Budget impact analysis of new drugs in oncology and haematology: Principles and practice.

Cancer is currently among the most prevalent and fatal diseases, so new, costly drugs for its treatment will be available in the coming years. Budget impact analyses (BIAs) are an essential component of the economic evaluation of new oncological and haematological drugs, and are increasingly required by health authorities in many countries as part of the pricing and reimbursement process. This article aims to provide updated guidance on the methodology for performing such analyses. In a BIA, the resource consumption in the reference scenario (before the new drug is introduced) is always compared with the resource consumption in the future scenario (after the new treatment is commercialized). The most important parts of a BIA include calculating the number of the existing patient population, the current mix of treatments and the expected mix after the coming of the new drug, the cost of the treatment mixes and other changes in cancer-related costs. The BIA's data sources should be drawn from the best available published evidence, such as clinical trials, observational studies, local epidemiological information, cost databases and expert opinion. Where possible, the decision maker's population and calculations for other parameter estimations should also be included. A deterministic analysis and a scenario sensitivity analysis should be carried out in every BIA. The BIA report must provide details of resource consumption and associated costs in the reference scenario and the future scenario. The difference between the 2 scenarios will represent the budget impact of introducing a new drug to the market.