The role of economic evaluation in the efficient allocation of healthcare r
esources has been widely debated. Whilst economic evidence is undoubtedly u
seful to purchasers, it does not address the issue of affordability which i
s an increasing concern. Healthcare purchasers are concerned not just with
maximising efficiency but also with the more simplistic goal of remaining w
ithin their annual budgets. These two objectives are not necessarily consis
tent.
This paper examines the issue of affordability, the relationship between af
fordability and efficiency and builds the case for why there is a growing n
eed for budget impact models to complement economic evaluation. Guidance cu
rrently available for such models is also examined and it is concluded that
this guidance is currently insufficient. Some of these insufficiencies are
addressed and some thoughts on what constitutes best practice in budget im
pact modelling are suggested. These suggestions include consideration of tr
ansparency, clarity of perspective, reliability of data sources, the relati
onship between intermediate and final end-points and rates of adoption of n
ew therapies. They also include the impact of intervention by population su
bgroups or indications, reporting of results, probability of re-deploying r
esources, the time horizon, exploring uncertainty and sensitivity analysis,
and decision-maker access to the model. Due to the nature of budget impact
models, the paper does not deliver stringent methodological guidance on mo
delling. The intention was to provide some suggestions of best practice in
addition to some foundations upon which future research can build.