Economic Evaluation for Palbociclib Plus Fulvestrant vs Ribociclib Plus Fulvestrant and Abemaciclib Plus Fulvestrant in Endocrine-Resistant Advanced or Metastatic Breast Cancer in Italy.

Background: To date, no study evaluated the cost-effectiveness of palbociclib (PAL) plus fulvestrant (FUL) vs ribociclib (RIB) plus FUL and abemaciclib (ABM) plus FUL in Italy. Cost-effectiveness analysis comparing the three cyclin-dependent 4/6 kinase inhibitors in combination with endocrine therapies for the management of postmenopausal women with HR+, HER2- advanced or metastatic breast cancer in Italy was developed. Material and Methods: To assess the cost-effectiveness of PAL plus FUL vs RIB plus FUL and ABM plus FUL, a cost-minimization has been carried out with a conservative scenario considering three CDK4/6 inhibitors with equal effectiveness in terms of overall survival (OS) (MAIC, Rugo et al 2021). Adverse events (AEs) associated with all therapies were obtained from clinical trials. Ad-hoc analysis was performed to estimate the cost-effectiveness considering the quality-of-life (QoL) data (Lloyd et al 2006). Results: Cost-minimization inputs were drugs, visits and exams, AE monitoring and best supportive care (BSC) before the progression state, active and BSC in the progression and terminal phase of the last two weeks of life. Given the comparability of PAL, RIB and ABM in terms of efficacy, this analysis demonstrated slight economic savings over a lifetime for PAL. Results showed saving per patient of €305 (lifetime) when PAL is compared with RIB; for PAL vs ABM a saving of €243 (lifetime) in a conservative scenario. Results of a budget impact analysis showed a potential savings of €319,563 for PAL vs RIB and €297,544 for PAL vs ABM. When QoL data were considered, results may favor PAL due to the lower impact of AE with savings and improvement in the QoL related to fewer AE. Conclusion: From the Italian perspective, a cost-saving profile associated with the use of PAL+FUL for the management of advanced/metastatic HR+/HER2- breast cancer compared to RIB+FUL and ABM+FUL emerged.

Burden of Crohn's disease: economics and quality of life aspects in Italy.

BACKGROUND: This was a prospective observational study designed to evaluate direct and indirect costs and quality of life for patients with Crohn's disease in Italy from the perspectives of the National Health System and of society. METHODS: A total of 162 male and female subjects aged 18-70 years with Crohn's disease in the active phase and a Crohn's Disease Activity Index score ≥150 were included in the study. Subjects were recruited from 25 Italian centers on a consecutive basis. The study consisted of four visits undertaken every 6 months with a follow-up period of 18 months. The study started on September 1, 2006 and was completed on April 12, 2010. Multivariate analyses were carried out on demographic characteristics, treatment costs based on the prescribed daily dose, resource use and other cost parameters, and changes in quality of life using the EQ5D questionnaire. RESULTS: Cost of illness per subject with Crohn's disease in Italy was estimated to be €15,521 per year, with direct costs representing 76% of total costs. Nonhealth care costs and loss of productivity accounted for 24% of total costs. Societal costs during the first months of enrolment were higher compared with costs in the final months of the study. Quality of life measured by the EQ-5D was 0.558 initially and then increased to 0.739, with a mean value of 0.677 during the enrolment period. The cost of illness was not correlated with age or gender. CONCLUSION: The cost of illness was correlated with quality of life; Crohn's disease had a negative impact on subjects' quality of life, and higher costs corresponded to a lower quality of life as measured with the EQ5D. Drug treatment may improve quality of life and reduce hospitalization costs. Our results appear to be in line with the results of other international cost-of-illness studies.

Candesartan in heart failure: assessment of reduction in mortality and morbidity (CHARM) and resource utilization and costs in Italy.

