Economic Impact of Inter-Regional Health Mobility In The Oldest European Administrative Region: A Starting Point For Changing Organizational Model?

Objectives: The aim of this study is to evaluate the inter-regional mobility expenditures, with particular reference to oncology, in Liguria Region. Study design: A descriptive analysis of inter-regional mobility expenditures from 2008 to 2015 was carried out. Methods: The analysis involved a detailed assessment of global balance of interregional health mobility by means the DRGs; the flow of specialist outpatient and pharmaceutical was also used. Results: Since 2008 until 2012 an increase of negative balance of global healthcare expenditure in Liguria Region was observed [34.7 \u20ac mill (2008) and 62.3 \u20ac mill (2012)]; subsequently a quite stable trend was recorded between 2012 and 2015 [ranging between 59.8 \u20ac mill (2013) and 63.2 \u20ac mill (2014)]. The passive mobility was 15.1% on the total spending for hospital acute care in 2012 and a similar value was detected in 2015 (15.2%). The higher costs for passive mobility were attributable to the surgical DRGs (69.4% in 2012 and 69.8% in 2015) with a double estimate of the expenditure in comparison with medical ones (2012: 99.4 \u20ac mill vs 43.8 \u20ac mill, \u394= 55.6 \u20ac mill; 2015: 96.6 \u20ac mill vs 41.9 \u20ac mill, \u394= 54.7 \u20ac mill). The highest cost sources in the process of passive mobility are the surgical areas, particularly the surgical hospitalizations for orthopaedic and cardiologic interventions. The spending analysis for oncologic DRG, divided into surgical and medical for passive and active mobility, showed that the surgical DRG determined a negative balance of 3.8 \u20ac mill in 2012 and 4.3 \u20ac mill in 2015, while the medical DRG showed a positive balance of 0.5 \u20ac mill in 2012 and 0.7 \u20ac mill in 2015. Conclusions: Our evaluation highlights that the inter-regional mobility for hospital acute care is the most relevant issue for the economic regional balance and reveals an important flow of patients moving from Liguria Region to neighbouring regions. As the equity of access and distribution of the supply of care remains a priority of Regional Health System, the active mobility in oncologic field could be a marker of quality health planning

Analisi di budget impact del biosimilare di pegfilgrastim nel trattamento della neutropenia febbrile in Italia

Introduction: Granulocyte-colony stimulating factors (G-CSFs) can significantly reduce the risk of febrile neutropenia (FN) among certain patients receiving chemotherapy. FN is associated with significant clinical and nonclinical complications. At present, the patent protection of pegfilgrastim (Neulasta®) has expired, and a biosimilar (Ziextenzo®) has been approved. Since the biosimilar price is expected to be lower as compared with the originator's, the present Drug Budget Impact analysis tries to evaluate whether and how much profitable the biosimilar availability will be for the Italian NHS, in terms of cost containment (savings).Methods and Results: The model time horizon extends to five years. The initial overall number of treatments with pegfilgrastim is estimated based on the number of pegfilgrastim packages (assuming a recommended dose of 6 mg is administered after each cytotoxic chemotherapy) and kept constant in time. The model assumes that, year by year, the number of treatments with the originator will partly switch to the biosimilar (according to an uptake rate assumed). The results show that the availability of the biosimilar would provide an €6.4 million cumulated savings to the NHS in the five years.Conclusions: According to the present analysis, the availability of the biosimilar would generate cumulated savings (in five years) as high as €6.4 million for the Italian NHS. (HTA & Market Access

Hormonal therapy followed by chemotherapy or the reverse sequence as first-line treatment of hormone-responsive, human epidermal growth factor receptor-2 negative metastatic breast cancer patients: Results of an observational study

Introduction Although hormonal-therapy is the preferred first-line treatment for hormone-responsive, HER2 negative metastatic breast cancer, no data from clinical trials support the choice between hormonal-therapy and chemotherapy. Methods Patients were divided into two groups according to the treatment: chemotherapy or hormonal-therapy. Outcomes in terms of clinical benefit and median overall survival (OS) were retrospectively evaluated in the two groups. To calculate the time spent in chemotherapy with respect to OS in the two groups, the proportion of patients in chemotherapy relative to those present in either group was computed at every day from the start of therapy. Results From 1999 to 2013, 119 patients received first-line hormonal-therapy (HT-first group) and 100 first-line chemotherapy (CT-first group). Patients in the CTfirst group were younger and with poorer prognostic factors as compared to those in HT-first group. Clinical benefit (77 vs 81%) and median OS (50.7 vs 51.1 months) were similar in the two groups. Time spent in chemotherapy was significantly longer during the first 3 years in CT-first group (54-34%) as compared to the HT-first group (11-18%). This difference decreased after the third year and overall was 28% in the CT-first group and 18% in the HT-first group. Conclusions The sequence first-line chemotherapy followed by hormonal-therapy, as compared with the opposite sequence, is associated with a longer time of OS spent in chemotherapy. However, despite the poorer prognostic factors, patients in the CTfirst group had a superimposable OS than those in the HT-first group

Attitude of Italian medical oncologists toward palliative care for patients with advanced cancer: results of the SIO project.

