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Marie-Christine Woronoff-Lemsi

Publications and source records attributed to Marie-Christine Woronoff-Lemsi.

At least 19 recordsLinked to original sources
PubMed2006

Clinical and economic impact of epoetin in adjuvant-chemotherapy for breast cancer.

INTRODUCTION: Anaemia is a common toxicity in cancer patients and epoetins (EPOs) are now an established treatment. The economic profile of EPO treatment was assessed in patients with breast cancer treated by adjuvant-chemotherapy. MATERIALS AND METHODS: Two strategies were compared: without treatment by EPO and with the possible use of treatment by EPO (epoetin alfa) when required. The clinical effectiveness criterion was time adjusted to quality of life and economic data included only direct medical costs. MAIN RESULTS: One hundred ninety-two patients were included. In the group with the strategy containing the possible use of EPO, 45.5% of patients effectively received EPO. A significant difference in the haemoglobin level profile over time was observed which provided a significant overall benefit of 0.0052 (p<10(-4)) quality-adjusted life year (QALY) associated with an extra cost of 1,615 (p<10(-4)). In the base case analysis, the cost per added QALY was estimated as 310,577 with the strategy containing the possible use of EPO. CONCLUSION: This robust result seems to be unacceptable, but the only relevant point of discussion might be the level of acceptable incremental cost-effectiveness ratio (ICER) for a patient.

Adult↗
PubMed2006

Economic impact of simplified de Gramont regimen in first-line therapy in metastatic colorectal cancer.

The cost of chemotherapy has dramatically increased in advanced colorectal cancer patients, and the schedule of fluorouracil administration appears to be a determining factor. This retrospective study compared direct medical costs related to two different de Gramont schedules (standard vs. simplified) given in first-line chemotherapy with oxaliplatin or irinotecan. This cost-minimization analysis was performed from the French Health System perspective. Consecutive unselected patients treated in first-line therapy by LV5FU2 de Gramont with oxaliplatin (Folfox regimen) or with irinotecan (Folfiri regimen) were enrolled. Hospital and outpatient resources related to chemotherapy and adverse events were collected from 1999 to 2004 in 87 patients. Overall cost was reduced in the simplified regimen. The major factor which explained cost saving was the lower need for admissions for chemotherapy. Amount of cost saving depended on the method for assessing hospital stay. In patients treated by the Folfox regimen the per diem and DRG methods found cost savings of Euro 1,997 and Euro 5,982 according to studied schedules; in patients treated by Folfiri regimen cost savings of Euro 4,773 and Euro 7,274 were observed, respectively. In addition, travel costs were also reduced by simplified regimens. The robustness of our results was showed by one-way sensitivity analyses. These findings demonstrate that the simplified de Gramont schedule reduces costs of current first-line chemotherapy in advanced colorectal cancer. Interestingly, our study showed several differences in costs between two costing approaches of hospital stay: average per diem and DRG costs. These results suggested that standard regimen may be considered a profitable strategy from the hospital perspective. The opposition between health system perspective and hospital perspective is worth examining and may affect daily practices. In conclusion, our study shows that the simplified de Gramont schedule in combination with oxaliplatin or irinotecan is an attractive option from the French Health System perspective. This safe and less costly regimen must compared to alternative options such as oral fluoropyrimidines.

Aged↗
PubMed2006

[Cost of hospital-based management of acute myeloid leukemia: from analytical to procedure-based tarification].

The confrontation of the macro- and micro-economic approaches of hospital costs is a recurrent question, in particular for pathologies where length of stay is highly variable, like acute myeloid leukemias (AML). This monocentric and retrospective study compares direct hospital medical costs of induction and relapse treatment sequences for AML, valued according to four different approaches: the analytic accounting system of our hospital, the French Diagnosis Related Group (DRG) cost databases of hospital discharges (readjusted, or not, to actual hospital stay duration), and official tariffs from the new French DRG prospective payment system. The average cost of hospital AML care valued by the analytic accounting system of our hospital is 61,248 euros for the induction phase and 91,702 euros for the relapse phase. All other national valuation methods result in a two- to four-fold underestimation of these costs. Even though AMLs are now individualized in the 10th version of the French diagnosis related group (DRG) classification, the impact of this issue in other pathologies is going to increase with the gradual implementation of the French DRG prospective payment system. That is why it must be assessed before the progressive extension of this financing system.

