The objective of this study was to evaluate the methodological characteristics of cost-effectiveness evaluations carried out in Spain, since 1990, which include LYG as an outcome to measure the incremental cost-effectiveness ratio. A systematic review of published studies was conducted describing their characteristics and methodological quality. We analyse the cost per LYG results in relation with a commonly accepted Spanish cost-effectiveness threshold and the possible relation with the cost per quality adjusted life year (QALY) gained when they both were calculated for the same economic evaluation. A total of 62 economic evaluations fulfilled the selection criteria, 24 of them including the cost per QALY gained result as well. The methodological quality of the studies was good (55%) or very good (26%). A total of 124 cost per LYG results were obtained with a mean ratio of 49,529€ and a median of 11,490€ (standard deviation of 183,080). Since 2003, a commonly accepted Spanish threshold has been referenced by 66% of studies. A significant correlation was found between the cost per LYG and cost per QALY gained results (0.89 Spearman-Rho, 0.91 Pearson). There is an increasing interest for economic health care evaluations in Spain, and the quality of the studies is also improving. Although a commonly accepted threshold exists, further information is needed for decision-making as well as to identify the relationship between the costs per LYG and per QALY gained.

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The use of cost per life year gained as a measurement of cost-effectiveness in Spain: a systematic review of recent publications

Background and Objectives: Economic value is an important consideration during all phases of the drug development process. We previously published an article in PharmacoEconomics in which we described a mechanism-based economic modelling approach that incorporates data obtained during phase II clinical studies on the relationships between dose, exposure and response. We now describe case studies of rituximab for the treatment of follicular non- Hodgkin’s lymphoma based on this methodology. Methods: We utilized a population pharmacokinetic and pharmacodynamic model linking serum rituximab concentration to progression-free survival, to simulate the effectiveness of rituximab in various clinical contexts. These served as inputs to economic models of follicular lymphoma, based on National Institute for Health and Clinical Excellence (NICE) appraisals, to assess the cost effectiveness of rituximab. Our results were compared with trial-based estimates from the NICE appraisals. In a further analysis, we simulated the results of an ongoing trial to generate predictions of cost effectiveness Results: Our analyses suggest an acceptable degree of concordance between simulation- and trial-based estimates of cost effectiveness. For first-line and maintenance therapy, deviations of £2099 and £1355 per QALY, respectively, from trial-based incremental cost-effectiveness ratio estimates of £8290 and £7721 per QALY gained would not affect reimbursement decisions. The probability of rituximab-containing regimens being cost effective at £20000 and £30000 per QALY thresholds was 1 for both first-line and maintenance therapy in both simulated and trial-based analyses. Conclusions: Our analyses demonstrate the feasibility of mechanism-based economic analyses, which may have applications during drug development to the following: (i) directing future research based on the cost of reducing uncertainty; (ii) assessing subgroups, dosing schedules and protocol deviations; and (iii) informing strategic research and development and pricing decisions.

Mechanism-Based Approach to the Economic Evaluation of Pharmaceuticals: Pharmacokinetic/Pharmacodynamic/Pharmacoeconomic Analysis of Rituximab for Follicular Lymphoma.

The monoclonal antibody rituximab has shown clinical effectiveness in combination with chemotherapy for the treatment of non-Hodgkin’s lymphoma (NHL) in several randomized controlled studies. Rituximab maintenance therapy is associated with significant improvement in progression-free and overall survival in patients with NHL. However, treatment with rituximab causes considerable costs for healthcare systems. This article provides an overview of economic evaluations of rituximab and appraises their methodological quality. A systematic literature search of cost-effectiveness studies on rituximab was carried out in nine electronic databases: MEDLINE, EMBASE, Cochrane Database of Systematic Reviews (CDSR), the German Agency of Health Technology Assessment (DAHTA) database, German Institute for Quality Improvement (DIQ)-Literatur, DIQ-Projekte, Database of Abstracts of Reviews of Effects (DARE), Health Technology Assessments (HTA) database and Sozialmedizin (SOMED) [languages: English, German, Dutch, French, Spanish and Italian; publication period: 1998 to 2010]. Based on pre-specified inclusion criteria, cost-effectiveness studies were identified that compared standard chemotherapy with standard chemotherapy plus rituximab in patients with a subtype of NHL. The methodological quality of the studies was assessed using a quality checklist. Fourteen economic evaluations from seven different countries were included in the review. All economic evaluations reported incremental cost-effectiveness ratios (ICERs) for the add-on therapy with rituximab that were below the country-specific thresholds. The studies differed significantly in their characteristics and methodological rigour. Most studies lacked transparency regarding identification and justification of data. In several studies, the rationale for the model structure was not described appropriately. Adding rituximab to standard chemotherapy is considered a cost-effective treatment option for NHL. However, the results of the analyses should be interpreted with caution due to methodological limitations.

Cost Effectiveness of Rituximab for Non-Hodgkin’s Lymphoma

Meningoencefalitis por Crytococcus neoformans en mujer tratada con rituximab

Economic evaluation of pharmacological can- cer treatment is a critical clinical problem currently under consideration worldwide. We have analysed their main characteristics in Spain between 1990 and 2010 following a systematic review of the 29 complete economic analyses published. The pathology most frequently evaluated was non-small cell lung cancer (31 %). Cost-effectiveness analyses (69 %) were the most frequent analyses. A wide range of incremental cost-effectiveness values (295- 160,667 €/QALY) has been reported, and mostly are developed from the perspective of the National Health System (65.5 %). However, none of the studies estimated the indirect costs. The major conclusion is that the absence of regulations concerning the application of the efficiency criterion in decision-making on the subject of price and financing and, most importantly, the fact that these are not included in Spanish hospitals forms make it difficult to analyse the real impact of economic evaluations of cancer treatments on such decisions.

Analysis of economic evaluations of pharmacological cancer treatments in Spain between 1990 and 2010

http://revistafarmaciahospitalaria.sefh.es/gdcr/index.php/fh/article/download/850/850

Grupo de Farmacoeconomía del Linfoma Folicular

Papers

Análisis farmacoeconómico de rituximab en el tratamiento de mantenimiento de los pacientes con linfoma folicular