Farmeconomia. Health economics and therapeutic pathways
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Cost of illness of community-acquired pneumonia. Review of the literature and possible strategies in the Serbian health care setting
Community-acquired pneumonia (CAP) represents a potentially severe illness with high incidence and significant economic impact. The estimated incidence varies from 1.6 to 13.4 cases/1000 inhabitants per year. Its burden of disease is attributed to high morbidity, mortality and serious health care utilization and expenditure throughout the world. The identification of determinants of high treatment costs could help in defining strategies for their reduction and more efficient use of the existing resources. In this article, a review of the existing literature about CAP cost-of-illness is provided, together with some considerations about possible strategies to decrease CAP costs in the Serbian health care setting. Available reports from cost-of-illness trials of CAP are relatively scarce. Most of them highlight the high costs generated by treatment protocols, with important differences between inpatients and outpatients. The inpatient cases of CAP varies from 18 to 60%. The therapy represents 10 to 15% of the overall costs of CAP. The costs of CAP treatment among inpatients are 7.9 times higher than those in outpatients. In case of complications and prolonged length of stay, this difference could even be 17 to 51 times higher. Frequent hospital admissions could be avoided, which would reduce the costs of CAP treatment. An important precondition for successful cost containment would be higher adherence to clinical guidelines, particularly reflected through Pneumonia Severity Index-a (PSI) application. Thus, it would be possible to significantly reduce the length of stay in hospital, in majority of patients, without jeopardizing their health or influencing the clinical course of illness
Clinical and economic profile of prucalopride in the treatment of chronic constipation in women
Chronic constipation is a common disorder, especially in women. Options available for different subgroups of constipation are limited and in most cases unsatisfactory. The most severe forms of chronic constipation often require the use of laxatives in high doses or the use of invasive therapies. The introduction of a new drug, such as prucalopride, active in promoting intestinal transit, can help to improve the therapy of patients with chronic idiopathic constipation who have not found relief from previous treatment with laxatives. In this review, after a brief discussion of pathophysiology and pharmacotherapy of chronic constipation, we evaluate the pharmacological profile, therapeutic and cost of prucalopride, recently authorized in the EU countries and also available in Italy for the treatment of chronic constipation in women who did not benefit from the use of laxative
Adherence to therapeutic guidelines among patients treated with statins. Results from STAR study
INTRODUCTION: the objective of this study was to analyze adherence to therapeutic guidelines among patients treated with lipid lowering drugs (statins).MATERIAL AND METHODS: a retrospective observational study including 5 Local Health Units (LHUs) was conducted using administrative databases. Patients who received at least one prescription for statins between January 1st, 2007 and June 30th, 2008 were selected and followed for 12 months. Patients were classified according to their level of absolute cardiovascular risk (moderate, high, very high according to Nota 13 AIFA).RESULTS: a total of 71,855 patients were included (14,133 newly treated patients with statins, representing 19.4% of total sample), (age 68.8±10.7, male 51%). Level of absolute cardiovascular risk were: moderate risk (45.4%), high risk (33.4%), very high risk (16.3%), familial hypercholesterolemia (4.9%). Statins assumed by patients in analysis were stratified in two groups (first or second choice), accordingly to their efficacy (level of LDL cholesterol reduction) in relation to the patient’s cardiovascular risk (coherently with new Nota 13 AIFA, 2011). Among patients with a very high cardiovascular risk, only 52.8% used statins indicated by Nota13 as a first choice while 2.9% used a second choice statin and 44.3% used an inadequate statin and/or dosage; among familial hypercholesterolemia patients, those percentages were, respectively: 53.8%, 21.1% and 25.1%. When only patients naïve to statins treatment were analyzed, similar percentages were found. Only few patients in very high risk group used adequate dosages: among patients treated with rosuvastatin and atorvastatin, 11.2% used atorvastatin 40 mg, and 0.2% used atorvastatin 80 mg (this population was not analyzed for events because of low numerosity) while 4.1% used rosuvastatin 20 mg and 0.2% used rosuvastatin 40 mg; overall, 84.3% of patients in this group used inadequate dosages. Cardiovascular events at one year of follow up were 1.6% for patients treated with rosuvastatin 20 mg, 1.6% for rosuvastatin 40 mg and 6.1% for atorvastatin 40 mg; death rates (any cause) were 0.9%, 0.0%, 2.6% respectively. The analysis of the sub-population of patients treated with rosuvastatin 20 mg with previous CV event showed a percentage of patients with a CV event during the observational period of 3.4%, a percentage of patients with cerebrovascular event of 0.9% and a mortality percentage of 0.9%.Conclusions: in real practice setting, the percentage of patients prescribed for recommended statins and dosages is low
