Farmeconomia. Health economics and therapeutic pathways
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Epidemiology and costs of HPV infection: review of the evidence
No full textHPV infection is a well-established cause of both benign and malign diseases. The HPV 16 and 18 genotypes are most commonly associated with cervical cancer whereas the HPV 6 and 11 genotypes are most commonly associated with anogenital warts. In Italy are currently approved two types of vaccine: Gardasil® is a tetravalent HPV 6, 11, 16 and 18 vaccine that prevents cervix cancer and genital warts, Cervarix® is a bivalent HPV 16 and 18 genotype vaccine that protects against cervical cancer and pre cancer forms. Aim of present study was to collect the available epidemiological data and the impact on the Italian National Health Service (NHS) budget of genital warts pathology. In Italy 40,000 genital warts cases per year could be estimated in the female population. The management cost in charge of Italian NHS for the female pathology is evaluated around 7 millions €. Comparing the available evidence NHS costs for genital wart pathology represent 3-4% of the total amount for prevention and treatment of cervix cancer
Umbria
Get PDFIn Umbria region 67,5% of women (aged 25-64) are screened regularly, meaning every 3 years.
Considering regional tariffs and vaccine acquisition cost, the vaccination of 12-year-old girls with a 90% coverage could prevent 13 cases of cervicocarcinoma and 6 related deaths and thus results to be cost-effective (23.398 €/QALY). When the vaccination programme is extended to 16-year-old girls a further 13 cancer cases and 5 deaths could be prevented, with a very similar cost-effectiveness ratio. In Umbria region, the net cost for woman vaccinated is 155 € for the single cohort and 159 € for the multiple cohort
Puglia
Get PDFIn Apulia region 43,9% of women (aged 25-64) are screened regularly, meaning every 3 years.
Considering regional tariffs and vaccine acquisition cost, the vaccination of 12-year-old girls with a 90% coverage could prevent 127 cases of cervicocarcinoma and 52 related deaths and thus results to be cost-effective (13.471€/QALY). When the vaccination programme is extended to 16-year-old girls a further 133 cancer cases and 54 deaths could be prevented, with a very similar cost-effectiveness ratio. In Apulia region, the net cost for woman vaccinated is 137€ for the single cohort and 141€ for the multiple cohort
Decision analytic economic paliperidone ER in relapsing schizophrenic patients in Italy
No full textSchizophrenia, with its typical chronic and relapsing course, is very burdensome, both clinically and economically. Its pharmacological management relies on two main drug classes: the older, or typical, antipsychotics, which are quite effective on positive symptoms, but limited by low tolerability and poor efficacy on negative symptoms, and atypical antipsychotics, which are better tolerated and effective on a wider range of psychotic symptoms. In this article, the authors briefly discuss current management options for patients with schizophrenia and highlight some unmet clinical needs in the field. After outlining the main clinical features shown by paliperidone ER, a novel antipsychotic, in its clinical development program, a decision analytic economic appraisal of its use in relapsing schizophrenic patients in Italy, as compared to the other available atypical antipsychotics, is presented. Under base-case assumption and after applying national costs and tariffs, the model predicts paliperidone ER to be associated with better clinical outcomes, expressed in terms of stable days, and lower costs; this means that paliperidone is dominant over the alternatives, according to the principles of economic evaluation of healthcare technologies. One-way sensitivity analyses conducted on structural and cost parameters indicated robustness of base-case estimates, which remain to be confirmed by “real world” national data
Piemonte
Get PDFIn Piedmont region 65% of women (aged 25-64) are screened regularly, meaning every 3 years.
