Cost-benefit of reflectance confocal microscopy in the diagnostic performance of melanoma.

BACKGROUND: The sub-optimal diagnostic accuracy for melanoma leads to excise a high number of benign lesions, with consequent costs. Reflectance confocal microscopy (RCM) improves diagnostic specificity, thus possibly inducing a reduction in unnecessary excisions and related costs. OBJECTIVE: To estimate the influence of RCM on number of benign lesions needed to excise (NNE) a melanoma, in term of clinical outcomes and costs per patient. PATIENTS AND METHODS: Skin neoplasms excised by the dermatology public service in the Province of Modena were retrieved form centralized pathology database. Differences in NNE between the territorial service (using dermoscopy only) and the University Hospital (adding also RCM to the patients' workflow) were calculated and cost analysis was performed through a micro-costing approach. RESULTS: A large reduction in benign lesions excised at University Hospital was evident, leading to NNE of 6.25 for University Hospital, compared to 19.41 for Territorial Dermatology. Since 4320 unnecessary excisions can be saved every million inhabitants, an overall yearly saving of over 280,000 Eur can be expected from the use of RCM. CONCLUSIONS: The systematic use of RCM was dramatically affecting the number of benign lesions excised, and this can be translated in a significant cost-benefit advantage.

Human recombinant follicle stimulating hormone (rFSH) compared to urinary human menopausal gonadotropin (HMG) for ovarian stimulation in assisted reproduction: a literature review and cost evaluation.

BACKGROUND: Gonadotropins are protein hormones which are central to the complex endocrine system that regulates normal growth, sexual development, and reproductive function. There is still a lively debate on which type of gonadotropin medication should be used, either human menopausal gonadotropin or recombinant follicle-stimulating hormone. The objective of the study was to perform a systematic review of the recent literature to compare recombinant follicle-stimulating hormone to human menopausal gonadotropin with the aim to assess any differences in terms of efficacy and to provide a cost evaluation based on findings of this systematic review. METHODS: The review was conducted selecting prospective, randomized, controlled trials comparing the two gonadotropin medications from a literature search of several databases. The outcome measure used to evaluate efficacy was the number of oocytes retrieved per cycle. In addition, a cost evaluation was performed based on retrieved efficacy data. RESULTS: The number of oocytes retrieved appeared to be higher for human menopausal gonadotropin in only 2 studies while 10 out of 13 studies showed a higher mean number of oocytes retrieved per cycle for recombinant follicle-stimulating hormone. The results of the cost evaluation provided a similar cost per oocyte for both hormones. CONCLUSIONS: Recombinant follicle-stimulating hormone treatment resulted in a higher oocytes yield per cycle than human menopausal gonadotropin at similar cost per oocyte.

Cost-effectiveness analysis of topical treatments for actinic keratosis in the perspective of the Italian health care system.

Actinic keratosis (AK) is the most common cutaneous malignant neoplasm and its prevalence continues to increase. According to the most recent findings, AK is currently considered the initial stage, in situ, of squamous cell carcinoma. Field-directed therapies for AKs are the preferred treatment since they have the advantage to clear the clinically visible lesions and also subclinical lesions within the cancerous field. We assessed the cost-effectiveness of topical treatments for AKs including 3% diclofenac in 2.5% hyaluronic acid (HA) gel, imiquimod 5% cream and photodynamic therapy with methyl aminolevulinate (MAL-PDT) in the perspective of the Italian Health Care System (SSN). We used a decision tree analytical approach and efficacy data were drawn from published clinical trials. Cost was evaluated from the SSN perspective during a time horizon of 3 months. A responder was defined as a patient with all lesions clinically cleared and showing an excellent cosmetic result. Based on the applied model, the cost per complete responder was calculated. Diclofenac 3% in HA was less expensive (Euro 256) than MAL-PDT (Euro 320) and imiquimod (Euro 342). Effectiveness was similar and better for diclofenac 3% in HA and MAL-PDT (0.813%) in comparison to 0.734% of imiquimod, respectively. The one-way and probabilistic sensitivity analyses confirmed the results of base case scenario. Based on this cost-effectiveness model, diclofenac 3% in HA can be considered the treatment of choice for AK lesions and surrounding field under a pharmacoeconomic point of view.

[How much does an antiinflammatory treatment cost?]. / Quanto costa una terapia con antinfiammatori?