Acute Disease↗
PubMed2006

[Appropriate cytotoxic drug usages in solid tumors: conformity to official labelling and level of scientific evidence].

The definition of appropriate use of drugs is questioned in oncology. Daily therapeutic practices were compared to official labelling and to published scientific data in this retrospective study. It was carried out in two respective specialised centers, from January to September 2004. All chemotherapies administered for adult solid tumours and including one of the eleven studied drugs were evaluated. The analysis of use was performed by drug : conformity to the validated labelling and level of scientific evidence (at the period study). The study included 1,561 drug uses in 1,211 patients. The overall rate of conformity to official labelling was 81.7 % (67.1 % of strict conformity). In 73.8 % of cases, the indications were supported by at least one randomized phase III trial. The results appeared to be significantly different in rare tumours. The potential economic stake of the "contrat de bon usage" was estimated as less than 5 % in our study. This analysis showed an appropriate and controlled use of onerous drugs in solid tumours. The official labelling of drugs are unable to answer to all clinical situations. The definition of a sufficient level of evidence is mandatory for the use of scientific data in clinical practice. This process has to be adapted for rare tumours.

Adolescent↗
PubMed2005

Use of a decision analysis model to assess the medicoeconomic implications of FDG PET imaging in diagnosing a solitary pulmonary nodule.

This study assessed the use of positron emission tomography (PET) in identifying and diagnosing solitary pulmonary nodules (SPNs). For this a decision analysis model was constructed, and three alternatives were compared: wait and watch (WW), PET and anatomical computed tomography (PET), and CT plus PET (CT+PET). Transition probabilities were estimated from published data and consultations with experts. Costs of diagnosis were derived from the French reimbursement scale, and treatment costs from a national hospital database of diagnosis-related groups. The base case was defined as a 65-year-old male smoker with a 2-cm SPN and an associated high risk of malignancy of 43%. Evaluation criteria included incremental cost-effectiveness ratios and the proportion of unnecessary operations avoided in patients without malignant SPN. For the base case WW was the least effective and cheapest strategy. CT+PET was more effective and presented lower incremental cost-effectiveness ratio ( 3,022 per life-year gained). It also was superior to PET in cost-effectiveness terms and resulted in 4.3% fewer unnecessary resections of benign SPN than did PET. Risk profile analyses performed on SPN malignancy risk showed that CT + PET remains the most cost-effective strategy in the range of 5.7-87%, and that WW is more cost-effective in the range of 0.3-5.0%. CT+PET is thus cost-effective in detecting malignant SPN in patients with a risk of malignity of at least 5.7% and may avoid inappropriate resections of benign SPN. These findings support the attempts to introduce a larger number of PETs in France for SPN diagnosis.

Aged↗
PubMed2005

Impact of medical practices on the costs of management of rheumatoid arthritis by anti-TNFalpha biological therapy in France.

UNLABELLED: When the anti-TNFalpha drugs first came onto the market, their high price was the subject of much debate. Moreover, we must add the costs associated with their administration to the purchase price. Variations in medical practices may be the source of substantial variations in these costs. OBJECTIVE: To compare the costs involved with the use of infliximab and etanercept in the treatment of rheumatoid arthritis (RA) and to study the impact of variations in medical practices on them. METHODS: A pragmatic cost minimization analysis was conducted from the payer's perspective to compare the costs of administration, that is, the direct medical costs, of the first two available anti-TNFalpha agents: infliximab and etanercept. Records of 60 patients from three university hospital rheumatology departments were reviewed retrospectively for a 52-week period. This analysis considered the following costs: purchase costs for the drugs and for any co-prescribed disease-modifying drugs, inpatient or outpatient administration, medical follow-up and the transportation costs associated with treatment that were reimbursed by the French health insurance system. Costs that did not differ between the two products were excluded (work-up for inclusion, etc.). RESULTS: Data were collected for 58 patients, 30 treated with infliximab and 28 with etanercept. Patients' mean age was 52 years; 81% were women. RA had first developed on average 15 years earlier; the disease was positive for rheumatoid factors in 68% of cases and erosive in 93%. The total average annual cost of administration did not differ for infliximab and etanercept: 19,469 and 19,619 , respectively (P=0.56). The mean costs of administration nonetheless varied considerably between the three hospital centers: from 16,566 to 24,313 for infliximab (P<0.0001) and from 16,069 to 24,383 for etanercept (P<0.0001). CONCLUSION: The financial burden of biological treatments for RA is strongly influenced by the substantial heterogeneity in medical practices.

