Patrizia Berto

Economic evaluation of sublingual immunotherapy vs symptomatic treatment in adults with pollen-induced respiratory allergy: the Sublingual Immunotherapy Pollen Allergy Italy (SPAI) study

BACKGROUND Few data are available on the pharmacoeconomic aspects of immunotherapy. OBJECTIVE To evaluate, from the health care system and societal perspectives, the costs and consequences of sublingual immunotherapy (SLIT) added to pharmacotherapy compared with drugs alone for respiratory allergy. METHODS This study compared costs, clinical outcomes, and cost-effectiveness ratios of 2 strategies in the management of allergic rhinitis and asthma, namely, SLIT associated with pharmacotherapy and pharmacotherapy alone (no SLIT). A decision tree was developed and populated with epidemiologic and resource utilization data concerning approximately 2,200 patients. Direct costs included visits, tests, pharmacotherapy, immunotherapy, and hospitalizations. Indirect costs and out-of-pocket drugs were also included. Outcome was calculated as the number of improved patients and asthma cases avoided at 6 years. Sensitivity analysis was performed by varying costs and epidemiologic data. RESULTS SLIT improved the symptoms of 399 of 1,000 patients and prevented asthma in 229 of 1,000 patients compared with drugs alone. For SLIT added to pharmacotherapy and pharmacotherapy alone, the direct cost per patient at more than 6 years was Euro2,400 and Euro3,026, whereas the indirect cost was Euro1,913 and Euro3,400. CONCLUSION From both perspectives and for both effectiveness end points, SLIT is less expensive and more effective than pharmacotherapy alone.

Cost-effectiveness of 123I-FP-CIT SPECT in the differential diagnosis of essential tremor and Parkinson's disease in Italy.

Economic evaluation (Italian NHS perspective) modeling 123I‐FP‐CIT SPECT (DaTSCAN®) compared to clinical judgment alone for differentiating essential tremor (ET) from Parkinsons Disease (PD). A 5‐year Markov model was constructed to assess the cost‐effectiveness of 123I‐FP‐CIT SPECT to differentiate ET from PD in patients referred to a movement disorder specialist in Italy. Published data and a double‐round, Delphi panel of 12 specialists populated the model. Effectiveness was expressed as the projected Years on potentially beneficial therapy (PBTYs). Costs were expressed in Euros (2005 values). The model suggests that over 5 years, the “current” diagnostic pathway generated an average of 2.3 PBTYs/patient at an estimated cost of €8,864. 123I‐FP‐CIT SPECT generated an average of 4.1 PBTYs/patient at an estimated cost of €8,422, which represented an additional 1.8 PBTYs at a cost saving of €442/patient (€341 when discounted at 5%). The estimated cost‐effectiveness of 123I‐FP‐CIT SPECT is under €1,000 per PBTY gained when the underlying disease prevalence is high (55–70%), and cost‐saving at prevalence under 55%. 123I‐FP‐CIT SPECT is likely to be regarded as economically advantageous to differentiate ET from PD, increasing time on potentially beneficial therapy at a lower overall cost to the healthcare system.

Comparison of costs of sublingual immunotherapy and drug treatment in grass-pollen induced allergy: results from the SIMAP database study

ABSTRACT Objectives: This analysis is focused on the comparison of costs of allergic rhinitis (R) alone or with allergic asthma (R + A) in grass pollen allergy, for subjects treated with sublingual immunotherapy (SLIT) and symptomatic drugs, versus standard care controls. Methods: The SIMAP (Sublingual IMmunotherapy in Allergic Patients) study is a longitudinal observational database operated by a network of Allergy centers. Patients suffering from grass pollen allergy were included in this analysis and assigned to SLIT (plus drugs as needed) or to treatment with drugs alone. Outcome measures included use of medications, SLIT, visits and tests. Costs were assessed from the perspective of the Italian National Health Service; unit costs were obtained from published sources to produce an average cost/patient for the first year after enrolment. Results: One hundred and two patients were analyzed. Demographics were comparable in the two groups. Overall per patient yearly cost of treatment was higher in SLIT patients, both in the whole sample (€311 vs. €180/patient), in the R (€288 vs. €116) and R + A (€362 vs. €230) subpopulations, with R + A patients generating more costs than R patients in both groups. Nevertheless considerable savings were obtained in the cost of symptomatic drugs (−22% for R; −34% for R + A) in SLIT patients. Conclusions: Other studies have shown that SLIT can reduce the use of drugs for asthma and rhinitis, but this is the first time this outcome has been demonstrated in a routine care population (in the medical practice environment of an observational study) within the first year of treatment.

