BackgroundIn recent decades, melanoma incidence has been increasing in European countries; in 2006, there were approximately 60,000 cases leading to 13,000 deaths. Within Europe there is some geographical variation in the incidence of melanoma, with the highest rates reported in Scandinavia (15 cases per 100,000 inhabitants per year) and the lowest in the Mediterranean countries (5 to 7 cases per 100,000 inhabitants per year).MethodsThe present article is based on the information collected in the MELODY study (MELanoma treatment patterns and Outcomes among patients with unresectable stage III or stage IV Disease: a retrospective longitudinal survey).In that study, the medical charts of patients were reviewed to document current treatment patterns and to analyse information on patients, disease characteristics and healthcare resource utilization related to the treatment of advanced melanoma regarding patients who presented with a diagnosis of malignant melanoma (stage I to IV) at participating sites between 01 July, 2005 and 30 June, 2006.ResultsSummarizing, though the length of the follow-up period varies among sample patients, an amount of the yearly cost per patient can be estimated, dividing the average per patient total cost (€ 5.040) by the average follow-up duration (17.5 months) and reporting to one year; on these grounds, unresectable stage III or stage IV melanoma in Italy would cost € 3,456 per patient per year.
OBJECTIVES: The aim of this study was to evaluate the cost‑effectiveness of apixaban in the prevention of thromboembolic events in patients with non‑valvular atrial fibrillation (NVAF) relatively to standard of care (warfarin or aspirin) from the Italian National Health System (SSN) perspective.METHODS: A previously published lifetime Markov model was adapted for Italian context. Clinical effectiveness data were acquired from head‑to‑head randomized trials (ARISTOTLE and AVERROES); main events considered in the model were ischemic and hemorrhagic stroke, systemic thromboembolism, bleeds (both major and clinically relevant minor) and cardiovascular hospitalizations, besides treatment discontinuations. Expected survival was projected beyond trial duration using national mortality data adjusted for individual clinical risks and adjusted by utility weights for health states acquired from literature. Unit costs were collected from published Italian sources and actualized to 2013. Costs and health gains accruing after the first year were discounted at an annual 3.5% rate. The primary outcome measure of the economic evaluation was the incremental cost effectiveness ratio (ICER), where effectiveness is measured in terms of life‑years and quality adjusted life‑years gained. Deterministic and probabilistic sensitivity analyses (PSA) were carried out to assess the effect of input uncertainty.RESULTS: Apixaban is expected to reduce the incidence of ischemic events relative to aspirin and to improve bleeding safety profile when compared to warfarin. Incremental LYs (0.31/0.19), QALYs (0.28/0.20), and costs (1,932/1,104) are predicted with the use of apixaban relative to aspirin and warfarin, respectively. The ICERs of apixaban were € 6,794 and € 5,607 per QALY gained, respectively. In PSA, the probability of apixaban being cost effective relative to aspirin and warfarin was 95% and 93%, respectively, for a WTP threshold of € 20,000 per QALY gained. Univariate analyses indicate that results were most sensitive to variations of the absolute risk reduction for cardiovascular events with apixaban.CONCLUSIONS: Apixaban is expected to increase life expectancy and quality‑adjusted life expectancy, but also costs dedicated to Italian NVAF patients, as compared to standard of care. The resulting ICERs have high probabilities of being below the conventional thresholds of WTP for health benefits of the SSN, indicating efficient allocation of health care resources.
clinical response to treatment and the number of QALYs per patient accrued during the study. Only direct medical costs (drug acquisition, administration and hospitalization costs) were incorporated in the model, as the analysis was conducted from a third-party payer perspective. With respect to administration cost, two alternative scenarios were considered in the base case analysis: administration in day-case unit and administration in the hospital outpatient department. Probabilistic sensitivity analysis was conducted. Primary outcomes were quality adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICER). Results: In the base case analysis, QALYs of FCM treated patients were higher compared to no iron treated patients by 0.04 QALYs. The total 24-week cost of FCM was higher by € 969 and € 204, it the two scenarios respectively. This difference was mainly attributed to the administration cost and drug acquisition cost related to FMC. Incremental cost effectiveness analysis showed that treatment with FCM was a cost-effective option resulting in an ICER of € 25,506 and € 5,368 per QALY gained in the scenarios respectively. Probabilistic sensitivity analysis revealed that FCM was likely to be cost-effective in over 80% and 99% in the two scenarios respectively, at a willingness-to-pay threshold of € 34,000 per QALY gained. ConClusions: Ferric carboxymaltose may be a cost -effective option in relation to no iron treatment for the management of iron deficiency of HF patients in Greece.objeCtives: Non-adherence to drug therapy poses a significant problem in the treatment of patients with presumed resistant hypertension (RH). It has been shown that therapeutic drug monitoring (TDM) is a useful tool for detecting non-adherence and identifying barriers to treatment adherence, leading to effective blood pressure (BP) control. However, the cost-effectiveness of TDM in the management of RH has not been investigated. Methods: A Markov model was used to evaluate life-years, quality-adjusted life-years (QALYs), costs, and incremental cost-effectiveness ratios in RH patients receiving either TDM optimized therapy or standard best medical therapy. The model ran from the age of 30 to 100 years or death, using a cycle length of 1 year. Efficacy of TDM was modeled by reducing risk of hypertension-related morbidity and mortality. Cost analyses were performed from a payer's perspective. Deterministic and probabilistic sensitivity analyses were conducted. Results: In the age group of 60-year olds, TDM gained 1.07 QALYs in men and 0.97 QALYs in women at additional costs of € 3,854 and € 3,922, respectively. Given a willingness-to-pay threshold of € 35,000 per QALY gained, the probability of TDM being cost-effective was ≥ 95% in all age groups from 30 to 90 years. Results were influenced mostly by the frequency of TDM testing, the rate of non-responders to TDM, and the magnitude of effect of TDM on BP. ConClusions: Therapeutic drug monitoring presents a potentialy highly cost-effective health care intervention in patie...
