F. Maurel

Effectiveness of a lumbar belt in subacute low back pain: an open, multicentric, and randomized clinical study.

Study Design. Multicentric, randomized, and controlled study of clinical evaluation of medical device in subacute low back pain. Objective. To evaluate the effects of an elastic lumbar belt on functional capacity, pain intensity in low back pain treatment, and the benefice on medical cost. Summary of Background Data. There is limited evidence of efficiency of lumbar supports for treatment of low back pain. There is also a lack of the methodology in the studies reported on the efficiency of this device. Methods. This study is randomized, multicentric, and controlled with 2 groups: a patient group treated with a lumbar belt (BWG) and a control group (CG). The main criteria of clinical evaluation were the physical restoration assessed with the EIFEL scale, the pain assessed by a visual analogic scale, the main economical criteria was the overall cost of associated medical treatments. Results. One hundred ninety-seven patients have participated. The results show a higher decrease in EIFEL score in BWG than CG between days 0 and 90 (7.6 ± 4.4 vs. de 6.1 ± 4.7;P = 0.023). Respectively significant reduction in visual analogic scale was also noticed (41.5 ± 21.4 vs. 32.0 ± 20; P = 0.002). Pharmacologic consumption decreased at D90 (the proportion of patients who did not take any medication in BWG is 60.8% vs. 40% in CG;P = 0.029). Conclusion. Lumbar belt wearing is consequent in subacute low back pain to improve significantly the functional status, the pain level, and the pharmacologic consumption. This study may be useful to underline the interest of lumbar support as a complementary and nonpharmacologic treatment beside the classic medication use in low back pain treatment.

Annual direct medical cost of active systemic lupus erythematosus in five European countries

Objectives To evaluate the annual direct medical cost of managing adult systemic lupus erythematosus (SLE) patients with active autoantibody positive disease in Europe. Methods A 2-year, retrospective, multicentre, observational study was conducted in five countries (France, Germany, Italy, Spain and the UK). Data included patients’ characteristics, disease activity and severity, flare assessments and health resource use (eg, laboratory tests, medications, specialist visits and hospitalisations). Costs were assessed from the public payers’ perspective. Cost predictors were estimated by multivariate regression models. Results Thirty-one centres enrolled 427 consecutive eligible patients stratified equally by disease severity. At baseline, mean (SD) age was 44.5 (13.8) years, 90.5% were women and mean (SD) SLE duration was 10.7 (8.0) years. The SELENA-SLEDAI (11.2 vs 5.3) and SLICC/ACR index (1.0 vs 0.7) scores were higher in severe patients. Over the study period, patients experienced on average 1.02 (0.71) flares/year. The mean annual direct medical cost was higher in severe compared to non-severe patients (€4748 vs €2650, p<0.001). Medication costs were €2518 in severe versus €1251 in non-severe patients (p<0.001). Medications represented 53% and 47% of the total cost for severe and non-severe patients, respectively, primarily due to immunosuppressants and biologics. Flares, especially severe flares, were identified as the major cost predictor, with each flare increasing the annual total cost by about €1002 (p<0.001). Conclusions The annual direct medical cost of SLE patients in Europe is related to disease severity and flares. Medical treatments were the main cost drivers. Severe flares and major organ involvement were identified as important cost predictors.

Spectacle independence and subjective satisfaction of ReSTOR ® multifocal intraocular lens after cataract or presbyopia surgery in two European countries

Purpose: To determine the percentage of patients implanted bilaterally with ReSTOR® requiring spectacles at 18 months, the patient satisfaction, and factors that predict spectacles independence. Methods: The medical and surgical data were collected from patient records. The ‘Freedom from Spectacles Value Scale’ (FGVS) was used to rank their experiences via telephone interview. A Bayesian network was used to predict postoperative spectacles use. Results: 304 patients (65.6 years) were included. Postoperative visual acuity was ≥0.8 in 93.3% of patients for near vision and in 88.6% of patients for distance vision. After surgery, 87.2% of the patients were spectacles free. 88.2% of the patients rated their vision as being better following the surgery and 93.1% thought that surgery resulted in a positive change. FGVS mean scores (5 the most favorable rating) were: ‘Practical Advantages’ 3.8, ‘Psychological Advantages’ 3.8, ‘Evaluation of the Result’ 4.5, ‘Feelings’ 4.4, and ‘Global Judgement’ 4.4. Patients who stated that spectacles wear was particularly bothersome and those who thought that their appearance was more favorable without spectacles were 3 times more likely not to wear spectacles postoperatively. Conclusion: ReSTOR® provides patients with good distance and near vision, a high rate of spectacles independence, and a high degree of patient satisfaction.

