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In Italy, there is a lack of evidence regarding the care and management of patients with dementia, as well as the associated costs. This study aims to fill this informational gap by utilizing data from both literature and national surveys.
Methods
A prevalence-based cost-of-illness (COI) model was developed to assess dementia-related costs from a societal perspective. The resources utilization for management and treatment of patients with dementia was derived from both the literature and the analysis of surveys conducted by the National Institute of Health on the social-health structures dedicated to dementia. Indirect costs from informal caregiving were evaluated through a human capital approach. Additionally, a cost–consequence analysis (CCA) was conducted to assess the economic impact of healthcare resource utilization changes.
Results
Based on an estimated 1,150,691 dementia cases in Italy, with approximately 12 percent institutionalized, the COI model estimated an annual expenditure of around EUR23.6 billion (USD25.7 billion) for dementia patient management, with 63 percent attributed to out-of-pocket expenses. CCA indicated that if all affiliated with Centers for Cognitive Disorders and Dementia (CDCD) received nonpharmacological interventions (versus the surveyed 25.5 percent), there would be a direct cost increase of approximately EUR4.3 million (USD4.7 million).
Conclusions
This analysis provides an updated overview of current dementia patient management in Italy, offering valuable insights for decision-makers to prioritize health policies and interventions for patients and their caregivers.
In Italy, a fixed proportion of health spending is allocated to pharmaceutical expenditure. While the main objective of setting a budget for pharmaceuticals is to control spending, the effectiveness of this ceiling is questionable. This study aims to investigate the determinants of pharmaceutical expenditure for orphan drugs and gather information for effective planning and programming of pharmaceutical spending.
Methods
Data analysis relied on pharmaceutical companies’ pricing and reimbursement (P&R) dossiers submitted to the Italian Medicines Agency (AIFA) for drug-reimbursement approval, along with AIFA’s internal procedural documents. The study encompassed all rare disease drugs reimbursed from January 2013 to January 2019. For each drug, a comparison was made between the expected post-negotiation expenditure and the actual spending observed over the three years following reimbursement approval. Potential determinants of the normalized ratio between observed and expected spending were identified using univariate and multivariate beta regression models. The same methodology was replicated to identify potential determinants of the difference between expected spending before and after negotiation.
Results
Fifty-two rare disease drugs admitted for reimbursement during the study period were analyzed. The median expenditure in the first three commercialization years was 7.6 percent lower than the expected post-negotiation spending. Beta regression analysis indicated a significantly lower reduction for innovative drugs (β 0.736, p-value 0.011 univariate, β 0.585, p-value 0.045 multivariate). Similar effects were observed for P&R procedures (β 0.902, p-value 0.007) and the number of indications presented (β 0.754, p-value 0.021), but only in univariate model. Beta regression analysis for the expected expenditure ratio before/after negotiation revealed a significant effect only for the payment-by-result variable (β 1.485, p-value 0.001).
Conclusions
Observed expenditure for orphan drugs aligns with the expected spending post-negotiation. However, in the subgroup of innovative orphan drugs, the observed pharmaceutical spending was higher than estimated. This could be attributed to prescriber preferences and to a prevalent patient pool awaiting innovative treatment. It appears that the recognition of innovativeness favors orphan drugs that are rewarded with faster market access.
The study goal was to estimate prevalence of population in secondary prevention for Atherosclerotic Cardiovascular Disease (ASCVD) stratified by the pharmacological treatment and related outcomes using Health Information Systems (HIS).
Methods
From HIS of Marche and Umbria Regions (1.8 millions of inhabitants) which collect information related to hospitalizations, drugs prescriptions, outpatient visits and results of laboratory tests, we identified all patients aged ≤ 80 years with one or more hospitalization with DRG related to Acute Coronary Syndrome, Peripheral Artery Disease, Ischemic Stroke and Transient Ischemic Attack and discharge date between 2011 and 2014 (study period). Pharmacological treatment for each subject was defined selecting all prescriptions of Statins, Ezetimibe and Simvastatin/Ezetimibe, retrieved between the date of the last prescription in the study period and the previous 90 days. We stratified patient in no-treated, treated with low/medium intensity statins (LMS), high-dose statins (HDS) and other Lipid-Lowering Therapies (LLTs). Furthermore, for Umbria region, we selected the last blood levels test of LDL-cholesterol occurred in period 2011-2016. Starting from test date, we defined the pharmacological treatment in the previous 90 days. Subject were stratified based on LDL-C levels in target (<70) and not at-target (≥70) patients.
