Lymph node status is the most important clinicopathological prognostic factor for breast cancer patients and in most breast units it reflects only the axillary lymph nodes. A second often overlooked basin consists of the internal mammary lymph nodes (IMLNs) whose evaluation is not done as a routine step during the staging process. We highlight the need to consider incorporation of IMLNs into a patient’s staging by presenting three cases of recurrent breast cancer with negative axilla and positive IMLN, a finding which altered their final management. We suggest that biopsy of IMLN should be a routine step in recurrent breast cancer when axillary lymphatics are disrupted by previous surgery although further research is required to define the optimal management of node positive cases.
model was adapted to the Italian context. The analysis compared nivolumab with observation (wait and watch approach) from the health-care payer perspective, over a 60-year time horizon. An indirect treatment comparison based on patient-level data from CheckMate 238 and CA184-029 trials informed the efficacy of nivolumab and observation on recurrence free survival (RFS). Overall survival (OS) was modelled using an RFS/ OS correlation equation supported by published literature. Local data informed subsequent therapy distributions in the two arms. Drug acquisition, administration, monitoring, subsequent therapy, adverse events and end-of life costs were sourced from published prices, DRG Italian tariffs and literature. Utility values based on Italian EQ-5D tariffs were obtained from CheckMate 238 collected data. Three percent annual discount rates were applied for costs and benefits. Results: Nivolumab was associated with higher utility versus observation (11.35 QALY vs 7.66 QALY) and incremental costs (V143,324 for nivolumab vs V94,433 for observation), resulting in an ICUR of V13,273/QALY compared to observation. This suggests that nivolumab is a cost-effective treatment at current published prices. Conclusions: Nivolumab is a cost-effective strategy for the adjuvant treatment of melanoma in Italy.
Objectives: Risankizumab (RIS) is an innovative drug registered by EMA in 2019 for the treatment of moderate-to-severe psoriasis. It has demonstrated high efficacy, best characterized by a response rate of PASI90 achieved by 75% of patients in a clinical trials. The aim of this study was to evaluate the cost-effectiveness of RIS compared with ustekinumab (UST) for the treatment of severe psoriasis from the perspective of a Polish public payer. Methods: An excel-based Markov model was developed to simulate a cohort of patients over 5-year horizon. Transition matrices were fitted to the aggregate-level data from UltIMMA-1 and UltIMMA-2 trials. Relapse rate was assumed to be the same for both treatments. The treatment regimens of both treatments were assumed to be intermittent. In line with current Polish clinical practice, time limit for a single cycle of treatment with UST was set at 48 weeks and with RIS at 96 weeks. The outcome was incremental cost-effectiveness ratio (ICER), calculated in two ways: as a ratio of incremental cost to incremental quality-adjusted life years (EUR/QALY) or a ratio of incremental cost to incremental symptom-free life years (EUR/PASI100 LY). Results: The model indicates that patients treated with RIS will gain an additional 0.91 life years with a response of PASI 100 compared to UST. The incremental health benefit expressed in QALYs was 0.14. ICER was 211.8K EUR/QALY and 33.3K EUR/PASI100 LY. Conclusions: ICER expressed in QALYs is above the current cost-effectiveness threshold in Poland, however it falls in a range of ICERs that is typical for this class of drugs reimbursed in the treatment of psoriasis. Other anti-interleukin agents (ixekizumab, ustekinumab, secukinumab) given their list prices have demonstrated ICERs from 50K to 280K EUR which were all beyond the acceptability threshold for reimbursement in Poland.
in Spain, an updated economic assessment is required. We analyzed the costeffectiveness of rosuvastatin compared to atorvastatin in the treatment of patients at moderate, high and very high cardiovascular risk (1% Systematic Coronary Risk Evaluation [SCORE]) from the Spanish National Healthcare System (NHS) perspective. METHODS: A Markov model was developed in Microsoft Excel. Four health states were defined: patients without cardiovascular event, cerebrovascular event, coronary event and death. The highest doses of each statin intensity group were compared: rosuvastatin 10mg versus atorvastatin 20mg (moderate-intensity), and rosuvastatin 20mg versus atorvastatin 80mg (high-intensity). A time horizon of 25 years and an annual cycle length were considered. Pharmacological, monitoring, and resource use costs related to cardiovascular events were included in the model. Rosuvastatin and atorvastatin efficacy in terms of c-LDL reduction were taken from the ESC/EAS 2016 European guidelines. Utility values were associated with each health state. A 3% annual discount rate was used for costs and benefits. Incremental cost-effectiveness ratios (ICER) were estimated for each comparison and SCORE risk profile (based on gender, age, total cholesterol, blood pressure and smoking habit). A willingnessto-pay threshold of V30,000/QALY was assumed. RESULTS: Overall, 426 SCORE risk profiles were evaluated: 288 moderate, 86 high and 52 very high risk. The ICERs showed that rosuvastatin 10mg was cost-effective versus atorvastatin 20mg in 35% of the moderate profiles, the ICERs remaining were above V30,000/ QALY; 98% of the high-risk profiles and 100% of the very high-risk profiles.
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