Specific immunotherapy by the sublingual route for respiratory allergy

Specific immunotherapy is the only treatment able to act on the causes and not only on the symptoms of respiratory allergy. Sublingual immunotherapy (SLIT) was introduced as an option to subcutaneous immunotherapy (SCIT), the clinical effectiveness of which is partly counterbalanced by the issue of adverse systemic reactions, which occur at a frequency of about 0.2% of injections and 2-5% of the patients and may also be life-threatening. A large number of trials, globally evaluated by several meta-analyses, demonstrated that SLIT is an effective and safe treatment for allergic rhinitis and allergic asthma, severe reactions being extremely rare. The application of SLIT is favored by a good compliance, higher than that reported for SCIT, in which the injections are a major factor for noncompliance because of inconvenience, and by its cost-effectiveness. In fact, a number of studies showed that SLIT may be very beneficial to the healthcare system, especially when its effectiveness persists after treatment withdrawal because of the induced immunologic changes.

Economic evaluation of sublingual immunotherapy vs symptomatic treatment in allergic asthma

BACKGROUND The worldwide increased prevalence of allergic diseases, and especially of respiratory allergy, is paralleled by increased health costs. This requires consideration of the cost to efficacy ratio of the available treatment to identify the optimal choice. OBJECTIVE To compare the different economic relevance, over a long evaluation time, of symptomatic pharmacologic therapy and sublingual immunotherapy (SLIT) in patients with allergic asthma. METHODS Seventy patients with perennial allergic asthma, sensitized to dust mites, were enrolled; 50 of these patients were treated with SLIT against house dust mites and 20 were treated with symptomatic drugs. The patients were evaluated for 2 years after discontinuing immunotherapy, which was performed for 3 years, to obtain a more complete follow-up. Symptom scores, medication scores, and all other direct medical costs were evaluated with a specific questionnaire. RESULTS Patients treated with SLIT plus drugs had a higher mean annual cost in the first year of SLIT treatment compared with patients only receiving drug treatment, but the mean annual cost became significantly lower since the end of SLIT both in the whole population and in the subgroups defined by disease severity. CONCLUSION The economic advantage measured alongside this prospective observational study was long lasting and still present at the fifth year of the follow-up (2 years after discontinuing SLIT) and could positively be related to the persistent good clinical control of patients.

Patient perspective on the management of atrial fibrillation in five European countries

BackgroundLong-term management of chronic conditions, such as atrial fibrillation (AF), require frequent interactions with the healthcare systems. The multinational EUropean Patient Survey in Atrial Fibrillation (EUPS-AF) was conducted to investigate patient satisfaction with AF management in different of five European healthcare systems at a time of changing treatment paradigms for stroke prophylaxis, prior to the advent of newer oral anticoagulants.MethodsAdults (>18 years) were recruited at random from the total populations of France, Germany, Italy, Spain and the UK using a randomized telephone dialling system. At least 300 respondents per country reporting to have a diagnosis of AF or receiving oral anticoagulation therapy for suspected AF or to have a heart rhythm disturbance completed a structured telephone interview.ResultsMost respondents were satisfied with their treatment for AF over the previous 12 months, with 85.5% (n = 1289) rating their care as good or better. Suboptimal clinical practices, however, were identified in several key areas. Coordination of primary and secondary care and a lack of patient engagement and support were particular issues, especially for those patients likely to have extensive contact with their healthcare system.ConclusionsIn the context of Europe-wide guidelines for management of AF, most patients with AF were satisfied with their care, but for a greater proportion of patients, some aspects are unsatisfactory. Patient-centred surveys, such as the EUPS-AF, are crucial for understanding the factors that contribute to patient satisfaction and compliance with long-term treatment for chronic conditions.

The PANDORA project : results of the cost of illness analysis

Aims: To evaluate the cost of illness from hypertension for the Italian National Health System (NHS).Methods and Results: A prospective analysis was carried out on clinical and economic data recorded in the general practitioners’ (GPs) database. Twenty-one GPs working in the Ravenna area in Italy took part in the project on a voluntary basis. The study included 1047 hypertensive patients enrolled between 1 June and 31 December 1997 and continued for 365 days from the date of enrolment. The following costs were calculated: antihypertensive drugs, laboratory tests and instrumental procedures, GP visits for blood pressure control, specialist visits, casualty visits, hospitalisation due to cardiovascular problems. In the whole sample, the most relevant cost is due to antihypertensive drugs (42.7%), followed by hospital admission (28.4%), GP visits (15.1%) and tests (10.6%). The total mean cost was significantly lower in incident (no previous treatment) than in prevalent patients (already treated) (457 512 vs 725 573 Italian Lira (ITL), P < 0.05) and in older rather than in younger patients (1171 410 vs 796 452 (ITL) P < 0.05). (In the text the equivalent is given in Euros, Pounds Sterling and US dollars).Conclusion: Our study should be considered as preliminary, nevertheless it could represent a step towards the evaluation of the true cost of hypertension.

