Responsible pricing in value-based assessment of cancer drugs: real-world data are an inevitable addition to select meaningful new cancer treatments.

Recently, NICE was given the task of governing the Cancer Drug Fund (CDF) in the UK as the latter was criticized for allowing too many insufficiently tested drugs to be covered [1, 2]. The CDF was initiated in 2012, but immediately received criticism from several health economists because of the rather strict coverage criteria that are commonly used by NICE for most other health services in the NHS. This led to questions about the use of different reimbursement criteria (why have a different fund otherwise?) for expensive cancer drugs. Such a separate fund would potentially take away large amounts of the collective health budget. This led to questions about the use of different reimbursement criteria (why have a different fund otherwise?) for expensive cancer drugs compared to other technologies. This is just one example of discussions that are taking place in many countries on the issue of drug coverage policies. This development takes place against a background of increasingly intense discussion on pricing and affordability of (new) cancer drugs, the responsible behavior of pharmaceutical companies that spend public resources for R&D, and the lack of transparency in pricing and R&D expenditure in combination with profit margins of sometimes up to 20%. We argue that Real-World Evidence (RWE) may play a much greater and, on occasion, pivotal role in developing sustainable cancer care, because it allows much better estimates of actual drug use and costs and increases transparency in health outcomes