In search for more confidence in health economic modelling : reducing uncertainty associated with modelling studies

Every government is eager to control the increase of expenses by the implementation of central cost containment policies particularly in relation to pharmaceuticals. For the most part. those measures have relied on budgeting or price controls. including negotiated prospective budgets for hospitals. centralized negotiated budgets for ambulatory physicians including drug prescriptions, and limitations on payments for particular medications. Because those traditional central cost containment measures were only partially successfuL due to lack of incentives. the health authorities in Europe started to establish incentives for efficient healthcare delivery. Both traditional and recent containment measures focus especially on the pharmaceutical drugs sector in many countries. as these constitute a health technology that is relatively easy to introduce and implement compared to other forms of care. Financing prescription medicines in ambulatory care has been a central responsibility based on the traditional clinical trial outcomes (efficacy/safety parameters) used for registration. Although there is large variety betvveen the various countries. there are three related trends: decentralization of the healthcare decision-making process. prescription restrictions, and extra data requirements. One can distinguish various extra data requirements which all relate to the use of the drug in real daily practice. while the traditional clinical trial outcomes are only derived from randomised clinical trials. At a central level the demand for cost-effectiveness and budgetary impact data is increasing. The requirement for health economic data resulted to formal reporting requirements in some countries already (e.g. Canada, Australia. The Netherlands. UK. Portugal and Finland). Although the most evident impact of health economic studies is expected to be on central reimbursement audiences. evidence for the use of health economic studies by other audiences is expected to increase (e.g. patients, hospitals. insurers. formulary committees). This background information is described in more detail in Chapter 2. which is the introduction to this thesis.