The daily cost of ICU patients: A micro-costing study in 23 French Intensive Care Units

OBJECTIVES To estimate the daily cost of intensive care unit (ICU) stays via micro-costing. METHODS A multicentre, prospective, observational, cost analysis study was carried out among 21 out of 23 French ICUs randomly selected from French National Hospitals. Each ICU randomly enrolled 5 admitted adult patients with a simplified acute physiology II score ≥ 15 and with at least one major intensive care medical procedure. All health-care human resources used by each patient over a 24-hour period were recorded, as well as all medications, laboratory analyses, investigations, tests, consumables and administrative expenses. All resource costs were estimated from the hospitals perspective (reference year 2009) based on unitary cost data. RESULTS One hundred and four patients were included (mean age: 62.3 ± 14.9 years, mean SAPS II: 51.5 ± 16.1, mean SOFA on the study day: 6.9 ± 4.3). Over 24 hours, 29 to 186 interventions per patient were performed by different caregivers, leading to a mean total time spent for patient care of 13:32 ± 05:00 h. The total daily cost per patient was € 1425 ± € 520 (95% CI = € 1323 to € 1526). ICU human resources represented 43% of total daily cost. Patient-dependent expenses (€ 842 ± € 521) represented 59% of the total daily cost. The total daily cost was correlated with the daily SOFA score (r = 0.271, P = 0.006) and the bedside-time given by caregivers (r = 0.716, P < 0.0001). CONCLUSION The average cost of one day of ICU care in French National Hospitals is strongly correlated with the duration of bedside-care carried out by human resources.

Quality of Life in Patients Suffering from Active Exudative Age-Related Macular Degeneration: The EQUADE Study.

Purpose: Age-related macular degeneration (AMD) is the main cause of visual loss in the elderly population. With the use of anti-vascular endothelial growth factor, the visual outcomes of exudative AMD patients have been improved. This study was aimed at assessing the quality of life (QoL) of exudative AMD patients treated with ranibizumab and at determining its drivers in a real-life setting. Methods: We performed a national, cross-sectional, observational survey based on questionnaires sent to members of French associations relative to AMD between December 2012 and March 2013. Patients suffering from exudative AMD with at least one intravitreal injection of ranibizumab within the last 6 months were included. Demographics, AMD characteristics, visual acuity (VA) and past and ongoing treatments were collected. The 25-item National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) was self-administered. A multivariate model was used to identify QoL drivers. Results: 416 questionnaires fulfilled the complete criteria for both QoL and cost analyses. The mean age of exudative AMD patients was 78.0 years and bilateral involvement was reported in 60.4%. The overall mean QoL score was 53.4. Mental health, driving and role difficulties were the most widely affected domains. After bivariate analyses, long-term illness status, worse VA and higher number of unpaid aids were associated with worse QoL, with odds ratios of 2.4, 5.2 and 11.6, respectively. The mean cost per year and per patient was 1,741 EUR. The main components of costs were aids and services and the purchase of visual equipment. Conclusions: The main predictors of QoL in exudative AMD patients treated with ranibizumab are VA outcomes, home healthcare and social services provided to the patients.

EQOFIX: a combined economic and quality‐of‐life study of hemophilia B treatments in France

EQOFIX is a medicoeconomic study that analyzed the health‐related quality of life (HRQoL) and costs of care of the moderate and severe forms of hemophilia B, treated on demand or by prophylaxis with either plasma‐derived Factor IX (pdFIX) or recombinant FIX (rFIX).

Patterns of use of oral anticancer treatments in France: a Retrospective Analysis of Cancer Treatments given ORally from 2004 to 2012 (Re-ACTOR study)

Abstract Backgrounds and objectives: Increasing use of oral anticancer treatments (OATs) in oncology is modifying the treatment paradigm for cancer. Nonetheless, available data on the pattern of use of OATs and its evolution over time are limited. The objective of this study was to describe the patterns of use of OATs in France from 2004 to 2012. Methods: A retrospective analysis was performed using Oncology Analyzer, a physician survey database. All patients actively treated by an oral or an intravenous anticancer treatment between October 2004 and September 2012 were enrolled in the database. Descriptive analyses were performed by treatment category with a focus on the last year of collection and the evolution across the study period. Results: From October 2011 to September 2012, a sample of 7426 patients treated by oral or intravenous active anticancer treatments was analyzed: 74% of patients receiving an OAT were diagnosed with a solid tumor, 52% of whom had a stage IV cancer. The use of OATs increased with age and was the highest in patients over 80 years. From 2004 to 2012, the proportion of cancer patients receiving OATs increased by four percentage points (from 28.4% to 32.5%). Additionally, for treatments available in both forms, a marked preference for oral formulations was observed. Limitations: The patterns and trend of use prior to 2004 were not addressed due to lack of information in the database. The use of a market research database is relevant for highly prevalent cancers but for rare cancers the sample size is limited, underlining the utility of using other data sources such as cancer registries. Conclusions: The Re-ACTOR study provides an overview of OAT use in France, which was prescribed to 32% of cancer patients in France in 2012, principally to older patients and to those with solid tumors and with metastatic disease.

