Cancer Drug Funding Decisions in the UK: Innovation And Value in the Biologics Era.

To review evidence-based processes used in UK cancer funding decisions, using biologics in metastatic colorectal cancer (mCRC) as a case study. We conducted an analysis of the peer-reviewed literature reporting overall survival (OS) in mCRC in randomised clinical trials (RCTs) and in real world studies (RWSs). Additionally, we investigated the use of RCTs and RWSs in UK cancer drug funding decisions. Recent RWSs report median OS levels in mCRC that are several months longer than those seen in pre-biologic RCTs (approximately 29.2 months in the post-biologic era versus 17.4 months pre-biologics, an incremental survival benefit of 11.8 months). The most recent data show real world median OS as long as 32 months. However, the scoring system for cancer funding decisions in the UK is currently predominantly focused on pre-launch RCT data, with no data drawn from RWSs referenced in National Institute for Health and Care Excellence (NICE) and Clinical Reference Group (CRG) evaluations. The current focus of the cancer funding scoring system on pre-launch RCTs may miss value gained from ‘innovation-in-use.’ Additionally, treatment holidays and sequencing steps could lead to further cost reductions that might increase value even without impact on OS. Therefore, NICE evaluations and the methodology for CRG scoring may undervalue the reality of real-world experience. The Cancer Drugs Fund (CDF) enables the UK National Health Service to realize the full scope of benefits of innovative drugs, overcoming the deficiencies currently inherent in NICE and CRG processes. Therefore, considerations for delisting of drugs from the CDF should be made in the light of data from RWSs as well as pre-launch data.