Belgian Methodological Guidelines for Pharmacoeconomic Evaluations: Toward Standardization of Drug Reimbursement Requests


Irina Cleemput, Belgian Health Care Knowledge Centre (KCE), Administratief Centrum Kruidtuin, Door Building (10th Floor), Kruidtuinlaan 55, 1000 Brussels, Belgium. E-mail:


Objective:  To develop methodological guidelines for pharmacoeconomic evaluation (PE) submitted to the Belgian Drug Reimbursement Committee as part of a drug reimbursement request.

Methods:  In 2006, preliminary pharmacoeconomic guidelines were developed by a multidisciplinary research team. Their feasibility was tested and discussed with all stakeholders. The guidelines were adapted and finalized in 2008.

Results:  The literature review should be transparent and reproducible. PE should be performed from the perspective of the health-care payer, including the governmental payer and the patient. The target population should reflect the population identified for routine use. The comparator to be considered in the evaluation is the treatment most likely to be replaced. Cost-effectiveness and cost–utility analyses are accepted as reference case techniques, under specific conditions. A final end point—as opposed to a surrogate end point—should be used in the incremental cost-effectiveness ratio (ICER). For the calculation of quality-adjusted life-years (QALYs), a generic quality-of-life measure should be used. PE should in principle apply a lifetime horizon. Application of shorter time horizons requires appropriate justification. Uncertainty around the ICER should always be assessed. Costs and outcomes should be discounted at 3% and 1.5%, respectively.

Conclusion:  The current guidelines are the result of a constructive collaboration between the Belgian Health Care Knowledge Centre, the National Institute for Health and Disability Insurance and the pharmaceutical industry. A point of special attention is the accessibility of existing Belgian resource use data for PE. As PE should serve Belgian health-care policy, they should preferably be based on the best available data.