Direct and indirect costs of cluster headache : a prospective analysis in a tertiary level headache centre

Cluster headache (CH) is the most frequent trigemino-autonomic cephalgia. CH can manifest as episodic (ECH) or chronic cluster headache (CCH) causing significant burden of disease and requiring attack therapy and prophylactic treatment. The few data available on the economic burden of CH come from retrospective studies based on questionnaires, population surveys and medical insurance claims database. Although all these studies showed an important economic burden, they provided different estimates depending on variability of CH awareness and management, healthcare systems, available therapies and use of treatments according to different guidelines. This prospective study aimed to quantify the total direct and indirect cost of ECH and CCH over a cluster period, both for the patient and for the National Health System (NHS), using data from subjects who consecutively attended an Italian tertiary headache centre between January 1, 2018 and December 31, 2018. A total 108 patients (89 ECH, 19 CCH) were included. Mean attack frequency was 2.3 ± 1.4 per day. Mean total cost of a CH bout was €4398 per patient and total cost of CCH was 5.4 times higher than ECH (€13,350 vs. €2487, p <  0.001). Direct costs represented the 72.1% of total cost and were covered for the 94.8% by the NHS. The costs for any item of expense were higher for CCH than for ECH (p <  0.001). Mean indirect costs for a CH bout were €1226 per patient and were higher for CCH compared to ECH (€3.538 vs. €732), but the difference was not significant. Days with reduced productive capacity impacted for the 64.6% of the total indirect costs. The analysis of the impact CH on work showed that 27%% of patients felt that CH had limited their career, 40% had changed their work pattern, 20% had changed their place of employment and 10% had lost a job due to the disease. Our results provide a valuable estimate of the direct and indirect costs of ECH and CCH in the specific setting of a tertiary headache centre and confirm the high economic impact of CH on both the NHS and patients

Evaluation of patients treated for diabetic retinopathy: an analysis of the administrative databases of the Lazio Region

BACKGROUND: In Italy there are an estimated 4 million patients suffering from diabetes mellitus (DM). The most important ocular complication of DM is diabetic retinopathy (DR), which affects about one third of diabetic patients.AIMS: To identify, within the Lazio Region, the cohort of patients starting treatment for DME in the years 2010-2016 and calculating the annual cost of therapy; and to assess the appropriateness of the drugs prescribed.METHODS: From the Health Information System of the Lazio Region were identified all subjects who, in the 2010-2016 period, had received at least one prescription for dexamethasone intravitreal implant (i.i.) or intravitreal triamcinolone or ranibizumab or aflibercept or bevacizumab. For the cohort of users selected, the appropriateness of the treatment were evaluated calculating the number of administrations performed in the first four months of the index prescription and the number of administrations performed during the 12 months of treatment.RESULTS: In 2016, 7,265 patients in the Lazio Region received at least one prescription of ranibizumab (43.0%), aflibercept (37.5%) and dexamethasone i.i. (19.5%). Among the 3,416 patients naïve at 6 months, who started treatment in the 2013-2015 period and who did not switch to different drugs, 78.7% started treatment with ranibizumab, 16.0% with dexamethasone i.i. and 5.3% with aflibercept. The mean annual cost for the treatment of a patient with DME and naïve at 6 months was equal to € 2,388; a total cost for only the naïve patients selected in the 2013-2015 period is therefore estimated at approximately € 8.2 million. The average annual cost of dexamethasone i.i. treatment was € 1,497, lower than that of ranibizumab (€ 2,562) and aflibercept (€ 2,485). The expenditure for patients receiving less than 3 administrations of ranibizumab or aflibercept in the first 10 months of treatment was estimate equal to € 1.3 million.CONCLUSIONS: The administrations of dexamethasone i.i. are in line with what is indicated in the prescribing information, while for ranibizumab and aflibercept a potential under-use has been identified. A greater appropriateness of the drugs prescribed, accompanied by an optimal adherence to therapy, would strongly reduce the current waste of resources

Economic evaluation of spondyloarthritis : economic impact of diagnostic delay in Italy

Spondyloarthritis (SpA) is a disease that normally affects the axial skeleton. It progressively leads to overall stiffness up to severe postural deformity of rachis and functional impotence. The objective of the study was to quantify, through an economic model, the impact of specialized testing and pharmacological treatments carried out by the National Health Service (NHS) in normal clinical practice, before the patient is diagnosed with SpA in Italy. In line with the analysis objective, the chosen perspective is that of the NHS

The Impact of Locoregional Treatment on Response to Nivolumab in Advanced Platinum Refractory Head and Neck Cancer: The Need Trial