NSAIDs are among the most popular drugs in the world for their efficacy in controlling pain and acute and chronic inflammation. The efficacy of these therapies is hampered by their safety profile, in particular regarding the gastroenteric tract. The NSAIDs' side effects may heavily influence the health of the single patient and the economy of the health systems. The pharmacoeconomic evaluation of antinflammatory treatment usually considers, in addition to the drug purchase prize, also the shadow costs. This cost is mainly due to the management and prevention of gastropathy. Coxibs, even if more expensive, may become cost-effective for their better gastronteric safety. As a matter of fact, coxib treatment can be considered equivalent to a treatment with NSAID plus PPI. However, the first requirement of these drugs, that should control pain, must be the efficacy and not only safety. In this case the NNT (Number Needed to Treat) is a good marker of efficacy. To calculate the real cost we must pay to reach the target (pain resolution in one patient), we can multiply NNT for the prize of a specific drug. The total cost will depend on drug prize (the cheaper, the better) and on the efficacy expressed by NNT (the lower, the better). In a recent meta-analysis, the NNT of several antinflammatory drugs has been calculated. When the treatment cost was adjusted for its efficacy (NNT), the difference in favour of NSAIDs became so little to disappear because of the higher safety of coxibs (especially of etoricoxiband the possibility to reach antinflammatory and analgesic doses that are difficult to obtain with NSAIDs. Moreover, if also the cost of gastroprotection is considered, the economic impact of NSAIDs can be much higher. In conclusion the pharmacoeconomic analysis of an antinflammatory therapy cannot be based only on safety issues but also on efficacy evaluation that is the main effect we ask to these drugs.

Pattern of use, economic burden and vial optimization of infliximab for rheumatoid arthritis in Italy.

OBJECTIVE: The aim of this study was to retrospectively examine the pattern of utilization in clinical practice and the costs of therapy of infliximab in the treatment of refractory rheumatoid arthritis (RA). METHODS: Ninety-five RA patients (22 newly treated and 73 maintenance patients) who received at least one infliximab infusion during a selected observation period of one year were studied. After induction phase, infliximab was given at initial dose of 3 mg/kg every 8 weeks. Based on clinical efficacy measured by Disease Activity Score 28 (DAS 28) index, dose adjustments were performed by increasing pro kg dose and/or reducing infusion interval. Overall one-year's treatment costs were also examined. RESULTS: Sixteen (17%) out of 95 patients discontinued treatment before the end of the study owing to lack of efficacy (15) or adverse events (1). Thirteen (59%) out of 22 newly treated patients experienced treatment escalation in the first year of therapy by increasing dose (13.6%), reducing interval (9%), or both (36.3%). The mean infliximab dose administered to all the patients was 3.57 mg/kg and the mean infusion interval was 50 days. Considering all expenditure items, the mean year treatment cost per patient was euro 8454,65. Infliximab vial optimization allows us to reduce this amount to euro 7505,85, with a significant saving of euro 948,80 per patient/year. CONCLUSIONS: In this observational study, adjustments in infliximab treatment in the first year of therapy were common. Despite dose escalation, the mean dosing schedule does not significantly differ from those recommended in the product label. The cost of treatment could be reduced by using infliximab vial optimization.

Feasibility of robotic-assisted locomotor training in children with central gait impairment.

Intensive, task-specific training enabled by a driven gait orthosis (DGO) may be a cost-effective means of improving walking performance in children. A paediatric DGO has recently been developed. This study was the first paediatric trial aimed to determine the feasibility of robotic-assisted treadmill training in children with central gait impairment (n=26; 11 females, 15 males; mean age 10 y 1 mo [SD 4 y]; range 5 y 2 mo-19 y 5 mo). Diagnoses of the study group included cerebral palsy (n=19; Gross Motor Function Classification System Levels I-IV), traumatic brain injury (n=1), Guillain-Barré syndrome (n=2), incomplete paraplegia (n=2), and haemorrhagic shock (n=1), and encephalopathy (n=1). Sixteen children were in-patients and 10 were outpatients. Twenty-four of the 26 patients completed the training which consisted of a mean of 19 sessions (SD 2.2; range 13-21) in the in-patient group and 12 sessions (SD 1.0; range 10-13) in the outpatient group. Gait speed and 6-Minute Walking Test increased significantly (p<0.01). Functional Ambulation Categories and Standing dimension (in-patient group p<0.01; outpatient group p<0.05) of the Gross Motor Function Measure improved significantly. DGO training was successfully integrated into the rehabilitation programme and findings suggest an improvement of locomotor performance.