Chronic heart failure (HF) is a major cause of morbidity and mortality particularly in the elderly and a growing healthcare burden in Italy. The objective was to assess the cost-effectiveness of candesartan cilexetil, an angiotensin II type 1 receptor blocker (ARB) for the treatment of HF. A pre-specified economic evaluation was conducted on resource utilization (cardiovascular drug treatment, cardiovascular and non-cardiovascular hospital admission, cardiovascular procedures/operations) prospectively collected alongside the CHARM program, a series of parallel randomized clinical trials comparing candesartan with placebo (standard therapy) in patients with NYHA Class II-IV HF: CHARM-Alternative (LVEF < or =40% patients not receiving ACE inhibitors because of previous intolerance); CHARM-Added (LVEF < or =40% patients currently receiving ACE inhibitors); or CHARM-Preserved (LVEF > or =40% patients). The primary outcome for the component trials was the composite of cardiovascular death or worsening hospital admission for HF and of the overall program all-cause mortality. Adjunctive treatment with candesartan in CHARM-Alternative and CHARM-Added led to clinical benefits and to either cost-savings or a small additional cost, depending on the trial. The less certain clinical benefit in CHARM-Preserved was obtained at modest extra cost. The incremental cost-effectiveness ratios (ICERs) were estimated to range from euro713 per life year gained for CHARM-Alternative to dominant for CHARM-Added and the pooled reduced LVEF trials.

An economic evaluation of aripiprazole vs olanzapine adapted to the Italian setting using outcomes of metabolic syndrome and risk for diabetes in patients with schizophrenia.

OBJECTIVE: To evaluate the cost-effectiveness of aripiprazole and olanzapine in patients with schizophrenia. METHODS: Data from a double-blind, randomized study demonstrating the efficacy of aripiprazole and olanzapine were used to observe new incidence of metabolic syndrome (26-week therapy) and to model the risk of developing diabetes over 5 years of therapy. Cumulative incidence of metabolic syndrome was compared using Kaplan-Meier estimates; diabetes risk was estimated using a validated, general population risk-prediction model. Economic assessment was conducted from the third-party payer perspective by evaluating pharmacotherapy costs of treating schizophrenia and medical costs associated with treating adverse metabolic effects in a hypothetical cohort of 1000 patients. Resource utilization and costs were derived from the underlying study and published data, using a 3% rate to discount costs and benefits. RESULTS: For the patients switched from olanzapine to aripiprazole, treatment with aripiprazole was a dominant cost-saving strategy. Use of aripiprazole avoided 184 events of metabolic syndrome over 26 weeks of treatment, contributing to a real-world (RW) cost savings of euro2.53 per patient and a total savings of approximately euro465.52 over a 5-year period. For the same cohort, the risk-prediction model indicated that 34 occurrences of diabetes could be avoided over 5 years, corresponding to a RW cost savings of euro56.86 per patient and a total saving of approximately euro1,933.24. These savings reflect avoided costs in treating adverse metabolic events and comparable costs in the acquisition of aripiprazole. CONCLUSIONS: Maintenance aripiprazole therapy offers medical and economic benefits over olanzapine, reflected by reduced incidence of metabolic syndrome and diabetes and associated lower costs.

[Management of acute pain in Italy. Economic aspects and quality of life]. / La gestione del dolore acuto in Italia: aspetti economici e qualità di vita.

OBJECTIVES: This study aims to measure quality of life and treatment costs of patients with acute pain due to osteoarticular diseases;2 to asses associations between pain, quality of life and treatment costs from NHS' perspective. PATIENTS AND METHODS: Observational, multicentric study; patients of both gender were enrolled sequentially from March to July 2002 and observed for 30 days. Type of pain was assessed by a McGill Pain Questionnaire, while degree of severity was measured by VAS (Visual Analogue Scale) ranging from 0 (no pain) to 10 (very severe pain). Quality of life was assessed by EQ-5D (EuroQol/Quality of Life in Europe-5 Dimensions). RESULTS: 188 patients matched by gender and age in to four group: male < or =65 years (51), female < or =65 years (59), male > 65 years (42), female > 65 years (36). Male's age ranged from 36 to 88 years, while female's ranged from 31 to 87 years. Groups differ for type of pain. Cost after enrollment (48.99 Euro) is due for about 60% to diagnostic examinations, while pharmacological therapies account for only 17.64 Euro. Mean score of EQ-5D shows a low level of utility (0.265) that reflects a rather law quality of life. Patient older than 65 years had lower score than patient of the same gender but younger. Differences are significant in the dimension anxiety/depression that afflicts women and older patients. CONCLUSIONS: This study valued utility of patients with non oncological acute pain in Italy and health cost of diagnostic and therapeutic path faced by patients.