Considering regional tariffs and vaccine acquisition cost, the vaccination of 12-year-old girls with a 90% coverage could prevent 69 cases of cervicocarcinoma and 29 related deaths and thus results to be cost-effective (24.955 €/QALY). When the vaccination programme is extended to 16-year-old girls a further 66 cancer cases and 28 deaths could be prevented, with a very similar cost-effectiveness ratio. In Piedmont region, the net cost for woman vaccinated is 187 € for the single cohort and 190 € for the multiple cohort
Natalizumab (Tysabri) in multiple sclerosis patients
No full textMultiple sclerosis (MS) is an autoimmune disease where dysregulated immune system elements (i.e. leucocytes) react against different components of the central nervous system (CNS), in particular myelin structures, causing several physical and mental symptoms,often progressing to total disability. While some treatments for MS provide only symptom relief, the most commonly drugs administered for altering the course of the disease are DMTs (disease-modifying therapies); nevertheless for more than ten years the only DMTs available were interferon β, glatiramer acetate (two immunomodulating drugs) and mitoxantrone (an immunosuppressant)
Friuli Venezia Giulia
Get PDFIn Friuli Venezia Giulia region 75,1% of women (aged 25-64) are screened regularly, meaning every 3 years. Considering regional tariffs and vaccine acquisition cost, the vaccination of 12-year-old girls with a 90% coverage could prevent 15 cases of cervicocarcinoma and 6 related deaths and thus results to be cost-effective (27.766 €/QALY). When the vaccination programme is extended to 16-year-old girls a further 14 cancer cases and 6 deaths could be prevented, with a very similar cost-effectiveness ratio. In Friuli Venezia Giulia region, the net cost for woman vaccinated is 167 € for the single cohort and 169 € for the multiple cohort
Cost-utility analysis of abatacept in rheumatoid arthritis in Italy
No full textObjective: a substantial number of patients with rheumatoid arthritis (RA) have an insufficient or unsustained response to Tumor Necrosis Factor-α antagonists (anti-TNFs). The aim of the present study was to estimate the cost-utility of abatacept, a new selective T-cell co-stimulation modulator, in patients with moderately to severely active RA and an insufficient response or intolerance to anti-TNFs in the Italian setting. Methods: a probabilistic patient level simulation model was developed to estimate long-term costs and health outcomes of abatacept versus anti-TNFs (etanercept, adalimumab, infliximab) in RA patients. The model predicted patients’ HAQ (Health Assessment Questionnaire) scores over time based on the initial response to treatment (% change in HAQ score at six months). Responding patients continued treatment with a reduced rate of HAQ progression until long-term treatment failure. Health-state utilities and use of health care resources (excluding RA therapies) were assumed to depend on HAQ scores. The model used data from a Phase III clinical trial of abatacept in patients with inadequate response to anti-TNFs (Abatacept Trial in Treatment of anti-TNF Inadequate Responders [ATTAIN]) and various secondary data sources. The study was performed using the National Health Service (NHS) perspective. Cost-utility of abatacept vs other anti-TNFs was derived in terms of incremental cost per quality-adjusted life-year (QALY) gained based on a lifetime horizon with costs expressed in Euros. Single-way sensitivity analyses were performed on key parameters. Costs and health effects were discounted at 3% annually. Results: abatacept therapy was estimated to yield 1.18 additional QALYs per patient (5.02 abatacept vs 3.84 anti-TNFs) at an incremental cost of € 21,996.41 based on a 20 years time horizon. Cost per QALY gained was € 18,567.24. These results were robust to variation of key model parameters and are well within the usual cost-utility acceptance ranges. Conclusions: This study shows that in Italy, compared to anti-TNFs, abatacept therapy is cost-effective in patients with moderately to severely active RA and with an insufficient response or intolerance to anti-TNFs
Cost-efficacy analysis of hormonal treatments for advanced prostate cancer
