Hospital resource utilisation from HPV-related diseases in England: a real-world cost analysis.

BACKGROUND AND OBJECTIVE: 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 objective of this study was to quantify the lifetime economic burden of HPV-related diseases based on hospital resources from the perspective of National Health Service (NHS) in England. METHODS: Patients' data were extracted, anonymised and aggregated by NHS digital from Hospital Episode Statistics (HES) database of patients admitted in 2015 and followed for three years. Data on hospitalizations were identified according to the International Classification of Diseases (ICD-10 CM). Health Resource Group (HRG) tariffs and National Reference Costs were used to estimate the hospitalization costs of anal, cervical, genital, oropharyngeal cancers as well as anogenital warts and cervical dysplasia. RESULTS: A total of 19,296 hospitalized patients were included in the estimation model, (39% was male and 61% female. At admission, the average age was 60 and 50 years old, respectively). Life-time costs per patients diagnosed with oropharyngeal cancer were £16,911 (£17,142 for male and £16,334 for female), penile cancer £12,539, vaginal cancer £12,676, anal cancer £13.773 (£12,590 for male, £14,525 for female). Cervical cancer accounted for £12,721, whereas cervical dysplasia for £3932. Resource used for hospitalized patients with anogenital warts was equal to £872 (£884 and £856 for men and women, respectively). On average, outpatient accounted for 39% of the total lifetime costs. CONCLUSION: The results of this study highlight that a substantial amount of resources is utilized for the treatment of HPV-related diseases at hospital level in England. These measures have the potential to inform policy decisions to ensure an optimal use of the NHS resources.

Human papillomavirus in Italy: retrospective cohort analysis and preliminary vaccination effect from real-world data.

INTRODUCTION: The objective of this study was to estimate the lifetime risk of hospitalization associated with all major human papillomavirus (HPV)-related diseases in Italy. Moreover, a preliminary vaccination effect was also performed. METHODS: A retrospective, nonrandomized, observational study was developed based on patients hospitalized between 2006 and 2018 in Italy. All hospitalizations were identified through administrative archives, according to the International Classification of Diseases (ICD-9 CM). Information related to the hospital discharges of all accredited public and private hospitals, both for ordinary and day care regimes, was taken into account. We included hospitalizations related to resident patients presenting one of the ICD-9-CM codes as primary or secondary diagnosis: genital warts (GW); 'cervical intraepithelial neoplasia (CIN)' (067.32-067.33); 'condyloma acuminatum' (078.11); 'anal cancers' (AC) (154.2-154.8); oropharyngeal cancers (OC): 'oropharyngeal cancer'(146.0-146.9) and 'head, face and neck cancers' (171.0); genital cancers (GC): 'penis cancer' (187.1-187.9) and 'cervical cancer' (180.0-180.9). Data were stratified by birth year and divided into two groups: (a) cohort born before 1996 (not vaccinable) and (b) cohort born after 1997 (vaccinable-first cohort that could be vaccinated at the beginning of immunization schedule in girls since 2008 in Italy). Disease-specific hospitalization risks for both groups were estimated by sex, year and age. RESULTS: Epidemiological data demonstrate that the peak hospitalization risk occurred at 24-26 years of age for GW (both male and female); 33-41 and 47-54 years for AC males and females, respectively; 53-59 and 52-58 years for OC males and females, respectively; and 54-60 and 39-46 years for GC males and females, respectively. Focusing on GW and GC, vaccinable females demonstrate a significant reduction in hospitalization risks (- 54% on average) compared to nonvaccinable females until 21 years of age (maximum follow-up available for girls born after 1997). Comparing the same birth cohort of males, no differences in hospitalization risk were found. CONCLUSIONS: These results support the importance of primary prevention strategies in Italy and suggest that increased VCRs and time of observation (genital cancers for which vaccination is highly effective, have a latency of some decades) will provide useful information for decision-makers.

Economic burden of HPV9-related diseases: a real-world cost analysis from Italy.

INTRODUCTION: The objectives of this study were to estimate the economic burden of 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: In 2018, the total annual direct costs were €542.7 million, with a range of €346.7-€782.0 million. These costs could increase considering innovative therapies for cancer treatment (range €16.2-€37.5 million). The fraction attributable to the HPV9 genotypes without innovative cancers treatment was €329.5 million, accounting for 61% of the total annual burden of HPV-related diseases in Italy. Of this amount, €135.9 million (41%) was related to men, accounting for 64% 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.