Background: Previous locoregional treatment could affect the response to nivolumab in platinum-refractory recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). The aim of this study is to evaluate the impact of the clinicopathological characteristics and previous treatment in predicting early progression to nivolumab in a real-world population. Methods: This is an observational, multicenter retrospective/prospective study including patients (pts) with platinum refractory R/M HNSCC who received nivolumab 240 mg every 2 weeks from October 2018 to October 2019. We analyzed the association between previous treatment, clinicopathological characteristics, and early progression (within 3 months). Results: Data from 61 pts were reviewed. Median age was 67 years (30–82). Forty-two pts (69%) received previous locoregional treatment. Early progression to nivolumab occurred in 36 pts (59%), while clinical benefit (stable disease and partial response) was achieved in 25 pts (41%). Early progression to nivolumab was significantly associated to previous locoregional treatment both at univariate and multivariate analysis (p = 0.005 and p = 0.048, respectively). Conclusion: nivolumab in R/M HNSCC is burdened with a high early progression rate. Previous wide neck dissection and high dose radiotherapy may compromise the efficacy of nivolumab, distorting the anatomy of the local lymphatic system and hindering the priming of immune response

Osteoporosis : economic burden of disease in Italy

Background and Objective Today, osteoporosis is the most common bone disease and an important public health problem in all developed countries. The objective of this study was to estimate the costs associated with the management and treatment of osteoporosis in order to assess the economic burden in Italy for 2017, in terms of direct medical costs and social security costs. Methods A cost of illness model was developed to estimate the average cost per year sustained by the NHS (National Health Service) and Social Security System in Italy. A systematic literature review was performed to obtain epidemiological, direct and indirect costs parameters where available. Hospitalisation costs were calculated considering the administrative database of the hospital discharge records for the period 2008-2016. Patients were enrolled in the analysis if they report the subsequent inclusion criteria: age &gt;= 45 years and presence of osteoporosis in primary or secondary diagnosis (ICD9-CM 733.0) and/or presence of a major fracture in primary or secondary diagnosis (excluding road accidents) in the following locations: spine (codes ICD9-CM: 805;806), femur (codes ICD9-CM: 820; 821), radius and ulna (codes ICD9-CM: 813.4; 813.5), humerus (codes ICD9-CM: 812.0-812.5), pelvis (code ICD9-CM: 808), tibia and fibula (codes ICD9-CM: 823), ankle (code ICD9: 824) and ribs (codes ICD9-CM: 807.0; 807.1). Costs were estimated considering the diagnosis-related group (DRG) national tariff associated with each hospitalisation. Finally, the administrative databases of the Italian National Social Security Institute (INPS) (2009-2015) were analysed for the estimate the pension and disability costs from the social perspective. Results The model estimated an average annual economic burden of osteoporosis in Italy of euro2.2 billion. Of this cost, approximately 80% (euro1.8 billion) was associated with hospitalisations, 16% (euro351 million) for pharmacological treatments, 3% (euro71 million) for ambulatory visits, and 0.6% (euro13 million) for social security costs. The average yearly cost per patient was equal to euro8691 (euro8591 for hospitalisations). Analysing severe patients, hospitalisation costs increase to euro12,336 (+ 44% if compared to non-severe osteoporosis patients). Conclusions The analysis showed that osteoporosis represents one of the main health problems in Italy and the ability to maintain patients in a non-severe health state could decrease the economic burden from both NHS and social perspective

An analysis of the social and economic costs of breast cancer in Italy

Background: Breast cancer is the most prevalent cancer affecting women and it represents an important economic burden. The aim of this study was to estimate the socio-economic burden of breast cancer (BC) in Italy both from the National Health Service (NHS) and the government perspectives (costs borne by the social security system). Methods: The economic analysis was based on the costs incurred by the NHS from 2008 to 2016 (direct costs related to hospitalizations) and by the National Social Security Institute (INPS) from 2009 to 2015 (costs of social security benefits) for patients with breast cancer. The analysis was based on the Hospital Information System (HIS) and Disability Insurance Awards databases. For both databases, patients affected by a malignant neoplasm of the female breast, carcinoma in situ, or secondary malignant neoplasm of the breast were considered. Results: Results show that more than 75,000 women were hospitalized for breast cancer every year, with an overall cost for hospitalization of about €300 million per year. From the Social Security analysis, a number of 29,000 beneficiaries each year was estimated. Considering per patient social costs, breast cancer at the primary stage cost €8828 per year, while secondary neoplasms cost €9780, with an average total economic burden of €257 million per year. Conclusions: This analysis focused on the economic impact of breast cancer in Italy, showing that an advanced stage of the disease was associated with a higher cost

Budget impact analysis of Dalbavancin in the treatment of acute bacterial skin and skin structure infections in three European countries

