OBJECTIVES: The National Institute for Health and Care Excellence (NICE) adopt a willingness to pay threshold (WTP) of £20,000-£30,000 to assess the cost-effectiveness of health technologies in England. This study aims to explore the distribution of NICE recommendations for therapies within and above the WTP range and assess key drivers for recommended therapies with incremental cost-effectiveness ratios (ICERs) >£30,000. Guidance on the NICE decision-making process provides considerations for recommending therapies above this acceptability threshold, e.g., end-of-life treatments.

METHODS: NICE technology appraisal guidance for pharmaceutical and biologic products published between January 2017-June 2020 were screened. Multiple technology assessments, terminated appraisals, appraisals for non-pharmaceutical/biologic products and appraisals where cost-effectiveness analyses were not applicable/reported were excluded. Key cost-effectiveness outcomes were extracted from relevant submissions.

RESULTS: A total of 170 appraisals were published in the time frame considered, 157 of which met inclusion criteria. Nineteen appraised products had ICERs <£20,000, all of which were recommended. Of the 59 treatments with ICERs >£30,000, 29 (49.2%) were recommended. The most common reasons for recommendations >£30,000 include: end-of-life treatments (65.5%), underestimation of health utility gains or other benefits (13.8%) and high potential clinical value (6.9%). Of 39 oncology appraisals not recommended for routine use, 29 (74.4%) treatments were instead recommended for the Cancer Drugs Fund (CDF). Thirty-six (22.9%) appraisals did not report a most plausible ICER or stated that the most plausible ICER was too uncertain to estimate; of these, 26 (72.2%) were recommended.

CONCLUSIONS: Most decisions by NICE complied with the accepted WTP thresholds. Products with ICERs >£30,000 can still be recommended by NICE if they meet end-of-life criteria, offer a patient access scheme or negotiate patient population limitations. Redirecting appraisals to the CDF was a common alternative for oncology products that were not recommended for routine use due to the need to accrue additional data.