Adult↗
PubMed2004

Infliximab continuation rates in patients with rheumatoid arthritis in everyday practice.

UNLABELLED: Infliximab is a major breakthrough in the management of rheumatoid arthritis (RA). We evaluated infliximab continuation rates and reasons for discontinuation in patients with RA. PATIENTS AND METHODS: We studied patients with RA started on infliximab at any time between March 2000 and December 2002, under the conditions of everyday practice (as opposed to clinical trial settings), as recommended by the French marketing license (3 mg/kg as an intravenous infusion at weeks 0, 2, and 6 then at 8-week intervals). The number of infliximab infusions, side effects, and nonresponse rates was recorded. The Kaplan-Meier method was used to evaluate treatment continuation. Reasons for discontinuation were studied. RESULTS: We included 41 patients, with a mean age of 54 years, a mean RA duration of 9 years, and a mean of three previous disease-modifying antirheumatic drug treatments. The total number of infliximab infusions was 461 with a mean of 10.8 per patient and a mean follow-up under treatment of 15.3 months. The proportions of patients still on infliximab were 82%, 74%, and 67% after 6, 12, and 24 months, respectively. The main reasons for discontinuation were escape phenomenon (n = 6, 42.8% of discontinuations) and allergy (n = 3); in one case each, the reason was primary ineffectiveness, severe infection, plans to start a pregnancy, poor compliance, and unavailability for follow-up. There were 59 recorded episodes of side effects, with a profile similar to that in the literature and in postmarketing databases. CONCLUSION: The infliximab continuation rate in everyday practice in patients with RA (67% after 2 years) was consistent with published data and with the results of controlled trials.

Adult↗
PubMed2004

Methodological validation of monitoring indicators of antibiotics use in hospitals.

BACKGROUND: For several years now, the French national recommendations have been trying to set up a surveillance system in hospitals to link data on antibiotic resistance and data on the use of antibiotics, particularly for certain 'micro-organism/antibiotic' pairs. The indicators recommended in the lastest newsletter of the Direction Générale de la Santé (French Public Health Department) for monitoring the consumption of antibiotics were the number of days of treatment or the number of defined daily doses (DDD), both (in)directly related to the number of days of hospitalisation and/or the number of patients hospitalised. OBJECTIVE: The aim of this study was to compare the actual number of days of treatment, which is an observed indicator, with two indicators calculated on the basis of the DDD and the DPD (daily prescribed dose), both in terms of feasibility of collection and the relevance of the information generated. MATERIALS AND METHODS: For several hospital care units, the 'length of exposure' to a given antibiotic was determined by four different indicators: two actual observed indicators [the patient's medical file (reference) and the named-patient based, computerised dispensing system from the central pharmacy] and two derived calculated indicators [obtained by dividing the number of grams prescribed by the DDD or by the DPD]. RESULTS: The average incidence density of antibiotic treatment (length of exposure per 1000 days of hospitalisation) obtained by the calculated indicators was higher than that obtained with the observed reference (+52% for the DDD and +33% for the DPD) but lower than that obtained with the second observed indicator (computerised system) (-10%). The differences were large and random (high variability depending on the hospital department, the antibiotic and the administration route; variations in both directions: actual length of treatment longer or shorter than the calculated length of treatment). CONCLUSION: The question which indicator should be chosen is inconclusive for the evaluation of the selection pressure exerted by an antibiotic. The two indicators proposed in the newsletter (observed indicator and calculated indicator) seem to be complementary for use in a regional or national network to monitor resistance and consumption of antibiotics. Each hospital should validate the indicators and define for itself which indicator is most appropriate for estimating the actual length of antibiotic exposure. This may imply different indicators for different units, antibiotics or even administration routes within one particular hospital setting. Once validated the hospital has a powerful tool generating data that can be linked to resistance data.