Cost-effectiveness of pneumococcal vaccination for prevention of invasive pneumococcal disease in the elderly: an update for 10 Western European countries.

Pneumococcal vaccine is effective in preventing invasive pneumococcal disease in adults >or=65 years of age, but it is not widely used in Western Europe. In this study, data from an earlier (1995) cost-effectiveness study on Belgium, France, Scotland, Spain, and Sweden are updated, and data on five new countries--Denmark, the UK (specifically, England and Wales), Germany, Italy and The Netherlands--are added. Epidemiological and economic variables specific for each country were used, and it was assumed that pneumococcal and influenza vaccines would both be administered during the same physician visit. In the base-case analyses, the cost-effectiveness ratios ranged from euro 9239 to euro 23,657 per quality-adjusted life-year. Because the incidence and mortality of invasive pneumococcal disease were underestimated in most countries, a country-by-country analysis was performed, assuming an incidence of 50 cases per 100,000 population and mortality rates of 20, 30 and 40%. For a mortality of 20%, the cost-effectiveness ratios ranged from euro 4,778 to euro 17,093, and for a mortality of 30%, they ranged from euro 3,186 to euro 11,395. Pneumococcal vaccination to prevent invasive pneumococcal disease in elderly adults was very cost-effective in all 10 countries. This evidence justifies the wider use of the vaccine in Western Europe.

Cost-effectiveness of universal pneumococcal vaccination for infants in Italy.

This study aimed at estimating the health and economic outcomes of universal infant vaccination with seven-valent pneumococcal conjugate vaccine (PCV-7) in Italy. A Markov model simulated lifetime evolution of a birth cohort (538,138 children): universal vaccination would avert 769 invasive infections, 18 deaths and 1323 life years. At base-case analysis, universal three-dose vaccination would cost euro 26,449 (95% CI: 1975-62,075) and euro 38,286 (95% CI: 22,164-70,801) per life year-saved in the societal and the NHS perspective, respectively. In the hypothesis of a 5-year long protection period, vaccination would cost euro 32,694 and euro 43,115 per life-year saved. Considering yearly incidence of invasive pneumococcal disease reported for Veneto and Sardinia regions, PCV-7 vaccination would result highly cost-effective determining a cost of euro 10,479 and euro 16,890 per life year-save in the NHS and the societal perspective, respectively.

[The role of economic evaluation for the implementation of vaccination strategies]. / Ruolo della valutazione economica nell'implementazione di strategie vaccinali.

The analysis described below tries to underline the major economic aspects of vaccination strategies both in childhood (polio, diphtheria, tetanus, H influenzae, measles, rubella, mumps, et) and in the elderly (limited to influenza control). As a result we could demonstrate that, in spite of the formal recognition of the paramount importance of prevention in general, and of vaccinal prevention in particular; vaccinations are at present very poorly considered by policymakers and politicians. This in contrast with the fact that the studies so far examined show that vaccinations are among the most productive interventions (lowest cost per year of life-year spared, very good cost-benefit ratio, thanks to the cases of diseases avoided). Such a convenience is highest when, in front of a given disease, the vaccinal strategy has been duly selected. Therefore, it is suggested that additional resources should be provided in the future to complete the framework and to increase the coverage of vaccinations, including the new offers against Varicella, N meningitidis and Str pneumoniae: and, in the future, against Rotavirus and HPV.

[Cost-of-illness study of pneumococcal disease in Italian children]. / Cost-of-illness delle malattie pneumococciche nel bambino in Italia.

Streptococcus pneumoniae (S pneumoniae, or pneumococcus) is a leading cause of illness in children, and causes illness and death among the elderly and persons with certain underlying conditions. A Cost-of-Illness (COI) estimate for each pneumococcal disease (meningitis, bacteremia, pneumonia, and otitis media) was determined using decision tree analysis that considered both direct and indirect costs. Information on the burden of pneumococcal disease in Italy, in terms of data on the incidence and seroprevalence of disease was collected from published and unpublished records, supplemented, and verified by Italian pediatric and infectious disease experts. The annual cost to society of caring for children with pneumococcal disease is estimated to be around 59,604,477 euro including both direct costs and indirect costs (productivity changes). Direct costs accounted for 39.9% of the total costs. The value of resources used to treat otitis media was 60.6% of the total direct costs; 31.9% was the value of resources for treating pneumonia; 6.5% for treating bacteremia; 1.0% for treating meningitis. A sensitivity analysis confirmed the robustness of the results.