P.A. Cortesi

Cost-Utility Analysis of Biologic Therapies to Treat Chronic Plaque Psoriasis in Italy: The Importance of Using Updated and Adequate Social Tariffs to Calculate Quality-Adjusted Life-Years

Spandonaro et al. [1] conducted an interesting cost-utilityanalysis to estimate the incremental cost/QALY (quality-adjusted life-year) ratio of biologic therapy for the treat-ment of chronic plaque psoriasis, adopting the perspectiveof the Italian National Health Service. The use of QALYsin the analysis allowed the calculation to include aparameter of effects measured in terms of health-relatedquality of life (HR-QOL), which is a component of healththat is significantly compromised in patients with chronicplaque psoriasis.It is not clear from their paper which social tariffs theauthors used to obtain the utility indexes necessary toestimate QALYs. The authors collected HR-QOL data withthe generic instrument EQ-5D-3L; hence, the Italian-spe-cific social tariffs published in 2013 by Scalone et al. [2]are appropriate for converting the participants’ responsesinto utility indexes. Previously, when a specific value setfor Italy was missing, UK or Spanish sets were used toconduct health economic evaluations for the Italianhealthcare system. However, comparisons of differentnational value sets have underlined the existence of dif-ferences across countries and the importance of assessingutilities that are country specific. The utility indexesobtained with the Italian social tariffs estimated in thepaper published in 2013 are systematically higher thanthose obtained with the UK and Spanish algorithmsestablished many years ago [3]: the mean (maximum)absolute differences correspond to 0.296 (0.551) with theUK tariffs and 0.301 (0.506) with the Spanish tariffs.Because the highest limit of the utility index correspondsto 1, higher utility indexes and consequently QALYs couldpotentially generate lower QALY differences (gains)between the two treatment options. Lower QALY gainswould potentially generate a higher incremental cost/QALY ratio, which could be relevant when addressingdecision makers’ willingness to pay.Since the Italian-specific social tariffs were published afew months before publication of the paper by Spandonaroet al., it is relevant to decision makers that the authorsclarify which social tariffs they used, and, if possible,provide updated and more appropriate values from thecurrently available data.References

Long Term Costs and Outcomes in Psoriatic Arthritis Patients Not Responding to Conventional Therapy Treated with Tumor Necrosis Factor Inhibitors: The Extension of Psoriatic Arthritis Cost Evaluation (PACE) Study

OBJECTIVESnPoor information on long-term outcomes and costs on tumour necrosis factor (TNF) inhibitors in psoriatic arthritis (PsA) are available. Our aim was to evaluate long-term costs and benefits of TNF- inhibitors in PsA patients with inadequate response to conventional treatment with traditional disease-modifying anti-rheumatic drugs (tDMARDs).nnnMETHODSnFifty-five out of 107 enrolled patients included in the study at one year, completed the 5-year follow-up period. These patients were enrolled in 8 of 9 centres included in the study at one year. Patients aged older than 18 years, with different forms of PsA and failure or intolerance to tDMARDs therapy were treated with anti-TNF agents. Information on resource use, health-related quality of life (HRQoL), disease activity, function and laboratory values were collected at baseline and through the 5 years of therapy. Costs (expressed in Euro 2011) and utility (measured by EQ-5D instrument) before TNF inhibitor therapy and after 1 and 5 years were compared.nnnRESULTSnThe majority of patients (46 out of 55; 83.6%) had a predominant or exclusive peripheral arthritis and 16.4% had predominant or exclusive axial involvement. There was a statistically significant improvement of the most important clinical variables after 1 year of follow-up. These improvements were maintained also after 5 years. The direct costs increased by approximately €800 per patient-month after 1 year, the indirect costs decreased by €100 and the overall costs increased by more than €700 per patient-month due to the cost of TNF inhibitor therapy. Costs at 5 year were similar to the costs at 1 year. The HRQoL parameters showed the same trends of the clinical variables. EQ-5D VAS, EQ-5D utility and SF-36 PCS score showed a significant improvement after 1 year, maintained at 5 years. SF-36 MCS showed an improvement only at 5 years.nnnCONCLUSIONSnThe results of our study suggest that TNF blockers have long-term efficacy. The higher cost of TNF inhibitor therapy was balanced by a significant improvement of HRQoL, stable at 5 years of follow-up. Our results need to be confirmed in larger samples of patients.

Benefits in pain perception, ability function and health-related quality of life in patients with failed back surgery syndrome undergoing spinal cord stimulation in a clinical practice setting

BackgroundFailed back surgery syndrome (FBSS) represents one main cause of chronic neuropathic or mixed pain, functional disability and reduced Health Related Quality of Life (HRQoL). Spinal Cord Stimulation (SCS) can be a value for money option to treat patients refractory to conventional medical management (CMM).We estimated from real-world data: 1) the amount of reduced levels of HRQoL of target patients compared to general population, 2) the relationship between pain intensity, functional disability, and overall HRQoL, and 3) the improvement of patients’ health from SCS intervention, and 4) we give some insights and make some suggestions on the selection of a battery of patients’ reported health instruments for use in routine clinical practice.MethodsAt recruitment (before SCS) and every 6xa0months for 2xa0years after SCS a battery of questionnaires/tests were completed: the generic EQ-5D and SF-36 for HRQoL, the specific Numerical Rating Scale (NRS) to measure pain intensity, and Oswestry Disability Index (ODI) to measure functional disability. We conducted multilevel regression analyses to investigate the association of HRQoL with the NRS and ODI indexes; multiple regression analyses to compare EQ-5D data with those of the general population adjusted for age, sex and education, and statistical tests to compare the changes of HRQoL, NRS and ODI estimates at baseline with those measured during the follow-up.ResultsEighty patients (40% male, mean ageu2009=u200958xa0years) participated. HRQoL was significantly worse in the patients than in the corresponding general population. Pain, functional disability and HRQoL significantly related each other during follow-up, Significant improvements (pu2009<u20090.001) in pain intensity, functional capability and HRQoL were reached after 6xa0months from SCS and generally remained stable during follow-up. Specific instruments provided detailed information on disability and pain, while generic instruments assessed the overall HRQoL and allowed a comparison with the general population’s one.ConclusionsSCSu2009+u2009CMM treatment reaches a statistically significant and probably a clinically relevant improvement in pain perception, functional disability and HRQoL in patients with FBSS refractory to CMM. An appropriate selection of instruments for use in clinical practice is crucial for a routine assessment of health perception in patients, aimed to guide decisions for optimal treatment.

The socioeconomic burden of patients affected by hemophilia with inhibitors

Hemophilia is associated with a high financial burden on individuals, healthcare systems, and society. The development of inhibitors significantly increases the socioeconomic burden of the diseases. This study aimed to review and describe the burden of hemophilia with inhibitors, providing a reference scenario to assess the impact of new products in the real word. Two systematic literature reviews were performed to collect data on (i) health economics and (ii) health‐related quality of life evidences in hemophilic patients with inhibitors. The costs associated with patients with hemophilia and inhibitors are more than 3 times greater than the costs incurred in those without inhibitors, with an annual cost per patient that can be higher than €1 000 000. The costs of bypassing agents account for the large majority of the total healthcare direct costs for hemophilia treatment. The quality of life is more compromised in patients with hemophilia and inhibitors compared to those without inhibitors, in particular the physical domains, whereas mental domains were comparable to that of the general population. The development of an inhibitor has a high impact on costs and quality of life. New treatments have the potential to change positively the management and socioeconomic burden of hemophilia with inhibitors.