Anti-Bacterial Agents↗
PubMed2004

From randomised clinical trials to clinical practice : a pragmatic cost-effectiveness analysis of Paclitaxel in first-line therapy for advanced ovarian cancer.

INTRODUCTION: Paclitaxel plus cisplatin is considered to be the standard first-line therapy for advanced ovarian cancer. Previous to this study, economic data on this combination resulted from randomised clinical trials (RCTs). Therefore, the objective of this study was to compare the clinical and economic outcomes associated with paclitaxel-cisplatin (PC) and cyclophosphamide-cisplatin (CC) regimens using a pragmatic perspective based on daily clinical practice in a French university hospital. METHOD: A retrospective cost-effectiveness analysis, from the hospital-payer perspective, was carried out as a before-after case study in fifty-nine consecutive women with verified International Federation of Gynaecology and Obstetrics (FIGO) stage II, III or IV ovarian cancer treated between 1995 and 2000. Median overall survival (OS) was used as the primary endpoint. The quality-adjusted time was assessed by the quality-adjusted time without symptoms or toxicity (Q-TWiST) method. Direct medical costs were collected for each patient. Monetary values for French prices in the year 2000 were used and converted to US dollars using an exchange rate of USD 1 = 7 French francs. Several univariate sensitivity analyses were carried out varying unit costs, medical practices and administration of paclitaxel. RESULTS: The incremental cost of the PC regimen was USD 10,716 per patient. OS and quality-adjusted time were improved by 10.8 and 9.3 months with the PC regimen. The cost per life-year gained and per added QALY were USD 11,907 and USD 13,827, respectively. The robustness of the results was confirmed in sensitivity analyses. CONCLUSION: Our study suggests that PC may be a cost-effective regimen for advanced ovarian cancer in a French university hospital setting. We reported higher incremental costs and lower clinical benefits than RCT-based findings, suggesting that RCT-based findings were clearly balanced by our pragmatic approach based on clinical practices. Observational studies can provide complementary and balanced data for decision making.

Adult↗
PubMed2004

[Economic impact of outpatient chemotherapy in multiple myeloma].

The development of alternatives to hospitalisation is mandatory in cancer patients. A retrospective analysis compared the costs relative to two modalities of administration of VAD chemotherapy (hospital versus outpatient) in multiple myeloma. This study was carried out from the perspective of the French health care system, including direct hospital and ambulatory costs. The robustness of results was tested in a sensitivity analysis. Forty four patients were included: 27 in the "hospitalisation" arm and 17 in the "outpatient" arm. Among the cycles planned to be administered in outpatient, only 5 cycles (4 patients) have to be administered in hospital. The length of hospitalisation was consequently reduced with outpatient administration (-11.2 days) and it induced a significant cost saving as 3,066 euros (-32%) per patient. In sensitivity analysis, this cost saving varied from 1,282 to 3,667 euros. Our study showed the safety and the economic interest of outpatient administration of VAD chemotherapy in multiple myeloma. Facilities and training are required to develop ambulatory chemotherapy.

Ambulatory Care↗
PubMed2004

[Prevention of preparation errors of cytotoxic drugs in centralized units: from epidemiology to quality assurance].

The centralized preparation of cytotoxic drugs is supposed to help preventing medication errors. Nevertheless, the residual risk of preparation errors has been demonstrated. Above all, prevention is based on the quality assurance policy. Following a previous work, this study valuates the effectiveness of a quality assurance policy and the impact of corrective actions. The study compares the rates of preparation errors observed before and after the corrective actions. The risk factors have also been studied. The study included 84,017 consecutive preparations. The results showed a significant reduction of overall (0.2% versus 0.4%) and major (0.1% versus 0.2%) errors between the two periods. This period impact has been validated by a multivariate analysis (OR were respectively 0.49 and 0.6, p < 10(-3)). The daily workload (> 60 preparations) appeared to be the most important risk factor (OR were respectively 2.4 and 3.2, p < or = 10(-3)). These results demonstrated the effectiveness of simple corrective actions. The follow-up on preparation errors appeared to be useful to raise technicians' awareness and to motivate them. An epidemiological approach allows to identify risk factors, and to definite relevant corrective actions.

Analysis of Variance↗