OBJECTIVES: Commercial agreements play a crucial role during the assessment process and is subject to intense discussion between applicants and NICE as drugs become more expensive. The use of commercial agreements within the negotiations can significantly influence the reimbursement decision and timing. Introducing commercial arrangements into the application process may also delay the assessment timeline. The objective of this research is to find out how final appraisals on reimbursement have been affected by the incorporation of commercial arrangements during the assessment process.

METHODS: Using Prismaccess database, 211 NICE STA guidances with appraisal consultations between 27^th Oct 2004 to 13^th May 2020 were extracted. To compare the NICE outcome between appraisal consultations and final appraisals, commercial arrangements and recommendations at both stages were identified extracting automatically from appraisal documents published using a natural language processing model.

RESULTS: At NICE, 161/211 (79.6%) were not recommended at the appraisal consultation, and of those not recommended 133/161 (82.6%) were recommended in the final appraisal. Of the 133 where the recommendation changed, 109/133 (81.9%) included commercial arrangements. Since 2004 to 2016, the proportion of assessments including commercial arrangements increased to reach a plateau at 2016 where 96/99 (97%) of all recommended decisions included commercial arrangements. For oncology products, all recommended decisions included commercial arrangements from 2015.

CONCLUSIONS: Results show that initial recommendations at the appraisal consultation can be overturned at NICE. However, this may require greater financial flexibility from the manufacturer. The proportion of final appraisals with commercial arrangements at NICE has dramatically increased since 2004 to 2019. This could be attributed to increase pressure for cost-effectiveness at NICE. Since 2016, commercial arrangements have almost become a requirement to achieve a positive recommendation, particularly for oncology products.