INTRODUCTION: Suboptimal adherence to medication is a serious issue in the management of chronic myeloid leukemia (CML) and contributes to worse clinical outcomes for patients. (Noens L, et al. Blood. 2009;113(22):5401-11.) The objective of this analysis is to evaluate adherence to treatment of patients diagnosed with CML and exposed to the tyrosine-kinase inhibitors (TKIs) imatinib, dasatinib or nilotinib and to analyze CML-related hospitalizations costs across adherence levels. METHODS: De-identified data from hospital databases and haematology files from 4 Italian sites were combined to select adult patients diagnosed with CML, newly treated with imatinib, dasatinib, or nilotinib from July 2009 until June 2012 (inclusion period). Newly treated patients were identified by the absence of previous prescriptions. Demographics and clinical characteristics were assessed at the date of the first prescription within the inclusion period. Adherence to TKIs was measured as proportion of days covered (PDC) over a 180-day period. (Wu EQ, et al. Curr Med Res Opin. 2010;26(12):2861-9.) PDC was computed as the actual number of days of TKI therapy supplied divided by 180, and multiplied by 100. Days' supply was calculated based on quantity dispensed and dosage unit per day prescribed to patients (a dose of 100 mg for dasatinib, 400 mg for imatinib and 800 mg for nilotinib). PDC (and, therefore, adherence) was categorized using standard thresholds: ≥80% (fully adherent'), 40%–79% (partially adherent'), and <40% (non-adherent'). (Rasmussen JN, et al. JAMA. 2007;297(2):177-86.) The average daily dose was also calculated dividing the total dose dispensed by the number of days of TKI therapy supplied. A multivariable logistic regression model was used to estimate the relationship between TKI therapy and adherence, controlling for age, gender, Charlson comorbidity index, prior use of antihypertensives, drugs for acid-related disorders and anti-inflammatory drugs and previous hospital discharges for cancer other than CML. Leukemia-related hospitalizations were also collected. The ethics committees for the local health units approved the study. RESULTS: We identified 88 CML newly treated imatinib patients, 59 newly treated dasatinib patients and 50 newly treated nilotinib patients. Age, gender, Charlson comorbidity index and the prior use of the drug treatments listed above were similar at baseline. Dasatinib patients had fewer previous hospital discharges for cancer (P<0.001). As indicated in Figure 1, dasatinib newly treated patients were more adherent than imatinib- and nilotinib-naïve patients (86.4% vs 76.9% and 46.0% respectively; P<0.001). Figure 1. Percentage of adherent patients (PDC≥80%) across the TKI therapy groups. Figure 1. Percentage of adherent patients (PDC≥80%) across the TKI therapy groups. The mean daily dose calculated on the basis of the adherence was 377 mg for imatinib, 97 mg for dasatinib and 676 mg for nilotinib. Comparing with dasatinib, multivariate logistic regression found significantly lower rates of adherence for imatinib (P=0.026) and for nilotinib (P<0.001), odds ratios (95% confidence intervals) resulted respectively of 0.24 (0.07-0.84) and of 0.10 (0.03-0.32). Independent of medication, higher adherence was associated with lower leukemia-related hospitalizations costs (the average cost per patient was 3,567 where PDC was 40%-79% and 554 where PDC≥80%). In addition, analyses were stratified by the presence or absence of previous hospital discharges for cancer. Among the 7 patients with previous hospital discharges for cancer, the average cost per patient was 6,935 where PDC was 40%-79% and 983 where PDC≥80%; while among the 190 patients with no previous hospitalizations for cancer, the average cost per patient was 536 where PDC was 40%-79% and 207 where PDC≥80%, confirming our findings in both cohorts. CONCLUSIONS: This study showed that CML patients newly treated with imatinib or nilotinib were significantly less adherent than patients receiving dasatinib. On average, lower adherent patients had higher leukemia-related hospitalization costs. Further research is necessary to understand the relationship between adherence level and treatment response. Disclosures No relevant conflicts of interest to declare.