Analisi costo-efficacia di rituximab + CHOP versus CHOP in soggetti affetti da linfoma non-Hodgkin aggressivo

SummaryObjectiveAim of this study was to evaluate the cost-effectiveness of rituximab + CHOP (R-CHOP) versus CHOP alone, in Italian patients with aggressive Non-Hodgkin lymphoma (NHL), in the NHS’ perspective.DesignThe economic analysis is based on an existing Markov model which was developed to evaluate costs and effects for two hypothetical cohorts of patients aged ≥ 60 years or aged < 60 years respectively, over a time frame of 15 years after administration of chemotherapy. The model is based on five health states (start therapy, complete response, no response, progression, death) and combines efficacy data from published clinical trials (GELA-98-5) with costs of therapies and follow-up after chemotherapy, based on Italian treatment patterns. Costs and effects were discounted respectively at 6% and 1.5% per year. Extensive 1-way and Monte Carlo sensitivity analyses were conducted to test the robustness of results.ResultsFor the two cohorts (age ≥ 60 or age < 60 years), incremental discounted survival gains with R-CHOP vs. CHOP were respectively 1.08 and 1.02 years per patient; incremental QALYs were 1.15 and 1.04 per patient; incremental cost/patient was €14 838 and €13 938; the incremental cost per life-year gained (cost/LYG) was therefore €13 732 and €13 717, while the incremental cost/QALY gained was €12 879 and €13 362.ConclusionsThe clinical advantage of R-CHOP is supported by values of incremental cost/LYG and cost/QALY gained, which are well below the thresholds commonly indicated both in the international and Italian literature. R-CHOP is a substantial improvement in the treatment of aggressive NHL, at a reasonable cost, in the perspective of the Italian NHS.

The Pandora Project: Cost of Hypertension from a General Practitioner Database

Aim: The Pandora Project is a longitudinal database - implemented by general practitioners since June 1997 in the Ravenna area (Italy) - providing information on patients with hypertension. Data from 1651 patients were followed up for 1 year in order to investigate the cost of hypertension. Only direct medical costs were considered in the perspective of the National Healthcare System. Findings : At enrolment, 552 patients were classified as normotensive, 1099 as hypertensive. After 1 year, among normotensive group, 352 patients remained normotensive and 200 became hypertensive; among hypertensive group, 323 patients became normotensive and 776 remained hypertensive. The average total cost per patient at follow-up was 779.59 Euros. About 46% of total cost was due to anti-hypertensive therapy, irrespective of the evolution of blood pressure levels registered, whilst other direct costs represented 54% of total patient cost in all cohorts. It is possible that co-morbidities play a significant role in this situation. Patient aged 80-89 years generate higher costs. Even if further investigation is needed on the burden of comorbidity on a per-patient cost of hypertension, this work provides evidence that the average total cost per patient is likely to increase with age and co-morbidities.

Cost-Effectiveness Analysis for Statin Therapies in the Primary Prevention of Coronary Heart Disease in Italy

AbstractObjective: The objective of this analysis was to compare the costs, benefits and cost effectiveness of two dosage regimens of cerivastatin (0.2 and 0.4 mg/day) with Italian National Health Service (NHS) reimbursed comparative statins in the primary prevention of coronary heart disease in Italy. This study is part of a broader analysis undertaken in five European countries. Design and Setting: A cost-effectiveness analysis (CEA) was performed, as the interventions have the same treatment objectives but vary in terms of magnitude of effectiveness. This CEA compared alternative treatments both in the NHS and from societal perspectives. Patients: A coronary heart disease risk assessment model, based on intervention study data from the Lipid Research Clinics Coronary Primary Prevention Trial, was used. This was augmented with demographic, disease, life expectancy, pharmacological and economic data for patients with coronary heart disease in Italy. Results: In terms of average cost effectiveness, our analysis showed that cerivastatin 0.2 mg/day compared favourably with pravastatin 20 mg/day, and compared similarly with simvastatin 20 mg/day in all age groups studied. The study also demonstrated that cerivastatin 0.4 mg/day compared favourably with both simvastatin 40 mg/day and pravastatin 20 mg/day. These results were consistent for both the NHS and societal perspective.The incremental cost per life-year gained [in 1998 Italian lire (L)] of simvastatin versus cerivastatin ranged from about L40 million [or Euro (Eur)20 658] to greater than L650 million (or Eur335 697). Cerivastatin 0.2 mg/day was more cost-effective than pravastatin 20 mg/day, while the incremental cost per life-year gained for cerivastatin 0.4 mg/day versus pravastatin 20 mg/day ranged from L11.1 million (or Eur5733) to L31.8 million (or Eur16 423) in the three age groups (35 to 39 years, 50 to 54 years and 65 to 69 years) for both perspectives. Conclusions: The results of this study showed that in primary prevention, average cost-effectiveness ratios of cerivastatin compared favourably with those of the other pharmacological interventions available on the Italian market.