Calabria
In Calabria region 56% of women (aged 24-64) are screened regularly, meaning every 3 years. The analysis on cross-protective activity exercised by bivalent and quadrivalent vaccines shows that the bivalent vaccine could prevent more pre-cancerous lesions and cases of cervicocarcinoma than quadrivalent, and that the latter could prevent genital warts that are not prevented by bivalent. The major number of cases avoided by the bivalent make it possible to fully offset the cost savings related to warts associated with the quadrivalent vaccine. Furthermore, a cost-effectiveness analysis shows that, considering regional tariffs, the multiple cohort (12-year-old + 25-year-old women) vaccination strategy with a 90% coverage could prevent 37 cases of cervicocarcinoma and 17 related deaths more than the vaccination of only 12-year-old girls, and thus proves to be cost-effective (9,767 €/QALY)
Valle d’Aosta
In Valle d’Aosta region 89% of women (aged 24-64) are screened regularly, meaning every 3 years. The analysis on cross-protective activity exercised by bivalent and quadrivalent vaccines shows that the bivalent vaccine could prevent more pre-cancerous lesions and cases of cervicocarcinoma than quadrivalent, and that the latter could prevent genital warts that are not prevented by bivalent. The major number of cases avoided by the bivalent make it possible to fully offset the cost savings related to warts associated with the quadrivalent vaccine. Furthermore, a cost-effectiveness analysis shows that, considering regional tariffs, the multiple cohort (12-year-old + 25-year-old women) vaccination strategy with a 90% coverage could prevent 1 case of cervicocarcinoma more than the vaccination of only 12-year-old girls, and thus proves to be cost-effective (11,365 €/QALY)
Clinical and economic impact of aliskiren in uncontrolled hypertensive patients
BACKGROUND: the majority of hypertensive patients do not achieve adequate blood pressure (BP) control and thus remain at risk of cardio-cerebrovascular events. Aliskiren, a novel antihypertensive drug acting as direct renin inhibitor, was authorized in Italy for the treatment of hypertension in patients who remain uncontrolled and at risk despite the use of at least two antihypertensive drugs. It was subject to an AIFA web-based monitoring registry. Results of the registry show a decrease of 20.8/9.2 mmHg in systolic/diastolic BP, within 6 months, when aliskiren is added to current therapy.OBJECTIVE: to evaluate the clinical and economic impact of such BP reduction in terms of avoidable cardio-cerebrovascular events.METHODS: an Excel-based Markov model compared aliskiren plus current antihypertensive treatment to current antihypertensive treatment alone over a 5-year horizon. Patients’ baseline characteristics and BP-reduction were taken from the AIFA registry and literature. Using Wilson and Anderson risk equations, the model simulated patient’s transitions from Pre-Event to Post-Event and Death, calculating the number of those who experience an event. Unit costs were assigned to treatments, events and follow-up. Sensitivity analyses considered: efficacy variability and societal costs of events.RESULTS: 2.47% of patients treated with aliskiren added-on to their antihypertensive therapy were expected to avoid an event. As observed in the AIFA registry, 19.8% of patients remained treated only with aliskiren whereas others reduced the number of antihypertensive treatments, leading to a 38.6% reduction of monthly concomitant antihypertensive treatment cost. Considering events and follow-up cost reduction, the per-patient annual incremental cost of aliskiren is calculated at € 187 and generates 0.042 QALYs over 5 years. The ICER was € 22,062 per QALY (€ 16,845 to € 30,771 for an efficacy range of ± 25%). Considering societal costs ICER was € 20,094 per QALY.Conclusions: AIFA registry real-world data confirmed aliskiren’s efficacy in uncontrolled hypertensive patients. Together with reaching their BP goals, patients consumed less medication from other antihypertensive drug classes and are expected to avoid cardio-cerebrovascular events. The ICER remained within acceptable thresholds, confirming that aliskiren represents a good investment in terms of health benefit
Assessment of the innovative quality of agomelatine through the Innovation Assessment Algorithm
Aim: the aim of this study was to assess the innovative quality of a medicine based on agomelatine, authorized by the European Commission through a centralized procedure on 19th February 2009 and distributed in Italy under the brands Valdoxan® and Thymanax®.Methodology: the degree of innovation of agomelatine was determined through the Innovation Assessment Algorithm (IAA), which considers the innovative quality of a medicine as a combination of multiple properties. The algorithm may be represented as a decision tree, with each branch corresponding to a property connected with innovation and having a fixed numerical value. The sum of these values establishes the degree of innovation of the medicine. The IAA is articulated in two phases: the first assesses the efficacy of the drug based on the clinical trials presented in support of the registration application (IAA-efficacy); the second reconsiders the degree of innovation on the basis of the efficacy and safety data resulting from clinical practice once the drug has been placed on the market (IAA-effectiveness).Results and conclusions: the score obtained for agomelatine was 592.73 in the efficacy phase and 291.3 in the effectiveness phase. The total score for the two phases was 884, which is equivalent to a good degree of innovation for the molecul