Background and Objective: Acute bacterial skin and skin structure infections (ABSSSIs) have been defined by the US Food and Drug Administration (FDA) in 2013 to include a subset of complicated skin and skin structure infections commonly treated with parenteral antibiotic therapy. Inpatient treatment of ABSSSIs involves a significant economic burden on the healthcare system. This study aimed to evaluate the economic impact on the National Health System associated with the management of non-severe ABSSSIs treated in hospitals with innovative long-acting dalbavancin compared to standard antibiotic therapy in Italy, Spain, and Austria. Methods: A budget impact analysis was developed to evaluate the direct costs associated with the management of ABSSSI from the national public health system perspective. The model considered the possibility of early discharge of patients directly from the Emergency Department (ED), after 1 night in the hospital, or after two or three nights in the hospital. A scenario with Standard of Care was compared with a dalbavancin scenario, where patients had the possibility of being discharged early. The epidemiological and cost parameters were extrapolated from national administrative databases and from a systematic literature review for each country. The analysis was conducted in a 3-year time horizon. A one-way deterministic sensitivity analysis was conducted to examine the robustness of the results. Results: The model estimated an average annual number of patients with non-severe ABSSSI in Italy, Spain, and Austria equal to 5396, 7884, and 1788, respectively. A total annual expenditure of about €9.9 million, €13.5 million, and €3.4 million was estimated for treating the full set of ABSSSI patients in Italy, Spain, and Austria, respectively. Dalbavancin reduced the in-hospital length of stay in each country. In the first year of its introduction, dalbavancin significantly reduced the total economic burden in Italy and Spain (− €352,252 and − €233,991, respectively), while it increased the total economic burden in Austria (€80,769, 0.7% of the total expenditure for these patients); in the third year of its introduction, dalbavancin reduced the total economic burden in each Country (− €1.1 million, − €810,650, and − €70,269, respectively). Conclusions: The introduction of dalbavancin in a new patient pathway to treat non-severe ABSSSI could generate a significant reduction in hospitalized patients and the overall patient length of stay in hospital

Cost of chronic and episodic migraine patients in continuous treatment for two years in a tertiary level headache centre

Abstract: Background: Migraine is one of the most common neurological diseases and an estimated 1.04 billion people worldwide have been diagnosed with migraine. Available data suggest that migraine is world widely associated with a high economic burden, but there is great variability in estimated costs that depends on the geographical, methodological and temporal differences between the studies. The purpose of this study was to quantify the annual direct cost of episodic migraine (EM) and chronic migraine (CM), both for the patient and for the National Health System (NHS), using data from subjects who attended an Italian tertiary headache centre. Furthermore, we evaluated comparatively the impact of gender and age on the economic burden of migraine. Methods: We conducted a retrospective and non-interventional observational analysis of the electronic medical records of subjects with EM and CM who consecutively attended the Regional Referral Headache Centre of Rome and undergoing continuous treatment in the 2 years prior to 31 January 2019. This approach was intended to prevent distorsions due to natural fluctuations in migraine status over time. The collected data included demographic characteristics, number of specialist visits, consumption of medications, diagnostic tests, accesses in the emergency department (ED) and days of hospitalization due to the pathology. Results: Our sample consisted of 548 patients (85.4% women and 14.6% men): 65.5% had CM and 34.5% had EM. The average annual expenditure per patient was €1482. 82.8% of the total cost (€1227) was covered by the NHS. The main item of expenditure were medications that represented 86.8% (€1286), followed by specialist visits (10.2%), hospitalizations for (1.9%), diagnostic tests for (1%) and ED visits for (0.1%). Costs were significantly higher for women than men (€1517 vs. €1274, p = 0.013) and increased with age (p = 0.002). The annual direct cost of CM was 4.8-fold higher than that of EM (€2037 vs. €427, p = 0.001). Conclusion: Our results provide a valuable estimate of the annual direct cost of CM and EM patients in the specific setting of a tertiary headache centre and confirm the high economic impact of migraine on both the NHS and patients

Burden of disease of human papillomavirus (HPV) : hospitalizations in the Marche and Veneto regions. An observational study

Background and Objectives HPV (human papillomavirus) is the virus most often responsible for sexually transmitted infections. The burden of HPV-related diseases on hospital resources represents a major public health problem. The aim of this study was to assess the economic burden of HPV-related diseases (anal cancer, genital cancer, genital warts, oropharyngeal cancer) on hospital resources in two Italian regions.Methods A retrospective, non-randomized, observational study was developed in the Marche and Veneto Regions, based on patients receiving hospitalization between 2008 and 2011. All hospitalizations were identified through administrative archives, according to the International Classification of Diseases (ICD-9 CM) to which a defined tariff was assigned.Results We identified 5299 hospitalized patients in Veneto and 1735 in the Marche Region. The mean annual hospitalization rate was 49.44 per 100,000 individuals in Veneto and 48.41 in Marche. The total mean annual cost attributable to HPV-related diseases was (sic)5.78 (SD 0.80) million in Veneto and (sic)2.24 (SD 0.17) million in Marche. Costs associated with genital cancer amounted to (sic)1.61 million in Veneto and (sic)1.06 million in Marche (28% and 47% of the total mean annual cost, respectively). Oropharyngeal cancer accounted for 36% in Veneto ((sic)2.08 million) and 28% in Marche ((sic)632,645). Hospitalization costs related to anal cancer were (sic)882,567 in Veneto and (sic) 377,719 in Marche; genital warts accounted for (sic)1.19 million in Veneto and (sic)171,406 in Marche. Finally, the mean cost per patient was (sic)4364 in Veneto and (sic)5176 in Marche.Conclusions The present work estimated the cost of HPV-related diseases for hospitalized patients in two Italian regions. The considerable estimated annual economic burden is a powerful driver for the governance of the public health sector