No full textIntroduction: prostatic cancer is the second more frequent cancer in Italy (after lung cancer) and is the third cancer-related death cause. Age is the principal risk factor and, given the ageing process undergoing in the Italian population, it seems clear that the public sanitary expenditure to treat the disease is bound to increase, arising the need to perform pharmacoeconomic evaluations of the therapeutic strategies available. Methods: we performed a cost/utility analysis, through a Markov model, of several hormonal therapies in patients with advanced prostate cancer who underwent radical prostatectomy, from the biochemical recurrence to death. Nine androgen suppression therapies were considered: orchiectomy, two nonsteroidal antiandrogens (NSAA), four luteinizing hormone-releasing hormone (LHRH) agonists, cyproterone acetate and the association of a NSAA and a LHRH (BAT). In the simulation the androgen suppression therapies were started at the PSA recurrence and never stopped until death. The model used the Italian NHS prospective and a time horizon corresponding to patient’s lifetime. Drug costs were calculated for each therapy, considering the less costly brand. Results: all the considered therapies produced a life expectancy (LE) of about 12 life years (LYs) with a small variability ranging from 12.3 LYs for BAT (the most effective) to 11.37 LYs for NSAA-flutamide (the least effective). Quality adjusted life expectancy ranged from 9.98 QALYs for BAT to 9.28 QALYs for NSAA-flutamide. The average cost per patient presented a more enhanced variability, from 12,538 Euro for orchiectomy to 59,496 Euro for NSAA-bicalutamide. Among all the alternatives orchiectomy resulted the most cost/effective alternative with a cost/utility ratio of about 1,300 Euro/QALY. In the LHRH-agonists class leuprorelin was the most cost/effective with about 2,200 Euro/QALY. A one-way sensitivity analysis showed a substantial stability of the results. Conclusions: BAT resulted the most effective therapy, but also the one associated with the highest expected cost. Orchiectomy was marginally less effective but at the same time generated the lowest cost and, thus, represented the most cost/effective strategy. Nonetheless, its application in actual clinical practice is difficult and quite always refused by patients. Among the class of LHRH-agonists leuprorelin (considering the less costly brand, Eligard®) dominated the alternatives and, thus, could provide an excellent therapeutic strategy
Pharmacoeconomic analysis of valsartan for the treatment of chronic congestive heart failure in Italy
No full textObjective: to evaluate pharmacoeconomic implications of the use of valsartan, an angiotensin II antagonist in addition to standard therapy for the treatment of chronic congestive heart failure (CHF). Methods: the study was conducted performing cost-utility and budget impact (B.I.) analyses by means of a cohort simulation based on a probabilistic Markov model and projecting 23-months follow-up results in the Val-HeFT trial study over a 10-years time horizon. The model included four states (class NYHA I, II and III and death), and had a cycle of 1 year. Two probabilistic simulations (varying first patients parameters and after model parameters) were performed using WinBUGS, a software for bayesian analysis. The distributions of patients parameters (sex, age, use of ACE inhibitors) corresponding to Val-HeFT inclusion criteria in the simulated population were derived from the Italian CHF patients population. Individual mortality was derived from general mortality by adjusting with a NYHA state-specific HR, and the probability of changing NYHA class from Val-HeFT. Costs were calculated in the perspective of the Italian NHS and account for drugs and CHF hospitalizations. Quality of life weights were obtained by elaborating published HRQoL data of CHF patients. A 3.5% annual discount rate was applied; probabilistic sensitivity analysis was performed on each parameter using original-source 95% CI, or a ±10% range where it was unavailable. Results: in the 10 years horizon, patients were estimated to live an average of 4.4 years or 3.2 QALYs, with slight increases in the valsartan group. In this group, hospitalizations are predicted to be sensitively reduced and overall costs decreased by about 500 €/pz. In subgroup analysis, valsartan loses dominance in NYHAII and ACE-using patients, for which ICURs are 17,330 and 27,000 €/QALY, respectively. B.I. analysis predicts a saving of about 172 millions €. Conclusions: valsartan in addition to standard therapy is predicted to be a cost/effective strategy for Italian patients with mild-to-severe CHF and cost-saving from the perspective of the NHS