Belgian guidelines for budget impact analyses.

OBJECTIVES: To develop methodological guidelines for budget impact analysis submitted to the Belgian health authorities as part of a reimbursement request. METHODS: A review of the literature was performed and provided the basis for preliminary budget impact guidelines. These guidelines were improved after discussion with health economists from the Belgian Health Care Knowledge Centre (KCE) and different Belgian stakeholders from both government and industry. Preliminary guidelines were also discussed in a workshop with health economists from The German Institute for Quality and Efficiency in Healthcare. Finally, the guidelines were also externally validated by three external experts. RESULTS: The guidelines give explicit guidance for the following components of a budget impact analysis: perspective of the evaluation, target population, comparator, costs, time horizon, modeling, handling uncertainty and discount rate. Special attention is given to handling varying target population sizes over time, applying a time horizon up to the steady state instead of short-term predictions, and similarities and differences between budget impact analysis and economic evaluations. CONCLUSION: The guidelines provide a framework for both researchers and assessors to set up budget impact analyses that are transparent, relevant, of high quality and apply a consistent methodology. This might improve the extent to which such evaluations can reliably and consistently be used in the reimbursement decision making process.

[Introduction of innovative high-risk medical devices in Europe: are clinical efficacy and safety guaranteed?]. / Mise sur le marché européen des dispositifs médicaux innovants à haut risque: l'efficacité clinique et la sécurité sont-elles garanties?

BACKGROUND: Innovative high-risk medical devices, such as new types of heart valves or hip prostheses, become available on the European market more rapidly than in USA. This is due to the European legislation allowing early marketing of innovative high-risk medical devices before high-quality clinical evidence is obtained from randomized controlled trials. METHODS: We studied the premarket clinical evaluation of innovative high-risk medical devices in Europe compared with the USA. We also discussed patient safety and the transparency of information. The literature and regulatory documents were checked. Representatives from industry, competent authorities, notified bodies, ethics committees, and health technology assessment agencies were consulted. RESULTS: In contrast to the US, there is no requirement in Europe to demonstrate the clinical efficacy of high-risk devices in the premarket phase. For the patient, this implies earlier access to innovative technology, but at the risk of potential safety issues. At this moment, European requirements for clinical studies are lower for medical devices than for drugs, and data from premarket clinical trials are scarce or remain unpublished. The European Medical Device Directives are currently being reworked. CONCLUSIONS: For innovative high-risk devices, and while awaiting a reworked Medical Device Directive, patient risk should be minimized by limiting the market introduction of novel high-risk devices with minimal clinical data to physicians with the necessary training and expertise. The new European legislation should require the premarket demonstration of clinical efficacy and safety, using a randomized controlled trial if possible, and a transparent clinical review, preferably centralized.

An economic evaluation of Herceptin in adjuvant setting: the Breast Cancer International Research Group 006 trial.

BACKGROUND: Herceptin (trastuzumab) is a humanized monoclonal antibody that is being tested in the adjuvant setting. Cost implications of using trastuzumab, as administered in the Breast Cancer International Research Group 006 trial, are being calculated. This provides information on the treatment's value for money. METHODS: Standard breast cancer treatment models were set up for different subpopulations according to stage (I, II, III) and menopausal condition (<50 and >50 years). Costs were calculated from the hospital's point of view, using the micro-costing method. Life expectancy data were based on literature. Our comparator was the existing practice. In addition to a sensitivity analysis, a threshold analysis on the prices of trastuzumab and docetaxel was performed to target an acceptable incremental cost-effectiveness ratio. RESULTS: Treatment costs were euro 45,034 (doxorubicin and cyclophosphamide --> docetaxel and trastuzumab) or euro 47,765 (docetaxel, carboplatin and trastuzumab). This was largely (79% and 75%, respectively) attributed to trastuzumab. According to our threshold analysis, an acceptable incremental cost-effectiveness ratio can be reached if health improvements are large enough and/or price discounts are given. CONCLUSIONS: Trastuzumab is a promising but very expensive antibody. With the current pressure on health-care budgets, cost implications of using trastuzumab in adjuvant setting must be calculated before use of the product becomes wide-spread. This provides essential information for price-setting policies and for policy makers considering reimbursement.

Comparing the cost of delayed and immediate autologous breast reconstruction in Belgium.

This study documents the cost of immediate and delayed DIEP flap breast reconstruction. Immediate reconstruction is more attractive from an economic perspective since it only requires one operation, one anaesthetic procedure and one recovery period in hospital. From the perspective of healthcare budget management, assessing the possible cost savings from immediate reconstruction yields interesting results. Since charges do not reflect the real costs of providing care, we calculated resource costs using the micro-costing method. About 95% of the initial mastectomy costs could be saved when performing an immediate breast reconstruction. This was about 35% of total standard direct and indirect costs due to mastectomy and delayed breast reconstruction. In a growing cost conscious environment of managed care, the economic evaluation should, therefore, encourage the trend towards more immediate reconstructions.