Abruzzo
In Abruzzo region 71% of women (aged 24-64) are screened regularly, meaning every 3 years. The analysis on cross-protective activity exercised by bivalent and quadrivalent vaccines shows that the bivalent vaccine could prevent more pre-cancerous lesions and cases of cervicocarcinoma than quadrivalent, and that the latter could prevent genital warts that are not prevented by bivalent. The major number of cases avoided by the bivalent make it possible to fully offset the cost savings related to warts associated with the quadrivalent vaccine. Furthermore, a cost-effectiveness analysis shows that, considering regional tariffs, the multiple cohort (12-year-old + 25-year-old women) vaccination strategy with a 90% coverage could prevent 16 cases of cervicocarcinoma and 7 related deaths more than the vaccination of only 12-year-old girls, and thus proves to be cost-effective (10,393 €/QALY)
HPV vaccination and allocative efficiency: regional analysis of the costs and benefits with the bivalent AS04-adjuvanted vaccine, from the perspective of public health, for the prevention of cervical cancer and its pre-cancerous lesions
Introduction: by means of the decisions on whether to introduce the HPV vaccination, Public Health has already established the importance of associating the vaccination strategy to the policy of secondary prevention. The screening + vaccination strategy is more effective than the two methods taken individually. In support of this combined strategy and in order to make available per each region concrete elements for their regional planning, an assessment has been made, which also takes into account the effect of cross-protection regarding high-risk strains not contained in both vaccines, bivalent and quadrivalent, and more frequently responsible for pre-cancerous lesions and cervical cancer (CCU). This analysis evaluates the costs and benefits of screening + vaccination strategy in a 12-year-old female cohort. Furthermore, the paper provides results that may be useful to assess the opportunity to extend the vaccination to a second cohort of 24-25-year-old women. The analysis is preceded by a brief summary of CCU epidemiology available data, public health policies that give precise guidelines for vaccination strategies and analytical tools suitable to support public policy makers to efficiently allocate resources. Methods: two different models were used for two regional analyses.The vaccines may have different sustained- and cross-protection levels against non-vaccine oncogenic HPV-types. In the first analysis, a prevalence-based model estimated the potential net difference in HPV-related lesions (abnormal pap smear, cervical intraepithelial neoplasia (CIN), cervical cancer (CC) and genital warts (GW)) and associated costs generated by the two vaccines. Vaccine efficacy rates were based on published data for each vaccine. Lifetime vaccine efficacy was assumed. Results are reported over one year after reaching a steady state. Incidence and treatment costs were obtained from Italian and European sources. We also performed a cost-effectiveness analysis with a Markov model for each Italian region, previously described and successfully adapted to the national scenario. The analysis compares the HPV vaccination of a single cohort (12-year-old females) with a multiple cohort (12- + 25-year-old girls). Resource use was based on a standard therapeutic path applied to all regions. However we quantified the impact of the so-called “decentralization progress” by collecting regional data on: pap test coverage, tariffs for treatments, and cost of the vaccination course. Results: the results are set out in 21 regional reports. Conclusions: in the Italian scenario, characterized by decentralization and local autonomy, a further level of detail is essential in order to describe the specific local settings and implications of a new health intervention. The results show that the vaccination on a multiple cohort is more effective than a single cohort. Indeed, a major number of pre-cancerous lesions, cases of cancer, and related deaths are avoided. In a period of sharp decline in the health budget, investment in prevention seems to be the most reasonable choice in view of avoiding in the medium term pre-cancerous and cancerous lesions generating a significant expense. Our analysis places the extent of HPV vaccination among the measures that the regional decision-makers should put in place to maximize the efficiency of scarce resource
Sicilia
In Sicilia region 64% of women (aged 24-64) are screened regularly, meaning every 3 years. The analysis on cross-protective activity exercised by bivalent and quadrivalent vaccines shows that the bivalent vaccine could prevent more pre-cancerous lesions and cases of cervicocarcinoma than quadrivalent, and that the latter could prevent genital warts that are not prevented by bivalent. The major number of cases avoided by the bivalent make it possible to fully offset the cost savings related to warts associated with the quadrivalent vaccine. Furthermore, a cost-effectiveness analysis shows that, considering regional tariffs, the multiple cohort (12-year-old + 25-year-old women) vaccination strategy with a 90% coverage could prevent 82 cases of cervicocarcinoma and 37 related deaths more than the vaccination of only 12-year-old girls, and thus proves to be cost-effective (10,534 €/QALY)