Economic evaluation of the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSIs) from the national payer perspective: introduction of a new treatment to the patient journey. A simulation of three European countries.

Background: The aim of this study was to develop a spending predictor model to evaluate the direct costs associated with the management of ABSSSIs from the National health-care provider's perspective of Italy, Romania, and Spain. Methodology: A decision-analytic model was developed to evaluate the diagnostic and clinical pathways of hospitalized ABSSSI patients based on scientific guidelines and real-world data. A Standard of Care (SoC) scenario was compared with a dalbavancin scenario in which the patients could be discharged early. The epidemiological and cost parameters were extrapolated from national administrative databases (i.e., hospital information system). A probabilistic sensitivity analysis (PSA) and one-way sensitivity analysis (OWA) were performed. Results: Overall, the model estimated an average annual number of patients with ABSSSIs of approximately 50,000 in Italy, Spain, and Romania. On average, the introduction of dalbavancin reduced the length of stay by 3.3 days per ABSSSI patient. From an economic perspective, dalbavancin did not incur any additional cost from the National Healthcare perspective, and the results were consistent among the countries. The PSA and OWA demonstrated the robustness of these results. Conclusion: This model represents a useful tool for policymakers by providing information regarding the economic and organizational consequences of an early discharge approach in ABSSSI management.

Economic burden of diverticular disease: An observational analysis based on real world data from an Italian region.

INTRODUCTION: Diverticular disease (DD), a herniation of the colonic mucosa through the muscle layer, covers a wide variety of conditions associated with the presence of diverticula in the colon. The most serious form is an acute episode of diverticulitis, which can lead to hospitalization and surgery with various types of consequences. The main aim of this study is to evaluate the economic burden of hospitalizations arising from acute episodes of diverticulitis using data from the administrative databases used in the Marche region in Italy and, as a secondary objective of this real-world data analysis, to study patient outcome variables following initial hospitalization for diverticulitis. METHOD: A deterministic linkage was performed at individual user level between the different administrative sources of the Marche region through anonymous ID number for a period of analysis between 1 January, 2008 and 31 December, 2014. We enrolled all patients with at least one hospitalization for "diverticulitis of the colon without mention of haemorrhage" (ICD-9-CM code 562.11) or "diverticulitis of the colon with haemorrhage" (ICD-9-CM code 562.13) as primary or secondary diagnosis. For each patient we assessed the cost of hospitalization, of medicines and of specialist services considering a time-scale of one year or cohort analysis 365days after first admission. RESULTS: The total number of residents in the Marche region who had at least one hospitalization for diverticulitis in the period 2008-2014 was 2987 (427 patients a year, corresponding to about 35 patients per 100,000 adult residents); the total number of admissions was 3453 (just over 490 a year). The direct healthcare costs incurred by the Marche region for episodes of diverticulitis in 2008-2014 amounted to approximately €11.4 million (€1.6 million a year), of which €10.9 million (95.5%) for the hospitalizations, € 246,000 (2.1%) for pharmaceutical treatment and €270,000 (2.4%) for specialist outpatient services. The average annual cost per patient was €3826, of which €3653 was for hospitalization, while pharmaceutical expenditure and specialist services accounted for €83 and €90, respectively. The cohort of patients undergoing a first admission for diverticulitis between 2010 and 2013 was made up of 1729 people (54.4% women, mean age 68.9 years), of whom 1500 (86.8%) did not undergo surgery while in hospital. Hospital mortality, recorded only for the over-65 age class, averaged 1.2%; for patients not receiving surgery during the initial hospitalization it was 0.5%, reaching 5.2% in patients undergoing surgery. The percentage of patients with one or more readmissions for diverticulitis within a year of the first was on average 7.8% and in 48% of cases this resulted in surgery. CONCLUSIONS: Our study is the first analysis in Italy to use real-world data to measure the financial impact of diverticular disease. Assuming that the diagnostic and therapeutic behaviour identified in the Marche region could be representative of the situation nationwide, the estimated annual number of hospitalizations in Italy for acute episodes of diverticulitis is 19,000. The total amount of economic resources needed to treat patients suffering from acute episodes of diverticulitis is estimated at €63.5 million a year.

Treatment plan comparison in acute and chronic respiratory tract diseases: an observational study of doxophylline vs. theophylline.

