Introducing nurse practitioners in healthcare requires organisational redesign and the reframing of professional boundaries. Especially the facilitators and barriers in the analytical themes of 'professional boundaries' and 'organisational environment' should be considered when reallocating tasks. If not, these factors might hamper the cost-effectiveness of task reallocation in practice.

Objectives: Research has shown that effectiveness, cost-effectiveness, and severity of illness each play a role in drug reimbursement decisions. However, the role of budget impact in such decisions is less obvious. Policy makers almost always demand a budget impact estimate yet seem reluctant to formally include budget impact as a rationing criterion. Health economists even reject budget impact as a legitimate criterion. For these reasons, it is important to examine its use in rationing decisions, and rationales underlying its use. Methods: We trace several rationales supporting the use of budget impact through a literature review, supplemented by semistructured interviews with eleven key stakeholders involved in drug reimbursement decisions in the Netherlands. Results: Budget impact arguments are used in certain instances, although policy makers appear uncomfortable with its use because well described rationales still are lacking. In addition, we identify the following rationales to support budget impact as a rationing criterion: opportunity costs, loss aversion, uncertainty and equal opportunity. Conclusions: Budget impact plays a role in drug reimbursement decisions and has rationales to support its use. However, policy makers do not easily admit that they consider budget impact and are even reluctant to explicitly use budget impact as a formal criterion. A debate would strengthen the theoretical foundation of budget impact as a legitimate criterion in the context of drug reimbursement decisions. Such discussion of budget impact's role will also enhance policy-makers' accountability.

There are three known criteria that underlie drug reimbursement decisions: therapeutic value, cost-effectiveness, and burden of disease. However, evidence from recent reimbursement decisions in several jurisdictions points to residual, unexplained variables, among which is budget impact. Budget impact refers to the total costs that drug reimbursement and use entail with respect to one part of the health care system, pharmaceutical care, or to the entire health care system, taking into account the possible reallocation of resources across budgets or sectors of the health care system. The economic and equity rationale for carrying out budget impact analyses is opportunity cost, or benefits forgone, measured in terms of utility or equitable distribution, by using resources in one way rather than another. In other words, by choosing to draw down the budget in one way, decision makers forgo other opportunities to use the same resources. Under a set of unrealistic assumptions, cost-effectiveness analysis accounts for opportunity cost while conveying to the decision maker the price of maximizing health gains, subject to a budget or resource constraint. However, the underlying assumptions are implausible, particularly in the context of pharmaceutical care. Moreover, budget impact analysis is more useful to the decision maker than cost-effectiveness analysis if the objective is not to maximize health gains subject to a budget or resource constraint, but to reduce variance in health gains. With respect to equitable distribution, budget impact analyses lay bare the individuals or groups who lose out - those who bear the opportunity cost of spending resources in accordance with one decision rule rather than another.

There are three known criteria that underlie drug reimbursement decisions: therapeutic value, cost effectiveness and burden of disease. However, evidence from recent reimbursement decisions in several jurisdictions points to residual unexplained variables, one of which may be budget impact. An economic rationale for carrying out budget impact analyses is opportunity cost, measured by the economic benefits foregone by using resources in one way rather than another. Under certain assumptions, cost-effectiveness analysis accounts for opportunity cost while conveying to the decision maker the price of maximising health gains, subject to a budget constraint. However, the underlying assumptions are implausible, particularly in the context of pharmaceutical care. Although drugs that are cost effective may lead to unambiguous health gains among patient groups for whom the drugs are indicated, the opportunity costs could conceivably lead to a reduction in aggregate health gains, or failure to meet different kinds of equity considerations. The pertinent policy question is where to find the resources to fund new innovations, such as cost-effective pharmaceuticals, or drugs targeting severe diseases. It may be a matter of redeployment of resources across healthcare sectors, cancelling the funding of (older) pharmaceuticals that are less cost effective, or delisting drugs that are cost effective but target less burdensome conditions.

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