The aim of this survey was to describe the attitude of Italian oncologists towards palliative care. A survey on palliative care was carried out among 400 Italian oncologists. Seventy-two percent indicated that the management of patients with advanced stage cancer represents the majority of their practice. They are often involved in the management of pain (78%) and complications of chemotherapy (61%), and frequently, in the treatment of terminal patients (60%). Only 8.5% reported having frequent collaboration with psychiatrists in support of emotional and psychological patients' disturbances. About 40% are often directly involved in the management of existential or spiritual distress. Discussions on euthanasia and assisted suicide, which are illegal in Italy, took place never (68%) or occasionally (27%). Respondents agreed that all oncology centres should have access to palliative care service. These results are in line with those of the European Society of Medical Oncology survey and may be usefully employed to improve the organisation of palliative care

Epoetin Alfa Improves Anemia and Anemia-Related, Patient-Reported Outcomes in Patients with Breast Cancer Receiving Myelotoxic Chemotherapy: Results of a European, Multicenter, Randomized, Controlled Trial

This study evaluated the effects of epoetin alfa on patient-reported outcomes in patients with breast cancer receiving myelotoxic chemotherapy. Early intervention with epoetin alfa was well tolerated and improved anemia-related patient-reported outcomes

gene expression profiling in breast cancer a clinical perspective

Gene expression profiling tests are used in an attempt to determine the right treatment for the right person with early-stage breast cancer that may have spread to nearby lymph nodes but not to distant parts of the body. These new diagnostic approaches are designed to spare people who do not need additional treatment (adjuvant therapy) the side effects of unnecessary treatment, and allow people who may benefit from adjuvant therapy to receive it. In the present review we discuss in detail the major diagnostic tests available such as MammaPrint dx, Oncotype dx, PAM50, Mammostrat, IHC4, MapQuant DX, Theros-Breast Cancer Gene Expression Ratio Assay, and their potential clinical applications

Bridging therapeutic opportunities: a survey by the Italian molecular tumor board workgroup of Alliance Against Cancer

Background: Molecular tumor boards (MTBs) match molecular alterations with targeted anticancer drugs upon failure of the available therapeutic options. Special and local needs are most likely to emerge through the comparative analysis of MTB networks, but these are rarely reported. This manuscript summarizes the state-of-art of 16 active Italian MTBs, as it emerges from an online survey curated by Alliance Against Cancer (ACC).Main text: Most MTBs (13/16) are exclusively supported through local Institutional grants and meet regularly. All but one adopts a fully virtual or a mixed face-to-face/virtual calling/attendance meeting model. It appears that the ACC MTB initiative is shaping a hub-and-spoke virtual MTB network reminiscent of non-redundant, cost-effective health-care organization models. Unfortunately, public awareness of MTB opportunities presently remains insufficient. Only one center has a website. Dedicated e-mail addresses are for the exclusive use of the MTB staff. More than half of ACC members consider a miscellanea of most or all solid and hematological malignancies, and more than one-third consider neoplasms arising at any anatomical location. The average number of Staff Members in MTBs is 9. More than 10 staff members simultaneously attend MTB meetings in 13 MTBs. A medical oncologist is invariably present and is in charge of introducing the clinical case either with (45%) or without previous discussion in organ-specific multidisciplinary Boards. All but two MTBs take charge of not only patients with no standard-of-care (SoC) therapy option, but also cases receiving NGS profiling in SoC settings, implying a larger number of yearly cases. All MTBs run targeted NGS panels. Three run whole-exome and/or RNAseq approaches. ESCAT-ESMO and/or Onco-KB levels of evidence are similarly used for diagnostic reporting. Most MTBs (11) provide a written diagnostic report within 15 days. Conclusions are invariably communicated to the patient by the medical oncologist.Conclusions: MTB networking is crucial not only for molecular diagnosis and therapy assignment, but also for healthcare governance. Survey results show that MTBs review therapeutic opportunities at the crossover between standard-of-care with off-label, the former task being much beyond their scope. Societal and scientific implications of this beyond-the-scope MTB function may be relevant for healthcare in Italy and abroad

Neutralizing antibodies to Omicron after the fourth SARS-CoV-2 mRNA vaccine dose in immunocompromised patients highlight the need of additional boosters

IntroductionImmunocompromised patients have been shown to have an impaired immune response to COVID-19 vaccines.MethodsHere we compared the B-cell, T-cell and neutralizing antibody response to WT and Omicron BA.2 SARS-CoV-2 virus after the fourth dose of mRNA COVID-19 vaccines in patients with hematological malignancies (HM, n=71), solid tumors (ST, n=39) and immune-rheumatological (IR, n=25) diseases. The humoral and T-cell responses to SARS-CoV-2 vaccination were analyzed by quantifying the anti-RBD antibodies, their neutralization activity and the IFN-γ released after spike specific stimulation.ResultsWe show that the T-cell response is similarly boosted by the fourth dose across the different subgroups, while the antibody response is improved only in patients not receiving B-cell targeted therapies, independent on the pathology. However, 9% of patients with anti-RBD antibodies did not have neutralizing antibodies to either virus variants, while an additional 5.7% did not have neutralizing antibodies to Omicron BA.2, making these patients particularly vulnerable to SARS-CoV-2 infection. The increment of neutralizing antibodies was very similar towards Omicron BA.2 and WT virus after the third or fourth dose of vaccine, suggesting that there is no preferential skewing towards either virus variant with the booster dose. The only limited step is the amount of antibodies that are elicited after vaccination, thus increasing the probability of developing neutralizing antibodies to both variants of virus.DiscussionThese data support the recommendation of additional booster doses in frail patients to enhance the development of a B-cell response directed against Omicron and/or to enhance the T-cell response in patients treated with anti-CD20