Results
Population in secondary prevention for ASCVD in period 2011-2014 in Marche and Umbria was estimated in 23,043 (prevalence: 4.3 x 1,000 inhabitants), corresponding to more than 800,000 subjects in Italian population. Within treated patients: 51.3% received LMS, 38.1% HDS and 10.6% other LLTs. No-treated patients were 27.8%. LDL-C target was achieved by 34.9% of patients treated with LMS and by 46.1% of patients treated with other LLTs.
Conclusions
The study, based on Italian administrative databases, allowed to estimate the very high risk population in secondary prevention for ASCVD. It highlighted a relevant proportion of no-treated patients, and an high proportion of patients that did not achieve recommended LDL-C target.
The objectives of this study were to estimate the economic burden of human papillomavirus (HPV) in Italy, accounting for total direct medical costs associated with nine major HPV-related diseases, and to provide a measure of the burden attributable to HPV 6, 11, 16, 18, 31, 33, 45, 52, 58 infections.
Methods:
A cost-of-illness incidence-based model was developed to estimate the incidences and costs of invasive cervical cancer, cervical dysplasia, cancer of the vulva, vagina, anus, penis, oropharyngeal, anogenital warts, and recurrent respiratory papillomatosis (RRP) in the context of the Italian National Health System (NHS). We used data from hospital discharge records (HDRs) of an Italian region and conducted a systematic literature review to estimate the lifetime cost per case, the number of incident cases, the prevalence of HPV9 types. Costs of therapeutic options not included in the diagnosis-related group (DRG) tariffs were estimated through a scenario analysis.
Results:
The total annual direct costs were EUR 540.7 million, with a range of EUR 338.3 – EUR 789.7 million. These costs could increase considering innovative therapies for cancers treatment (range EUR 16.2 – EUR 37.6 million). The fraction attributable to the HPV9 genotypes without innovative cancers treatment was EUR 329.2 million (range EUR 150.1 – EUR 576.7 million), accounting for sixty-one percent of the total annual burden of HPV-related diseases in Italy. Of this amount, EUR 136.7 million (forty-two percent) was related to men, accounting for sixty-four percent of the costs associated with non-cervical conditions.
Conclusions:
The infections by HPV9 strains and the economic burden of non-cervical HPV-related diseases in men were found to be the main drivers of direct costs. The fraction of the total direct lifetime costs attributable to infections by HPV9 strains and the economic burden of non-cervical HPV-related diseases in men were found to be the main drivers of direct costs.
The introduction of new biologic treatments has radically changed the management of Immune-mediated inflammatory diseases (IMID). Due to the high costs of the treatments a strong control and monitoring of claims databases could help decision makers to understand the consequences of their decisions.
The objective of the study was to identify the cohort of biologics treatment-naïve patients in the years 2011–2013 in the Lazio region (6 millions of inhabitants), in order to investigate the parameters influencing the biologic treatment expense at the regional level.
METHODS:
Patients were enrolled based on administrative databases of the Lazio region. Treatment-naïve patients were defined as subjects who did not have a prescription in the two years before the index prescription. Switcher patients were defined as those who had an Anatomical Therapeutic Chemical classification (ATC) prescription different than the one at enrolment, within one year of the index date. Treatment adherence was estimated as the number of doses actually prescribed as compared to the number indicated in the Summary of Product Characteristics (SPC).
RESULTS:
From a total number of 10,120 patients treated with biologic drugs between 2011–2013 in the Lazio region, 2,929 were estimated as treatment-naïve patients (42 percent male). The most frequently used drugs were etanercept (31 percent), adalimumab (30 percent) and infliximab (17 percent). Considering the disease treatment distribution, 28.6 percent of patients were treated for rheumatoid arthritis, 25.5 percent for psoriatic arthritis, 16.4 percent for psoriasis and the remaining patients for other diseases. Some patients switched biologic therapy (367), of which 22.6 percent were within the first 120 days. Total mean adherence was estimated in 87.7 percent: 21.5 percent of patients showed a low adherence (SPC< 60 percent) while 18.1 percent were estimated as dose increase patients (SPC>110 percent), 11.4 percent for rheumatic diseases, 32.3 percent for dermatological diseases and 26.9 percent for inflammatory bowel disease.
CONCLUSIONS:
The study provides a map of the current treatment settinga with biologics in the Lazio region considering the disease, adherence and prescribed treatments. A considerable number of treatment-naïve patients were identified (2,929), 12.5 percent of whom switched ATC within 1 year. Total mean adherence was estimated in 87.7 percent, low adherence occurred in 21.5 percent of patients, while dose-increase was in 18.1 percent.
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