appropriate therapeutic choice: taking into account the embolic and hemorrhagic patient risk, and the risk associated with the use of anticoagulant therapy. The pharmacoeconomic analyses below have been carried out by adapting a decision tree/ Markov model simulating the clinical experience of NVAF patients according to their probability of incurring an ischemic event, or cardiovascular disease. The first paper reports on a cost/effectiveness analysis of the use of apixaban relative to the standard of care in the prevention of thromboembolic events in vitamin K antagonist suitable and unsuitable patients. The second presents a budget impact analysis that compares NVAF patients eligible for treatment with NOACs in two scenarios -with and without apixaban. Clinical comparative effectiveness parameters among NOACs originate from on adjusted indirect comparison (Bucher's method) using warfarin as common comparator. We hope that this information will support informed decisions by clinicians and especially payers.
OBJECTIVE: This study aims to perform a budget impact analysis of the use of three available novel oral anticoagulant agents (NOACs) for preventing thromboembolic events in Italian patients with non‑valvular atrial fibrillation (NVAF).METHODS: Estimated Italian population of patients was run through a previously published lifetime decision tree/Markov model simulating their treatment with the available therapeutic options: dabigatran at two dose levels (110 mg/bid for the over 80 years old, 150 mg/bid for younger NVAF patients), rivaroxaban (20 mg/uid), and apixaban (5 mg/bid). Effectiveness and safety estimates derive from an adjusted indirect treatment comparison using warfarin as link. The main clinical events considered in the model are ischemic and hemorrhagic stroke, systemic thromboembolism, bleeds (both major and clinically relevant minor) and cardiovascular hospitalizations, besides treatment discontinuations. Epidemiological data and unit costs, actualized to 2013, are collected from Italian published sources. The budget impact analysis evaluates the financial impact of apixaban introduction by comparing expected 1,2, and 3 years costs in hypothetical scenarios: with and without apixaban. Italian NVAF patient population estimation is based on official apixaban reimbursement criteria, applying the characteristics of the trial population to national epidemiologic data. Numbers of patients for each regimen are estimated by projecting share evolution. Sensitivity analysis is performed on an alternative non‑experimental population of NVAF patients.RESULTS: Among available NOACs, apixaban was expected to be the least expensive in an estimated patient population of 364,000 Italian patients, allowing for savings of € 1,180,549, € 3,841,429 and € 5,368,918 at 1,2, and 3 years, respectively. Results of the simulation run on an alternative non‑experimental population of NVAF patients yields comparable estimates.CONCLUSIONS: The different safety and effectiveness profiles of the three available NOACs emerging from the adjusted indirect comparison indicate that apixaban could improve health care expenditure control while maintaining or increasing therapeutic appropriateness in the Italian NVAF population.
A479ates the financial impact of apixaban introduction by comparing expected 1,2, and 3 years costs in hypothetical scenarios: with and without apixaban. Italian NVAF patient population estimation is based on official apixaban reimbursement criteria, applying the characteristics of the trial population to national epidemiologic data. Sensitivity analysis is performed on an alternative non-experimental population of NVAF patients. Results: Among available NOACs, apixaban is expected to be the least expensive at 1,2, and 3 years in an estimated patient population of 364,000 Italian patients, allowing for savings of over 5 million € by the third year. Results of the simulation run on an alternative non-experimental population of NVAF patients yields comparable estimates. Exclusive use of apixaban for three years in the identified population would allow for savings of € 8,832,500, € 14,446,551 and € 27,282,998 when compared with dabigatran (110 mg), dabigatran (150 mg) and rivaroxaban, respectively. ConClusions: The different safety and effectiveness profiles of the available NOACs emerging from the adjusted indirect comparison indicate that the introduction of apixaban could improve health care expenditure control while maintaining or increasing therapeutic appropriateness in the Italian NVAF population.
endogenous cost-effectiveness analysis policies aimed at lowering spending may actually raise it. Second, reimbursement policy based on endogenous cost-effectiveness levels may lead to adoption of more inefficient treatments. Under the standard conditions when producer costs are unobservable, we provide a test for these conditions using data on technology appraisals in the UK OBJECTIVES:The paper is to improve the quality of life and health of the peoples of the world by fostering and maintaining high standards of care in general practice/ family medicine and other clinicians. METHODS: By comparing the general practitioners/family physicians with the clinicians of specialities, summarizing the shortcomings of present health care services, the proposals for promoting health care services around the world were suggested. RESULTS: The article initiates that the values of general practice/family medicine should be fostered into other clinicians when all the clinicians take care of the patients in any conditions, critical or ordinary, by adopting to the values of general practice/family medicine. While the clinicians also take into account of their own specialities. CONCLUSIONS: In applying these proposals, a healthy world and high quality of life of the peoples of the world will come soon! So the quality of life and health of the peoples of the world can be promoted and enhanced.
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