[Quality of life and treatment costs in patients with non-cancer chronic pain]. / Qualità della vita e costi di trattamento in pazienti con dolore cronico benigno.

BACKGROUND: there is still little information about the use of generic questionnaires [e.g. the 36-item Short Form health survey (SF-36)] and utility questionnaires [e.g. the EuroQOL instrument (EQ-5D) and visual analogue scale (VAS)] in patients with non-cancer chronic pain. OBJECTIVES: (i) to measure quality of life and utility in patients with non-cancer chronic pain using the SF-36 and the EuroQOL questionnaires; (ii) to assess direct costs and to evaluate the impact of some clinical variables on diagnostic or treatment costs. PARTICIPANTS: 153 patients from 9 Italian Center for treatment non-cancer chronic pain (54% male, mean age 57 years) completed both quality of life questionnaires and diagnostic and treatment prescription questionnaire. RESULTS: the mean scores for the 8 domains of the SF-36 ranged from 23.7 (physical role) to 53.7 (mental health). The EuroQOL mean score was 0.28 in the self-classifier (EQ-5D) version and 6.4 in the visual analogue scale (VAS) version. The direct costs was assessed in 173 Euro, in two months observation period (the analysis was conducted from the National Health System perspectives); we found some differences between pathologies observed: about 180 Euro for back pain or arthrosis, about 155 Euro for periarthritis of the shoulder. CONCLUSIONS: our study, quantified the quality of life in patients with non-cancer chronic pain, showed that the presence of pain had an important role. The EuroQOL measurements obtained from these patients will aid evaluation of the cost-utility ratio for pain therapies.

Cost utility and budget impact of third-generation aromatase inhibitors for advanced breast cancer: a literature-based model analysis of costs in the Italian National Health Service.

BACKGROUND: Third-generation aromatase inhibitors are effective alternatives to tamoxifen in patients with advanced breast cancer. However, their acquisition costs might burden fixed-budget health care systems. OBJECTIVE: This study is a decision analysis of the clinical and economic consequences of alternative first-line hormone therapies for postmenopausal women with estrogen receptor-positive metastatic breast cancer in a real-life Italian health care setting. METHODS: A Markov model was developed to describe disease evolution according to data from previously published, randomized clinical trials. The costs incurred by a local community hospital in the Italian National Health Service were considered (year-2003 values). Clinical data were taken from previously published trials. A 3% discount rate was applied to both resources and life-years gained. RESULTS: Based on model estimates, mean survival times with the third-generation aromatase inhibitors anastrozole and letrozole were 30.72 and 30.64 months, respectively, as opposed to 27.28 months with tamoxifen. Mean survival times after adjustment for quality of life were 18.84 and 18.78 months with anastrozole and letrozole, respectively, and 16.14 months with tamoxifen. Baseline analysis produced incremental cost-effectiveness ratios per quality-adjusted life-year gained of 10,795 Euro (95% CI, 7737 Euro-12,899 Euro) and 16,886 Euro (95% CI, 9117 Euro-15,465 Euro) for anastrozole and letrozole, respectively, compared with tamoxifen. The observed difference between the 2 cost-utility ratios may have been mainly due to the higher acquisition costs of letrozole compared with anastrozole. Despite similar incremental cost-effectiveness ratios, anastrozole and letrozole might increase the budget for advanced breast cancer care by 12% and 18%, respectively, based on the year-2003 Italian market prices of the 2 drugs. CONCLUSIONS: In this cost-effectiveness analysis using previously published clinical data and year-2003 cost data from a community hospital in the Italian National Health Service, anastrozole and letrozole were both cost-effective alternatives to tamoxifen for first-line therapy of postmenopausal women with advanced estrogen receptor-positive breast cancer.