Daily costs of prostaglandin analogues as monotherapy or in fixed combinations with timolol, in Denmark, Finland, Germany and Sweden.

Background: To compare the daily costs of 3 prostaglandin analogues (bimatoprost, latanoprost, travoprost), alone, and associated with timolol in 4 European countries (Denmark, Finland, Germany, and Sweden). Methods: Six glaucoma products were sampled by buying 5 bottles from 1 suburban pharmacy in each of the 4 countries. Drops were weighed by a single operator at 1 site according to standardized procedures. Residual drops were then counted. Unit bottle costs were estimated from tariff lists. Eye-drop weights were entered into a nested analysis of variance comprising drug, instillation day, country, the interaction, and a sample factor nested within the country factor. Effectiveness was represented by treatment failure rates estimated from a meta-analysis and a general practitioner survey. Results: Every drug bottle contained sufficient drops to treat 1 patient for 28/31 days. Drop-size heterogeneity between countries was observed for bimatoprost and bimatoprost/timolol. Mean travoprost and travoprost/timolol drop-sizes were the smallest, and drop-counts per bottle were the lowest for latanoprost, or latanoprost/timolol. In all 4 countries annual costs were least for travoprost and travoprost/timolol. Conclusions: On taking into account drug costs and effectiveness, travoprost and travoprost/timolol were cheaper and more effective than latanoprost and latanoprost/timolol and were cheaper than bimatoprost and bimatoprost/timolol.

PG13 PHARMACOECONOMIC ASSESSMENT OF LANREOTIDE IN THE MANAGEMENT OF POST-OPERATIVE DIGESTIVE FISTULAS

PGI13 PHARMACOECONOMIC ASSESSMENT OF LANREOTIDE IN THE MANAGEMENT OF POST-OPERATIVE DIGESTIVE FISTULAS De Pouvourville G, Levesque K, Nestrigue C, Maurel F, Brignone M, Ménégaux F, Buscail L, Levesque E,Tilleul P ESSEC Business School, Cergy-pontoise, France, IMS Health, Puteaux, France, Hopital Saint antoine, APHP, Paris, France, Pitié Salpêtrière Hospital, Paris, France, Rangueil Hospital,Toulouse, France, Paul Brousse Hospital,Villejuif, France, St-Antoine Hospital, Paris, France OBJECTIVES: Post-operative fistulas are a serious complication of gastrointestinal tract surgery that can highly increase the length of hospitalization stays. Somatostatin, such as lanreotide, are being used to reduce time elapsed for fistula closure. In France, non expensive drugs are directly financed through DRG tariff. In this context, the objective of the study was to evaluate, from a public hospital perspective, whether the additional costs associated with lanreotide treatment could be counter-balanced by its impact on health resources consumption and length of stay compared to conventional care management and natural somatostatin. METHODS: We assumed that the treatment duration corresponds to the time required for fistula closure and data used were based on published clinical trials findings. Hospital stays were identified from the French national hospital database (PMSI) and costs of stays were determined through the French national hospital costs database (ENC). Daily average cost of stay was estimated considering both, length of stay, fix and variable costs within the ENC and was weighed by the number of stays in each identified DRG. RESULTS: The analysis was based on 2193 hospitalizations representing 74% of the stays with a fistula diagnosis. The average daily cost of stay was evaluated to €170. Based on the clinical data available, the time for fistula closing was comparable for both drug treatments (12 days for lanreotide and natural somatostatine) and, 18 days for the conventional treatment. Thus, the total costs of stay including the cost of drug were of €2929 for the lanreotide, €7747 for the natural somatostatine and of €2981 for the conventional treatment. CONCLUSIONS: The decreased fistula closing time associated with lanreotide treatment can potentially lead to a reduction of the hospitalization length of stay which can compensate the overcost of the drug.