinical criteria and patient preferences assessed by the attending physician. Further studies are needed to confirm long-term safety and efficacy.

Estimating the impact of hepatitis C virus therapy on future liver-related morbidity, mortality and costs related to chronic hepatitis C.

BACKGROUND/AIMS: Chronic Hepatitis C virus (HCV) infection is common and often produces a progressive disease. Some studies suggest that HCV related complications will increase in the future. Our aim was to estimate the future morbidity, mortality and costs of chronic HCV infection in a cohort of patients infected by HCV and to evaluate the impact of HCV therapy. METHODS: A mathematical model was used to project over the next 30 years, the HCV related complications and costs in a cohort of 419,895 infected patients representing the HCV infected population in Spain. The impact of HCV therapy with peginterferon and ribavirin in this population was also projected. RESULTS: A gradual decline in the infected population is expected in the future, however, the proportion of patients with cirrhosis will increase by up to 14% and morbidity associated with HCV infection by up to 10% by the year 2030 with a subsequent increment in HCV related costs. However, treating from 10 to 50% of the HCV population will result in a reduction of 6 and 26% in morbidity and 4 and 20% in mortality, respectively. The cost per year of life gained ranges from 6078 for a 29-year-old patient to 8911 for a 59-year-old patient. CONCLUSIONS: In the future, HCV infection mortality, morbidity and associated costs will increase. Treatment of the chronic HCV infected population can eradicate the infection, increase patients' survival and reduce the need for liver transplantation, making this a cost-effective strategy.