[Methods for the analysis and treatment of cost data by micro- and gross-costing approaches]. / Méthodes d'analyse et de traitement des données de coût : approches par « micro-costing ¼ et « gross-costing ¼.

This work addresses the analysis of individual cost data in the setting of interventional or observational studies using statistical analysis software once the costs per patient have been estimated. It is in fact necessary to be able to present and describe data in an appropriate manner in each of the studied health strategies and to test whether the difference in costs observed between treatment groups is due to chance or not. Furthermore, cost analysis differs from conventional statistical analysis in that cost data have a certain number of specific properties, including their use by health decision-makers. This work also addresses the difficulties that generally arise in regard to the distribution of cost; it explains why the mathematical average constitutes the only relevant measure for economists; and it outlines which analyses are required for inter-strategy cost comparisons. It also covers the issue of missing or censored data, features that are inherent to information collected regarding costs and to sensitivity analyses.

[ISO 9001 certification of innovation and clinical research departments: Extending the scope of health assessment]. / Certification ISO 9001 des Directions de la recherche clinique et de l'innovation : vers une extension du périmètre aux évaluations économiques.

BACKGROUND: The International organization for standardization (ISO) is the world leader in providing industrial and commercial standards and certifications. Beyond medical devices, four French clinical research and innovation departments have received an ISO 9001 certification (the standard for quality management). Simultaneously, medico-economic studies have become increasingly important in the public decision process. Using the clinical research and innovation department from the Léon-Bérard Cancer Center as an example, the purpose of this article is to show how the scope of the ISO 9001 certification has been extended to cover medico-economic studies. METHOD: All of the processes, procedures, operating modes, documents, and indicators used by the clinical research and innovation department of the Léon-Bérard center were investigated. Literature searches were conducted using Medline keywords. The recommendations from the French national authority for health and other organizations, such as the International society for pharmacoeconomics and outcomes research (ISPOR), were also considered, as well as the recommendations of the General inspectorate of social affairs. RESULTS: In accordance with the national and international recommendations, two procedures were created and four procedures were revised at this center. Five indicators of quality and an evaluation chart were developed. CONCLUSION: By adopting the ISO 9001 certification into its medico-economic studies, the clinical research and innovation department of the Léon-Bérard center has used an innovative approach in the context of the growing importance of economic studies in decision-making.

[Valorisation of brachytherapy and medico-economic considerations]. / Curiethérapie : valorisation et aspects médico-économiques.

Economic data in the literature for brachytherapy are still sparse and heterogeneous, with few controlled prospective studies and a perspective most often limited to those of the provider (health insurances). Moreover, these observation and conclusions are difficult to generalize in France. The prospective health economic studies performed in France in the framework of a national program to sustain innovative and costly therapies (STIC program) launched by the French cancer national institute are therefore of most importance. With the exception of prostate brachytherapy with permanent seeds, the valorisation of the brachytherapy activity by the French national health insurance does not take into account the degree of complexity and the real costs supported by health institutions (i.e. no specific valorisation for 3D image-based treatment planning and dose optimization and for the use of pulsed dose rate brachytherapy).

[Prospective economic evaluation of image-guided radiation therapy for prostate cancer in the framework of the national programme for innovative and costly therapies assessment]. / Évaluation économique prospective de la radiothérapie guidée par l'image des cancers de la prostate dans le cadre du programme national de soutien aux thérapeutiques innovantes et coûteuses.

PURPOSE: The main objective of the economical study was to prospectively and randomly assess the additional costs of daily versus weekly patient positioning quality control in image-guided radiotherapy (IGRT), taking into account the modalities of the 3D-imaging: tomography (CBCT) or gold seeds implants. A secondary objective was to prospectively assess the additional costs of 3D versus 2D imaging with portal imaging for patient positioning controls. PATIENTS AND METHODS: Economics data are issued from a multicenter randomized medico-economics trial comparing the two frequencies of patient positioning control during prostate IGRT. A prospective cohort with patient positioning control with PI (control group) was constituted for the cost comparison between 3D (IGRT) versus 2D imaging. The economical evaluation was focused to the radiotherapy direct costs, adopting the hospital's point of view and using a microcosting method applied to the parameters that may lead to cost differences between evaluated strategies. RESULTS: The economical analysis included a total of 241 patients enrolled between 2007 and 2011 in seven centres, 183 in the randomized study (128 with CBCT and 55 with fiducial markers) and 58 in the control group. Compared to weekly controls, the average additional cost per patient of daily controls was €847 (CBCT) and €179 (markers). Compared to PI, the average additional cost per patient was €1392 (CBCT) and €997 (fiducial markers) for daily controls; €545 (CBCT) and €818 (markers) in case of weekly controls. CONCLUSION: A daily frequency for image control in IGRT and 3D images patient positioning control (IGRT) for prostate cancer lead to significant additional cost compared to weekly control and 2D imaging (PI). Long-term clinical assessment will permit to assess the medico-economical ratio of these innovative radiotherapy modalities.

