OBJECTIVES: Since 2006, the National Institute of Health and Care Excellence (NICE) have issued guidance on whether new health technologies should be adopted by the National Health Service (NHS) in England and Wales. The cost-effectiveness of a new technology expressed as the incremental cost per Quality Adjusted Life Year gained is a key appraisal criterion. However, recent affordability challenges in reimbursing some new innovations resulted in NICE introducing an additional annual budget impact threshold of £20 million in April 2017. If a new therapy was anticipated to exceed this threshold during any of its first 3 years on the market, it would need to enter a second process of price negotiation before it can be made available on the NHS. This research aims to evaluate the proportion of technologies likely to be impacted by this new process.

METHODS: NICE single technology appraisal Resource Impact reports were screened (15/04/2012-31/05/2017) to extract the number of patients and annual budget impact. For technologies with a patient access scheme, the budget impact data are considered commercial in confidence. In such cases, the cost per patient was extracted from the corresponding Scottish Medicines Consortium report.

RESULTS: Of 133 appraisals screened, annual budget impact data was calculated for 51 technologies. The mean and median annual budget impact was £33,422,815 and £6,599,808 in year 1, £47,623,183 and £10,659,825 in year 2, and £70,730,456 and £14,886,400 in year 3, respectively. The anticipated budget impact exceeded the annual £20 million threshold within the first 3 years in 43% (22/51) of appraisals.

CONCLUSIONS: The new budget impact threshold introduced by NICE is likely to impact a substantial proportion of appraisals. The precise consequences of this second round of price negotiations are not yet clear but this additional reimbursement hurdle will likely negatively impact market access for innovative new therapies.