BackgroundBiological drugs are effective treatments for chronic plaque psoriasis. The doses tend to be reduced when the drug has demonstrated sustained effectiveness.PurposeThe main objective was to assess the average cost per patient of each anti-TNF drug based on its prescribed doses. The secondary objective was two-fold: to estimate the annual costs per responder and the incremental cost.Material and methodsA cross-sectional observational study was conducted from January to June 2014. Patients with psoriasis who had received biological treatment for at least six months were included. The effectiveness endpoint was the proportion of patients with at least 75% improvement in the psoriasis area-and-severity index (PASI75). Mean prescribed doses of each anti-TNF drug were calculated and translated into a percentage of the label doses. The average cost per patient for each drug was assessed with the mean prescribed doses (real costs, RC) and the theoretical costs (TC) were estimated based on the label doses of the drugs. The incremental cost (IC) was calculated by comparing the theoretical vs. real costs. For the purpose of calculating the annual costs, the real costs of six months of treatment were extrapolated. This study was performed from the pharmacoeconomic perspective of the hospital.ResultsWe included 143 patients.Abstract CP-142 Table 1Adalimumab (N = 45)Etanercept (N = 44)Ustekinumab (N = 32)Infliximab (N = 22)Cost per patient based on the doses prescribed€4,777.06 €4,722.38 €5,337.34 €6,546.82 Cost per patient based on its label doses€6.245.72 €5.788.19 €5,689.02 €6,546.82 Proportion of patients with PASI7598% 90% 90% 100% Estimated annual real costs per responder€9,771.27 €10,389.24 €11,778.95 €13,093.65 Estimated TC€12,491.44€11,576.38€11,378.05€13,093.65Estimated RC€9,554.13€9,444.76€10,674.68€13,093.65IC€-2,937.30€-2,131.62€-703.360€ConclusionThe average RC of each biological drug was lower than TC, except for infliximab. Both the annual RC and the IC of adalimumab were better than the other drugs, followed by etanercept and ustekinumab. Infliximab did not allow dose reduction. Reducing doses of biological treatments permits cost minimisation while maintaining clinical effectiveness.References and/or AcknowledgementsNo conflict of interest.
BackgroundBenboubker et al. recently reported the results of lenalidomide + dexamethasone (Ld) in transplant-ineligible patients with melanoma versus the standard treatment, with a difference between medians of 4.3 months in progression-free survival (PFS). Nevertheless, as seen in the shape of the curves, difference in median survival (DMS) may not provide a good estimate of the survival benefit.PurposeTo reanalyse the survival benefit of lenalidomide from the PFS curves using an area-under-the curve (AUC)-based method.Material and methodsKaplan-Meier PFS and OS curves were extracted from Benboubker et al.’s article. Graphical AUC methods were applied to continuous Ld vs. standard treatment curves and compared to DMS. The AUC was calculated according to a previously published method.1 Vertical cutting lines at the tail ends of the graphs were made based on the number of patients at risk. It was agreed that this cut-off point was defined as placing at least 10 at-risk patients in each group or 30 in total. The AUC method quantified the difference between areas, and the results were expressed in time units. Photoshop-CS6 was used for graphical AUC calculation.ResultsAUC-based reanalysis of PFS curves included 67.5% patients with 47 months of follow-up, at least 30 patients remaining at risk. PFS was 17.0 vs. 14.3 months, a benefit of 2.7 months in favour of continuous Ld. For OS, with 43.5% patients analysed and 50 months of follow-up, the AUC method showed a benefit of 5.3 months (25.5 vs. 20.2).Abstract CP-148 Figure 1ConclusionAUC-based analysis showed a shorter survival benefit than the difference in median survival. This is probably related to the shape of the curves, which diverged at the medium zone of the graph. OS reanalysis is very limited because the observation time is insufficient to provide mature data.References and/or AcknowledgementsAlegre-DelRey EJ, et al. Area-based measures for assessing survival benefit in Kaplan-Meier’s curves. ESMO Congress, Amsterdam 2013. URL: (accessed 08/10/2014)No conflict of interest.
Background Intravenous immunoglobulins (IgIV) represent a therapeutic option with high cost and limited availability. As a consequence it is necessary to evaluate their use basing it on the scientific evidence and prioritising the indications. Purpose To examine the suitability of immunoglobulin prescriptions regarding the indication and recommended dose. Materials and methods We studied patients treated with IgIV between January 2012 and June 2013. We checked the prescriptions against The Clinical Guidelines for Immunoglobulin Use edited by the British Department of Health. We recorded the prescribing department, indication for the prescription, dosing regimens and approved or non-approved indications. Results A total of 34 patients were treated with a standard dose of 0.4 g/kg, 44% of prescriptions came from Haematology, 24% from Oncology, 15% Immunology, 9% Neurology and 8% from other services. The distribution of patients according to the prescribing indication was: idiopathic thrombocytopenic purpura (38%), primary immunodeficiencies (23%), secondary immunodeficiencies (15%), autoimmune haemolytic anaemia (6%), Rasmussen’s syndrome (3%) and others (15%). 91% of the prescriptions were for an approved indication, 3% were approved but not scientifically supported and 6% not approved or accepted. The most frequent patterns were 30 g for 4 days and 35 g every 28 days. Conclusions Most of the prescriptions written were for approved indications. A low percentage of prescriptions were for unapproved indications, which were required as compassionate use. The pattern and duration of treatment were appropriate to the treated pathologies. No conflict of interest.