BACKGROUND: The main objective of this article is to estimate the global cost related to the use of the two drugs (associated drugs, specialist visits, hospital admissions, plasma drug monitoring). METHODS: The drug prescriptions were extracted from the Information System of the Pharmaceutical Prescriptions of the Marche Region for each ATC code in the years 2008-2012 and the number of patients per year and other outcomes measure were obtained. RESULTS: 13,574 patients were treated with theophylline and 19,426 patients with doxophylline. The number of patients treated was approximately 5,000 per year. Co-prescription with other drugs, use of corticosteroids, mean number of visits and hospital admissions (per 100 patients) were lower for doxophylline vs theophylline (1.55vs5.50, 0.3vs0.7, 2.05vs3.73 and 1.57vs3.3 respectively). The annual mean cost per patient was €187.4 for those treated with doxophylline and €513.5 for theophylline. CONCLUSIONS: In our study, doxophylline resulted to be associated with a reduction of the overall cost.

Economic aspects in the management of diabetes in Italy.

BACKGROUND: Diabetes mellitus (DM) is a chronic-degenerative disease associated with a high risk of chronic complications and comorbidities. The aim of this study is to estimate the average annual cost incurred by the Italian National Health Service (NHS) for the treatment of DM stratified by patients' comorbidities. Moreover, the model estimates the economic impact of implementing good clinical practice for the management of patients with DM. METHODS: Data were extrapolated from administrative database of the Marche Region and specific inclusion and exclusion criteria were developed from a clinical board in order to estimate patients with DM only, DM+1, DM+2, DM+3 and DM+4 comorbidities (cardiovascular disease, neuropathy, nephropathy and retinopathy). Regional data were considered a good proxy for implementing a previously developed cost-of-illness (COI) model from Italian NHS perspective already published. A scenario analysis was considered to estimate the economic impact of good clinical practice implementation in the treatment of DM and its comorbidities in Italy. RESULTS: The model estimated an average number of patients with DM per year in the Marche region of 85.909 (5.5% of population) from 2008 to 2011. The mean costs per patients with DM only, DM+1, DM+2, DM+3 and DM+4 comorbidities were €341, €1,335, €2,287, €5,231 and €7,085 respectively. From the Italian NHS perspective, the total economic burden of DM in Italy amounted to €8.1. billion/year (22% for drugs, 74% for hospitalization and 4% for visits). Scenario analysis demonstrates that the implementation of good clinical practice could save over €700 million per year. CONCLUSIONS: This model is the first study that considers real world data and COI model to estimate the economic burden of DM and its comorbidities from the Italian NHS perspective. Integrated management of the patients with DM could be a good driver for the reduction of the costs of this disease in Italy.

Cost of poor adherence to anti-hypertensive therapy in five European countries.

The financial burden for EU health systems associated with cardiovascular disease (CV) has been estimated to be nearly €110 billion in 2006, corresponding to 10% of total healthcare expenditure across EU or a mean €223 annual cost per capita. The main purpose of this study is to estimate the costs related to hypertension and the economic impact of increasing adherence to anti-hypertensive therapy in five European countries (Italy, Germany, France, Spain and England). A probabilistic prevalence-based decision tree model was developed to estimate the direct costs of CV related to hypertension (CV defined as: stroke, heart attack, heart failure) in five European countries. Our model considered adherence to hypertension treatment as a main driver of blood pressure (BP) control (BP < 140/90 mmHg). Relative risk of CV, based on controlled or uncontrolled BP group, was estimated from the Framingham Heart Study and national review data. Prevalence and cost data were estimated from national literature reviews. A national payer (NP) perspective for 10 years was considered. Probabilistic sensitivity analysis was performed in order to evaluate uncertainty around the results (given as 95% confidence intervals). The model estimated a total of 8.6 million (1.4 in Italy, 3.3 in Germany, 1.2 in Spain, 1.8 in France and 0.9 in England) CV events related to hypertension over the 10-year time horizon. Increasing the adherence rate to anti-hypertensive therapy to 70% (baseline value is different for each country) would lead to 82,235 fewer CV events (24,058 in Italy, 7,870 in Germany, 18,870 in Spain, 24,855 in France and 6,553 in England). From the NP perspective, the direct cost associated with hypertension was estimated to be 51.3 billion (8.1 in Italy, 17.1 in Germany, 12.2 in Spain, 8.8 in France and 5.0 in England). Increasing adherence to anti-hypertensive therapy to 70% would save a total of 332 million (CI 95%: €319-346 million) from the NPs perspective. This study is the first attempt to estimate the economic impact of non-adherence amongst patients with diagnosed hypertension in Europe, using data from five European countries (Italy, France, Germany, Spain and England).