A randomised phase II study of the efficacy, safety and cost-effectiveness of pegfilgrastim and filgrastim after autologous stem cell transplant for lymphoma and myeloma (PALM study).

AIM: To evaluate in a multicentre randomised study the effect on duration of febrile neutropenia (FN), the safety and cost-effectiveness of a single subcutaneous pegfilgrastim injection compared with daily injections of filgrastim after peripheral blood stem cell transplantation in patients receiving high dose chemotherapy for myeloma and lymphoma. METHODS: Patients were randomly assigned to a single dose of pegfilgrastim at day 5 (D5) or daily filgrastim from D5 to the recovery of absolute neutrophil count (ANC) to 0.5 G/L. Duration of FN, of neutrophil and platelet recovery, transfusion and antibiotic requirements were the main end-points of the study. Costs were calculated from D0 until transplant unit discharge. The incremental cost-effectiveness ratio was expressed as the cost per day of FN prevented. Probabilistic sensitivity analysis was performed by non-parametric bootstrap methods. RESULTS: Between October 2008 and September 2009, 10 centres enrolled 151 patients: 80 patients with lymphoma and 71 patients with myeloma. The mean duration of FN was 3.07 days (standard deviation (SD) 1.96) in the pegfilgrastin arm and 3.29 (SD 2.54) in the filgrastim one. Mean total costs were 23,256 and 25,448 euros for pegfilgrastim and filgrastim patients, respectively. There was a 62% probability that pegfilgrastim strictly dominates filgrastim. CONCLUDING STATEMENT: Pegfilgrastim after PBSC transplantation in myeloma and lymphoma is safe, effective when compared with filgrastim and could represent a cost-effective alternative in this setting.

[Contribution of economic evaluation and budget impact analysis to public decision in health: the example of breast cancer]. / Apports de l'évaluation économique et de l'analyse d'impact budgétaire pour la décision publique en santé : l'exemple du cancer du sein.

The aim of this paper is to draw the reader's attention to the problem of dissemination of costly innovations, particularly in the field of oncology, in a context of scarce resources.Comparison of five economic aggregates related to health and the gross domestic product captures the weight of this sector in the national economy but also its cost to the community. A focus on oncology shows that during the year 2004, the cost of cancer in France, all sites being taken into account, amounted to 10.9 billion euros and the societal cost to 32 billion euros (2% of gross domestic product). The cost of breast cancer (36% of all female cancers) reached 1.5 billion euros for treatment and 3.5 billion euros for societal expenses (0.2% of gross domestic product). Due to the significant, rapid expansion of these costs (+19.2% in 2006 and 18.5% in 2007 for diagnosis-related group outliers) but also to the scarcity of resources, the development of costly innovations remains problematic. This article, based on concrete examples of breast cancer treatment, provides information on the contribution of health technology assessment (particularly cost-utility and budget impact analyses) to public decision. Economic evaluation, in particular, cost-utility assessment, allows comparison of costs and consequences (generic result usually expressed in quality-adjusted life years) in order to prioritize diagnostic and/or therapeutic strategies and to make choices based on social acceptability. Budget impact analysis, without consideration of efficacy, makes it possible to balance the financing needs arising from the adoption of a costly innovation with the paying capabilities of a given institution.

[Necessary harmonization of health cost assessment. Autologous peripheral blood progenitor cell transplantation in France]. / Vers une nécessaire harmonisation des évaluations de coûts en santé

BACKGROUND: The purpose of this study was to determine to what extent methods used to assess health cost affect the total cost of a therapeutic procedure. METHOD: We assessed total cost of 160 consecutive therapeutic intensification procedures using autologous blood progenitor cell transplantation, 95 for lymphoma and 65 for breast tumor. RESULTS: The average total cost of the therapeutic intensification for patients with lymphoma was 227156 francs (34630 euros), including 60720 francs (9257 euros) for mobilization, 14947 francs (22402 euros) for the treatment period and 19489 francs (2971 euros) for secondary hospitalization. The average total cost for patients with a breast tumor was 199626 francs (30433 euros), including 39269 francs (5987 euros) for mobilization, 14912 francs (22737 euros) for the treatment period, and 11215 francs (1709 euros) for secondary hospitalization. CONCLUSION: We compared our findings with those from six earlier French studies. Differences in the methodologies used focuses attention on the need for incentives for better harmonization of health cost assessment.