Background The new protease inhibitors (PIs) have proved effective in increasing the rate of Sustained Virological Response (SVR) in hepatitis C, 25%-30% better than standard treatment. However, triple therapy is associated with undesirable effects: skin rash (telaprevir), anaemia (telaprevir and boceprevir) and taste disorder (boceprevir). Purpose To analyse effectiveness and safety with telaprevir and boceprevir in patients with hepatitis C, who met the inclusion criteria established by the Spanish Health Ministry and profile of these treatments. Materials and methods The study period started after the inclusion of PIs in the pharmacotherapeutic guide. Patients who met the inclusion criteria were selected: Genotype 1, treatment-naïve or previously treated, F4 fibrosis stages in biopsy or FibroScan >9.5 Kilopascals, haemoglobin concentration >12 g/dl in women and >13 g/dl in men and compensated liver disease. Effectiveness was assessed based on SVR of triple therapy, at weeks 4 and 12 with telaprevir and at weeks 8 and 24 with boceprevir. SVR was defined as undetectable viral RNA in these weeks. Safety was assessed based on adverse events recorded in the clinical history or during the therapeutic drug monitoring. Abstract DI-012 Table 1 Viral Load at week 4 Viral Load at week 12 Viral Load at week 8 Viral Load at week 24 Adverse events Telaprevir(14 patients) 71% detectable29% undetectable 93% undetectable7% detectable Not applicable Not applicable 21% skin rash29% ano-rectal discomfort43% anaemia Boceprevir(3 patients) Not applicable Not applicable 100% undetectable 1 undetectable2 not reached 100% taste disorder14% ano-rectal discomfort14% anaemia Results A total of 20 patients (59% relapsers, 23% treatment-naïve, 12% non-responders and 6% partial responders) started treatment with PIs (16 telaprevir and 4 boceprevir). All patients met the inclusion criteria. Three patients were excluded due to not adequately following the protocol, withdrawal of medicines for adverse event (pancreatitis for telaprevir) and non recording of the viral load in the clinical history. Blood transfusion and rescue treatment with darbepoetin alfa was performed in 3 patients. Conclusions The rate of effectiveness achieved was higher than in clinical trials. However the main limitations of the study were the small sample size and the insufficient follow-up period. Overall, the main adverse events were anaemia and taste disorders with telaprevir and boceprevir respectively. These results were similar to those of previous reports. No conflict of interest.
BackgroundDue to the recent commercialisation of subcutaneous trastuzumab (Tsc) for the treatment of HER2+ breast cancer, there is an opportunity to minimise costs with a potential significant impact on the public health system.PurposeThe objective of this study was to assess the cost minimisation achieved by using subcutaneous (600 mg/21 days) versus intravenous trastuzumab (various dosifications) for the treatment of HER2+ breast cancer.Material and methodsA retrospective and descriptive study of all patients who received trastuzumab for the treatment of HER2+ breast cancer from 1 January 2015 to 30 September 2015 was done. The following data were collected: route of administration, associated costs, body weight and number of administrations. The oncology and management databases of the hospital pharmacy service were the sources of information. The different protocols used for intravenous trastuzumab were comparable with the use of 6 mg/kg/21 days. The calculations were made considering this posology. As Tsc is administered at a fixed dose, there could be cost savings in patients above a certain body weight. This body weight was calculated. The cost for each patient was calculated according to the subcutaneous and intravenous dosifications and the number of administrations received.ResultsDuring the study period, 73 patients were treated with trastuzumab: 67 received Tiv (92%) and 6 Tsc (8%). The cost of trastuzumab 600 mg vial (sc) was 1326€ (fixed dose) and Tsc vial 150 mg (iv) 527€. Subcutaneous administration was cheaper above 63 kg in body weigth. 48/73 patients had a body weight >63 kg, and 6 of them (12.5%) received Tsc. The total cost for the 312 intravenous administrations associated with patients >63 kg was 528 587€ compared with 415 833€ theoretical cost for Tsc. The potential cost savings were 112 754€.ConclusionTwo-thirds of patients who received trastuzumab weighted >63 kg.A few patients in this group received Tsc.Most of the patients in the study received a treatment with a higher cost than the new form of subcutaneous trastuzumab.No conflict of interest.
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